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Background: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up., Aims: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up., Methods: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan-Meier methods, applying the log-rank test for between-group comparison., Results: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75-1.17], p log-rank  = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24-0.93], p log-rank  = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39-0.93], p log-rank  = 0.023)., Conclusions: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes., (© 2024 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background., Aims: To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1‑year clinical outcome after percutaneous coronary intervention., Methods: In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1 year., Results: Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had a positive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates., Conclusions: Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials., (© 2024. The Author(s).)

Aims: Patients with premature coronary artery disease (CAD) have a higher incidence of myocardial infarction (MI) than patients with non-premature CAD. The aim of the present study is to asess differences in clinical outcome after a first acute MI, percutaneously treated with new-generation drug-eluting stents between patients with premature and non-premature CAD., Methods and Results: We pooled and analysed the characteristics and clinical outcome of all patients with a first MI (and no previous coronary revascularization) at time of enrolment, in four large-scale drug-eluting stent trials. Coronary artery disease was classified premature in men aged <50 and women <55 years. Myocardial infarction patients with premature and non-premature CAD were compared. The main endpoint was major adverse cardiac events (MACE): all-cause mortality, any MI, emergent coronary artery bypass surgery, or clinically indicated target lesion revascularization. Of 3323 patients with a first MI, 582 (17.5%) had premature CAD. These patients had lower risk profiles and underwent less complex interventional procedures than patients with non-premature CAD. At 30-day follow-up, the rates of MACE [hazard ratio (HR): 0.22, 95% confidence interval (CI): 0.07-0.71; P = 0.005), MI (HR: 0.22, 95% CI: 0.05-0.89; P = 0.020), and target vessel failure (HR: 0.30, 95% CI: 0.11-0.82; P = 0.012) were lower in patients with premature CAD. At 1 year, premature CAD was independently associated with lower rates of MACE (adjusted HR: 0.50, 95% CI: 0.26-0.96; P = 0.037) and all-cause mortality (adjusted HR: 0.24, 95% CI: 0.06-0.98; P = 0.046). At 2 years, premature CAD was independently associated with lower mortality (adjusted HR: 0.16, 95% CI: 0.05-0.50; P = 0.002)., Conclusions: First MI patients with premature CAD, treated with contemporary stents, showed lower rates of MACE and all-cause mortality than patients with non-premature CAD, which is most likely related to differences in cardiovascular risk profile. TWENTE trials: TWENTE I, clinicaltrials.gov: NCT01066650), DUTCH PEERS (TWENTE II, NCT01331707), BIO-RESORT (TWENTE III, NCT01674803), and BIONYX (TWENTE IV, NCT02508714)., Competing Interests: Conflict of interest: C.v.B. reports that the research department of Thoraxcentrum Twente has received research grants provided by Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. R.L.A. reports a teaching grant from Biotronik, a license from Sanofi, a speaking fee from Abiomed and support from Amgen for attending a meeting, all outside the submitted work. All other authors declared that they have no conflict of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Early aspirin withdrawal, also known as P2Y 12 -inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI., Methods: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y 12 -inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT., Conclusions: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y 12 -inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS., Competing Interests: Disclosures Dr. Yolande Appelman has received a research grant from the Dutch Heart Foundation. Prof. dr. Jurriën M. ten Berg has received research grants from the ZonMw and speaker fees from Accumetrics, AstraZeneca, Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo, Eli Lilly, Ferrer, the Medicines Company and Pfizer. Dr. Peter Damman has received a research grant from AstraZeneca. Dr. Tim P. van de Hoef has received research grants and speaker fees and from Abbott and Philips. Dr. Bimmer E.P.M. Claessen has received speaker fees from Abiomed and consultancy fees from Amgen, Sanofi, Boston Scientific and Philips. Prof. dr. José P.S. Henriques has received research grants from Abbott Vascular, AstraZeneca, B. Braun, Getinge, Ferrer, Infraredx and ZonMw. All other authors have no relationships with industry to disclose., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: We assessed differences in risk profile and 3-year outcome between patients undergoing percutaneous coronary intervention (PCI) for premature and non-premature coronary artery disease (CAD)., Background: The prevalence of CAD increases with age, yet some individuals develop obstructive CAD at younger age., Methods: Among participants in four randomized all-comers PCI trials, without previous coronary revascularization or myocardial infarction (MI), we compared patients with premature (men <50 years; women <55 years) and non-premature CAD. Various clinical endpoints were assessed, including multivariate analyses., Results: Of 6,171 patients, 887 (14.4%) suffered from premature CAD. These patients had fewer risk factors than patients with non-premature CAD, but were more often smokers (60.7% vs. 26.4%) and overweight (76.2% vs. 69.8%). In addition, premature CAD patients presented more often with ST-segment elevation MI and underwent less often treatment of multiple vessels, and calcified or bifurcated lesions. Furthermore, premature CAD patients had a lower all-cause mortality risk (adj.HR: 0.23, 95%-CI: 0.10-0.52; p  < 0.001), but target vessel revascularization (adj.HR: 1.63, 95%-CI: 1.18-2.26; p  = 0.003) and definite stent thrombosis risks (adj.HR: 2.24, 95%-CI: 1.06-4.72; p  = 0.034) were higher. MACE rates showed no statistically significant difference (6.6% vs. 9.4%; adj.HR: 0.86, 95%-CI: 0.65-1.16; p  = 0.33)., Conclusions: About one out of seven PCI patients was treated for premature CAD. These patients had less complex risk profiles than patients with non-premature CAD; yet, their risk of repeated revascularization and stent thrombosis was higher. As lifetime event risk of patients with premature CAD is known to be particularly high, further efforts should be made to improve modifiable risk factors such as smoking and overweight., Twente Trials: (TWENTE I, clinicaltrials.gov: NCT01066650 ), DUTCH PEERS (TWENTE II, NCT01331707 ), BIO-RESORT (TWENTE III, NCT01674803 ), and BIONYX (TWENTE IV, NCT02508714 )., Competing Interests: CvB reports that the research department of Thoraxcentrum Twente has received research grants provided by Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. RLA reports a teaching grant from Biotronik, a license from Sanofi, a speaking fee from Abiomed and support from Amgen for attending a meeting, all outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Pinxterhuis, Ploumen, Zocca, Doggen, Schotborgh, Anthonio, Roguin, Danse, Benit, Aminian, Hartmann, Linssen and von Birgelen.)

Background: In patients with peripheral arterial disease (PADs), who underwent percutaneous coronary intervention (PCI), little is known about the potential impact of using different new-generation drug-eluting stents (DES) on outcome. In PCI all-comers, the results of most between-stent comparisons-stratified by strut thickness-suggested some advantage of coronary stents with ultrathin-struts. The current post-hoc analysis aimed to assess outcomes of PCI with ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) vs. thin-strut durable polymer zotarolimus-eluting stents (DP-ZES) in patients with PADs., Methods: We pooled 3-year patient-level data from two large-scale randomized all-comer trials to compare Orsiro ultrathin-strut BP-SES vs. Resolute-type thin-strut DP-ZES in trial participants with concomitant PADs. BIO-RESORT (December 2012 to August 2015) and BIONYX (October 2015 to December 2016) included all-comer patients who were aged 18 years or older, capable of providing informed consent, and required a PCI. The trials had web-based randomization, with block sizes of 4 and 8, performed in a 1:1:1 or 1:1 fashion. Assessors, research staff, and patients were blinded to the type of stent used. We assessed the composite main clinical endpoint target vessel failure [TVF: cardiac death, target vessel related myocardial infarction (MI), or clinically indicated target vessel revascularization (TVR)], its components, and stent thrombosis., Results: Of 4,830 trial participants, 360 had PADs: 177 (49.2%) were treated with BP-SES and 183 (50.8%) with DP-ZES. Baseline characteristics were similar. For BP-SES, the 3-year TVF rate was 11.0% and for DP-ZES 17.9% [hazard ratio (HR): 0.59, 95% CI: 0.33-1.04; P=0.07]. For BP-SES, the TVR rate was lower than for DP-ZES (4.1% vs. 11.0%; HR: 0.36, 95% CI: 0.15-0.86; P=0.016), but this did not translate into between-group differences in cardiac death or MI. In small vessels (<2.75 mm), the TVR rate was also lower in BP-SES (5.6% vs. 13.9%; HR: 0.32, 95% CI: 0.11-0.91; P=0.024). Definite-or-probable stent thrombosis rates were 1.2% and 2.3% (P=0.43)., Conclusions: In PCI patients with PADs, the 3-year TVF incidence was numerically lower in the ultrathin-strut BP-SES vs. the thin-strut DP-ZES group. Furthermore, TVR risk was significantly lower in ultrathin-strut BP-SES, mainly driven by a lower TVR rate in small vessels., Trial Registration: BIO-RESORT trial: clinicaltrials.gov ( NCT01674803 ); BIONYX trial: clinicaltrials.gov ( NCT02508714 )., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-22-584/coif). EHP reports that the Research Department of Thoraxcentrum Twente has received institutional research grants from these companies (Biotronik, Boston Scientific, and Medtronic) for performing the 2 RCTs on which the analyses of this manuscript are based. In addition, the Research Department of Thoraxcentrum Twente has received an institutional research grant for performing a stent study, not directly related with the content of the present manuscript. RLA reports a teaching grant from Biotronik, a license from Sanovi, a speaking fee from Abiomed and support from Amgen for attending a meeting, all outside the submitted work. CvB reports that the Research Department of Thoraxcentrum Twente has received institutional research grants from these companies (Biotronik, Boston Scientific, and Medtronic) for performing the 2 RCTs on which the analyses of this manuscript are based. In addition, the Research Department of Thoraxcentrum Twente has received an institutional research grant for performing a stent study, not directly related with the content of the present manuscript. The author is a DSMB member in a TAVI trial and a vascular surgical trial. The other authors have no conflicts of interest to declare., (2023 Cardiovascular Diagnosis and Therapy. All rights reserved.)

In this proof-of-principle trial, the hypothesis was investigated that sodium thiosulfate (STS), a potent antioxidant and hydrogen sulfide donor, reduces reperfusion injury. A total of 373 patients presenting with a first ST-segment elevation myocardial infarction received either 12.5 g STS intravenously or matching placebo at arrival at the hospital and 6 hours later. The primary outcome, infarct size, measured by cardiac magnetic resonance at 4 months after randomization, did not differ between the treatment arms. Secondary outcomes were comparable as well, suggesting no clinical benefit of STS in this population at relatively low risk for large infarction., Competing Interests: This study is supported by a grant of the Netherlands Organization for Health Research and Development and the Dutch Heart Foundation (ZonMW; project No: 95105012), Siemens health care GmbH (Push project IPA No.10), and the University Medical Centre Groningen. The subsidizers had no role in the design and conduct of the study, study analyses, drafting or editing of the manuscript, and its final contents. Dr Anthonio has received a Biotronic Teaching Grant, a Sanofi CTCue license for 1 year, and payment for Abiomed Impella Webcast; and Amgen paid for attendance at the New York Cardiovascular Symposium 2019. Dr van der Meer has received consultancy fees and/or grants from Novartis, Novo Nordisk, Vifor Pharma, AstraZeneca, Pfizer, Pharmacosmos, Pharma Nord and Ionis. Dr Nijveldt has received unrestricted research grants from Biotronik and Philips; and has received speaker fees from Sanofi Genzyme and Bayer. Dr Lipsic has received an educational grant from Abbott Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)

Background: Both patients with obstructive coronary artery disease (CAD) and patients with peripheral arterial disease (PADs) have an increased bleeding risk. Information is scarce on bleeding in CAD patients, treated with percutaneous coronary intervention (PCI), who have comorbid PADs. We assessed whether PCI patients with PADs have a higher bleeding risk than PCI patients without PADs. Furthermore, in PCI patients with PADs we evaluated the extent by which bleeding increased the risk of further adverse events., Methods: Three-year pooled patient-level data of two randomized PCI trials (BIO-RESORT, BIONYX) with drug-eluting stents were analyzed to assess mortality and the composite endpoint major adverse cardiac events (MACE: all-cause mortality, any myocardial infarction, emergent coronary artery bypass surgery, or target lesion revascularization)., Results: Among 5989 all-comer patients, followed for 3 years, bleeding occurred in 7.7% (34/440) with comorbid PADs and 5.0% (279/5549) without PADs (HR: 1.59, 95%CI: 1.11-2.23, p = 0.010). Of all PADs patients, those with a bleeding had significantly higher rates of all-cause mortality (HR: 4.70, 95%CI: 2.37-9.33, p < 0.001) and MACE (HR: 2.39, 95%CI: 1.23-4.31, p = 0.003). Furthermore, PADs patients with a bleeding were older (74.4 ± 6.9 vs. 67.4 ± 9.5, p < 0.001). After correction for age and other potential confounders, bleeding remained independently associated with all-cause mortality (adj.HR: 2.97, 95%CI: 1.37-6.43, p = 0.006) while the relation of bleeding with MACE became borderline non-significant (adj.HR: 1.85, 95%CI: 0.97-3.55, p = 0.06)., Conclusion: PCI patients with PADs had a higher bleeding risk than PCI patients without PADs. In PADs patients, bleeding was associated with all-cause mortality, even after adjustment for potential confounders., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background and Aims: A considerable number of patients who undergo percutaneous coronary intervention (PCI) also have peripheral arterial disease (PAD) - a signal of more advanced atherosclerosis. After bare metal and early-generation drug-eluting coronary stent implantation, PAD patients showed inferior outcome. As stents and medical treatment were further improved, we aimed to assess the impact of PAD on outcome of PCI with contemporary new-generation stents., Methods: We analyzed 3-year pooled patient-level data from 4 large-scale randomized new-generation stent trials to compare all-comer patients with and without (core lab-verified) history of symptomatic PAD, defined as obstructive lesions in peripheral locations including lower and upper extremities, carotid, vertebral, mesenteric and renal arteries. Main endpoint was target vessel failure: cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization., Results: Of all 9204 patients, 695 (7.6%) had a history of symptomatic PAD. They were older and had more often diabetes, renal failure, hypertension, hypercholesterolemia, and prior stroke. PAD was an independent risk factor for target vessel failure (adjusted-HR:1.42, 95%-CI:1.12-1.73, p = 0.001). Target vessel revascularization (adjusted-HR:1.37, 95%-CI:1.04-1.80, p = 0.026), death (adjusted-HR:1.52, 95%-CI:1.17-1.99, p = 0.002), and major adverse cardiovascular event risks (adjusted-HR:1.36, 95%-CI:1.13-1.64, p = 0.001) were also substantially higher., Conclusions: A history of symptomatic PAD still allows to simply identify patients with increased risk of unfavorable clinical outcome after PCI, including a higher risk of repeated coronary revascularization, despite using contemporary stents. In clinical practice, this knowledge about higher event risks of PAD patients is helpful both during Heart Team discussions and when informing patients about the procedural risk., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The current study aimed to evaluate changes in treatment delay and outcome for ST-segment elevation myocardial infarction (STEMI) in the Netherlands during the first coronavirus disease 2019 (COVID-19) outbreak, thereby comparing regions with a high and low COVID-19 hospitalisation rate., Methods: Clinical characteristics, STEMI timing variables, 30-day all-cause mortality and cardiovascular complications of all consecutive patients admitted for STEMI from 1 January to 30 June in 2020 and 2019 to six hospitals performing a high volume of percutaneous coronary interventions were collected retrospectively using data from the Netherlands Heart Registry, hospital records and ambulance report forms. Patient delay, pre-hospital delay and door-to-balloon time before and after the outbreak of COVID-19 were compared to the equivalent periods in 2019., Results: A total of 2169 patients were included. During the outbreak median total treatment delay significantly increased (2 h 51 min vs 2 h 32 min; p = 0.043) due to an increased patient delay (1 h 20 min vs 1 h; p = 0.030) with more late presentations > 24 h (1.1% vs 0.3%) in 2020. This increase was particularly evident during the peak phase of COVID-19 in regions with a high COVID-19 hospitalisation rate. During the peak phase door-to-balloon time was shorter (38 min vs 43 min; p = 0.042) than in 2019. All-cause 30-day mortality was comparable in both time frames (7.8% vs 7.3%; p = 0.797)., Conclusions: During the outbreak of COVID-19 patient delay caused an increase in total ischaemic time for STEMI, with a more pronounced delay in high-endemic regions, stressing the importance of good patient education during comparable crisis situations., (© 2022. The Author(s).)

Background: Ischemia and subsequent reperfusion cause myocardial injury in patients presenting with ST-segment elevation myocardial infarction (STEMI). Hydrogen sulfide (H 2 S) reduces "ischemia-reperfusion injury" in various experimental animal models, but has not been evaluated in humans. This trial will examine the efficacy and safety of the H 2 S-donor sodium thiosulfate (STS) in patients presenting with a STEMI., Study Design: The Groningen Intervention study for the Preservation of cardiac function with STS after STEMI (GIPS-IV) trial (NCT02899364) is a double-blind, randomized, placebo-controlled, multicenter trial, which will enroll 380 patients with a first STEMI. Patients receive STS 12.5 grams intravenously or matching placebo in addition to standard care immediately at arrival at the catheterization laboratory after providing consent. A second dose is administered 6 hours later at the coronary care unit. The primary endpoint is myocardial infarct size as quantified by cardiac magnetic resonance imaging 4 months after randomization. Secondary endpoints include the effect of STS on peak CK-MB during admission and left ventricular ejection fraction and NT-proBNP levels at 4 months follow-up. Patients will be followed-up for 2 years to assess clinical endpoints., Conclusions: The GIPS-IV trial is the first study to determine the effect of a H 2 S-donor on myocardial infarct size in patients presenting with STEMI., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Diabetes is associated with adverse outcomes after percutaneous coronary intervention with drug-eluting stents (DES), but for prediabetes this association has not been definitely established. Furthermore, in patients with prediabetes treated with contemporary stents, bleeding data are lacking. We assessed 3-year ischemic and bleeding outcomes following treatment with new-generation DES in patients with prediabetes and diabetes as compared to normoglycemia., Methods: For this post-hoc analysis, we pooled patient-level data of the BIO-RESORT and BIONYX stent trials which both stratified for diabetes at randomization. Both trials were multicenter studies performed in tertiary cardiac centers. Study participants were patients of whom glycemic state was known based on hemoglobin A1c, fasting plasma glucose, or medically treated diabetes. Three-year follow-up was available in 4212/4330 (97.3 %) patients. The main endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization., Results: Baseline cardiovascular risk profiles were progressively abnormal in patients with normoglycemia, prediabetes, and diabetes. The main endpoint occurred in 54/489 patients with prediabetes (11.2 %) and 197/1488 with diabetes (13.7 %), as compared to 142/2,353 with normoglycemia (6.1 %) (HR: 1.89, 95 %-CI 1.38-2.58, p < 0.001, and HR: 2.30, 95 %-CI 1.85-2.86, p < 0.001, respectively). In patients with prediabetes, cardiac death and target vessel revascularization rates were significantly higher (HR: 2.81, 95 %-CI 1.49-5.30, p = 0.001, and HR: 1.92, 95 %-CI 1.29-2.87, p = 0.001), and in patients with diabetes all individual components of the main endpoint were significantly higher than in patients with normoglycemia (all p ≤ 0.001). Results were consistent after adjustment for confounders. Major bleeding rates were significantly higher in patients with prediabetes and diabetes, as compared to normoglycemia (3.9 % and 4.1 % vs. 2.3 %; HR:1.73, 95 %-CI 1.03-2.92, p = 0.040, and HR:1.78, 95 %-CI 1.23-2.57, p = 0.002). However, after adjustment for confounders, differences were no longer significant., Conclusions: Not only patients with diabetes but also patients with prediabetes represent a high-risk population. After treatment with new-generation DES, both patient groups had higher risks of ischemic and bleeding events. Differences in major bleeding were mainly attributable to dissimilarities in baseline characteristics. Routine assessment of glycemic state may help to identify patients with prediabetes for intensified management of cardiovascular risk factors., Trial Registration: BIO-RESORT ClinicalTrials.gov: NCT01674803, registered 29-08-2012; BIONYX ClinicalTrials.gov: NCT02508714, registered 27-7-2015., (© 2021. The Author(s).)

Objectives: To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents., Background: In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx., Methods: This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods., Results: Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; p log-rank  = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, p log-rank  = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; p log-rank  = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053)., Conclusions: Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: To assess long-term safety and efficacy of the Xposition S self-apposing stent in the treatment of unprotected left main coronary artery (ULMCA) disease., Background: Percutaneous intervention with stents has emerged as a valid alternative to surgical revascularization to treat ULMCA disease. Conventional balloon-expandable stents face technical challenges, particularly in large left main diameter requiring extensive optimization and side branch access in distal bifurcation. Xposition S allows for optimal apposition, bridging diameter differences, and allows expansion to vessel diameters up to 6.0 mm., Methods: Between June 2016 and July 2017, 205 patients were enrolled in this international, prospective, multicenter registry. Patients with SYNTAX score ≥ 33 or recent STEMI were excluded. IVUS during procedure was performed in a prespecified subgroup of 50 patients. The primary clinical endpoint was 12 months Target lesion failure (TLF) and the primary efficacy endpoint was angiographic success., Results: Distal left main bifurcation was involved in 92.7%, treated with provisional approach in most cases (79.4%). TLF rate at 12 months was 8.3%, which was defined as a composite of cardiac death (2.0%), target-vessel MI (2.9%), and TLR (5.4%). Most revascularizations occurred at SB ostium. IVUS analysis demonstrated optimal stent apposition with only one reported malapposition and promising poststenting minimal stent area measures., Conclusions: The TRUNC study confirms that Xposition S self-apposing stent is a valid and feasible option for the treatment of ULMCA disease. Such results were reached without the systematic need of stent optimisation techniques, focusing mainly on lesion treatment., (© 2019 Wiley Periodicals, Inc.)

Worldwide, a myocardial infarction (MI) is an important cause of death. Acute MI occurs most commonly at an older age. However, the incidence of acute MI in adolescents is increasing. This is partly due to an increase in cardiovascular risk factors (e.g. smoking, unhealthy diet), which might lead to premature atherosclerosis. However, several non-atherosclerotic causes of MI in adolescents are also described in the literature, such as vascular spasm due to the use of cocaine. We may assume that acute MI is not considered to be the most likely cause of chest pain in adolescents. Therefore, the risk of a dramatic outcome in this patient category may be significant. This point of view article addresses the pathophysiological process and subsequent diagnostic approach in adolescents with MI resulting from either premature atherosclerosis or of non-atherosclerotic causes. Insight into the potential operational mechanisms of the coronary artery incident may have a major impact on the clinical course following admission. We would like to underline that a personalised clinical approach remains of utmost importance in each patient treated by protocolised medicine. This is particularly true when acute MI occurs at a young age, since the underlying cause more frequently differs from the conventional atherosclerotic process in this patient category.

Background: During the past decade, many patients had zotarolimus-eluting stents implanted, which had circular shape cobalt-chromium struts with limited radiographic visibility. The Resolute Onyx stent was developed to improve visibility while reducing strut thickness, which was achieved by using a novel composite wire with a dense platinum-iridium core and an outer cobalt-chromium layer. We did the first randomised clinical trial to assess the safety and efficacy of this often-used stent compared with the Orsiro stent, which consists of ultrathin cobalt-chromium struts., Methods: We did an investigator-initiated, assessor-blinded and patient-blinded, randomised non-inferiority trial in an allcomers population at seven independently monitored centres in Belgium, Israel, and the Netherlands. Eligible participants were aged 18 years or older and required percutaneous coronary intervention with drug-eluting stents. After guide wire passage with or without predilation, members of the catheterisation laboratory team used web-based computer-generated allocation sequences to randomly assign patients (1:1) to either the Resolute Onyx or the Orsiro stent. Randomisation was stratified by sex and diabetes status. Patients and assessors were masked to allocated stents, but treating clinicians were not. The primary endpoint was target vessel failure at 1 year, a composite of cardiac death, target-vessel-related myocardial infarction, and target vessel revascularisation, and was assessed by intention to treat (non-inferiority margin 2·5%) on the basis of outcomes adjudicated by an independent event committee. This trial is registered with ClinicalTrials.gov, number NCT02508714., Findings: Between Oct 7, 2015, and Dec 23, 2016, 2516 patients were enrolled, 2488 of whom were included in the intention-to-treat analysis (28 withdrawals or screening failures). 1243 participants were assigned to the Resolute Onyx group, and 1245 to the Orsiro group. Overall, 1765 (70·9%) participants presented with acute coronary syndromes and 1275 (51·2%) had myocardial infarctions. 1-year follow-up was available for 2478 (99·6%) patients. The primary endpoint was met by 55 (4·5%) patients in the Resolute Onyx group and 58 (4·7%) in the Orsiro group. Non-inferiority of Resolute Onyx to Orsiro was thus established (absolute risk difference -0·2% [95% CI -1·9 to 1·4]; upper limit of the one-sided 95% CI 1·1%; p non-inferiority =0·0005). Definite or probable stent thrombosis occurred in one (0·1%) participant in the Resolute Onyx group and nine (0·7%) in the Orsiro group (hazard ratio 0·11 [95% CI 0·01-0·87]; p=0·0112)., Interpretation: The Resolute Onyx stent was non-inferior to Orsiro for a combined safety and efficacy endpoint at 1-year follow-up in allcomers. The low event rate in both groups suggests that both stents are safe, and the very low rate of stent thrombosis in the Resolute Onyx group warrants further clinical investigation., Funding: Biotronik and Medtronic., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Introduction and Objectives: In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI., Methods: The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non-ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization., Results: Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non-ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56)., Conclusions: Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting., (Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Objectives: This study sought to assess sex differences in chest pain after percutaneous coronary intervention (PCI) with newer generation drug-eluting stents (DES)., Background: Sex-based data on chest pain after PCI with DES are scarce., Methods: The authors performed a patient-level pooled analysis of the TWENTE and DUTCH PEERS randomized trials, in which patients were treated with newer generation permanent polymer-coated DES. At 1 and 2 years, clinical follow-up was available in 99.8% and patient-reported chest pain data in 94.1% and 93.6%, respectively., Results: Among all 3,202 patients, the 871 (27.2%) women were older (67.5 ± 10.2 years vs. 62.8 ± 10.6 years; p < 0.001) and had more cardiovascular risk factors: diabetes (24.2% vs. 17.8%; p < 0.001), hypertension (63.6% vs. 51.6%; p < 0.001), and positive family history (54.5% vs. 50.1%; p = 0.03). At 1- and 2-year follow-up, women reported more clinically relevant chest pain (16.3% vs. 10.5%; p < 0.001, and 17.2% vs. 11.1%; p < 0.001, respectively). Multivariate analysis demonstrated that female sex independently predicted clinically relevant chest pain at 1- and 2-year follow-up both during daily activities and at minimum physical exertion/at rest (1 year adjusted odds ratio [OR]: 1.7; 95% confidence interval [CI]: 1.2 to 2.4; p = 0.002; and adjusted OR: 1.8; 95% CI: 1.3 to 2.5; p < 0.001; 2-year adjusted OR: 1.8; 95% CI: 1.3 to 2.6; p < 0.001; and adjusted OR: 1.7; 95% CI: 1.3 to 2.3; p = 0.001). Nevertheless, the 2-year rates of death, myocardial infarction, revascularization, stent thrombosis, and various composite clinical endpoints were similar for both sexes., Conclusions: Although the incidence of adverse cardiovascular events was low and similar for both sexes, women showed a statistically significantly higher prevalence of clinically relevant chest pain, which might be largely related to mechanisms other than epicardial coronary obstruction., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts)., Background: For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce., Methods: The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations., Results: The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03)., Conclusions: During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Primary percutaneous coronary intervention (PCI) is a widely practised therapeutic procedure to treat ST-elevation myocardial infarction (STEMI). However, a significant proportion of patients undergoing primary PCI suffers from adverse events, such as incomplete myocardial reperfusion. It is currently unknown to which degree these adverse events are operator related., Methods and Results: We investigated inter-operator variation using objective safety and efficacy endpoints during primary PCI for STEMI. All PCIs were performed by six experienced interventional cardiologists as part of a randomised single centre trial. The primary endpoint of this study was optimal myocardial reperfusion (myocardial blush grade 3 [MBG]). All 1,071 patients enrolled in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) were included in this analysis. In the six operator groups, the rate of the primary endpoint MBG 3 ranged between 29.2% and 55.5%. The variable for operators remained significantly associated with MBG 3 after adjustment for baseline and procedural differences. There were no statistical differences observed with regard to safety endpoints., Conclusions: This study illustrates the observation that even in a controlled setting significant inter-operator variation may exist in the efficacy of primary PCI. This study supports the routine collection of high-quality datasets to evaluate and improve individual operator competence and skills.

Introduction: Aorto-ostial stenting remains one of the most demanding and risky types of angioplasty to perform. We report a case outlining a creative solution for the reengagement of a protruding aorto-ostial stent., Case Presentation: A 69-year-old Caucasian man was admitted to our hospital's coronary care unit with progressive unstable angina five years following coronary artery bypass grafting and three years after percutaneous coronary intervention of the graft. Several attempts to engage the protruding part of the aorto-ostial stent in the graft failed. A catheter was eventually floated towards the protruding part using a wire to moor the catheter to the stent through the side-strut. The proximal part of the protruding stent was subsequently crushed with a new stent. Stent patency was observed 12 months after the procedure was performed., Conclusion: Although careful cannulation of a aorto-ostial stent during repeat coronary angiography coupled with the placement of a guidewire and stent through the true stent lumen during repeat intervention remains the ideal approach for aorto-ostial in-stent restenosis, this case report confirms the feasibility of the side-strut stenting technique in reaching a long-term positive outcome.

Background: Coronary microvascular dysfunction is frequently seen in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention. Previous studies have suggested that the administration of intravenous adenosine resulted in an improvement of myocardial perfusion and a reduction in infarct size. Intracoronary adenosine (bolus of 30 to 60 microg) is a guideline-recommended therapy to improve myocardial reperfusion. The effect of intracoronary adenosine during primary percutaneous coronary intervention has not been investigated in a large randomized trial., Methods and Results: Patients presenting with acute ST-elevation myocardial infarction were randomized to 2 bolus injections of intracoronary adenosine (2 x 120 microg in 20 mL NaCl) or placebo (2 x 20 mL NaCl). The first bolus injection was given after thrombus aspiration and the second after stenting of the infarct-related artery. The primary end point was the incidence of residual ST-segment deviation <0.2 mV, 30 to 60 minutes after percutaneous coronary intervention. Secondary end points were ST-segment elevation resolution, myocardial blush grade, Thrombolysis in Myocardial Infarction flow on the angiogram after percutaneous coronary intervention, enzymatic infarct size, and clinical outcome at 30 days. A total of 448 patients were randomized to intracoronary adenosine (N=226) or placebo (N=222). The incidence of residual ST-segment deviation <0.2 mV did not differ between patients randomized to adenosine or placebo (46.2% versus 52.2%, P=NS). In addition, there were no significant differences in secondary outcome measures., Conclusions: In this randomized placebo controlled trial enrolling 448 patients with ST-elevation myocardial infarction, administration of intracoronary adenosine after thrombus aspiration and after stenting of the infarct-related artery did not result in improved myocardial perfusion.

Clinical decision making in intervention cardiology often depends on information about the presence of myocardial viability and the extent of ischemia. Especially in the case of an occluded collaterally filled coronary branch, online decision making in selected patients may accelerate and improve patient care. The electromechanical NOGA mapping system offers the opportunity for online viability assessment. We describe two cases in which this diagnostic tool was used during daily practice. In our opinion, NOGA mapping can be helpful for 'online' viability evaluation in patients with an occluded collaterally filled coronary artery. In these patients, noninvasive viability evaluation may cause unnecessary delay in the overall treatment approach.

Aorto-ostial disease is difficult to approach percutaneously; therefore, a surgical option may be more desirable. We describe a case of an octogenarian in which the clinical arguments and technical approach have been summarised for a successful percutaneous therapeutic strategy. (Neth Heart J 2009;17:30-2.).

Objectives: To investigate the feasibility and safety of manual thrombus aspiration in patients undergoing percutaneous coronary intervention (PCI) for non-ST-elevation myocardial infarction (NSTEMI)., Background: Myocardial necrosis in patients with acute coronary syndromes may be a sign of microvascular obstruction, owing to spontaneous or PCI-induced embolization of atherothrombotic material. Manual thrombus aspiration results in improved myocardial reperfusion in patients undergoing PCI for ST-elevation myocardial infarction. Currently, no published data on thrombus aspiration in patients with NSTEMI are available., Methods: As part of a prospective cohort study, 70 patients undergoing PCI for NSTEMI were treated with thrombus aspiration (Export Aspiration Catheter, Medtronic, Minneapolis, MN). Histopathological analysis was performed on aspirated material., Results: Thrombus aspiration was effective in 58 patients (83%) and resulted in a marked reduction of TIMI-thrombus score 4/5 (40% pre- versus 7% postthrombus aspiration) and increase of the rate of TIMI-flow 3 (36% pre- versus 66% postthrombus aspiration). The incidence of myocardial blush grade 2 and 3 were 39 and 45%, respectively. Distal embolization was visible in three patients (4%) on the final angiogram., Conclusion: This study demonstrates that thrombus aspiration in most NSTEMI patients is feasible and safe and is associated with a high rate of retrieval of thrombotic material., (Copyright 2008 Wiley-Liss, Inc.)

Aims: To investigate the influence of interlead distance and lead positioning on success of cardiac resynchronization therapy (CRT) in patients with advanced chronic heart failure and electrical dyssynchrony. Despite application of established selection criteria, 20-40% of the patients do not respond to CRT., Methods and Results: We examined consecutive patients in whom CRT was implanted. Response to CRT was defined as a decrease in the left ventricular end-systolic volume >or=10% after 6 months. A comparison was made between patients who were responders to CRT and those who were non-responders. A univariate and stepwise multivariate logistic regression was performed with regard to predictors for response. Between January 2004 and January 2008, 174 patients who were treated with CRT were classified as responders [n = 95 (55%)] or non-responders [n = 79 (45%)]. Responders had a significantly larger horizontal interlead distance on the lateral thoracic X-ray [odds ratio (OR) 2.8 (1.2-6.6), P = 0.01], a septal-to-lateral delay >60 ms [OR 4.9 (2.0-11.4), P < 0.0001], non-ischaemic cardiomyopathy [OR 3.0 (1.3-6.9), P = 0.009], a left ventricular end-diastolic diameter <67 mm [OR 4.2 (1.8-9.9), P = 0.001], angiotensin-converting enzyme inhibitor use [OR 8.1 (1.7-38.2), P = 0.008], and no tricuspid valve insufficiency [OR 6.9 (1.3-35.5), P = 0.02]. Post-implantation responders had a significantly greater decrease in the intraventricular delay (septal-to-lateral delay 62 +/- 62 vs. 26 +/- 65 ms, P = 0.001), but not in the interventricular mechanical delay., Conclusion: Larger interlead distance on the lateral thoracic X-ray, associated with positioning of the left ventricular lead in the posterior position, is associated with response after 6 months of follow-up. Furthermore, diminishing the septal-to-lateral delay is predictive for response.

Background: Identifying the risk for restenosis is of critical importance in the stent selection process of patients undergoing percutaneous coronary intervention (PCI). Therefore, we sought to determine if a history of clinical recurrence (CR) after PCI increases the risk of CR after treatment of a de novo lesion in another coronary artery., Methods: We retrospectively analysed all 12,763 patients who underwent PCI between 1993 and 2004 and selected patients with two or more interventions in two different native vessels. These patients were divided into two groups: patients without CR, and patients with CR after the first PCI. Clinical recurrence was defined as revascular-isation of the target vessel by either PCI or CABG within one year., Results: A total of 1010 patients with two or more interventions in two different native vessels were identified: 727 patients without and 283 patients with CR after the first PCI. Baseline patient characteristics and conventional risk factors were comparable between the two groups. Patients with a history of CR had a higher risk of CR after a second intervention in a second vessel (OR=3.4, 95% CI=2.3 to 4.9). A total of 112 patients also had a third intervention in a third native vessel: 12 patients with two CR, 30 patients with one CR and 70 patients with no CR after the first two interventions. CR rates in these patients were 50, 17 and 3%, respectively (p<0.001)., Conclusion: Patients with a history of CR have a markedly increased risk of developing CR after a second or third PCI in a different coronary artery. Therefore, in the decision-making process on whether to use a bare metal stent or drug-eluting stent, the history of CR is a simple and powerful aid. (Neth Heart J 2008;16:376-81.).

Objectives: The objective of this study was to compare 2 manual thrombus aspiration catheters in unselected patients with ST-segment elevation myocardial infarction., Background: Distal embolization is common during percutaneous coronary intervention in ST-segment elevation myocardial infarction and can induce impaired myocardial perfusion. Several aspiration thrombectomy devices have been introduced to prevent distal embolization, however, with conflicting clinical results. Currently, it is unclear to what extent this variance in outcome can be explained by device-related factors, such as internal lumen size., Methods: We performed a prospective cohort study in which patients undergoing primary percutaneous coronary intervention were treated with a large-internal-lumen catheter (Diver, Invatec, Roncadelle, Italy). Outcomes were compared with a matched population of the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) trial, in which patients were treated with a medium-sized catheter (Export, Medtronic, Minneapolis, Minnesota). A histopathological analysis was performed of retrieved material., Results: A total of 160 patients, treated with the Diver (n = 80) or Export (n = 80) aspiration catheter, were enrolled. Effective thrombus aspiration was seen in 70.3% of the patients treated with the Diver catheter versus 81.8% with the Export catheter (p = 0.10) No significant difference was found in myocardial blush grade or electrocardiographic outcome between the 2 devices. Size distribution of retrieved thrombotic particles was similar per device. Erythrocyte-rich thrombi were found in 34.8% of the cases and were predominately seen in patients with low initial Thrombolysis In Myocardial Infarction flow grade (p = 0.008)., Conclusions: A larger internal lumen diameter does not result in retrieval of larger thrombotic particles, nor in improved angiographic or electrocardiographic outcomes.

Background: Primary percutaneous coronary intervention (PCI) is effective in opening the infarct-related artery in patients with myocardial infarction with ST-segment elevation. However, the embolization of atherothrombotic debris induces microvascular obstruction and diminishes myocardial reperfusion., Methods: We performed a randomized trial assessing whether manual aspiration was superior to conventional treatment during primary PCI. A total of 1071 patients were randomly assigned to the thrombus-aspiration group or the conventional-PCI group before undergoing coronary angiography. Aspiration was considered to be successful if there was histopathological evidence of atherothrombotic material. We assessed angiographic and electrocardiographic signs of myocardial reperfusion, as well as clinical outcome. The primary end point was a myocardial blush grade of 0 or 1 (defined as absent or minimal myocardial reperfusion, respectively)., Results: A myocardial blush grade of 0 or 1 occurred in 17.1% of the patients in the thrombus-aspiration group and in 26.3% of those in the conventional-PCI group (P<0.001). Complete resolution of ST-segment elevation occurred in 56.6% and 44.2% of patients, respectively (P<0.001). The benefit did not show heterogeneity among the baseline levels of the prespecified covariates. At 30 days, the rate of death in patients with a myocardial blush grade of 0 or 1, 2, and 3 was 5.2%, 2.9%, and 1.0%, respectively (P=0.003), and the rate of adverse events was 14.1%, 8.8%, and 4.2%, respectively (P<0.001). Histopathological examination confirmed successful aspiration in 72.9% of patients., Conclusions: Thrombus aspiration is applicable in a large majority of patients with myocardial infarction with ST-segment elevation, and it results in better reperfusion and clinical outcomes than conventional PCI, irrespective of clinical and angiographic characteristics at baseline. (Current Controlled Trials number, ISRCTN16716833.), (Copyright 2008 Massachusetts Medical Society.)

Revascularisation strategies for acute myocardial infarction have evolved from early admission to coronary care units, bed rest and cardiac rhythm monitoring, to thrombolytic therapy and primary angioplasty. Although mechanical intervention for a failed prior revascularisation attempt is common widespread clinical practice, the outcome of this two-step modality may yet be an issue of debate. The available evidence is selected and reviewed within a clinical reference framework. This enables the presentation of a practical model for all stakeholders participating in cardiovascular care.

Objectives: To investigate the incidence and angiographic predictors of functional collateral perfusion in patients with stable coronary artery disease, scheduled for elective PCI., Background: Functional collateral perfusion is defined as a Pw/Pa ratio>or=0.24. Since this can only be measured intracoronary, it is important to investigate baseline clinical and angiographic predictors for functional collateral perfusion., Methods: Collateral perfusion was measured during balloon inflation, with the use of a pressure-monitoring guide wire. Baseline clinical and angiographic characteristics were analyzed and collateral grading was done according to Rentrop's classification for coronary angiograms., Results: Functional collateral perfusion was found in 40 of the 89 patients (45%). Angiographic signs of collaterals (Rentrop>or=1) were present in 15 of the 89 patients. Of the 40 patients with the functional collateral perfusion 11 patients (28%) had Rentrop>or=1; of the 49 patients without functional collaterals there were 4 patients with Rentrop>or=1 (8%) (P=0.02). There were no significant differences in baseline clinical characteristics or in other angiographic characteristics., Conclusions: In patients with stable coronary artery disease scheduled for elective PCI, 45% have functional collaterals. Rentrop's angiographic classification can be used to predict the presence or absence of functional collaterals, however with a rather modest positive and negative predictive value., (Copyright (c) 2007 Wiley-Liss, Inc.)

Background: Electrical neurostimulation can be used to treat patients with refractory angina, it reduces angina and ischemia. Previous data have suggested that electrical neurostimulation may alleviate myocardial ischaemia through increased collateral perfusion. We investigated the effect of electrical neurostimulation on functional collateral perfusion, assessed by distal coronary pressure measurement during acute coronary occlusion. We sought to study the effect of electrical neurostimulation on collateral perfusion., Methods: Sixty patients with stable angina and significant coronary artery disease planned for elective percutaneous coronary intervention were split in two groups. In all patients two balloon inflations of 60 seconds were performed, the first for balloon dilatation of the lesion (first episode), the second for stent delivery (second episode). The Pw/Pa ratio (wedge pressure/aortic pressure) was measured during both ischaemic episodes. Group 1 received 5 minutes of active neurostimulation before plus 1 minute during the first episode, group 2 received 5 minutes of active neurostimulation before plus 1 minute during the second episode., Results: In group 1 the Pw/Pa ratio decreased by 10 +/- 22% from 0.20 +/- 0.09 to 0.19 +/- 0.09 (p = 0.004) when electrical neurostimulation was deactivated. In group 2 the Pw/Pa ratio increased by 9 +/- 15% from 0.22 +/- 0.09 to 0.24 +/- 0.10 (p = 0.001) when electrical neurostimulation was activated., Conclusion: Electrical neurostimulation induces a significant improvement in the Pw/Pa ratio during acute coronary occlusion.

Purpose: The purpose of this study is to assess the diagnostic accuracy of 64-MDCT in symptomatic patients after CABG and to explore the advantages of the 64-MDCT results on the CAG procedure., Material and Methods: From December 2004 until August 2005, 34 post-CABG patients (29 men, mean age 63.5 +/- 8.5 years) with 69 coronary artery bypass grafts were scanned on a 64-MDCT (Somatom Sensation 64, Siemens AG, Forchheim, Germany) prior to CAG. Angiograms and 64-MDCT images were evaluated for the existence of occlusions or significant stenosis (>or=50% lumen reduction) in bypass grafts and native coronary arteries., Results: 64-MDCT had a sensitivity, a specificity, and a diagnostic accuracy of 100% for occlusion detection. For stenosis detection, sensitivity was 100%, specificity 98.7% and diagnostic accuracy 98.7%. For detecting significant stenosis in native coronary arteries, 64-MDCT had a sensitivity of 80.0%, specificity of 90.8%, and a diagnostic accuracy of 87.1%. Seventeen patients (50.0%) did not need invasive treatment, 14 patients (41.2%) underwent a percutaneous coronary intervention (PCI), and 3 patients (8.8%) underwent surgery. Treatment advice based on 64-MDCT was correct in 88.2% of patients and when 64-MDCT results would have been known 58.8% of diagnostic CAG procedures could have been prevented., Conclusion: In conclusion, 64-MDCT has a high diagnostic accuracy in detecting bypass graft stenosis and occlusions, and 64-MDCT based treatment advice was correct in 88.2% of patients.

Aim: The objective of this study was to investigate whether persistent atrial fibrillation (AF) and new-onset AF are associated with appropriate shocks, cardiovascular mortality, chronic heart failure (CHF), and inappropriate shocks in implantable cardioverter defibrillator (ICD) patients with left ventricular dysfunction., Methods: We included 290 consecutive ICD patients with a documented left ventricular ejection fraction < or = 0.35 and compared outcomes between patients without AF (n = 207), those with persistent AF (n = 64), and those with new-onset AF (n = 19)., Results: The patients with persistent AF were older, more frequently had valve disease and cardiac surgery, and less frequently had coronary artery disease as compared with the patients without AF. Patients with persistent AF had a higher New York Heart Association class, however, left ventricular ejection fraction rates between these 2 groups were comparable (0.28 +/- 0.07 vs 0.29 +/- 0.08, P = not significant). No difference was found between patients with new-onset AF and those without AF. During follow-up (2.6 +/- 1.9 years), more patients with persistent AF received appropriate ICD shocks as compared with those without AF (24 [38%] vs 49 [24%], P = .04). Deterioration of CHF occurred more often in patients with persistent AF (19 [30%], P = .001) and those with new-onset AF (9 [47%], P < .001) as compared with patients without AF (31 [14%]). Multivariate analysis revealed that patients with persistent AF had an increased risk for appropriate ICD shocks (adjusted hazard ratio [HR] 1.9, 95% CI 1.2-3.2, P = .009). Persistent AF (adjusted HR 2.1, 95% CI 1.1-3.9, P = .03) and new-onset AF (adjusted HR 2.5, 95% CI 1.1-5.7, P = .02) were found to be independent risk indicators of CHF deterioration., Conclusions: In ICD patients with left ventricular dysfunction, persistent AF is associated with appropriate ICD shocks and deterioration of CHF. New-onset AF is related to deterioration of CHF.

Background: Right ventricular (RV) pacing in implantable cardioverter-defibrillator (ICD) patients may have detrimental effects on morbidity and mortality, in particular by inducing heart failure (HF)., Objective: We investigated whether RV pacing increases the risk of HF in an asymptomatic ICD population., Methods: We evaluated all patients without symptomatic HF who received an ICD. The primary endpoint was the occurrence of HF, which was defined as new HF, hospitalization for HF, or death due to HF. The secondary endpoint was appropriate shocks., Results: The study population consisted of 456 patients with mean left ventricular ejection fraction (LVEF) 40% +/- 13%. Mean follow-up was 31 +/- 22 months. Because of the bimodal distribution of pacing, patients were divided into two groups: paced 50% (median 96%; n = 143). HF occurred more often in the paced >50% group (20% versus 9%; P <.001). Multivariate analysis identified RV pacing >50% (adjusted hazard ratio [HR] 1.85; 95% confidence interval [CI] 1.08-3.15; P = .03), baseline LVEF <26% (adjusted HR 3.15; 95% CI 1.77-5.59; P <.001), angina pectoris, history of atrial fibrillation, and baseline diuretic use as independent predictors of HF. RV pacing caused more HF events in patients with LVEF <26% (n = 64; 55% of paced >50% patients versus 20% of paced 50% also independently predicted appropriate shocks (adjusted HR 1.50; 95% CI 1.02-2.20; P = .04)., Conclusion: RV pacing was associated with an increased risk of HF in asymptomatic ICD patients, particularly in those with preexistent left ventricular dysfunction.

Aims: Atrial fibrillation (AF) is often present in patients with left ventricular dysfunction who receive an implantable cardioverter-defibrillator (ICD). The purpose of this study was to investigate whether AF is associated with appropriate shocks and cardiovascular mortality in primary prevention ICD patients with left ventricular dysfunction., Methods and Results: We included 80 primary prevention ICD patients with left ventricular dysfunction and compared the outcome between patients with a history of AF (n=29) and patients with no history of AF (n=51). The primary endpoint was occurrence of appropriate shocks. Secondary endpoints were: (1) the composite of cardiovascular mortality/appropriate shocks; and (2) inappropriate shocks. During follow-up (median 8 months, range 1-60), patients with a history of AF more often received appropriate shocks than patients with no history of AF (24 vs. 6%, P=0.03). The composite endpoint of cardiovascular mortality/appropriate shocks was also more likely to occur in patients with a history of AF (34 vs. 12%, P=0.02). History of AF predicted appropriate shocks (HR 6.9, 95% CI 1.7-27.5, P=0.006) and the composite endpoint of cardiovascular mortality/appropriate shocks (adjusted HR 5.1, 95% CI 1.7-15.1, P=0.003). There were no differences in occurrence of inappropriate shocks., Conclusion: Our study demonstrates that history of AF is associated with increased risk of appropriate shocks and cardiovascular mortality in primary prevention ICD patients with left ventricular dysfunction.

Background/objectives: Clinical data have shown that electrical neurostimulation may improve myocardial ischaemia. Our aim was to investigate the possible effect of electrical neurostimulation on collateral perfusion., Methods: Thirty patients with stable angina and significant single-vessel coronary artery disease scheduled for elective percutaneous coronary intervention (PCI) were randomised into three groups. In all patients two balloon inflations were performed, one for predilatation of the lesion, the second for stent delivery. Group one received active neurostimulation during the first ischaemic episode (predilatation), group two during the second ischaemic episode (stent delivery), and group three received placebo neurostimulation continuously. During both ischaemic episodes the collateral flow index was determined., Results: No significant differences were found between active, inactive or placebo neurostimulation. In a post-hoc analysis the patients were stratified for presence or absence of significant collaterals. In patients with pre-existing significant collaterals, the collateral flow index was significantly higher during active neurostimulation compared with inactive neurostimulation (p=0.012) and compared with the merged inactive and placebo groups (p=0.011)., Conclusion: The present data show no effect of electrical neurostimulation on collateral perfusion in patients with single-vessel disease. In a post-hoc analysis in patients with evidence of collaterals, defined as a collateral flow index of >0.24, an increase in collateral perfusion was found during electrical neurostimulation.

Perforation of the left main stem is a rare complication associated with combined aortic valve replacement and by-pass surgery. One-year following aortic valve replacement a 70-year-old male presented with chest pain. This was related to a slowly expanding haematoma caused by a low profile chronic perforation of the left main. Subsequently, a tailored percutaneous modification of the main stem was performed. At three months follow-up, he had no complaints and selective coronary angiography confirmed the successful sealing of the perforation with a concomitant regression of the prior haematoma.