59 results on '"Vlachojannis, GJ"'
Search Results
2. Data on sex differences in one-year outcomes of out-of-hospital cardiac arrest patients without ST-segment elevation
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Spoormans, EM, Lemkes, JS, Janssens, GN, van der Hoeven, NW, Jewbali, Lucia, Dubois, Eric, van de Ven, PM, Meuwissen, M, Rijpstra, TA, Bosker, HA, Blans, MJ, Bleeker, GB, Baak, R, Vlachojannis, GJ, Eikemans, BJW, van der Harst, P, van der Horst, ICC, Voskuil, M, van der Heijden, JJ, Beishuizen, A, Stoel, M, Camaro, C, van der Hoeven, H, Henriques, JP, Vlaar, APJ, Vink, MA, van den Bogaard, B, Heestermans, T, de Ruijter, W, Delnoij, TSR, Crijns, H, Jessurun, G A J, Oemrawsingh, PV, Gosselink, MTM, Plomp, K, Magro, M, Elbers, PW, Appelman, Y, Royen, N, Spoormans, EM, Lemkes, JS, Janssens, GN, van der Hoeven, NW, Jewbali, Lucia, Dubois, Eric, van de Ven, PM, Meuwissen, M, Rijpstra, TA, Bosker, HA, Blans, MJ, Bleeker, GB, Baak, R, Vlachojannis, GJ, Eikemans, BJW, van der Harst, P, van der Horst, ICC, Voskuil, M, van der Heijden, JJ, Beishuizen, A, Stoel, M, Camaro, C, van der Hoeven, H, Henriques, JP, Vlaar, APJ, Vink, MA, van den Bogaard, B, Heestermans, T, de Ruijter, W, Delnoij, TSR, Crijns, H, Jessurun, G A J, Oemrawsingh, PV, Gosselink, MTM, Plomp, K, Magro, M, Elbers, PW, Appelman, Y, and Royen, N
- Published
- 2020
3. Very Late Scaffold Thrombosis in Absorb BVS Association With DAPT Termination?
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Felix, Cordula, Vlachojannis, GJ, IJsselmuiden, AJ, Onuma, Yoshinobu, van Geuns, Robert Jan, and Cardiology
- Published
- 2017
4. Enhanced expression of group IIA secreted phospholipase A2 by elevated glucose levels in cytokine-stimulated rat mesangial cells and in kidneys of diabetic rats
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K. Scholz-Pedretti, Fierlbeck W, Kaszkin M, Helmut Geiger, Vlachojannis Gj, and Pfeilschifter J
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Male ,medicine.medical_specialty ,Renal glomerulus ,medicine.medical_treatment ,Enzyme-Linked Immunosorbent Assay ,Kidney ,Sensitivity and Specificity ,Phospholipases A ,Streptozocin ,Proinflammatory cytokine ,Diabetes Mellitus, Experimental ,Diabetic nephropathy ,Rats, Sprague-Dawley ,Internal medicine ,Diabetes mellitus ,medicine ,Animals ,Diabetic Nephropathies ,RNA, Messenger ,Promoter Regions, Genetic ,Cells, Cultured ,Probability ,Analysis of Variance ,Mesangial cell ,business.industry ,General Medicine ,medicine.disease ,Streptozotocin ,Blotting, Northern ,Glomerular Mesangium ,Rats ,Disease Models, Animal ,Phospholipases A2 ,medicine.anatomical_structure ,Cytokine ,Endocrinology ,Gene Expression Regulation ,Nephrology ,Enzyme Induction ,Hyperglycemia ,Cytokines ,Female ,business ,medicine.drug - Abstract
Background: Group IIA secreted phospholipase A 2 (SPLA 2 -IIA) has been implicated in various inflammatory processes including the kidney. Previously it has been shown that potent proinflammatory cytokines such as interleukin 1β (IL-1β) increase sPLA 2 -IIA expression and secretion in rat mesangial cells. Aim: The present study examines the effects of glucose on sPLA 2 -IIA regulation in interleukin-1β (IL-1β) treated mesangial cell cultures and in diabetic kidneys of Sprague-Dawley rats. Materials and Methods: Rat mesangial cells were grown either in low glucose (5,55 mM D-Glucose) or high glucose (25 mM) conditions followed by assessment of sPLA 2 -IIA transcription, expression and secretion after 24 h. The model of streptozotocin induced diabetes mellitus in Sprague-Dawley rats was used for the in vivo experiments. Diabetic kidneys where examined for sPLA 2 -IIA-mRNA and -protein expression as well as IL-1β-levels at 2, 4 and 6 weeks after induction of diabetes mellitus. Results: Increased concentration of glucose had a weak, but significant stimulatory effect on sPLA 2 -IIA expression, which was markedly up-regulated (2 - 3-fold) in IL-1β treated mesangial cells compared to the levels obtained in low glucose medium. Concerning the underlying mechanism, we found that high concentration of glucose increased the activity of the rat sPLA 2 -IIA-promoter, whereas mRNA stability was not affected. Furthermore, the in vivo experiments revealed a marked up-regulation of sPLA 2 -IIA mRNA and protein in the diabetic rat kidneys 2 - 4 weeks after induction. Since the strong up-regulation of sPLA 2 -IIA in vitro under high glucose conditions occurred mainly in presence of cytokine, we measured the levels of IL-1β in diabetic kidneys by ELISA. We detected rat IL-1β only in diabetic, but not in control rat kidneys. Conclusions: The changes of sPLA 2 -IIA expression under increased glucose concentrations as well as in diabetic rat kidneys suggest a function of this enzyme as an acute phase protein providing lipid autacoids that may contribute to early changes in the course of diabetic nephropathy.
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- 2005
5. Single-centre experience with the Impella CP, in patients with cardiogenic shock.
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Rodriguez, GM Jimenez, Kraaijeveld, AO, Voskuil, M, Vlachojannis, GJ, Rittersma, ZH, and Stella, PR
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- 2022
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6. Real-World Implementation of a Genotype-Guided P2Y 12 Inhibitor De-Escalation Strategy in Acute Coronary Syndrome Patients.
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Azzahhafi J, van den Broek WWA, Chan Pin Yin DRPP, van der Sangen NMR, Sivanesan S, Bofarid S, Peper J, Claassens DMF, Janssen PWA, Harmsze AM, Walhout RJ, Tjon Joe Gin M, Nicastia DM, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, van Schaik RHN, Henriques JPS, Kikkert WJ, and Ten Berg JM
- Abstract
Background: CYP2C19 genotype-guided de-escalation from ticagrelor or prasugrel to clopidogrel may optimize the balance between ischemic and bleeding risk in patients with acute coronary syndrome (ACS)., Objectives: This study sought to compare bleeding and ischemic event rates in genotyped patients vs standard care., Methods: Since 2015, ACS patients in the multicenter FORCE-ACS (Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome) registry received standard dual antiplatelet therapy (DAPT). Since 2021, genotype-guided P2Y
12 inhibitor de-escalation was recommended at a single center, switching noncarriers of the loss-of-function allele CYP2C19∗3 or CYP2C19∗2 from ticagrelor or prasugrel to clopidogrel, whereas loss-of-function carriers remained on ticagrelor or prasugrel. The primary ischemic endpoint, a composite of cardiovascular mortality, myocardial infarction, or stroke, and the primary bleeding endpoint, Bleeding Academic Research Consortium 2, 3, or 5 bleeding, were compared between a genotyped cohort and a cohort treated with standard DAPT after 1 year., Results: Among 5,321 enrolled ACS patients, 406 underwent genotyping compared with 4,915 nongenotyped ACS patients on standard DAPT. In the genotyped cohort, 65.3% (n = 265) were noncarriers, 88.7% (n = 235) of whom were switched to clopidogrel. The primary ischemic endpoint occurred in 5.2% (n = 21) of patients in the genotyped cohort compared to 6.9% (n = 337) in the standard care cohort (adjusted HR: 0.82; 95% CI: 0.53-1.28). The primary bleeding rate was significantly lower in the genotyped cohort compared to the standard care cohort (4.7% vs 9.8%; adjusted HR: 0.47; 95% CI: 0.30-0.76)., Conclusions: The implementation of a CYP2C19 genotype-guided P2Y12 inhibitor de-escalation strategy in a real-world ACS population resulted in lower bleeding rates without an increase in ischemic events compared to a standard DAPT regimen., Competing Interests: Funding Support and Author Disclosures The FORCE-ACS registry is supported by grants from ZonMw, the St. Antonius Research Fund, and AstraZeneca. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents. Dr Vlachojannis has received institutional research grants from MicroPort and Ferrer; and has received personal fees from Terumo and AstraZeneca. Dr Appelman has received an institutional research grant from the Dutch Heart Foundation. Dr Henriques has received institutional research grants from Abbott Vascular, AstraZeneca, B. Braun, Getinge, Ferrer, Infraredx, and ZonMw. Dr Kikkert has received an institutional research grant from AstraZeneca. Dr ten Berg has received institutional research grants from AstraZeneca, Daiichi Sankyo, and ZonMw; and has received personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, CeleCor Therapeutics, Daiichi Sankyo, Eli Lilly, Ferrer, and Idorsia. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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7. Prehospital crushed versus integral prasugrel loading dose in STEMI patients with a large myocardial area.
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Wilschut JM, Vogel RF, Elscot JJ, Delewi R, Lemmert ME, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Smits PC, Vlachojannis GJ, Van Mieghem NM, and Diletti R
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- Humans, Platelet Aggregation Inhibitors therapeutic use, Prasugrel Hydrochloride therapeutic use, Treatment Outcome, Emergency Medical Services, Myocardial Infarction drug therapy, Percutaneous Coronary Intervention adverse effects, ST Elevation Myocardial Infarction drug therapy
- Abstract
Background: The effect of administering a crushed prasugrel loading dose is uncertain in patients presenting with a large myocardial infarction and ST-segment elevation myocardial infarction (STEMI)., Aims: The aim of this study was to investigate if patients with a large myocardial infarction may benefit from prehospital administration of a crushed prasugrel loading dose., Methods: Patients from the CompareCrush trial with an available ambulance electrocardiography (ECG) were included in the study. An independent core laboratory confirmed a prehospital large myocardial area. We compared pre- and postprocedural angiographic markers, including Thrombolysis in Myocardial Infarction (TIMI) 3 flow in the infarct-related artery, high thrombus burden, and myocardial blush grade 3, in STEMI patients with and without a prehospital large myocardial area., Results: Ambulance ECG was available for 532 patients, of whom 331 patients were identified with a prehospital large myocardial area at risk. Crushed prasugrel significantly improved postprocedural TIMI 3 flow rates in STEMI patients with a prehospital large myocardial area at risk (92% vs 79%, odds ratio [OR] 3.00, 95% confidence interval [CI]: 1.50-6.00) but not in STEMI patients without a prehospital large myocardial area at risk (91% vs 95%, OR 0.47, 95% CI: 0.14-1.57; p
interaction =0.009)., Conclusions: Administration of crushed prasugrel may improve postprocedural TIMI 3 flow in STEMI patients with signs of a large myocardial area at risk on the ambulance ECG. The practice of crushing tablets of prasugrel loading dose might, therefore, represent a safe, fast and cost-effective strategy to improve myocardial reperfusion in this high-risk STEMI subgroup undergoing primary percutaneous coronary intervention.- Published
- 2024
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8. Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial.
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Lansky AJ, Xu B, Baumbach A, Kelbæk H, van Royen N, Zheng M, Knaapen P, Slagboom T, Johnson TW, Vlachojannis GJ, Arkenbout KE, Holmvang L, Janssens L, Brugaletta S, Naber CK, Schmitz T, Anderson R, Rittger H, Berti S, Barbato E, Toth GG, Maillard L, Valina CM, Buszman PE, Thiele H, Schächinger V, and Wijns W
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- Humans, Sirolimus, Prospective Studies, Treatment Outcome, Absorbable Implants, Everolimus, Polymers, Drug-Eluting Stents adverse effects, Percutaneous Coronary Intervention adverse effects, Myocardial Infarction etiology
- Abstract
Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months., Aims: We aimed to report the final study outcomes at 5 years., Methods: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components)., Results: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups., Conclusions: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.
- Published
- 2023
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9. Direct Stenting versus Conventional Stenting in Patients with ST-Segment Elevation Myocardial Infarction-A COMPARE CRUSH Sub-Study.
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Vogel RF, Delewi R, Wilschut JM, Lemmert ME, Diletti R, van Vliet R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC, and Vlachojannis GJ
- Abstract
Background: Direct stenting (DS) compared with conventional stenting (CS) after balloon predilatation may reduce distal embolization during percutaneous coronary intervention (PCI), thereby improving tissue reperfusion. In contrast, DS may increase the risk of stent underexpansion and target lesion failure., Methods: In this sub-study of the randomized COMPARE CRUSH trial (NCT03296540), we reviewed the efficacy of DS versus CS in a cohort of contemporary, pretreated ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. We compared DS versus CS, assessing (1) stent diameter in the culprit lesion, (2) thrombolysis in myocardial infarction (TIMI) flow in the infarct-related artery post-PCI and complete ST-segment resolution (STR) one-hour post-PCI, and (3) target lesion failure at one year. For proportional variables, propensity score weighting was applied to account for potential treatment selection bias., Results: This prespecified sub-study included 446 patients, of whom 189 (42%) were treated with DS. Stent diameters were comparable between groups (3.2 ± 0.5 vs. 3.2 ± 0.5 mm, p = 0.17). Post-PCI TIMI 3 flow and complete STR post-PCI rates were similar between groups (DS 93% vs. CS 90%, adjusted OR 1.16 [95% CI, 0.56-2.39], p = 0.69, and DS 72% vs. CS 58%, adjusted OR 1.29 [95% CI 0.77-2.16], p = 0.34, respectively). Moreover, target lesion failure rates at one year were comparable (DS 2% vs. 1%, adjusted OR 2.93 [95% CI 0.52-16.49], p = 0.22)., Conclusion: In this contemporary pretreated STEMI cohort, we found no difference in early myocardial reperfusion outcomes between DS and CS. Moreover, DS seemed comparable to CS in terms of stent diameter and one-year vessel patency.
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- 2023
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10. The Prognostic Value of Troponin-T in Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: A COACT Substudy.
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Spoormans EM, Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van der Pas S, and van Royen N
- Abstract
Background: In out-of-hospital cardiac arrest (OHCA) without ST-elevation, predictive markers that can identify those with a high risk of acute coronary syndrome are lacking., Methods: In this post hoc analysis of the Coronary Angiography after Cardiac Arrest (COACT) trial, the baseline, median, peak, and time-concentration curves of troponin-T (cTnT) (T-AUC) in OHCA patients without ST-elevation were studied. cTnT values were obtained at predefined time points at 0, 3, 6, 12, 24, 36, 28, and 72 hours after admission. All patients who died within the measurement period were not included. The primary outcome was the association between cTnT and 90-day survival. Secondary outcomes included the association of cTnT and acute thrombotic occlusions, acute unstable lesions, and left ventricular function., Results: In total, 352 patients were included in the analysis. The mean age was 64 ± 13 years (80.4% men). All cTnT measures were independent prognostic factors for mortality after adjustment for potential confounders age, sex, history of coronary artery disease, witnessed arrest, time to BLS, and time to return of spontaneous circulation (eg, for T-AUC: hazard ratio, 1.44; 95% CI, 1.06-1.94; P = .02; P value for all variables ≤.02). Median cTnT (odds ratio [OR], 1.58; 95% CI, 1.18-2.12; P = .002) and T-AUC (OR, 2.03; 95% CI, 1.25-3.29; P = .004) were independent predictors for acute unstable lesions. Median cTnT (OR, 1.62; 95% CI, 1.17-2.23; P = .003) and T-AUC (OR, 2.16; 95% CI, 1.27-3.68; P = .004) were independent predictors for acute thrombotic occlusions. CTnT values were not associated with the left ventricular function (eg, for T-AUC: OR, 2.01; 95% CI, 0.65-6.19; P = .22; P value for all variables ≥.14)., Conclusion: In OHCA patients without ST-segment elevation, cTnT release during the first 72 hours after return of spontaneous circulation was associated with clinical outcomes., (© 2023 The Author(s).)
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- 2023
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11. Impact of recurrent ischaemic and bleeding events on quality of life in patients with acute coronary syndrome: Insights from the FORCE-ACS registry.
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van der Sangen NMR, Azzahhafi J, Chan Pin Yin DRPP, Rayhi S, van Weede VM, Walhout RJ, Tjon Joe Gin M, Pisters R, Nicastia DM, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Ten Berg J, and Kikkert W
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- Humans, Female, Aged, Male, Quality of Life, Prospective Studies, Hemorrhage epidemiology, Hemorrhage etiology, Registries, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome therapy, Acute Coronary Syndrome epidemiology
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Objective: Patients with acute coronary syndrome (ACS) remain at high risk for recurrent ischaemic and bleeding events during follow-up. Our study aimed to quantify and compare the impact of these adverse events on quality of life (QoL)., Methods: Data from patients with ACS prospectively enrolled in the FORCE-ACS registry between January 2015 and December 2019 were used for this study. The primary ischaemic and bleeding events of interest were hospital readmission for ACS and Bleeding Academic Research Consortium type 2 or 3 bleeding during 12 months follow-up. QoL was measured using the EQ-5D Visual Analogue Scale (VAS) score and the 12-item Short Form Survey version 2 derived Physical Component Summary (PCS) and Mental Health Component Summary (MCS) scores at 12 months follow-up., Results: In total, 3339 patients (mean age 66.8 years, 27.9% women) were included. During follow-up, ischaemic events occurred in 202 patients (6.0%) and bleeding events in 565 patients (16.9%). After adjustment for demographic and clinical characteristics, ischaemic events remained independently associated with lower QoL regardless of metric used. Bleeding was also independently associated with lower EQ-5D VAS and PCS scores, but not with a lower MCS score. The QoL decrement associated with ischaemic events was numerically larger than the decrement associated with bleeding., Conclusions: Ischaemic and bleeding events remain prevalent and are independently associated with lower QoL at 12 months follow-up in patients previously admitted for ACS. The incidence and impact of these adverse events should be considered when balancing individual ischaemic and bleeding risks., Competing Interests: Competing interests: WK has received an institutional research grant from AstraZeneca. GJV has received institutional research grants from MicroPort and Ferrer and personal fees from Terumo and AstraZeneca. YA has received an institutional research from the Dutch Heart Foundation. JPSH has received institutional research grants from Abbott Vascular, AstraZeneca, B. Braun, Getinge, Ferrer, Infraredx and ZonMw. JtB has received institutional research grants from AstraZeneca, Daiichi Sankyo and ZonMw and personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, CeleCor Therapeutics, Daiichi Sankyo, Eli Lilly, Ferrer and Idorsia. All other authors have no relationships with industry to disclose., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
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12. Evaluating the Arteriotomy Size of a New Sutureless Coronary Anastomosis Using a Finite Volume Approach.
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Crielaard H, Hoogewerf M, van Putte BP, van de Vosse FN, Vlachojannis GJ, Stecher D, Stijnen M, and Doevendans PA
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- Humans, Coronary Angiography, Coronary Artery Bypass adverse effects, Hemodynamics, Anastomosis, Surgical, Coronary Vessels diagnostic imaging, Coronary Vessels surgery, Fractional Flow Reserve, Myocardial, Coronary Stenosis
- Abstract
Objectives: The ELANA® Heart Bypass creates a standardized sutureless anastomosis. Hereby, we investigate the influence of arteriotomy and graft size on coronary hemodynamics., Methods: A computational fluid dynamics (CFD) model was developed. Arteriotomy size (standard 1.43 mm
2 ; varied 0.94 - 3.6 mm2 ) and graft diameter (standard 2.5 mm; varied 1.5 - 5.0 mm) were independent parameters. Outcome parameters were coronary pressure and flow, and fractional flow reserve (FFR)., Results: The current size ELANA (arteriotomy 1.43 mm2 ) presented an estimated FFR 0.65 (39 mL/min). Enlarging arteriotomy increased FFR, coronary pressure, and flow. All reached a maximum once the arteriotomy (2.80 mm2 ) surpassed the coronary cross-sectional area (2.69 mm2 , i.e. 1.85 mm diameter), presenting an estimated FFR 0.75 (46 mL/min). Increasing graft diameter was positively related to FFR, coronary pressure, and flow., Conclusion: The ratio between the required minimal coronary diameter for application and the ELANA arteriotomy size effectuates a pressure drop that could be clinically relevant. Additional research and eventual lengthening of the anastomosis is advised., (© 2023. The Author(s).)- Published
- 2023
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13. Sex-stratified differences in early antithrombotic treatment response in patients presenting with ST-segment elevation myocardial infarction.
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Delewi R, Vogel RF, Wilschut JM, Lemmert ME, Diletti R, van Vliet R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Doevendans PA, Van Mieghem NM, Smits PC, and Vlachojannis GJ
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- Female, Humans, Male, Fibrinolytic Agents therapeutic use, Hemorrhage chemically induced, Hemorrhage epidemiology, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride therapeutic use, Treatment Outcome, Percutaneous Coronary Intervention adverse effects, ST Elevation Myocardial Infarction therapy
- Abstract
Background: The mechanisms underlying the increased risk of bleeding that female patients with ST-segment Elevation Myocardial Infarction (STEMI) exhibit, remains unclear. The present report assessed sex-related differences in response to pre-hospital dual antiplatelet therapy (DAPT) initiation in patients with STEMI., Methods: The COMPARE CRUSH trial randomized patients presenting with STEMI to receive a pre-hospital loading dose of crushed or integral prasugrel tablets in the ambulance. In this substudy, we compared platelet reactivity levels and the occurrence of high platelet reactivity (HPR; defined as platelet reactivity ≥208) between sexes at 4 prespecified time points after DAPT initiation, and evaluated post-PCI bleeding between groups., Results: Out of 633 STEMI patients, 147 (23%) were female. Females compared with males presented with significantly higher levels of platelet reactivity and higher HPR rates at baseline (232 [IQR, 209-256] vs 195 [IQR, 171-220], P < .01, and 76% vs 41%, OR 4.58 [95%CI, 2.52-8.32], P < .01, respectively). Moreover, female sex was identified as the sole independent predictor of HPR at baseline (OR 5.67 [95%CI, 2.56-12.53], P < .01). Following DAPT initiation, levels of platelet reactivity and the incidence of HPR were similar between sexes. Post-PCI bleeding occurred more frequently in females compared with males (10% vs 2%, OR 6.02 [95%CI, 2.61-11.87], P < .01). Female sex was an independent predictor of post-PCI bleeding (OR 3.25 [95%CI, 1.09-9.72], P = .04)., Conclusions: In this contemporary STEMI cohort, female STEMI patients remain at risk of bleeding complications after primary PCI. However, this is not explained by sex-specific differences in the pharmacodynamic response to pre-hospital DAPT initiation., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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14. Pre-hospital treatment with crushed versus integral tablets of prasugrel in patients presenting with ST-Segment Elevation Myocardial Infarction-1-year follow-up results of the COMPARE CRUSH trial.
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Vogel RF, Delewi R, Wilschut JM, Lemmert ME, Diletti R, van Vliet R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Smits PC, Van Mieghem NM, and Vlachojannis GJ
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- Follow-Up Studies, Humans, Platelet Aggregation Inhibitors therapeutic use, Prasugrel Hydrochloride therapeutic use, Purinergic P2Y Receptor Antagonists therapeutic use, Tablets, Treatment Outcome, Emergency Medical Services, Percutaneous Coronary Intervention methods, ST Elevation Myocardial Infarction drug therapy
- Abstract
The present research letter reports the 1-year clinical outcomes of the randomized COMPARE CRUSH trial, which allocated STEMI patients at first medical contact in the ambulance to receive either crushed or integral tablets of prasugrel loading dose. This trial aimed to investigate whether early enhanced antiplatelet effect constituted by the crushed potent oral P2Y
12 inhibitor prasugrel could lead to improved early myocardial reperfusion and clinical outcomes., (Copyright © 2022 Elsevier Inc. All rights reserved.)- Published
- 2022
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15. Current Status and Future Direction of Antithrombotic Therapy for Patients with STEMI Undergoing Primary PCI.
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Vogel RF, Delewi R, Badimon L, Angiolillo DJ, and Vlachojannis GJ
- Abstract
Since the introduction of the first pharmacological therapy for the treatment of patients with acute myocardial infarction in the early 20th century, treatment of myocardial infarction has evolved extensively throughout the years. Mechanical revascularization therapies such as the percutaneous transluminal coronary angioplasty, combined with the ongoing development of pharmacological therapies have successfully improved the survival of patients with acute myocardial infarction. To date, antiplatelet therapy (consisting of aspirin and an oral P2Y 12 inhibitor) and anticoagulation therapy represent the main stay of pharmacological treatment in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). The routine use of clopidogrel as antiplatelet agent has been largely replaced by the use of the more potent P2Y 12 inhibitors ticagrelor and prasugrel. Unfractionated heparin remains the preferred anticoagulant therapy, despite the development of other anticoagulants, including enoxaparin and bivalirudin. To date, limited evidence exists supporting a pre-hospital initiation of antiplatelet and anticoagulant therapy in STEMI patients. The use of potent intravenous antiplatelet agents, including the glycoprotein IIb/IIIa inhibitors and the intravenous P2Y 12 inhibitor cangrelor, is currently restricted to specific clinical settings. While several potent antithrombotic agents already exist, the search for novel potent antithrombotic agents continues, with a focus on balancing antithrombotic properties with an improved safety profile to reduce excess bleeding. This review provides an overview of currently available pharmacological therapies for the treatment of STEMI patients undergoing primary PCI, and an outlook for the ongoing development of novel agents in this field., Competing Interests: RFV and RD have nothing to disclose. LB declares to have acted as SAB member of Sanofi, to have a Research Grant of AstraZeneca, to have received speaker fees of Sanofi and Bayer and to have founded the Spin-offs Glycardial Diagnostics SL and Ivastatin Therapeutics S (all unrelated to this work). DJA declares that he has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, and Sanofi. DJA also declares that his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions and Scott R. MacKenzie Foundation. GJV declares that he has received consulting fees or honoraria from AstraZeneca. GJV also declares that his institution has received research grants from Daiichi-Sankyo, MicroPort and Ferrer. Lina Badimon is serving as one of the Editorial Board members of this journal. We declare that Lina Badimon had no involvement in the peer review of this article and has no access to information regarding its peer review. Full responsibility for the editorial process for this article was delegated to Antonio Mangieri, George Dangas and Christian Hengstenberg., (Copyright: © 2022 The Author(s). Published by IMR Press.)
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- 2022
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16. Ischaemic electrocardiogram patterns and its association with survival in out-of-hospital cardiac arrest patients without ST-segment elevation myocardial infarction: a COACT trials' post-hoc subgroup analysis.
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Spoormans EM, Lemkes JS, Janssens GN, Soultana O, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, and van Royen N
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- Coronary Angiography methods, Electrocardiography methods, Humans, Troponin T, Out-of-Hospital Cardiac Arrest therapy, ST Elevation Myocardial Infarction
- Abstract
Aims: ST-depression and T-wave inversion are frequently present on the post-resuscitation electrocardiogram (ECG). However, the prognostic value of ischaemic ECG patterns is unknown., Methods and Results: In this post-hoc subgroup analysis of the Coronary Angiography after Cardiac arrest (COACT) trial, the first in-hospital post-resuscitation ECG in out-of-hospital cardiac arrest patients with a shockable rhythm was analysed for ischaemic ECG patterns. Ischaemia was defined as ST-depression of ≥0.1 mV, T-wave inversion in ≥2 contiguous leads, or both. The primary endpoint was 90-day survival. Secondary endpoints were rate of acute unstable lesions, levels of serum troponin-T, and left ventricular function. Of the 510 out-of-hospital cardiac arrest patients, 340 (66.7%) patients had ischaemic ECG patterns. Patients with ischaemic ECG patterns had a worse 90-day survival compared with those without [hazard ratio 1.51; 95% confidence interval (CI) 1.08-2.12; P = 0.02]. A higher sum of ST-depression was associated with lower survival (log-rank = 0.01). The rate of acute unstable lesions (14.5 vs. 15.8%; odds ratio 0.90; 95% CI 0.51-1.59) did not differ between the groups. In patients with ischaemic ECG patterns, maximum levels of serum troponin-T (μg/L) were higher [0.595 (interquartile range 0.243-1.430) vs. 0.359 (0.159-0.845); ratio of geometric means 1.58; 1.13-2.20] and left ventricular function (%) was worse (44.7 ± 12.5 vs. 49.9 ± 13.3; mean difference -5.13; 95% CI -8.84 to -1.42). Adjusted for age and time to return of spontaneous circulation, ischaemic ECG patterns were no longer associated with survival., Conclusion: Post-arrest ischaemic ECG patterns were associated with worse 90-day survival. A higher sum of ST-depression was associated with lower survival. Adjusted for age and time to return of spontaneous circulation, ischaemic ECG patterns were no longer associated with survival., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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17. External validation of the GRACE risk score and the risk-treatment paradox in patients with acute coronary syndrome.
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van der Sangen NMR, Azzahhafi J, Chan Pin Yin DRPP, Peper J, Rayhi S, Walhout RJ, Tjon Joe Gin M, Nicastia DM, Langerveld J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Ten Berg JM, and Kikkert WJ
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- Aftercare, Humans, Patient Discharge, Registries, Risk Assessment, Risk Factors, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome therapy
- Abstract
Objectives: To validate the Global Registry of Acute Coronary Events (GRACE) risk score and examine the extent and impact of the risk-treatment paradox in contemporary patients with acute coronary syndrome (ACS)., Methods: Data from 5015 patients with ACS enrolled in the FORCE-ACS registry between January 2015 and December 2019 were used for model validation. The performance of the GRACE risk score for predicting in-hospital and 1-year mortality was evaluated based on indices of model discrimination and calibration. Differences in the delivery of guideline-recommended care among patients who survived hospitalisation (n=4911) per GRACE risk stratum were assessed and the association with postdischarge mortality was examined., Results: Discriminative power of the GRACE risk score was good for predicting in-hospital (c-statistic: 0.86; 95% CI: 0.83 to 0.90) and 1-year mortality (c-statistic: 0.82; 95% CI: 0.79 to 0.84). However, the GRACE risk score overestimated the absolute in-hospital and 1-year mortality risk (Hosmer-Lemeshow goodness-of-fit test p<0.01). Intermediate-risk and high-risk patients were 12% and 29% less likely to receive optimal guideline-recommended care compared with low-risk patients, respectively. Optimal guideline-recommended care was associated with lower mortality in intermediate- and high-risk patients., Conclusions: The GRACE risk score identified patients at higher risk for in-hospital and 1-year mortality, but overestimated absolute risk levels in contemporary patients. Optimal guideline-recommended care was associated with lower mortality in intermediate-risk and high-risk patients, but was less likely to be delivered with increasing mortality risk., Competing Interests: Competing interests: Dr Wouter J Kikkert has received a research grant from AstraZeneca. Dr Georgios J Vlachojannis has research grants from MicroPort and Ferrer and personal fees from Terumo and AstraZeneca. Dr Yolande Appelman has received a research grant from the Dutch Heart Foundation. Professor Dr José PS Henriques has received research grants from Abbott Vascular, AstraZeneca, B. Braun, Getinge, Ferrer, Infraredx and ZonMw. Professor Dr Jurriën M ten Berg has received research grants from AstraZeneca and ZonMw and personal fees from AstraZeneca, Accu-Metrics, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Ferrer, Idorsia, Pfizer and The Medicines Company. All other authors have no relationships with industry to disclose., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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18. Cost Analysis From a Randomized Comparison of Immediate Versus Delayed Angiography After Cardiac Arrest.
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Camaro C, Bonnes JL, Adang EM, Spoormans EM, Janssens GN, van der Hoeven NW, Jewbali LS, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJ, van der Harst P, van der Horst IC, Voskuil M, van der Heijden JJ, Beishuizen B, Stoel M, van der Hoeven H, Henriques JP, Vlaar AP, Vink MA, van den Bogaard B, Heestermans TA, de Ruijter W, Delnoij TS, Crijns HJ, Jessurun GA, Oemrawsingh PV, Gosselink MT, Plomp K, Magro M, Elbers PW, van de Ven PM, Lemkes JS, and van Royen N
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- Coronary Angiography methods, Costs and Cost Analysis, Humans, Quality of Life, Treatment Outcome, Out-of-Hospital Cardiac Arrest diagnostic imaging, Out-of-Hospital Cardiac Arrest therapy, Percutaneous Coronary Intervention
- Abstract
Background In patients with out-of-hospital cardiac arrest without ST-segment elevation, immediate coronary angiography did not improve clinical outcomes when compared with delayed angiography in the COACT (Coronary Angiography After Cardiac Arrest) trial. Whether 1 of the 2 strategies has benefits in terms of health care resource use and costs is currently unknown. We assess the health care resource use and costs in patients with out-of-hospital cardiac arrest. Methods and Results A total of 538 patients were randomly assigned to a strategy of either immediate or delayed coronary angiography. Detailed health care resource use and cost-prices were collected from the initial hospital episode. A generalized linear model and a gamma distribution were performed. Generic quality of life was measured with the RAND-36 and collected at 12-month follow-up. Overall total mean costs were similar between both groups (EUR 33 575±19 612 versus EUR 33 880±21 044; P =0.86). Generalized linear model: (β, 0.991; 95% CI, 0.894-1.099; P =0.86). Mean procedural costs (coronary angiography and percutaneous coronary intervention, coronary artery bypass graft) were higher in the immediate angiography group (EUR 4384±3447 versus EUR 3028±4220; P <0.001). Costs concerning intensive care unit and ward stay did not show any significant difference. The RAND-36 questionnaire did not differ between both groups. Conclusions The mean total costs between patients with out-of-hospital cardiac arrest randomly assigned to an immediate angiography or a delayed invasive strategy were similar during the initial hospital stay. With respect to the higher invasive procedure costs in the immediate group, a strategy awaiting neurological recovery followed by coronary angiography and planned revascularization may be considered. Registration URL: https://trialregister.nl; Unique identifier: NL4857.
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- 2022
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19. Targeted Temperature Management in Out-of-Hospital Cardiac Arrest With Shockable Rhythm: A Post Hoc Analysis of the Coronary Angiography After Cardiac Arrest Trial.
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Spoormans EM, Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, Girbes ARJ, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, van de Ven PM, van Royen N, and Elbers PWG
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- Aged, Coronary Angiography statistics & numerical data, Female, Humans, Hypothermia, Induced methods, Hypothermia, Induced statistics & numerical data, Male, Middle Aged, Netherlands, Out-of-Hospital Cardiac Arrest epidemiology, Resuscitation methods, Resuscitation statistics & numerical data, Treatment Outcome, Coronary Angiography methods, Electric Countershock statistics & numerical data, Hypothermia, Induced standards, Out-of-Hospital Cardiac Arrest therapy
- Abstract
Objectives: The optimal targeted temperature in patients with shockable rhythm is unclear, and current guidelines recommend targeted temperature management with a correspondingly wide range between 32°C and 36°C. Our aim was to study survival and neurologic outcome associated with targeted temperature management strategy in postarrest patients with initial shockable rhythm., Design: Observational substudy of the Coronary Angiography after Cardiac Arrest without ST-segment Elevation trial., Setting: Nineteen hospitals in The Netherlands., Patients: The Coronary Angiography after Cardiac Arrest trial randomized successfully resuscitated patients with shockable rhythm and absence of ST-segment elevation to a strategy of immediate or delayed coronary angiography. In this substudy, 459 patients treated with mild therapeutic hypothermia (32.0-34.0°C) or targeted normothermia (36.0-37.0°C) were included. Allocation to targeted temperature management strategy was at the discretion of the physician., Interventions: None., Measurements and Main Results: After 90 days, 171 patients (63.6%) in the mild therapeutic hypothermia group and 129 (67.9%) in the targeted normothermia group were alive (hazard ratio, 0.86 [95% CI, 0.62-1.18]; log-rank p = 0.35; adjusted odds ratio, 0.89; 95% CI, 0.45-1.72). Patients in the mild therapeutic hypothermia group had longer ICU stay (4 d [3-7 d] vs 3 d [2-5 d]; ratio of geometric means, 1.32; 95% CI, 1.15-1.51), lower blood pressures, higher lactate levels, and increased need for inotropic support. Cerebral Performance Category scores at ICU discharge and 90-day follow-up and patient-reported Mental and Physical Health Scores at 1 year were similar in the two groups., Conclusions: In the context of out-of-hospital cardiac arrest with shockable rhythm and no ST-elevation, treatment with mild therapeutic hypothermia was not associated with improved 90-day survival compared with targeted normothermia. Neurologic outcomes at 90 days as well as patient-reported Mental and Physical Health Scores at 1 year did not differ between the groups., Competing Interests: Dr. Lemkes received funding from The Netherlands Heart Institute (NHLI) and Biotronik. Drs. Lemkes and Vlachojannis received funding from AstraZeneca. Dr. Rijpstra’s institution received funding from Principle Investigator. Dr. Vlachojannis’ institution received funding from MicroPort and Daiichi Sankyo; he received funding from Abbott. Dr. Vlachojannis reports receiving grant support from MicroPort Orthopedics and Daiichi Sankyo. Dr. van Royen’s institution received funding from Biotronik, AstraZeneca, the NHLI, Abbott, and Medtronic; he received funding from Novartis, MicroPort, Castor, Rainmed, Biotronik, Abbott, Medtronic, and Philips; he received support for article research from the NLHI. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2021 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)
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- 2022
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20. Provisional Stenting for the Treatment of Bifurcation Lesions: In Vitro Insights.
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Ng CKJ, Paradies V, Vlachojannis GJ, Toh HW, Leo HL, Wong EHP, Foin N, and Ang HY
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- Angioplasty, Balloon, Coronary adverse effects, Computer Simulation, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease physiopathology, Coronary Circulation, Coronary Thrombosis etiology, Coronary Thrombosis physiopathology, Hemodynamics, Humans, Hydrodynamics, Models, Anatomic, Models, Cardiovascular, Stress, Mechanical, Tomography, Optical Coherence, Angioplasty, Balloon, Coronary instrumentation, Coronary Artery Disease therapy, Coronary Vessels physiopathology, Drug-Eluting Stents
- Abstract
Provisional stenting is considered the gold standard approach for most bifurcation lesions, but the benefit of routine side branch (SB) strut dilatation has not been fully elucidated. A benchtop model was used to determine the benefits of routine side branch (SB) dilatation techniques on strut apposition, acute thrombogenicity, and flow disruption. Three different provisional bifurcation techniques were compared: no SB dilatation "keep it open" method (KIO), sequential balloon dilatation (SBD), and kissing balloon inflation (KBI). Stents were deployed in a silicon bifurcation model and perfused with blood at a flow rate of 200 ml/min for 60 min. Optical coherence tomography (OCT) pullbacks were obtained before and after flow perfusion to conduct strut analysis and acute thrombus measurement respectively. Computational fluid dynamics (CFD) models were created using OCT pullbacks and simulated based on experimental conditions to analyze flow disruption. The strut analysis showed that KBI had the lowest percentage of floating (10.6 ± 2.3%) (p = 0.0004) and malapposed (41.2 ± 8.5%) struts (p = 0.59), followed by SBD and then KIO. This correlated to KBI having the lowest amount of thrombus formed at the SB, followed by SBD, with KIO being the most thrombogenic (KBI: 0.84 ± 0.22mm
2 , SBD: 1.17 ± 0.25mm2 , KIO: 1.31 ± 0.36mm2 , p = 0.18). CFD models also predicted a similar trend, with KBI having the lowest amount of area of high shear rate as well as flow recirculation. Based on this benchtop model, SB intervention strategies demonstrated a reduction in number of struts and resulting thrombogenicity at the bifurcation ostia. Graphical abstract., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)- Published
- 2021
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21. The effect of immediate coronary angiography after cardiac arrest without ST-segment elevation on left ventricular function. A sub-study of the COACT randomised trial.
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Lemkes JS, Spoormans EM, Demirkiran A, Leutscher S, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, van Loon RB, and van Royen N
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- Coronary Angiography, Humans, Netherlands, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Out-of-Hospital Cardiac Arrest diagnostic imaging, Out-of-Hospital Cardiac Arrest therapy, Percutaneous Coronary Intervention
- Abstract
Background: The effect of immediate coronary angiography and percutaneous coronary intervention (PCI) in patients who are successfully resuscitated after cardiac arrest in the absence of ST-segment elevation myocardial infarction (STEMI) on left ventricular function is currently unknown., Methods: This prespecified sub-study of a multicentre trial evaluated 552 patients, successfully resuscitated from out-of-hospital cardiac arrest without signs of STEMI. Patients were randomized to either undergo immediate coronary angiography or delayed coronary angiography, after neurologic recovery. All patients underwent PCI if indicated. The main outcomes of this analysis were left ventricular ejection fraction and end-diastolic and systolic volumes assessed by cardiac magnetic resonance imaging or echocardiography., Results: Data on left ventricular function was available for 397 patients. The mean (± standard deviation) left ventricular ejection fraction was 45.2% (±12.8) in the immediate angiography group and 48.4% (±13.2) in the delayed angiography group (mean difference: -3.19; 95% confidence interval [CI], -6.75 to 0.37). Median left ventricular end-diastolic volume was 177 ml in the immediate angiography group compared to 169 ml in the delayed angiography group (ratio of geometric means: 1.06; 95% CI, 0.95-1.19). In addition, mean left ventricular end-systolic volume was 90 ml in the immediate angiography group compared to 78 ml in the delayed angiography group (ratio of geometric means: 1.13; 95% CI 0.97-1.32)., Conclusion: In patients successfully resuscitated after out-of-hospital cardiac arrest and without signs of STEMI, immediate coronary angiography was not found to improve left ventricular dimensions or function compared with a delayed angiography strategy., Clinical Trial Registration: Netherlands Trial Register number, NTR4973., Competing Interests: Declaration of Competing Interest The authors report no declarations of interest., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2021
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22. Pharmacodynamic Effects of Pre-Hospital Administered Crushed Prasugrel in Patients With ST-Segment Elevation Myocardial Infarction.
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Vogel RF, Delewi R, Angiolillo DJ, Wilschut JM, Lemmert ME, Diletti R, van Vliet R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Krucoff MW, van Mieghem NM, Smits PC, and Vlachojannis GJ
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- Hospitals, Humans, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride adverse effects, Purinergic P2Y Receptor Antagonists adverse effects, Treatment Outcome, Myocardial Infarction drug therapy, Percutaneous Coronary Intervention adverse effects, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction drug therapy
- Abstract
Objectives: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y
12 inhibitor prasugrel in crushed versus integral tablet formulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI)., Background: Early dual antiplatelet therapy is recommended in STEMI patients. Yet, onset of oral P2Y12 inhibitor effect is delayed and varies according to formulation administered., Methods: The COMPARE CRUSH (Comparison of Pre-hospital Crushed Versus Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions) trial randomized patients with suspected STEMI to crushed or integral prasugrel 60-mg loading dose in the ambulance. Pharmacodynamic measurements were performed at 4 time points: before antiplatelet treatment, at the beginning and end of pPCI, and 4 h after study treatment onset. The primary endpoint was high platelet reactivity at the end of pPCI. The secondary endpoint was impact of platelet reactivity status on markers of coronary reperfusion., Results: A total of 441 patients were included. In patients with crushed prasugrel, the occurrence of high platelet reactivity at the end of pPCI was reduced by almost one-half (crushed 34.7% vs. uncrushed 61.6%; odds ratio [OR] = 0.33; 95% confidence interval [CI] = 0.22 to 0.50; p < 0.01). Platelet reactivity <150 P2Y12 reactivity units at the beginning of coronary angiography correlated with improved Thrombolysis In Myocardial Infarction flow grade 3 in the infarct artery pre-pPCI (OR: 1.78; 95% CI: 1.08 to 2.94; p = 0.02) but not ST-segment resolution (OR: 0.80; 95% CI: 0.48 to 1.34; p = 0.40)., Conclusions: Oral administration of crushed compared with integral prasugrel significantly improves platelet inhibition during the acute phase in STEMI patients undergoing pPCI. However, a considerable number of patients still exhibit inadequate platelet inhibition at the end of pPCI, suggesting the need for alternative agents to bridge the gap in platelet inhibition., Competing Interests: Funding Support and Author Disclosures The COMPARE CRUSH trial was funded by Maasstad Research B.V. (Rotterdam, the Netherlands), which received unrestricted grants from Daiichi-Sankyo and Shanghai MicroPort Medical. The funding companies were not involved in the conduct of the trial, the analysis of the data, or the drafts of the manuscripts. Dr. Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St. Jude Medical; and has received institutional research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr. Alexopoulos has received consulting fees or honoraria from AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Chiesi Hellas, Medtronic, and Pfizer. Dr. Montalescot has received research or institutional grant support or consulting/lecture fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CellProthera, Europa, IRIS-Servier, Novartis, Medtronic, MSD, Pfizer, Quantum Genomics, and Sanofi. Dr. Van Mieghem has received institutional research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Teleflex, PulseCath BV, and Daiichi-Sankyo. Dr. Smits has received research grant support from Daiichi-Sankyo and Shanghai MicroPort. Dr. Vlachojannis has received consulting fees from AstraZeneca; and research grant support from Daiichi-Sankyo and Shanghai MicroPort. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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23. Genome-wide analysis identifies novel susceptibility loci for myocardial infarction.
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Hartiala JA, Han Y, Jia Q, Hilser JR, Huang P, Gukasyan J, Schwartzman WS, Cai Z, Biswas S, Trégouët DA, Smith NL, Seldin M, Pan C, Mehrabian M, Lusis AJ, Bazeley P, Sun YV, Liu C, Quyyumi AA, Scholz M, Thiery J, Delgado GE, Kleber ME, März W, Howe LJ, Asselbergs FW, van Vugt M, Vlachojannis GJ, Patel RS, Lyytikäinen LP, Kähönen M, Lehtimäki T, Nieminen TVM, Kuukasjärvi P, Laurikka JO, Chang X, Heng CK, Jiang R, Kraus WE, Hauser ER, Ferguson JF, Reilly MP, Ito K, Koyama S, Kamatani Y, Komuro I, Stolze LK, Romanoski CE, Khan MD, Turner AW, Miller CL, Aherrahrou R, Civelek M, Ma L, Björkegren JLM, Kumar SR, Tang WHW, Hazen SL, and Allayee H
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- Endothelial Cells, Genetic Predisposition to Disease genetics, Genome-Wide Association Study, Humans, Japan, Polymorphism, Single Nucleotide genetics, Risk Factors, Coronary Artery Disease genetics, Myocardial Infarction genetics
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Aims: While most patients with myocardial infarction (MI) have underlying coronary atherosclerosis, not all patients with coronary artery disease (CAD) develop MI. We sought to address the hypothesis that some of the genetic factors which establish atherosclerosis may be distinct from those that predispose to vulnerable plaques and thrombus formation., Methods and Results: We carried out a genome-wide association study for MI in the UK Biobank (n∼472 000), followed by a meta-analysis with summary statistics from the CARDIoGRAMplusC4D Consortium (n∼167 000). Multiple independent replication analyses and functional approaches were used to prioritize loci and evaluate positional candidate genes. Eight novel regions were identified for MI at the genome wide significance level, of which effect sizes at six loci were more robust for MI than for CAD without the presence of MI. Confirmatory evidence for association of a locus on chromosome 1p21.3 harbouring choline-like transporter 3 (SLC44A3) with MI in the context of CAD, but not with coronary atherosclerosis itself, was obtained in Biobank Japan (n∼165 000) and 16 independent angiography-based cohorts (n∼27 000). Follow-up analyses did not reveal association of the SLC44A3 locus with CAD risk factors, biomarkers of coagulation, other thrombotic diseases, or plasma levels of a broad array of metabolites, including choline, trimethylamine N-oxide, and betaine. However, aortic expression of SLC44A3 was increased in carriers of the MI risk allele at chromosome 1p21.3, increased in ischaemic (vs. non-diseased) coronary arteries, up-regulated in human aortic endothelial cells treated with interleukin-1β (vs. vehicle), and associated with smooth muscle cell migration in vitro., Conclusions: A large-scale analysis comprising ∼831 000 subjects revealed novel genetic determinants of MI and implicated SLC44A3 in the pathophysiology of vulnerable plaques., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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24. Sex differences in patients with out-of-hospital cardiac arrest without ST-segment elevation: A COACT trial substudy.
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Spoormans EM, Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, van de Ven PM, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, der Harst PV, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, Appelman Y, and van Royen N
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- Coronary Angiography, Female, Humans, Male, Netherlands epidemiology, Sex Characteristics, Out-of-Hospital Cardiac Arrest therapy, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
- Abstract
Background: Whether sex is associated with outcomes of out-of-hospital cardiac arrest (OHCA) is unclear., Objectives: This study examined sex differences in survival in patients with OHCA without ST-segment elevation myocardial infarction (STEMI)., Methods: Using data from the randomized controlled Coronary Angiography after Cardiac Arrest (COACT) trial, the primary point of interest was sex differences in OHCA-related one-year survival. Secondary points of interest included the benefit of immediate coronary angiography compared to delayed angiography until after neurologic recovery, angiographic and clinical outcomes., Results: In total, 522 patients (79.1% men) were included. Overall one-year survival was 59.6% in women and 63.4% in men (HR 1.18; 95% CI: 0.76-1.81;p = 0.47). No cardiovascular risk factors were found that modified survival. Women less often had significant coronary artery disease (CAD) (37.0% vs. 71.3%;p < 0.001), but when present, they had a worse prognosis than women without CAD (HR 3.06; 95% CI 1.31-7.19;p = 0.01). This was not the case for men (HR 1.05; 95% CI 0.67-1.65;p = 0.83). In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93)., Conclusion: In OHCA patients without STEMI, we found no sex differences in overall one-year survival. Women less often had significant CAD, but when CAD was present they had worse survival than women without CAD. This was not the case for men. Both sexes did not benefit from a strategy of immediate coronary angiography as compared to delayed strategy with respect to one-year survival., Clinical Trial Registration Number: Netherlands trial register (NTR) 4973., (Copyright © 2020. Published by Elsevier B.V.)
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- 2021
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25. Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial.
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Vlachojannis GJ, Wilschut JM, Vogel RF, Lemmert ME, Delewi R, Diletti R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, and Smits PC
- Subjects
- Aged, Ambulances, Blood Platelets metabolism, Drug Administration Schedule, Female, Hemorrhage chemically induced, Humans, Male, Middle Aged, Netherlands, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride adverse effects, Prospective Studies, Purinergic P2Y Receptor Antagonists adverse effects, ST Elevation Myocardial Infarction diagnosis, Tablets, Time Factors, Time-to-Treatment, Treatment Outcome, Blood Platelets drug effects, Emergency Medical Services, Percutaneous Coronary Intervention adverse effects, Platelet Aggregation Inhibitors administration & dosage, Prasugrel Hydrochloride administration & dosage, Purinergic P2Y Receptor Antagonists administration & dosage, ST Elevation Myocardial Infarction therapy
- Abstract
Background: Early treatment with a potent oral platelet P2Y
12 inhibitor is recommended in patients presenting with ST-segment-elevation myocardial infarction scheduled to undergo primary percutaneous coronary intervention (pPCI). The impact on coronary reperfusion of crushed P2Y12 inhibitor tablets, which lead to more prompt and potent platelet inhibition, is unknown., Methods: We conducted a randomized controlled, multicenter trial in the Netherlands, enrolling patients with ST-segment-elevation myocardial infarction scheduled to undergo pPCI. Patients were randomly allocated to receive in the ambulance, before transfer, a 60-mg loading dose of prasugrel either as crushed or integral tablets. The independent primary end points were thrombolysis in myocardial infarction (TIMI) 3 flow in the infarct-related artery at initial coronary angiography, and complete (≥70%) ST-segment resolution 1 hour after pPCI. The safety end points were TIMI major and Bleeding Academic Research Consortium ≥3 bleedings. Secondary end points included platelet reactivity and ischemic outcomes., Results: A total of 727 patients were assigned to either crushed or integral tablets of prasugrel loading dose. The median time from study treatment to wire-crossing during pPCI was 57 (47-70) minutes. The primary end point TIMI 3 flow in the infarct-related artery before pPCI occurred in 31.0% in the crushed group versus 32.7% in the integral group (odds ratio, 0.92 [95% CI, 0.65-1.30], P =0.64). Complete ST-segment resolution 1 hour after pPCI was present in 59.9% in the crushed group versus 57.3% in the integral group (odds ratio, 1.11 [95% CI, 0.78-1.58], P =0.55). Platelet reactivity at the beginning of pPCI, measured as P2Y12 reactivity unit, differed significantly between groups (crushed, 192 [132-245] versus integral, 227 [184-254], P ≤0.01). TIMI major and Bleeding Academic Research Consortium ≥3 bleeding occurred in 0% in the crushed group versus 0.8% in the integral group, and in 0.3% in the crushed group versus 1.1% in the integral group, respectively. There were no differences observed between groups regarding ischemic events at 30 days., Conclusions: Prehospital administration of crushed prasugrel tablets does not improve TIMI 3 flow in the infarct-related artery before pPCI or complete ST-segment resolution 1 h after pPCI in patients presenting with ST-segment-elevation myocardial infarction scheduled for pPCI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03296540.- Published
- 2020
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26. Coronary Angiography After Cardiac Arrest Without ST Segment Elevation: One-Year Outcomes of the COACT Randomized Clinical Trial.
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Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen MM, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak RR, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, Spoormans EM, van de Ven PM, Oudemans-van Straaten HM, and van Royen N
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Out-of-Hospital Cardiac Arrest therapy, Resuscitation, ST Elevation Myocardial Infarction, Time Factors, Treatment Outcome, Coronary Angiography, Out-of-Hospital Cardiac Arrest diagnostic imaging
- Abstract
Importance: Ischemic heart disease is a common cause of cardiac arrest. However, randomized data on long-term clinical outcomes of immediate coronary angiography and percutaneous coronary intervention (PCI) in patients successfully resuscitated from cardiac arrest in the absence of ST segment elevation myocardial infarction (STEMI) are lacking., Objective: To determine whether immediate coronary angiography improves clinical outcomes at 1 year in patients after cardiac arrest without signs of STEMI, compared with a delayed coronary angiography strategy., Design, Setting, and Participants: A prespecified analysis of a multicenter, open-label, randomized clinical trial evaluated 552 patients who were enrolled in 19 Dutch centers between January 8, 2015, and July 17, 2018. The study included patients who experienced out-of-hospital cardiac arrest with a shockable rhythm who were successfully resuscitated without signs of STEMI. Follow-up was performed at 1 year. Data were analyzed, using the intention-to-treat principle, between August 29 and October 10, 2019., Interventions: Immediate coronary angiography and PCI if indicated or coronary angiography and PCI if indicated, delayed until after neurologic recovery., Main Outcomes and Measures: Survival, myocardial infarction, revascularization, implantable cardiac defibrillator shock, quality of life, hospitalization for heart failure, and the composite of death or myocardial infarction or revascularization after 1 year., Results: At 1 year, data on 522 of 552 patients (94.6%) were available for analysis. Of these patients, 413 were men (79.1%); mean (SD) age was 65.4 (12.3) years. A total of 162 of 264 patients (61.4%) in the immediate angiography group and 165 of 258 patients (64.0%) in the delayed angiography group were alive (odds ratio, 0.90; 95% CI, 0.63-1.28). The composite end point of death, myocardial infarction, or repeated revascularization since the index hospitalization was met in 112 patients (42.9%) in the immediate group and 104 patients (40.6%) in the delayed group (odds ratio, 1.10; 95% CI, 0.77-1.56). No significant differences between the groups were observed for the other outcomes at 1-year follow-up. For example, the rate of ICD shocks was 20.4% in the immediate group and 16.2% in the delayed group (odds ratio, 1.32; 95% CI, 0.66-2.64)., Conclusions and Relevance: In this trial of patients successfully resuscitated after out-of-hospital cardiac arrest and without signs of STEMI, a strategy of immediate angiography was not found to be superior to a strategy of delayed angiography with respect to clinical outcomes at 1 year. Coronary angiography in this patient group can therefore be delayed until after neurologic recovery without affecting outcomes., Trial Registration: trialregister.nl Identifier: NTR4973.
- Published
- 2020
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27. Data on sex differences in one-year outcomes of out-of-hospital cardiac arrest patients without ST-segment elevation.
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Spoormans EM, Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, van de Ven PM, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, Appelman Y, and van Royen N
- Abstract
Sex differences in out-of-hospital cardiac arrest (OHCA) patients are increasingly recognized. Although it has been found that post-resuscitated women are less likely to have significant coronary artery disease (CAD) than men, data on follow-up in these patients are limited. Data for this data in brief article was obtained as a part of the randomized controlled Coronary Angiography after Cardiac Arrest without ST-segment elevation (COACT) trial. The data supplements the manuscript "Sex differences in out-of-hospital cardiac arrest patients without ST-segment elevation: A COACT trial substudy" were it was found that women were less likely to have significant CAD including chronic total occlusions, and had worse survival when CAD was present. The dataset presented in this paper describes sex differences on interventions, implantable-cardioverter defibrillator (ICD) shocks and hospitalizations due to heart failure during one-year follow-up in patients successfully resuscitated after OHCA. Data was derived through a telephone interview at one year with the patient or general practitioner. Patients in this randomized dataset reflects a homogenous study population, which can be valuable to further build on research regarding long-term sex differences and to further improve cardiac care., Competing Interests: Supported by unrestricted research grants from the Netherlands Heart Institute, Biotronik, and AstraZeneca. Dr. Vlachojannis reports receiving grant support from MicroPort Orthopedics and Daiichi Sankyo; and Dr. van Royen, receiving grant support from Philips, Biotronik, and Abbott and honoraria from Medtronic. No other potential conflict of interest relevant to this article was reported., (© 2020 The Authors.)
- Published
- 2020
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28. The role of risk scores for prediction of adverse events in patients undergoing PCI.
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Vlachojannis GJ
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- Humans, Risk Assessment, Risk Factors, Percutaneous Coronary Intervention
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- 2020
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29. Rationale and Design of the Future Optimal Research and Care Evaluation in Patients with Acute Coronary Syndrome (FORCE-ACS) Registry: Towards "Personalized Medicine" in Daily Clinical Practice.
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Chan Pin Yin DRPP, Vos GA, van der Sangen NMR, Walhout R, Tjon Joe Gin RM, Nicastia DM, Langerveld J, Claassens DMF, Gimbel ME, Azzahhafi J, Bor WL, Oirbans T, Dekker J, Vlachojannis GJ, van Bommel RJ, Appelman Y, Henriques JPS, Kikkert WJ, and Ten Berg JM
- Abstract
Diagnostic and treatment strategies for acute coronary syndrome have improved dramatically over the past few decades, but mortality and recurrent myocardial infarction rates remain high. An aging population with increasing co-morbidities heralds new clinical challenges. Therefore, in order to evaluate and improve current treatment strategies, detailed information on clinical presentation, treatment and follow-up in real-world patients is needed. The Future Optimal Research and Care Evaluation in patients with Acute Coronary Syndrome (FORCE-ACS) registry (ClinicalTrials.gov Identifier: NCT03823547) is a multi-center, prospective real-world registry of patients admitted with (suspected) acute coronary syndrome. Both non-interventional and interventional cardiac centers in different regions of the Netherlands are currently participating. Patients are treated according to local protocols, enabling the evaluation of different diagnostic and treatment strategies used in daily practice. Data collection is performed using electronic medical records and quality-of-life questionnaires, which are sent 1, 12, 24 and 36 months after initial admission. Major end points are all-cause mortality, myocardial infarction, stent thrombosis, stroke, revascularization and all bleeding requiring medical attention. Invasive therapy, antithrombotic therapy including patient-tailored strategies, such as the use of risk scores, pharmacogenetic guided antiplatelet therapy and patient reported outcome measures are monitored. The FORCE-ACS registry provides insight into numerous aspects of the (quality of) care for acute coronary syndrome patients.
- Published
- 2020
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30. COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.
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Vlachojannis GJ, Vogel RF, Wilschut JM, Lemmert ME, Delewi R, Diletti R, van Vliet R, van der Waarden N, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, and Smits PC
- Subjects
- Administration, Oral, Aged, Coronary Angiography, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors administration & dosage, Preoperative Period, ST Elevation Myocardial Infarction diagnosis, Treatment Outcome, Percutaneous Coronary Intervention, Prasugrel Hydrochloride administration & dosage, ST Elevation Myocardial Infarction therapy
- Abstract
Background: Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y
12 inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown., Hypothesis: The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose., Study Design: COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours., Conclusions: The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540., (Copyright © 2020 Elsevier Inc. All rights reserved.)- Published
- 2020
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31. A Multicenter Comparison of 2 Point-of-Care Activated Clotting Time Test Systems.
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Kemna EWM, Schellings MWM, Vlachojannis GJ, Falter F, Milané-Santman A, Hesselink T, Scholten M, and Krabbe JG
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- Humans, Reproducibility of Results, Sensitivity and Specificity, Point-of-Care Systems, Point-of-Care Testing, Whole Blood Coagulation Time methods, Whole Blood Coagulation Time standards
- Published
- 2019
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32. Rationale for catheter-based therapies in acute pulmonary embolism.
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de Winter MA, Vlachojannis GJ, Ruigrok D, Nijkeuter M, and Kraaijeveld AO
- Abstract
Pulmonary embolism (PE) is a common disease resulting in significant morbidity and mortality. High-risk features of PE are hypotension or shock, and early reperfusion is warranted to unload the strained right ventricle and improve clinical outcomes. Currently, systemic thrombolysis (ST) is the standard of care but is associated with bleeding complications. Catheter-based therapies (CDT) have emerged as a promising alternative having demonstrated to be equally effective while having a lower risk of bleeding. Several CDT are currently available, some combining mechanical properties with low-dose thrombolytics. Recent guidelines suggest that CDT may be considered in patients with high-risk PE who have high bleeding risk, after failed ST, or in patients with rapid haemodynamic deterioration as bail-out before ST can be effective, depending on local availability and expertise. In haemodynamically stable patients with right ventricular (RV) dysfunction (intermediate-risk PE), CDT may be considered if clinical deterioration occurs after starting anticoagulation and relative contraindications for ST due to bleeding risk exist. Decision on treatment modality should follow a risk-benefit analysis on a case by case base, weighing the risk of PE-related complications; i.e. haemodynamic deterioration vs. bleeding. As timely initiation of treatment is warranted to prevent early mortality, bleeding risk factors should be assessed at an early stage in all patients with acute PE and signs of RV dysfunction. To ensure optimal management of complex cases of PE and assess a potential CDT strategy, a multidisciplinary approach is recommended. A dedicated Pulmonary Embolism Response Team may optimize this process., (Published on behalf of the European Society of Cardiology. © The Author(s) 2019.)
- Published
- 2019
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33. Petechial purpuric rash after non-invasive blood pressure measurement: Rumpel-Leede sign.
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van Rhijn BD, Vlachojannis GJ, and Balak DMW
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- Humans, Male, Middle Aged, Exanthema etiology, Purpura etiology, Sphygmomanometers adverse effects
- Abstract
Competing Interests: Competing interests: None declared.
- Published
- 2019
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34. Abluminal biodegradable polymer biolimus-eluting versus durable polymer everolimus-eluting stent in patients with diabetes mellitus: 5 years follow-up from the COMPARE II trial.
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Paradies V, Vlachojannis GJ, Royaards KJ, Wassing J, van der Ent M, and Smits PC
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- Aged, Aged, 80 and over, Diabetes Mellitus diagnosis, Diabetes Mellitus epidemiology, Female, Follow-Up Studies, Humans, Immunosuppressive Agents administration & dosage, Male, Middle Aged, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention trends, Polymers, Sirolimus administration & dosage, Time Factors, Absorbable Implants trends, Diabetes Mellitus therapy, Drug-Eluting Stents trends, Everolimus administration & dosage, Percutaneous Coronary Intervention methods, Sirolimus analogs & derivatives
- Abstract
Background: Drug eluting stents with biodegradable polymers have been developed to address the risk of very late adverse events. Long-term comparison data between the biodegradable polymer-coated biolimus-eluting stent (BES; Nobori®) and the second-generation durable polymer-coated everolimus-eluting stent (EES; XIENCE V® or XIENCE PRIME® or PROMUS™) in diabetic patients are scarce., Methods: The COMPARE II trial was an investigator-initiated, multicenter, open-label, randomized, all-comers trial which assigned patients undergoing percutaneous coronary intervention (PCI) in a 2:1 fashion to either BES or EES. We analyzed the safety and efficacy outcomes in diabetic patients at 5 year follow-up. The primary pre-specified composite endpoint major adverse cardiac event (MACE) was defined as cardiac death, non-fatal target-vessel myocardial infarction (TV-MI), or clinically indicated target vessel revascularization (CD-TVR)., Results: Out of 2707 study patients, 588 were diabetics (21.7%) of whom 391 were treated with BES and 197 with EES. At 5 years follow-up, MACE occurred in 87 patients (22.2%) in the BES group and in 34 patients (17.2%) in the EES group (p = .34). Other safety and efficacy endpoints did not differ between stent groups., Conclusions: At 5 years follow-up, no differences in terms of MACE as well as all analyzed safety and efficacy measures, including stent thrombosis, between the biodegradable polymer-coated BES and the durable polymer-coated EES in diabetic patients were observed., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2019
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35. Coronary Angiography after Cardiac Arrest without ST-Segment Elevation.
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Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, Oudemans-van Straaten HM, and van Royen N
- Subjects
- Aged, Female, Heart Diseases complications, Heart Diseases therapy, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Out-of-Hospital Cardiac Arrest mortality, Out-of-Hospital Cardiac Arrest therapy, Coronary Angiography, Electrocardiography, Heart Diseases diagnostic imaging, Out-of-Hospital Cardiac Arrest diagnostic imaging, Percutaneous Coronary Intervention, Time-to-Treatment
- Abstract
Background: Ischemic heart disease is a major cause of out-of-hospital cardiac arrest. The role of immediate coronary angiography and percutaneous coronary intervention (PCI) in the treatment of patients who have been successfully resuscitated after cardiac arrest in the absence of ST-segment elevation myocardial infarction (STEMI) remains uncertain., Methods: In this multicenter trial, we randomly assigned 552 patients who had cardiac arrest without signs of STEMI to undergo immediate coronary angiography or coronary angiography that was delayed until after neurologic recovery. All patients underwent PCI if indicated. The primary end point was survival at 90 days. Secondary end points included survival at 90 days with good cerebral performance or mild or moderate disability, myocardial injury, duration of catecholamine support, markers of shock, recurrence of ventricular tachycardia, duration of mechanical ventilation, major bleeding, occurrence of acute kidney injury, need for renal-replacement therapy, time to target temperature, and neurologic status at discharge from the intensive care unit., Results: At 90 days, 176 of 273 patients (64.5%) in the immediate angiography group and 178 of 265 patients (67.2%) in the delayed angiography group were alive (odds ratio, 0.89; 95% confidence interval [CI], 0.62 to 1.27; P = 0.51). The median time to target temperature was 5.4 hours in the immediate angiography group and 4.7 hours in the delayed angiography group (ratio of geometric means, 1.19; 95% CI, 1.04 to 1.36). No significant differences between the groups were found in the remaining secondary end points., Conclusions: Among patients who had been successfully resuscitated after out-of-hospital cardiac arrest and had no signs of STEMI, a strategy of immediate angiography was not found to be better than a strategy of delayed angiography with respect to overall survival at 90 days. (Funded by the Netherlands Heart Institute and others; COACT Netherlands Trial Register number, NTR4973.)., (Copyright © 2019 Massachusetts Medical Society.)
- Published
- 2019
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36. Angiographic and Midterm Outcomes of Bioresorbable Vascular Scaffold for Coronary Bifurcation Lesions.
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Paradies V, Vlachojannis GJ, Royaards KJ, Wassing J, van der Ent M, and Smits PC
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- Coronary Artery Disease diagnosis, Coronary Vessels diagnostic imaging, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prosthesis Design, Retrospective Studies, Time Factors, Tomography, Optical Coherence methods, Treatment Outcome, Absorbable Implants, Coronary Angiography methods, Coronary Artery Disease surgery, Coronary Vessels surgery, Percutaneous Coronary Intervention methods, Tissue Scaffolds
- Abstract
Data on the angiographic and clinical performance of bioresorbable vascular scaffolds (BVS) for bifurcation lesions treatment are still limited. Data were examined of 107 patients with at least 1 coronary bifurcation lesion involving a side branch ≥2mm. Angiographic and clinical outcomes were collected. Optical coherence tomography analysis was performed in a subgroup of patients. Between July 2009 and December 2015, 423 patients underwent PCI with Absorb BVS. A total of 110 lesions were identified as bifurcations, of which 24.5% were classified as true bifurcation lesions. Lesion complexity B2/C was 68.1%. Ninety-five out of 110 lesions were treated by provisional stenting technique while 2 stenting strategy was the final approach in 15 lesions. Procedural success of main branch was 100% whereas side-branch impairment at the end of the procedure was 4.5%. The mean follow-up was 21 months with one-third of the patients followed up for at least 2 years. The overall target lesion failure and scaffold/stent thrombosis rate at 1 year was 7.8% and 3.9%, respectively. In conclusion the results of the present analysis suggest the BVS implanted in bifurcations lesions are associated with procedural safety and angiographic success as well as acceptable target lesion failure rate at 1 year., (Copyright © 2018. Published by Elsevier Inc.)
- Published
- 2018
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37. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months).
- Author
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Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamié D, Kraaijeveld AO, Hovasse T, and Vlachojannis GJ
- Subjects
- Aged, Cardiovascular Agents adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Vessels diagnostic imaging, Europe, Female, Humans, Hyperplasia, Male, Middle Aged, Neointima, Percutaneous Coronary Intervention adverse effects, Predictive Value of Tests, Prospective Studies, Prosthesis Design, Risk Factors, Sirolimus adverse effects, Time Factors, Treatment Outcome, Wound Healing drug effects, Absorbable Implants, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Coronary Vessels drug effects, Drug-Eluting Stents, Percutaneous Coronary Intervention instrumentation, Polyesters chemistry, Sirolimus administration & dosage, Tomography, Optical Coherence
- Abstract
Background: To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage., Methods and Results: The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively. The median neointimal hyperplasia thickness was 0.04, 0.05, and 0.06 mm, whereas mean neointimal hyperplasia obstruction was 4.5±2.4%, 5.2±3.4%, and 6.6±3.3% at 1, 2, and 3 months, respectively., Conclusions: Nearly complete strut coverage was observed in this complex population very early after implantation of Ultimaster drug-eluting stent., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843., (© 2017 American Heart Association, Inc.)
- Published
- 2017
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38. Everolimus eluting stent vs first generation drug-eluting stent in primary angioplasty: A pooled patient-level meta-analysis of randomized trials.
- Author
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De Luca G, Smits P, Hofma SH, Di Lorenzo E, Vlachojannis GJ, Van't Hof AWJ, van Boven AJ, Kedhi E, Stone GW, and Suryapranata H
- Subjects
- Angioplasty methods, Humans, ST Elevation Myocardial Infarction epidemiology, Angioplasty trends, Drug-Eluting Stents trends, Everolimus administration & dosage, Randomized Controlled Trials as Topic methods, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction therapy
- Abstract
Background: Several concerns have emerged about the higher risk of very late stent thrombosis (ST) with first generation drug-eluting stent (DES) especially among STEMI patients. Newer generation DES has demonstrated to reduce ST at mid-term follow-up. Therefore, the aim of the present study is to perform an individual patient's data meta-analysis of trials comparing 1st generation DES vs. 2nd generation DES (everolimus-eluting stent, EES) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI., Methods: We performed a formal search of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2010 to June 2016. We included all completed randomized trials comparing 1st vs. EES for patient presenting with STEMI., Results: Individual patients data were obtained from 3 trials, including a total of 1581 patients (686 or 43.4% randomized to 1st generation DES and 895 or 56.4% randomized to EES). At long-term follow-up (1584±588days), EES did not significantly reduce mortality (7.8.% vs 11.7%, HR [95%CI]=0.77 [0.52, 1.13], p=0.18, p
heterogeneity =0.93), cardiac mortality (6.2% vs 7.6%, HR [95%CI]=0.90 [0.56, 1.44], p=0.65, pheterogeneity =0.85), and reinfarction (8.1% versus 11.2%, respectively; HR [95%CI]=0.74 [0.51, 1.07], p=0.11, pheterogeneity =0.52). However, EES significantly reduced the occurrence of ST (3.4% versus 6.1% respectively, HR [95%CI]=0.56 [0.32, 0.97], p=0.04, pheterogeneity =0.42) and target vessel revascularization (TVR) (14.2% versus 20.1%; HR [95%CI]=0.63 [0.42, 0.96], p=0.03, pheterogeneity =0.55). Landmark analysis showed more consistent benefits in ST with EES within 1year, whereas benefits in TVR were mostly observed later than 1year., Conclusions: The present pooled patient-level meta-analysis demonstrates that among STEMI patients undergoing primary PCI, EES as compared to 1st generation DES is associated with a significant reduction in ST and TVR at long-term follow-up., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)- Published
- 2017
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39. Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).
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Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vázquez N, Valdés M, Voudris V, Slagboom T, Goy JJ, den Heijer P, and van der Ent M
- Subjects
- Aged, Cardiovascular Agents adverse effects, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Coronary Thrombosis etiology, Coronary Thrombosis mortality, Everolimus adverse effects, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction etiology, Myocardial Infarction mortality, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prospective Studies, Prosthesis Design, Risk Factors, Sirolimus administration & dosage, Sirolimus adverse effects, Time Factors, Treatment Outcome, Absorbable Implants, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Drug-Eluting Stents, Everolimus administration & dosage, Percutaneous Coronary Intervention instrumentation, Polymers chemistry, Sirolimus analogs & derivatives
- Abstract
Objectives: This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention., Background: Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce., Methods: The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization., Results: Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17)., Conclusions: The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2017
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40. Everolimus-eluting bioresorbable vascular scaffolds for treatment of complex chronic total occlusions.
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Fam JM, Ojeda S, Garbo R, Latib A, La Manna A, Vaquerizo B, Boukhris M, Vlachojannis GJ, van Geuns RJ, Ezhumalai B, Kawamoto H, van der Sijde J, Felix C, Pan M, Serdoz R, Boccuzzi GG, De Paolis M, Sardella G, Mancone M, Tamburino C, Smits PC, Di Mario C, Seth A, Serra A, Colombo A, Serruys P, Galassi AR, Zijlstra F, Van Mieghem NM, and Diletti R
- Subjects
- Adult, Aged, Chronic Disease, Drug-Eluting Stents adverse effects, Female, Humans, Male, Middle Aged, Percutaneous Coronary Intervention methods, Registries, Tissue Scaffolds adverse effects, Treatment Outcome, Absorbable Implants, Coronary Artery Disease therapy, Coronary Occlusion therapy, Everolimus therapeutic use
- Abstract
Aims: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO)., Methods and Results: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score ≥2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73±0.43 mm. The mean scaffold length was 59.75±25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35±0.44 mm. Post-PCI minimal lumen diameter was 2.50±0.51 mm and percentage diameter stenosis 14.53±10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation., Conclusions: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.
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- 2017
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41. Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months.
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Felix CM, Vlachojannis GJ, IJsselmuiden AJJ, Fam JM, Smits PC, Lansink WJ, Diletti R, Zijlstra F, Regar ES, Boersma E, Onuma Y, and van Geuns RJM
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- Aged, Aspirin adverse effects, Cardiovascular Agents adverse effects, Clopidogrel, Coronary Thrombosis diagnosis, Coronary Thrombosis epidemiology, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Incidence, Male, Middle Aged, Netherlands epidemiology, Percutaneous Coronary Intervention adverse effects, Platelet Aggregation Inhibitors adverse effects, Prosthesis Design, Registries, Retrospective Studies, Risk Factors, Ticlopidine administration & dosage, Ticlopidine adverse effects, Time Factors, Treatment Outcome, Absorbable Implants, Aspirin administration & dosage, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible, Coronary Thrombosis prevention & control, Percutaneous Coronary Intervention instrumentation, Platelet Aggregation Inhibitors administration & dosage, Ticlopidine analogs & derivatives
- Abstract
Aims: The aim of this study was to investigate the impact of dual antiplatelet therapy (DAPT) termination on late and very late scaffold thrombosis (ScT) in patients treated with the Absorb bioresorbable vascular scaffold (BVS)., Methods and Results: Data from the registries of three centres were pooled (808 patients). To investigate the effect of DAPT termination on ScT after a minimum of six months, we selected a subgroup ("DAPT study cohort" with 685 patients) with known DAPT status >6 months and excluded the use of oral anticoagulants and early ScT. In this cohort, definite/probable ScT incidence for the period on DAPT was compared to ScT incidence after DAPT termination. ScT incidence was 0.83 ScT/100 py with 95% confidence interval (CI): 0.34-1.98. After DAPT termination, the incidence was higher (1.77/100 py; 95% CI: 0.66-4.72), compared to the incidence on DAPT (0.26/100 py, 95% CI: 0.04-1.86; p=0.12) and increased within the month after DAPT termination (6.57/100 py, 95% CI: 2.12-20.38; p=0.01). No very late ScT occurred in patients who continued on DAPT for a minimum of 18 months., Conclusions: The incidence of late and very late definite/probable ScT was acceptable. The incidence was low while on DAPT but potentially higher when DAPT was terminated before 18 months.
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- 2017
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42. Very Late Scaffold Thrombosis in Absorb BVS: Association With DAPT Termination?
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Felix CM, Vlachojannis GJ, IJsselmuiden AJ, Onuma Y, and van Geuns RJ
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- Coronary Artery Disease diagnostic imaging, Coronary Thrombosis diagnostic imaging, Coronary Thrombosis therapy, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Risk Factors, ST Elevation Myocardial Infarction etiology, Time Factors, Treatment Outcome, Absorbable Implants, Coronary Artery Disease surgery, Coronary Thrombosis etiology, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Platelet Aggregation Inhibitors administration & dosage
- Published
- 2017
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43. Biolimus-eluting versus everolimus-eluting stents in coronary artery disease: a pooled analysis from the NEXT (NOBORI biolimus-eluting versus XIENCE/PROMUS everolimus-eluting stent) and COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) randomised trials.
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Vlachojannis GJ, Puricel S, Natsuaki M, Morimoto T, Smits PC, and Kimura T
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- Adult, Aged, Aged, 80 and over, Everolimus administration & dosage, Female, Follow-Up Studies, Humans, Male, Middle Aged, Percutaneous Coronary Intervention methods, Sirolimus administration & dosage, Treatment Outcome, Coronary Artery Disease therapy, Drug-Eluting Stents, Everolimus therapeutic use, Myocardial Infarction therapy, Sirolimus therapeutic use
- Abstract
Aims: This study sought to investigate the safety and efficacy of a biolimus-eluting stent with biodegradable polymer (BP-BES) (Nobori; Terumo Corp.) compared to an everolimus-eluting stent with durable polymer (DP-EES) (XIENCE V or Prime; Abbott Vascular, or PROMUS; Boston Scientific)., Methods and Results: The all-comers NEXT and COMPARE II clinical trials randomly assigned 5,942 patients to BP-BES (N=3,412) or DP-EES (N=2,530). We conducted a patient level pooled analysis at three-year follow-up with specified study endpoints: definite stent thrombosis (ST), the combined safety endpoint cardiac death or target vessel myocardial infarction (TV-MI), and the efficacy endpoint target lesion revascularisation (TLR). At three-year follow-up, all endpoints, namely definite stent thrombosis (BP-BES 0.8% vs. 0.4%, p=0.20), death or TV-MI (BP-BES 7.8% vs. 6.7%, p=0.07), as well as TLR (BP-BES 6.4% vs. 6.4%, p=0.78) were similar between groups. Interestingly, unadjusted (BP-BES 5.6% vs. 4.5%, p=0.02) and adjusted (HR 1.36; 1.01-1.82, p=0.04) TV-MI rates were higher in the BP-BES group than in the DP-EES group., Conclusions: In this large-scale patient level pooled analysis of the NEXT and COMPARE II randomised trials, the use of BP-BES compared with DP-EES resulted in similar outcomes, but with an observed higher rate of TV-MI in the BP-BES group.
- Published
- 2017
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44. Coronary angiography after cardiac arrest: Rationale and design of the COACT trial.
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Lemkes JS, Janssens GN, Straaten HM, Elbers PW, van der Hoeven NW, Tijssen JG, Otterspoor LC, Voskuil M, van der Heijden JJ, Meuwissen M, Rijpstra TA, Vlachojannis GJ, van der Vleugel RM, Nieman K, Jewbali LS, Bleeker GB, Baak R, Beishuizen B, Stoel MG, van der Harst P, Camaro C, Henriques JP, Vink MA, Gosselink MT, Bosker HA, Crijns HJ, and van Royen N
- Subjects
- Adult, Humans, Intention to Treat Analysis, Out-of-Hospital Cardiac Arrest diagnostic imaging, Prospective Studies, Research Design, Time-to-Treatment, Coronary Angiography, Out-of-Hospital Cardiac Arrest therapy, Percutaneous Coronary Intervention
- Abstract
Background: Ischemic heart disease is a major cause of out-of-hospital cardiac arrest. The role of immediate coronary angiography (CAG) and percutaneous coronary intervention (PCI) after restoration of spontaneous circulation following cardiac arrest in the absence of ST-segment elevation myocardial infarction (STEMI) remains debated., Hypothesis: We hypothesize that immediate CAG and PCI, if indicated, will improve 90-day survival in post-cardiac arrest patients without signs of STEMI., Design: In a prospective, multicenter, randomized controlled clinical trial, 552 post-cardiac arrest patients with restoration of spontaneous circulation and without signs of STEMI will be randomized in a 1:1 fashion to immediate CAG and PCI (within 2 hours) versus initial deferral with CAG and PCI after neurological recovery. The primary end point of the study is 90-day survival. The secondary end points will include 90-day survival with good cerebral performance or minor/moderate disability, myocardial injury, duration of inotropic support, occurrence of acute kidney injury, need for renal replacement therapy, time to targeted temperature control, neurological status at intensive care unit discharge, markers of shock, recurrence of ventricular tachycardia, duration of mechanical ventilation, and reasons for discontinuation of treatment., Summary: The COACT trial is a multicenter, randomized, controlled clinical study that will evaluate the effect of an immediate invasive coronary strategy in post-cardiac arrest patients without STEMI on 90-day survival., (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Published
- 2016
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45. One-year results of the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) Study.
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Giustino G, Baber U, Mastoris I, Vlachojannis GJ, Yu J, Teirstein PS, Downey WE, Batchelor WB, Casterella PJ, Nikolsky E, Wong SC, Theodoropoulos KN, Dangas GD, and Mehran R
- Subjects
- Acute Kidney Injury diagnosis, Acute Kidney Injury mortality, Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary mortality, Coronary Angiography mortality, Coronary Artery Disease mortality, Disease Progression, Double-Blind Method, Female, Humans, Ioxaglic Acid analogs & derivatives, Kidney Failure, Chronic diagnosis, Kidney Failure, Chronic mortality, Male, Middle Aged, Myocardial Infarction etiology, Myocardial Infarction mortality, Predictive Value of Tests, Prospective Studies, Risk Factors, Time Factors, Treatment Outcome, Acute Kidney Injury chemically induced, Angioplasty, Balloon, Coronary adverse effects, Contrast Media adverse effects, Coronary Angiography adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Ioxaglic Acid adverse effects, Kidney Failure, Chronic complications, Triiodobenzoic Acids adverse effects
- Abstract
Background: Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear., Methods: The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes., Results: After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75)., Conclusions: The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted., (© 2015 Wiley Periodicals, Inc.)
- Published
- 2016
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46. Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice).
- Author
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Smits PC, Vlachojannis GJ, McFadden EP, Royaards KJ, Wassing J, Joesoef KS, van Mieghem C, and van de Ent M
- Subjects
- Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Female, Humans, Kaplan-Meier Estimate, Male, Metals, Middle Aged, Myocardial Infarction etiology, Netherlands, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prospective Studies, Prosthesis Design, Risk Factors, Single-Blind Method, Thrombosis etiology, Time Factors, Treatment Outcome, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Drug-Eluting Stents, Everolimus administration & dosage, Paclitaxel administration & dosage, Percutaneous Coronary Intervention instrumentation
- Abstract
Objectives: This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI)., Background: The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce., Methods: We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR)., Results: Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel., Conclusions: The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2015
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47. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial.
- Author
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Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vázquez N, Valdés M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, and van der Ent M
- Subjects
- Absorbable Implants, Aged, Coronary Thrombosis epidemiology, Everolimus chemistry, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Infarction epidemiology, Polymers chemistry, Treatment Outcome, Coronary Artery Disease surgery, Drug-Eluting Stents, Everolimus therapeutic use
- Abstract
Aims: The aim of this analysis was to compare the long-term safety and efficacy of the biodegradable polymer biolimus-eluting stent (BES) with that of the durable polymer everolimus-eluting stent (EES)., Methods and Results: The COMPARE II study was a prospective, randomised, multicentre, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BES or EES. The pre-specified endpoint at three years was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularisation (TVR). Moreover, the combined endpoint all-cause death or MI was analysed as a safety, and TVR as an efficacy measure. Three-year follow-up was available in 2,683 patients (99.1%). At three years, MACE occurred in 213 patients (11.9%) in the BES group and in 101 patients (11.1 %) in the EES group (p=0.57). The rate of the combined safety endpoint all-cause death or MI was 9.3% in the BES group vs. 8.4% (p=0.52), while the efficacy measure TVR was 7.6% in BES vs. 6.5% (p=0.27). Interestingly, definite stent thrombosis rates did not differ between groups (1.2% for BES vs. 0.8%, p=0.33)., Conclusions: At three-year follow-up, MACE as well as safety and efficacy measures including stent thrombosis were not statistically different between the biodegradable polymer-coated BES and the durable polymer-coated EES. ClinicalTrials.gov Identifier: NCT01233453.
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- 2015
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48. Long-Term Safety of Drug-Eluting and Bare-Metal Stents: Evidence From a Comprehensive Network Meta-Analysis.
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Palmerini T, Benedetto U, Biondi-Zoccai G, Della Riva D, Bacchi-Reggiani L, Smits PC, Vlachojannis GJ, Jensen LO, Christiansen EH, Berencsi K, Valgimigli M, Orlandi C, Petrou M, Rapezzi C, and Stone GW
- Subjects
- Drug-Eluting Stents adverse effects, Follow-Up Studies, Humans, Myocardial Infarction diagnosis, Myocardial Infarction epidemiology, Percutaneous Coronary Intervention adverse effects, Randomized Controlled Trials as Topic trends, Stents adverse effects, Stents trends, Thrombosis diagnosis, Thrombosis epidemiology, Time Factors, Treatment Outcome, Drug-Eluting Stents trends, Metals adverse effects, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention trends
- Abstract
Background: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety and efficacy of these devices are unknown. Many recent studies have now reported extended follow-up data., Objectives: This study sought to investigate the long-term safety and efficacy of durable polymer-based DES, bioabsorbable polymer-based biolimus-eluting stents (BES), and BMS by means of network meta-analysis., Methods: Randomized controlled trials comparing DES to each other or to BMS were searched through MEDLINE, EMBASE, and Cochrane databases and proceedings of international meetings. Information on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted., Results: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target-vessel revascularization were reduced with all DES compared with BMS, with cobalt-chromium EES, platinum chromium-EES, SES, and BES also having lower target-vessel revascularization rates than PES., Conclusions: After a median follow-up of 3.8 years, all DES demonstrated superior efficacy compared with BMS. Among DES, second-generation devices have substantially improved long-term safety and efficacy outcomes compared with first-generation devices., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2015
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49. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients – long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study.
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Saito S, Maehara A, Vlachojannis GJ, Parise H, and Mehran R
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- Combined Modality Therapy, Coronary Angiography, Coronary Restenosis diagnostic imaging, Coronary Restenosis epidemiology, Coronary Restenosis prevention & control, Heart Diseases mortality, Humans, Incidence, Japan epidemiology, Myocardial Infarction epidemiology, Myocardial Revascularization statistics & numerical data, Neointima diagnostic imaging, Neointima epidemiology, Neointima prevention & control, Platelet Aggregation Inhibitors therapeutic use, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Prospective Studies, Risk Factors, Sirolimus administration & dosage, Sirolimus adverse effects, Sirolimus therapeutic use, Treatment Outcome, Ultrasonography, Interventional, Coronary Stenosis surgery, Drug-Eluting Stents, Sirolimus analogs & derivatives
- Abstract
Background: This study evaluated the safety and efficacy of the RESOLUTE(TM)zotarolimus-eluting stent (R-ZES; Medtronic, Inc, Santa Rosa, CA, USA) in Japanese patients for the treatment of de novo native coronary lesions., Methods and Results: Both RESOLUTE Japan (R-Japan) and RESOLUTE Japan Small Vessel Study (R-Japan SVS) were prospective, multicenter, single-arm observational studies. R-Japan enrolled 100 patients (reference vessel diameter, 2.5-3.5 mm) and R-Japan SVS enrolled 65 patients (at least 1 lesion suitable for 2.25-mm stent) treated with R-ZES. In R-Japan, in-stent late lumen loss (LLL; the primary endpoint) at 8 months was 0.12 ± 0.22 mm and volume obstruction on intravascular ultrasound was 2.33 ± 3.51%. At 4 years, there were no cases of clinically driven target lesion revascularization (TLR); the target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, and clinically driven TLR) was 5.6% (5/90). In R-Japan SVS, in-stent LLL at 9 months was 0.27 ± 0.33 mm, TLF (primary endpoint) was 4.6% (3/65), without incidence of TLR. At 3 years, TLF was 7.9% (5/63) and clinically driven TLR, 3.2% (2/63)., Conclusions: R-Japan and R-Japan SVS demonstrate substantial suppression of neointimal hyperplasia, low LLL, and excellent and sustained long-term clinical outcome with R-ZES in Japanese patients.
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- 2015
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50. Effect of bivalirudin on aortic valve intervention outcomes study: a two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty.
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Kini A, Yu J, Cohen MG, Mehran R, Baber U, Sartori S, Vlachojannis GJ, Kovacic JC, Pyo R, O'Neill B, Singh V, Jacobs E, Poludasu S, Moreno P, Kim MC, Krishnan P, Sharma SK, and Dangas GD
- Subjects
- Aged, Aged, 80 and over, Anticoagulants adverse effects, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis mortality, Female, Florida, Hemorrhage chemically induced, Hemorrhage prevention & control, Heparin adverse effects, Hirudins adverse effects, Hospitals, High-Volume, Humans, Logistic Models, Male, Multivariate Analysis, Myocardial Infarction etiology, Myocardial Infarction mortality, New York City, Odds Ratio, Peptide Fragments adverse effects, Propensity Score, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Registries, Retrospective Studies, Risk Factors, Severity of Illness Index, Stroke etiology, Stroke mortality, Time Factors, Treatment Outcome, Anticoagulants therapeutic use, Aortic Valve Stenosis therapy, Balloon Valvuloplasty adverse effects, Balloon Valvuloplasty mortality, Heparin therapeutic use, Peptide Fragments therapeutic use
- Abstract
Aims: We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin., Methods and Results: We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08)., Conclusions: In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.
- Published
- 2014
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