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Aims: We evaluated the occurrence and physiology of respiration-related beat-to-beat variations in resting Pd/Pa and FFR during intravenous adenosine administration, and its impact on clinical decision-making. Methods and Results: Coronary pressure tracings in rest and at plateau hyperemia were analyzed in a total of 39 stenosis from 37 patients, and respiratory rate was calculated with ECG-derived respiration (EDR) in 26 stenoses from 26 patients. Beat-to-beat variations in FFR occurred in a cyclical fashion and were strongly correlated with respiratory rate (R2 = 0.757, p < 0.001). There was no correlation between respiratory rate and variations in resting Pd/Pa. When single-beat averages were used to calculate FFR, mean ΔFFR was 0.04 ± 0.02. With averaging of FFR over three or five cardiac cycles, mean ΔFFR decreased to 0.02 ± 0.02, and 0.01 ± 0.01, respectively. Using a FFR ≤ 0.80 threshold, stenosis classification changed in 20.5% (8/39), 12.8% (5/39) and 5.1% (2/39) for single-beat, three-beat and five-beat averaged FFR. The impact of respiration was more pronounced in patients with pulmonary disease (ΔFFR 0.05 ± 0.02 vs 0.03 ± 0.02, p = 0.021). Conclusion: Beat-to-beat variations in FFR during plateau hyperemia related to respiration are common, of clinically relevant magnitude, and frequently lead FFR to cross treatment thresholds. A five-beat averaged FFR, overcomes clinically relevant impact of FFR variation.

Introduction: P2Y(12)-inhibitor monotherapy following 1-3 months of dual antiplatelet therapy (DAPT) reduces (major) bleeding without an apparent increase in ischemic events and has therefore emerged as an alternative to 6-12 months of DAPT following percutaneous coronary intervention (PCI). However, there are important differences between the available P2Y(12)-inhibitors (clopidogrel, prasugrel, and ticagrelor) as agents of choice for P2Y(12)-inhibitor monotherapy.Areas covered: This review critically appraises the evidence for P2Y(12)-inhibitor monotherapy after PCI using either clopidogrel, prasugrel, or ticagrelor. Furthermore, we discuss ongoing trials and future directions for research.Expert opinion: P2Y(12)-inhibitor monotherapy following 1-3 months of DAPT is an alternative to 6-12 months of DAPT following PCI. Ticagrelor may be considered the current preferred option due to its reliable effect on platelet reactivity and its predominant use in clinical trials. Prasugrel could serve as a useful substitute for those not tolerating ticagrelor, but more research into prasugrel monotherapy is warranted. Alternatively, clopidogrel can be used, although there are concerns of high platelet reactivity, especially when genotyping and/or platelet function testing are not used. Future research will need to address the minimal duration of DAPT before switching to P2Y(12)-inhibitor monotherapy and what the optimal antithrombotic therapy beyond 12 months is.

Aims To assess differences in long-term outcome and functional status of patients with cardiogenic shock (CS) treated by percutaneous mechanical circulatory support (pMCS) and intra-aortic balloon pump (IABP). Methods and results Long-term follow-up of the multicentre, randomized IMPRESS in Severe Shock trial (NTR3450) was performed 5-year after initial randomization. Between 2012 and 2015, a total of 48 patients with severe CS from acute myocardial infarction (AMI) with ST-segment elevation undergoing immediate revascularization were randomized to pMCS by Impella CP (n = 24) or IABP (n = 24). For the 5-year assessment, all-cause mortality, functional status, and occurrence of major adverse cardiac and cerebrovascular event (MACCE) were assessed. MACCE consisted of death, myocardial re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting, and stroke. Five-year mortality was 50% (n = 12/24) in pMCS patients and 63% (n = 15/24) in IABP patients (relative risk 0.87, 95% confidence interval 0.47–1.59, P = 0.65). MACCE occurred in 12/24 (50%) of the pMCS patients vs. 19/24 (79%) of the IABP patients (P = 0.07). All survivors except for one were in New York Heart Association Class I/II [pMCS n = 10 (91%) and IABP n = 7 (100%), P = 1.00] and none of the patients had residual angina. There were no differences in left ventricular ejection fraction between the groups (pMCS 52 ± 11% vs. IABP 48 ± 10%, P = 0.53). Conclusions In this explorative randomized trial of patients with severe CS after AMI, there was no difference in long-term 5-year mortality between pMCS and IABP-treated patients, supporting previously published short-term data and in accordance with other long-term CS trials., Graphical Abstract

Patients with new-onset stable angina constitute a substantial part of the population seen by cardiologists. Currently, the diagnostic workup of these patients depends on the pre-test probability of having obstructive coronary artery disease. It consists of either functional testing for myocardial ischaemia or anatomical testing by using coronary computed tomographic angiography (CCTA) or invasive coronary angiography. In case the pre-test probability is > 5%, the current guidelines for the management of chronic coronary syndromes do not state a clear preference for one of the noninvasive techniques. However, based on the recently published cost-effectiveness analysis of the PROMISE trial and considering the diagnostic yield in patients with angina and nonobstructive coronary artery disease, we argue a more prominent role for CCTA as a gatekeeper for patients with new-onset stable angina.

Purpose: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. Methods: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). Results: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01–2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91–6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. Conclusions: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Background: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS. Methods and results: We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). Conclusion: In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.

Background Transcatheter mitral valve repair (TMVR) is increasingly used to treat mitral regurgitation (MR) in high risk patients. Optimal transseptal access and guiding catheter position are essential to perform adequate repair. Anatomy of the inter-atrial septum (IAS) and mitral annulus (MA) are often complex and difficult to determine from echocardiography. Purpose The aim of the current study was to evaluate whether pre-TMVR cardiac CT and 3D reconstruction of the IAS and MA could discriminate for complexity and hemodynamic effect of TMVR. Methods Patients planned for TMVR, underwent cardiac CT scan (if eligible). Post-processing software was used to segment and reconstruct the aortic root, IAS, fossa ovalis (FO) and MA, resulting in a 3D model. The following parameters were measured in each model: (1) IAS angle (°) (2) Posterior-FO angle (°) (3) FO-perpendicularity angle (°) (4) MA area (cm2). Patient specific anatomy was categorized in 4 groups as either (1) Posterior-perpendicular (PP) FO + limited IAS angle, (2) PP FO + wide IAS angle, (3) non-PP FO + limited IAS angle or (4) non-PP FO + wide IAS angle. PP FO was defined as posterior-FO angle >65° and FO-perpendicularity angle >135°. IAS angle was considered limited if Results 46 patients (mean age 75 years, 41% male) were included. Anatomy was classified (1) PP FO + limited IAS angle in 13, (2) PP FO + wide IAS angle in 13, (3) Non-PP FO + limited IAS angle in 8 and (4) Non-PP FO + wide IAS angle in 12. Median device implantation time was 20 min in group 1, compared to 39 min in group 2 (p=0.02), 33 min in group 3 (p=0.03) and 29 min in group 4 (p=0.08). In patients with MA area Conclusion The current study showed that TMVR seemed less complex in patients with an optimal anatomy. In patients with limited mitral annulus area a more favorable hemodynamic effect was achieved. Cardiac CT and 3D reconstruction could therefore be of strong aid for procedural planning of TMVR. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Abbott Vascular Anatomy and device implantation timeHemodynamic effect of annulus area

Cangrelor is the first and only intravenous P2Y12-inhibitor and is indicated when (timely) administration of an oral P2Y12 inhibitor is not feasible in patients undergoing percutaneous coronary intervention (PCI). Our study evaluated the first years of cangrelor use in two Dutch tertiary care centers. Cangrelor-treated patients were identified using a data-mining algorithm. The cumulative incidences of all-cause death, myocardial infarction, definite stent thrombosis and major bleeding at 48 h and 30 days were assessed using Kaplan–Meier estimates. Predictors of 30-day mortality were identified using uni- and multivariable Cox regression models. Between March 2015 and April 2021, 146 patients (median age 63.7 years, 75.3% men) were treated with cangrelor. Cangrelor was primarily used in ST-segment elevation myocardial infarction (STEMI) patients (84.2%). Approximately half required cardiopulmonary resuscitation (54.8%) or mechanical ventilation (48.6%). The cumulative incidence of all-cause death was 11.0% and 25.3% at 48 h and 30 days, respectively. Two cases (1.7%) of definite stent thrombosis, both resulting in myocardial infarction, occurred within 30 days, but after 48 h. No other cases of recurrent myocardial infarction transpired within 30 days. Major bleeding occurred in 5.6% and 12.5% of patients within 48 h and 30 days, respectively. Cardiac arrest at presentation was an independent predictor of 30-day mortality (adjusted hazard ratio 5.20, 95%-CI: 2.10–12.9, p &lt, 0.01). Conclusively, cangrelor was used almost exclusively in STEMI patients undergoing PCI. Even though cangrelor was used in high-risk patients, its use was associated with a low rate of stent thrombosis.

Background: Interventional cardiologists are inevitably exposed to low-dose radiation, and consequently are at risk for radiation induced diseases like cataract and left-sided brain tumours. Operator behaviour may possibly be the largest influencer on radiation exposure. We hypothesised that awareness regarding radiation exposure grows as skill and the general experience in the catheterization laboratory increase. Objectives: In this study we determined the difference in the relative radiation exposure of staff interventional cardiologists compared with cardiology fellows-in-training. Methods: During this prospective trial the operator’s radiation exposure (E in µSv) was measured at chest height during 766 diagnostic catheterisations and percutaneous coronary interventions. Also, the patient exposure (DAP in mGy·cm2), representing the amount of radiation administered by the operator per procedure, was collected. The primary outcome of this study was the difference in relative exposure between staff interventional cardiologists versus cardiology fellows-in-training (E/DAP). Results: From January to May 2017, staff interventional cardiologists performed 637 procedures and cardiology fellows-in-training 129 procedures. The performance of relatively complex procedures by staff interventional cardiologists resulted in a 74% higher use of radiation compared with fellows-in-training. Consequently, staff interventional cardiologists were exposed to 50% higher levels of actual radiation exposure. However, when correcting for the complexity of the procedure, by comparing the relative operator exposure (E/DAP), fellows-in-training were exposed to a 34% higher relative exposure compared with staff interventional cardiologists (p = 0.025). Conclusions: In the current study, when corrected for complexity, cardiology fellows-in-training were exposed to significantly higher radiation levels than staff interventional cardiologists during catheterisation procedures.

Vasospastic angina (VSA) is considered a broad diagnostic category including documented spontaneous episodes of angina pectoris produced by coronary epicardial vasospasm as well as those induced during provocative coronary vasospasm testing and coronary microvascular dysfunction due to microvascular spasm. The hallmark feature of VSA is rest angina, which promptly responds to short-acting nitrates; however, VSA can present with a great variety of symptoms, ranging from stable angina to acute coronary syndrome and even ventricular arrhythmia. VSA is more prevalent in females, who can present with symptoms different from those among male patients. This may lead to an underestimation of cardiac causes of chest-related symptoms in female patients, in particular if the coronary angiogram (CAG) is normal. Evaluation for the diagnosis of VSA includes standard 12-lead ECG during the attack, Holter monitoring, exercise testing, and echocardiography. Patients suspected of having VSA with a normal CAG without a clear myocardial or non-cardiac cause are candidates for provocative coronary vasospasm testing. The gold standard method for provocative coronary vasospasm testing involves the administration of a provocative drug during CAG while monitoring patient symptoms, ECG and documentation of the coronary artery. Treatment of VSA consists of lifestyle adaptations and pharmacotherapy with calcium channel blockers and nitrates.

To assess the need for additional invasive coronary angiography (CAG) after initial computed tomography coronary angiography (CTCA) in patients awaiting non-coronary cardiac surgery and in patients with cardiomyopathy, heart failure or ventricular arrhythmias, and to determine differences between patients that were referred to initial CTCA or direct CAG, consecutive patients were included between August 2017 and January 2020 and categorized as those referred to initial CTCA (conform protocol), and to direct CAG (non-conform protocol). Out of a total of 415 patients, 78.8% (327 patients, mean age: 57.9 years, 67.3% male) were referred to initial CTCA, of whom 260 patients (79.5%) had no obstructive lesions (&lt, 50% DS). A total of 55 patients (16.8%) underwent additional CAG after initial CTCA, which showed coronary lesions of &gt, 50% DS in 21 patients (6.3% of 327). Eighty-eight patients (mean age: 66.0 years, 59.1% male) were directly referred to CAG (non-conform protocol). These patients were older and had more cardiovascular risk factors compared to patients that underwent initial CTCA (conform protocol), and coronary lesions of &gt, 50% DS were detected in 16 patients (17.2%). Revascularization procedures were infrequently performed in both groups: initial CTCA (3.0%), direct CAG (3.4%). The use of CTCA as a gatekeeper CAG in the diagnostic work-up of non-coronary cardiac surgery, cardiomyopathy, heart failure and ventricular arrhythmias is feasible, and only 17% of these patients required additional CAG after initial CTCA. Therefore, CTCA should be considered as the initial imaging modality to rule out CAD in these patients.

BACKGROUND The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. METHODS AND RESULTS We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). CONCLUSIONS Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

Background Coronary vasomotor function disorders, such as microvascular angina (MVA) and vasospastic angina (VSA) can be diagnosed in three quarters of all patients with signs and symptoms of ischemia and no obstructive coronary artery disease (INOCA). Intracoronary acetylcholine provocation testing (Ach-test) is considered the gold standard for the assessment of VSA and MVA. Our aim is to identify the correlation between a positive Ach-test identifying an abnormal coronary vasomotor response and predictive traditional and non-traditional risk factors in patients with INOCA. Methods In this single centre retrospective cohort study, data from all patients who were referred for an Ach-test between 2002 and 2019 was collected. All patients underwent an invasive test with assessment of the vasomotor responses by intracoronary acetylcholine and assessment of coronary microvascular dysfunction (CMD) by measuring the coronary flow reserve (CFR). VSA and MVA were diagnosed on the basis of the criteria as proposed by the Coronary Vasomotor Disorders International Study Group (COVADIS). The predictive risk factors were analyzed by means of logistic regression. Results A total of 134 patients were included, median age was 57 years and 85.1% were female. The Ach-test revealed VSA in 95 patients (70.9%), MVA in 13 patients (9.7%) and a negative Ach-test in 26 patients (19.4%). A multivariable logistic regression model showed smoking as an independent variable for a positive Ach-test (OR of 3.0 with 95% CI 1.1–8.2; p=0.031) and as an independent predictor for VSA (OR of 2.9 95% CI 1.1–7.9 p=0.039). In addition we showed that migraine (OR of 6.7 95% CI 1.4–32.9 p=0.019) is an independent predictor for MVA and MVA has a strong association with female patients who have a history of recurrent miscarriages (p=0.015). Conclusion MVA and VSA are associated with different risk factors which support a different underlying pathophysiology. Smoking is an independent predictor for a positive Ach-test and an independent predictor for VSA. In addition, we showed that migraine is an independent predictor for MVA and MVA has a strong association with female patients who have a history of miscarriages. MVA and VSA require a different treatment strategy and because there are no clear predictive values for a positive Ach-test, it is important to support identification with an Ach-test. Funding Acknowledgement Type of funding source: None

International audience; Background: Chronic kidney disease (CKD) patients undergoing percutaneous coronary intervention (PCI) experience greater ischemic events including clinically driven target lesion revascularization (CD-TLR). Whether the COMBO biodegradable-polymer sirolimus-eluting stent promotes better outcomes in these patients by virtue of endothelial progenitor cell capture technology is unknown.Objective: We examined one-year outcomes by CKD status from the COMBO collaboration.Methods: The COMBO collaboration was a patient-level pooled dataset from the REMEDEE and MASCOT registries (3,614 patients) of all-comers undergoing attempted COMBO stent PCI. The primary endpoint was one-year target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or CD-TLR. Secondary endpoints included stent thrombosis (ST).Results: The study included 6.4% (n = 231) CKD and 93.6% (n = 3,361) non-CKD patients. CKD patients were older and included more women with greater prevalence of several comorbidities but similar rate of acute coronary syndrome (50.6% vs. 54.5%, p = .26). CKD patients underwent radial PCI less often (56.1% vs. 70.3%, p < .001) and received clopidogrel (78.6% vs. 68.3%) more often (p = .004). One-year TLF occurred in 7.9% CKD vs. 3.7% non-CKD patients, p = .001. CKD patients also demonstrated greater incidence of cardiac death (6.2% vs. 1.2%, p < .0001), TV-MI (2.7% vs. 1.1%, p = .04) but similar CD-TLR (2.7% vs 2.2%, p = .61) and definite/probable ST (1.4% vs. 0.8%, p = .42), compared to non-CKD patients.Conclusions: CKD patients treated with COMBO stents had significantly greater incidence of one-year TLF compared to non-CKD patients driven by cardiac death and to a lesser extent TV-MI but not CD-TLR. They had similar rates of definite/probable ST.

BACKGROUND: Between 16% and 51% of patients with chronic thromboembolic pulmonary hypertension will have residual pulmonary hypertension (PH) after pulmonary endarterectomy (PEA). Whether residual PH is related to remaining (sub-)segmental macrovascular lesions or to microvascular disease is unknown. New imaging techniques can provide detailed information about (sub-)segmental pulmonary arteries and parenchymal perfusion. The aim of this study was to describe the prevalence after PEA of remaining (sub-)segmental vascular lesions on electrocardiogram-gated computed tomography pulmonary angiography (CTPA) and parenchymal hypoperfusion on magnetic resonance imaging (MRI) and to relate these imaging abnormalities to the presence or absence of residual PH after PEA.METHODS: In a prospective cohort of patients with operable chronic thromboembolic pulmonary hypertension, hemodynamics, CTPA, and lung perfusion MRI were performed before and 6 months after PEA. The percentage of (sub-)segmental vascular lesions was calculated on CTPA and parenchymal hypoperfusion on lung perfusion MRI.RESULTS: PEA led to significant improvements in hemodynamics and a reduction of imaging abnormalities. Residual PH was present in 45% of patients after PEA, whereas remaining (sub-)segmental vascular lesions and parenchymal hypoperfusion were present in 20% and 21% of the pulmonary vasculature, respectively. Patients with and without residual PH after PEA had similar percentages of remaining (sub-)segmental vascular lesions (25% +/- 14% vs 17% +/- 15%; p = 0.16) and similar degrees of parenchymal hypoperfusion (20% +/- 7% vs 19% +/- 6%; p = 0.63).CONCLUSIONS: After successful PEA, advanced imaging shows that around 20% of the pulmonary vasculature remains abnormal, independent of the presence of residual PH. This may suggest that microvascular disease, rather than residual macrovascular lesions, plays a prominent role in residual PH after PEA. (C) 2019 International Society for Heart and Lung Transplantation. All rights reserved.

Background and Aim: Quantitative Blush Evaluator (QuBE) is a software application that allows quantifying myocardial perfusion in coronary angiograms after a percutaneous coronary intervention. QuBE has some limitations such as the application of a crude filter to remove large scale structures and the absence of correction for cardiac motion. This study investigates the extent of these limitations and we hypothesize that enhanced image analysis methods can provide improvements.Methods: We calculated QuBE scores of 117 patients from the HEBE Trial and determined its association with the Myocardial Blush Grade (MBG) score. Accuracy of large-structure removal is qualitatively assessed for various sizes of a median filter. The influence of cardiac motion was evaluated by comparing the blush curve and QuBE score of the native QuBE with manually motion-corrected QuBE for 40 patients. The effect of different kernel sizes and motion correction to a potential improvement of the association between QuBE score and MBG was studied.Results: In our population, there was no significant association between QuBE score and MBG (p = 0.14). Median filters of various kernel sizes were unable to remove large structure related noise. Variations in filters and cardiac movement correction did not result in an improvement in the association with MBG scores (observer 1: p = 0.66; observer 2: p = 0.72).Conclusions: There was no significant association of QuBE with MBG scores in our population, which suggests that QuBE is not suitable for a quantitative assessment of myocardial perfusion. Alternative kernel sizes for the large structure removal filter and cardiac motion correction did not improve QuBE performance.Relevance for patients: Further improvements of QuBE to overcome its inherent limitations are necessary in order to establish QuBE as a reliable myocardial perfusion assessment method.

Contains fulltext : 190517.pdf (Publisher’s version ) (Open Access) BACKGROUND: Coronary artery spasm may be the underlying mechanism in up to 10% of cases of acute coronary syndrome (ACS) and sudden cardiac death. Asian individuals exhibit a 3-times greater incidence of spasm than Caucasians; this is likely due to different types of mechanisms. Consequently, solid data is limited about the long-term prognosis in Caucasian patients presenting with ACS and/or out-of-hospital cardiac arrest (OHCA) caused by coronary spasm. METHODS: Between 2002 and 2015, thirty Caucasian patients with coronary artery spasm presenting with ACS (N = 29) and/or OHCA (N = 11) were enrolled in this prospective registry. Follow-up, consisting of regular outpatient visits, was conducted with a mean follow-up period of 7.5 +/- 3.3 years. Outcomes included presence of stable angina pectoris, recurrence of ACS, occurrence of implantable cardioverter defibrillator (ICD) shocks and death. RESULTS: The majority of patients (60%) remained asymptomatic during the entire follow-up period. At the end of the follow-up period only 3 patients still experienced stable angina (10%). Only 2 patients (7%) had a recurrent cardiac event, in which the ICD provided appropriate shock therapy. Half of the patients treated with stenting (N = 6), required re-interventions. CONCLUSION: Coronary spasm with ACS and/or OHCA in a Caucasian patient cohort has a relatively benign prognosis in the majority of patients in long-term follow-up, if treated appropriately with medical therapy. Both the role of ICD in OHCA secondary to coronary spasm, and the efficacy of stenting to treat vasospastic angina, warrant further study in large-sized prospective clinical trials.

Background Patients presenting with acute coronary syndrome (ACS) are at increased risk of complications after percutaneous coronary intervention with stent placement compared to patients with stable angina (SA) treated in an elective setting. The novel pro-healing COMBO stent is a bio-engineered drug eluting stent designed to promote vessel healing. Therefore, the stent may reduce this difference in clinical outcomes between elective and ACS-patients and prevent late stent thrombosis. Methods and Results The European, prospective, multicenter, 1000 all-comers patient REMEDEE registry evaluates clinical outcomes after COMBO stent placement in ACS- and elective patients. The primary endpoint at 12 months is target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction and target lesion revascularization. A total of 49.9% (n = 498) of patients presented with acute coronary syndrome. TLF was 7.1% in ACS patients, definite and probable stent thrombosis was observed in 0.5% of ACS patients and in all within 9 days post stenting. We found no significant difference in TLF between ACS and non-ACS patients and a low overall rate of TLF. Conclusions The COMBO stent is a safe and efficient device for patients presenting with ACS. Low ST rate and only early stent thrombosis were observed. © 2017 Wiley Periodicals, Inc.

Summary Background When the pro-healing COMBO stent is used, a short duration of dual-antiplatelet therapy (DAPT) might be safe. However, no cases have been described of patients with short duration of DAPT after COMBO stent placement. Methods and results We investigate clinical outcomes at 1 year after early discontinuation of DAPT in patients participating in the REMEDEE Registry. This is a prospective, multicentre, European, all-comers registry with a 1000 patients treated with COMBO stent. Target lesion failure (TLF), a composite of target vessel-myocardial infarction (tv-MI), cardiac death and target lesion revascularization, and the occurrence of stent thrombosis (ST) in relation with DAPT cessation before 30 and 180 days of follow-up is evaluated. At 30 days follow-up 48 patients were not on DAPT, at 180 days follow-up of 78 patients had no DAPT. Patients with DAPT discontinuation were older, had overall lower left ventricle ejection fraction and more frequent chronic renal failure. No TLF and especially no stent thrombosis were observed in these patients. Conclusions Discontinuation of DAPT within 6 months after COMBO stent placement did not influence the rate of TLF up to 1-year follow-up. Large randomized trials are needed to confirm the safety of short duration of DAPT after COMBO stent placement.

Background Data of long-term safety and efficacy of the COMBO dual-therapy stent is lacking. REMEDEE Registry evaluated the COMBO stent and showed low clinical event rates up to 3 year. We report the clinical outcomes at 4-year follow-up of this registry. Methods The REMEDEE Registry is a prospective, multicenter registry with minimal exclusion criteria, evaluating clinical outcomes after treatment with the COMBO stent. A 1000 patients were enrolled between June 2013 and March 2014. Target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR), at 4-year follow-up was the primary focus of this analysis. Results Four-year follow-up data were obtained in 97.3% of patients. TLF was present in 117 patients (11.9%). Cardiac death occurred in 45 patients (4.6%), TV-MI was observed in 25 patients (2.6%) and TLR was performed in 73 patients (7.5%). Of the 7.5% TLR at 4 years, 1.5% were beyond 2 years. Definite ST was seen in 7 patients (0.7%) and probable ST in 1 (0.1%). No definite or probable ST occurred between 3 and 4 years follow-up. At 4-year follow-up, 93.1% of patients were free of ischemic symptoms. Conclusion This registry showed excellent 4-year results after COMBO stent placement, with no ST beyond 3 years.

Aims: Mortality in cardiogenic shock patients remains high. Short-term mechanical circulatory support with Impella can be used to support the circulation in these patients, but data from randomised controlled studies and ‘real-world’ data are sparse. The aim is to describe real-life data on outcomes and complications of our 12 years of clinical experience with Impella in patients with cardiogenic shock after acute myocardial infarction and to identify predictors of 6-month mortality. Methods: We describe a single-centre registry from October 2004 to December 2016 including all patients treated with Impella for cardiogenic shock after acute myocardial infarction. We report outcomes and complications and identify predictors of 6-month mortality. Results: Our overall clinical experience consists of 250 patients treated with Impella 2.5, Impella CP or Impella 5.0. A total of 172 patients received Impella therapy for cardiogenic shock, of which 112 patients had cardiogenic shock after acute myocardial infarction. The mean age was 60.1±10.6 years, mean arterial pressure was 67 (56–77) mmHg, lactate was 6.2 (3.6–9.7) mmol/L, 87.5% were mechanically ventilated and 59.6% had a cardiac arrest before Impella placement. Overall 30-day mortality was 56.2% and 6-month mortality was 60.7%. Complications consisted of device-related vascular complications (17.0%), non-device-related bleeding (12.5%), haemolysis (7.1%) and stroke (3.6%). In a multivariate analysis, pH before Impella placement is a predictor of 6-month mortality. Conclusions: Our registry shows that Impella treatment in cardiogenic shock after acute myocardial infarction is feasible, although mortality rates remain high and complications occur.

Aims We evaluated the impact of the complexity of coronary disease assessed by SYNTAX score (SXscore) on the clinical outcomes in the AIDA trial. Methods and results In the AIDA trial, we compared Absorb versus Xience in routine clinical practice. Clinical outcomes were stratified by SXscore tertiles: SXlow (SXscore≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15). SXscore was available in 1661 of the 1845 (90%) patients. Event rate of TVF was numerically lower in Absorb compared to Xience (3.7% versus 5.6%; p=0.257) in the Sxlow tertile, numerically higher in Absorb in in the Sxmid tertile (11.4% versus 9.3%, p=0.421) and similar in the Sxhigh tertile (15.5% versus. 15.6%; p=0.960) . The rates of definite/probable device thrombosis in Absorb versus Xience were significantly higher in the Sxmid tertile (3.3% versus 0.8%, p=0.043) and in the SXhigh tertile (3.7% versus 0.8%, p=0.006) Patients treated with Absorb and a SXscore>8 had numerically, but non significantly, higher rates of myocardial revascularization and revascularization rates when compared to Xience. Conclusions We found no significantly different rates of TVF between Absorb and Xience patients. Absorb treated patients in the Sxmid and SXhigh tertile, however, had an increased risk of device thrombosis when compared to Xience treated patients. The rates of device thrombosis in the SXlow tertile, while still higher for Absorb, but are more acceptable than in SXmid and SXhigh score tertiles.

BackgroundIn selected patients with an acute myocardial infarction (AMI) complicated by Cardiogenic shock (CS), mechanical circulatory support with Impella may be beneficial, although conclusive evidence is still lacking. Nevertheless, it has been suggested that Impella initiation prior to primary PCI might improve survival.ObjectiveTo investigate the effect pre-PCI versus immediate post-PCI Impella initiation on short term mortality.MethodsA prospective, single center, observational study, was performed including all patients with STEMI complicated by CS, treated with primary PCI and Impella. Thirty day mortality was compared between patients with Impella initiation pre-PCI and immediately post-PCI.ResultsA total of 88 patients were included. In the pre-PCI group (n = 21), admission heart rate was lower (84 versus 94 bpm, p = 0.04) and no IABP was implanted before Impella initiation, versus 17.9% in post-PCI group (n = 67), p = 0.04. Total 30-day all-cause mortality was 58%, and was lower in pre-PCI group, 47.6% versus 61.2% in the post-PCI group, however not statistically significant (HR 0.7, 95% CI 0.3-1.3, p = 0.21). Thirty-day cardiac mortality was significantly lower in the pre-PCI group, 19% versus 44.7% in the post-PCI group (HR 0.3, 95% CI 0.09-0.96, p = 0.042).ConclusionPre-PCI Impella initiation in AMICS patients was not associated with a statistically significant difference in 30-day all-cause mortality, compared to post-PCI Impella initiation.

Item does not contain fulltext OBJECTIVES: To assess the long-term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberte paclitaxel-eluting stent (PES) in lesions with a high risk of restenosis. BACKGROUND: Instead of the use of cytotoxic or cytostatic drugs in drug-eluting stents, a "pro-healing" approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts. METHODS: In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for >/=1 month after ECS and for >/=6 months after PES. RESULTS: At 5 years follow-up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) -17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI -20.8% to -2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group. CONCLUSION: This is the first randomized study providing very long-term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow-up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure.

The novel COMBO dual-therapy stainless-steel coronary stent (DTS) (OrbusNeich Medical BV, Hoevelaken, the Netherlands) is a device that combines a sirolimus-eluting layer with a prohealing layer with anti-CD34+ antibodies, which attracts circulating endothelial progenitor cells. These endothelial

Acute coronary syndrome (ACS) is associated with higher rates of recurrent ischemic events, myocardial infarction (MI), and stent thrombosis (ST). The dual-therapy COMBO stent combines a sirolimus-eluting biodegradable polymer with anti-CD34+ antibodies promoting rapid endothelialization of the

Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI) might lead to better outcomes when compared to conventional treatment with metallic drug-eluting stents. ACS patients (STE-ACS

AIMS To describe long-term outcome following surgical and percutaneous revascularization in graft failure. METHODS We analyzed consecutive patients with graft failure after heart-team assignment to percutaneous coronary intervention (PCI) or redo coronary artery bypass grafting (CABG) between 2003 and 2008. The primary endpoint was the composite of death, myocardial infarction (MI) or target vessel revascularization (TVR). Kaplan-Meier event rate estimates were calculated up to a 5-year follow-up. Independent predictors for outcomes were identified by backward selection in a multivariable Cox proportional hazard model. RESULTS We identified 287 patients treated for graft failure: 243 with PCI and 44 with redo CABG. Patients undergoing PCI more frequently presented with ST-elevated myocardial infarction (STEMI) (P < 0.001), multivessel disease (P < 0.001), vein graft failure (P = 0.04), a history of MI (P < 0.001) and shorter time-to-graft failure (P = 0.001). Bare-metal stents (BMS) were used in 81.3% of the PCI-treated lesions and drug-eluting stents (DES) in 18.7%. The median follow-up was 3.9 years. Five-year rate of composite all-cause death, MI or TVR was 57.6% after PCI and 51% after CABG (P = 0.51). Repeat revascularization [TVR and target lesion revascularization (TLR)] was 30.7 and 21.3% after PCI, and 8.0 and 3.2% following CABG (P = 0.009; P = 0.008). In the PCI group, BMS was associated with higher rates of TVR (35.1 vs. 12.6%; P = 0.04) and TLR (24.8 vs. 7.6%; P = 0.04), but similar rate of death or MI compared with DES. Independent predictors for the primary outcome were creatinine [hazard ratio 1.008 per μmol/l, 95% confidence interval (CI) 1.005-1.011, P < 0.001] and peak creatine kinase MB (hazard ratio 1.001 per U/l, 95% CI 1.000-1.002, P = 0.027). CONCLUSION Clinical outcomes are similarly poor after heart-team triage for surgical or percutaneous intervention in patients with graft failure. Repeat revascularization occurred more frequent after PCI, particularly following BMS implantation.

Objectives This study sought to evaluate 30-day all-cause mortality of patients treated with primary percutaneous coronary intervention (PCI) presenting with an acute myocardial infarction (AMI) due to an unprotected left main coronary artery (ULMCA) culprit lesion. In addition, an average estimated mortality rate was extrapolated from the available data. Background There are limited data available on clinical outcome after primary PCI in patients presenting with AMI with unprotected left main as the infarct-related coronary artery. Methods Medical literature databases were searched to identify cohort studies reporting on primary PCI for unprotected left main–related AMI. A total of 13 retrospective studies meeting all pre-specified criteria were included in the meta-analysis. No randomized trials were available. The primary endpoint for the meta-analysis was 30-day all-cause mortality. Results This meta-analysis comprises a total of 977 patients, of which 252 (26%) presented in cardiogenic shock. Thirty-day all-cause mortality was evaluated using a forest plot analysis and showed higher event rates in patients presenting with cardiogenic shock among all subgroups. The average estimated 30-day all-cause mortality was 15% in patients presenting without signs of cardiogenic shock and 55% in patients presenting with cardiogenic shock (relative risk: 3.74, 95% confidence interval [CI]: 2.95 to 4.76, p Conclusions In this large meta-analysis of patients treated with primary PCI for AMI due to an ULMCA culprit lesion, the 30-day all-cause mortality in patients presenting with shock is much higher than in patients not presenting with shock. The estimated all-cause mortality data may serve as a benchmark for future reference.

Background— The Navvus pressure sensor–equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter. Methods and Results— In patients with intermediate coronary stenosis, coronary pressure and flow velocity were measured using a dual sensor–equipped guidewire before and after introduction of Navvus. Patients were randomized to microcatheter-first or guidewire-first measurement. The primary end point was the difference in hyperemic stenosis resistance index between measurements before and after introduction of Navvus. Measurements were completed in 28 patients (28 stenoses). Mean hyperemic stenosis resistance was 0.37±0.19 Hg/cm/s for wire-only assessment and 0.48±0.26 Hg/cm/s after Navvus introduction ( P P =0.001). Passing–Bablok analysis revealed absence of a constant difference but significant proportional difference between the methods. Mean fractional flow reserve was 0.86±0.06 for wire-only assessment and 0.82±0.07 after Navvus introduction ( P P =0.036). Passing–Bablok analysis revealed significant constant and proportional differences between methods. Similar results were documented for resting indices of stenosis severity. Conclusions— Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis.

Background: We assessed the 3-year clinical outcome in our single-center cohort of mainly unselected patients treated with the endothelial progenitor cell capturing stent (ECS). The ECS is coated with CD34+ antibodies specifically targeting the circulating endothelial progenitor cells population to accelerate endothelialization that in turn may prevent the occurrence of in-stent restenosis and stent thrombosis (ST). Methods: All patients in our study had coronary artery lesions that were treated with an ECS. The majority of patients had complex lesions with an estimated high risk of restenosis. Results: A total of 405 patients were enrolled. The primary end-point of target lesion failure (TLF) was defined as the composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR). At 3 years, TLF was 18.3% and TLR was 14.2%. Early ST occurred in 2 patients. No cases of late and very late definite ST were reported. Conclusions: This single-center study demonstrates the safety at 3 years of the ECS in an unselected patient population, including a fair number of patients with complex lesions, reflecting daily practice. Our data compare well with drug-eluting stent and bare metal stent registries enrolling unselected patient populations. Importantly, in our analysis, no cases of late or very late definite ST were reported. (J Interven Cardiol 2011;24:442–449)

Objectives This study sought to demonstrate the noninferiority of endothelial progenitor cell capturing stents (ECS) relative to drug-eluting stents (DES) regarding target lesion failure (TLF) and the composite of cardiac death, myocardial infarction, and target lesion repeat revascularization within 1 year. Background A “pro-healing” approach for prevention of in-stent restenosis is theoretically favorable over the use of cytotoxic/cytostatic drugs released from DES to treat coronary artery disease. Promoting accelerated endothelialization of the stent, ECS have shown promising results in studies with patients carrying noncomplex lesions. Methods We undertook an international, clinical trial in 26 centers planning to randomize 1,300 patients with stable coronary artery disease and with a high risk of restenosis between treatment, with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was higher and treatment of new patients with an ECS would be unreasonable. Results At 1 year evaluating 304 patients receiving ECS and 318 receiving DES, TLF occurred in 17.4% of the ECS-treated patients and in 7.0% of the DES-treated patients (p = 0.98 for noninferiority). Conclusions Within 1 year, inhibition of intimal hyperplasia by the ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. Furthermore, long-term follow-up is pivotal to fully appreciate the clinical value of ECS, including the effect on late intimal hyperplasia regression.

OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous EPC capturing R stent during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry. BACKGROUND: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). METHODS: In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. Results: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. CONCLUSION: The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294).

Objective In the National Institute for Clinical Excellence (NICE) guidelines, lesions with a reference vessel diameter of less than 3.0mm or lesions with a length of greater than 15mm are considered carrying a high risk of restenosis. In contrast, lesions with a reference vessel diameter of at least 3.0mm or a lesion length of 15mm or less are considered at low risk of restenosis. We performed a retrospective analysis of consecutive patients undergoing nonurgent percutaneous coronary intervention (PCI) comparing bare metal stent (BMS) with drug-eluting stent (DES) using the NICE guidelines. Methods and results Between 2003 and 2007, a total of 3883 patients underwent a nonurgent PCI for a de-novo coronary lesion; 2050 patients were considered to be at low risk and 1833 patients were considered at high risk of restenosis according to the NICE criteria. In the low-risk group, the 1-year composite of cardiac death, myocardial infarction, and target vessel revascularization was 10.5% in the BMS group and 11.1% in the DES group (P = 0.85). Target lesion revascularization (TLR) was 5.3% by PCI and 1.6% by coronary artery bypass grafting (CABG) in the BMS group and 4.0 and 3.0% in the DES group (P = 0.59 and P = 0.24). In the high-risk group, the composite of cardiac death, myocardial infarction, and target vessel revascularization was 12.1 and 11.0% in the BMS and DES groups (P = 0.48). TLR was 6.7% by PCI and 1.3% by CABG in the BMS group and 3.9 and 2.8% in the DES group (P = 0.01; P = 0.02). Definite stent thrombosis (ST) was 0.8% in the BMS-treated patients and 1.7% in the DES-treated patients (P = 0.09). Conclusion In patients with lesions carrying a low risk of restenosis, no differences were observed between BMS and DES in composite end points, TLR, or ST at 1-year follow-up. In patients with lesions carrying a high risk of restenosis, patients treated with BMS had a significantly higher rate of TLR by PCI, but a significantly lower rate of TLR by CABG compared with patients treated with DES. A nonsignificant lower rate of definite ST was observed in the BMS group compared with the DES group. Coron Artery Dis 22:32-39 (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins

Background: We evaluated the Genous(TM) Bio-engineered R stent(TM) in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis (ST). Methods and Results: In the e-HEALING registry, 2,651 patients were

Item does not contain fulltext AIMS: e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous EPC capturing R stent. Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis. METHODS AND RESULTS: We planned a 5,000 patient registry with >/=1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received >/=1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively. CONCLUSIONS: Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST. 7 p.

Background: In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberte™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr. Methods: A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent. Results: Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI −6.2–15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference −4.2%; 95%CI −8.2% to −0.2%). Conclusions: In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation. © 2011 Wiley-Liss, Inc.

Objectives We investigated whether multiple biomarkers improve prognostication in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. Background Few data exist on the prognostic value of combined biomarkers. Methods We used data from 1,034 STEMI patients undergoing primary percutaneous coronary intervention in a high-volume percutaneous coronary intervention center in the Netherlands and investigated whether combining N-terminal pro-brain natriuretic peptide, glucose, C-reactive protein, estimated glomerular filtration rate, and cardiac troponin T improved the prediction of mortality. A risk score was developed based on the strongest predicting biomarkers in multivariate Cox regression. The additional prognostic value of the strongest predicting biomarkers to the established prognostic factors (age, body weight, diabetes, hypertension, systolic blood pressure, heart rate, anterior myocardial infarction, and time to treatment) was assessed in multivariable Cox regression. Results During follow-up (median, 901 days), 120 of the 1,034 patients died. In Cox regression, glucose, estimated glomerular filtration rate, and N-terminal pro-brain natriuretic peptide were the strongest predictors for mortality (p l 0.05, for all). A risk score incorporating these biomarkers identified a high-risk STEMI subgroup with a significantly higher mortality when compared with an intermediate- or low-risk subgroup (p l 0.001). Addition of the 3 biomarkers to established prognostic factors significantly improved prediction for mortality, as shown by the net reclassification improvement (0.494, p l 0.001) and integrated discrimination improvement (0.0295, p l 0.01). Conclusions Our data suggest that addition of a multimarker to a model including established risk factors improves the prediction of mortality in STEMI patients undergoing primary percutaneous coronary intervention. Furthermore, the use of a simple risk score based on these biomarkers identifies a high-risk subgroup.

Objectives: To evaluate the long-term outcomes of the selected patients by the local Heart Team to undergo percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) stenosis and to compare patients considered at low surgical risk versus at high surgical risk for coronary artery bypass grafting (CABG). Background: CABG is recommended in patients with ULMCA stenosis according to the AHA/ACC and ESC guidelines, and there are limited data on the long-term outcomes in patients selected by the local Heart Team to undergo PCI. Methods: Between 1996 and 2007, 227 patients underwent PCI for ULMCA stenosis based on decision of the local Heart Team and patient's and/or physician's preference. All patients were contacted at 1 year and in November 2008. Results: Long-term follow-up was up to 8 years with a mean of 3.9 +/- 2.6 years. Overall, the Kaplan-Meier estimate of the composite of cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) was 14.8% at 1 year, 18.3% at 3 years, and 20.9% at 5 years with no events occurring thereafter. Patients considered at low surgical risk for CABG had a significantly lower incidence of cardiac death or MI compared to patients considered at high surgical risk at 8 years (1.4 vs. 16.8%; 1.4 vs. 14.8%, respectively); however, no significant difference was observed for cardiac death, MI, or TLR (18.6 vs. 24.4%). Conclusions: PCI of ULMCA stenosis in patients selected by the Heart Team resulted in good long-term clinical outcomes with most events occurring within the 1st year. Patients considered at low surgical risk for CABG have a significantly better long-term survival than patients at high risk for surgery. (C) 2010 Wiley-Liss, Inc

Aims The purpose of this study was to evaluate the Genous(TM) endothelial progenitor cell capturing stent vs. the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions with a high-risk of coronary restenosis. Methods and results We randomly assigned 193 patients with lesions carrying a high risk of restenosis to have the Genous stent or the Taxus stent implanted. Lesions were considered high risk of restenosis if one of the following applied: chronic total occlusion, lesion length >23 mm, vessel diameter

Background— This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial. Methods and Results— This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively ( P =0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33�0.37 mm versus PES, 0.34�0.34 mm; P =0.84) and percentage volume obstruction (EES, 5.18�6.22% versus PES, 5.80�6.31%; P =0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%). Conclusions— Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.

Background— The cyclin-dependent kinase inhibitor p27 kip1 is a key regulator of smooth muscle cell and leukocyte proliferation in vascular disease, including in-stent restenosis. We therefore hypothesized that common genetic variations or single nucleotide polymorphisms in p27 kip1 may serve as a useful tool in risk stratification for in-stent restenosis. Methods and Results— Three single nucleotide polymorphisms concerning the p27 kip1 gene (−838C>A, rs36228499; −79C>T, rs34330; +326G>T, rs2066827) were determined in a cohort of 715 patients undergoing coronary angioplasty and stent placement. We discovered that the p27 kip1 -838C>A single nucleotide polymorphism is associated with clinical in-stent restenosis; the −838AA genotype decreases the risk of target vessel revascularization (hazard ratio, 0.28; 95% confidence interval, 0.10 to 0.77). This finding was replicated in another cohort study of 2309 patients (hazard ratio, 0.61; 95% confidence interval, 0.40 to 0.93). No association was detected between this end point and the p27 kip1 -79C>T and +326G>T single nucleotide polymorphisms. We subsequently studied the functional importance of the −838C>A single nucleotide polymorphism and detected a 20-fold increased basal p27 kip1 transcriptional activity of the −838A allele containing promoter. Conclusions— Patients with the p27 kip1 -838AA genotype have a decreased risk of in-stent restenosis corresponding with enhanced promoter activity of the −838A allele of this cell-cycle inhibitor, which may explain decreased smooth muscle cell proliferation.

Background: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) poses a high-risk for distal coronary thromboembolic events. Glycoprotein IIb/IIIa inhibitors are frequently used in hope of reducing the impact of this, although the safety and efficacy of these drugs to improve outcomes in this setting are understudied. Methods: Patients were included if they had prior coronary artery bypass surgery and subsequently underwent PCI of >= 1 SVG graft at a Dutch academic center between 1997 and 2008. These patients were matched 1: 1 based on peri-procedural use of abciximab using a propensity-score matching algorithm based on 17 variables. Conditional logistic regression and Cox regression stratified on matched pairs were performed to evaluate the association between abciximab use and MACCE (the composite measure of mortality, myocardial infarction, stroke and repeat revascularization) at 30 days and up to 1 year. Results: The composite of 30-day MACCE occurred in 18 patients (15.3%) in the abciximab group and 16 patients (13.6%) in the propensity matched control group (OR: 1.13, 95% CI: 0.57-2.21, p = 0.73). At 1-year follow-up, MACCE rates were also similar (32.5% vs. 33.9%, HR: 0.97, 95% CI: 0.59-1.59). Major bleeding (BARC types 3a-c) was higher in the abciximab group (11.9% vs. 4.2%, OR: 2.80, 95% CI: 1.01-7.77). Ischemic outcomes did not differ among patients with acute coronary syndromes. Conclusion: The use of intravenous abciximab was not associated with improved clinical outcomes up to 1-year among patients undergoing SVG PCI, but was related to more bleeding. (C) 2015 Elsevier Inc. All rights reserved.