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Background The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. Design COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. Conclusions The prospective COMPARE ABSORB randomized trial ( ClinicalTrials.gov NCT02486068 ) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.

Introduction and objectives The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. Methods The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. Results Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P = .003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P = .003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P = .003). This difference was driven by both access and nonaccess bleeding. Conclusions Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access.

Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11–1.53) and 1.71 (1.41–2.07), respectively ( P trend Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear.We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models.Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002).In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

Background: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. Methods: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory–assessed SS using multivariable Cox proportional hazards regression. Results: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5–74); 24.1% of patients had angiographic core laboratory–assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P =0.40) and did not vary according to SS ( P interaction =0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P =0.01), a difference which rose progressively with increasing SS ( P interaction =0.03). Conclusions: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier NCT01205776.

Background Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. Methods We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). Results Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p Conclusion We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.

BACKGROUND: The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. DESIGN: MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. CONCLUSIONS: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation. ispartof: AMERICAN HEART JOURNAL vol:209 pages:97-105 ispartof: location:United States status: published

Aims The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial. Methods and results By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40–0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19–5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22–4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (P interaction = 0.56) and all-cause death (P interaction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis. Conclusion In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important.

Objectives: To evaluate the impact of coronary artery disease (CAD) with or without recent (≤ 30 days) percutaneous coronary intervention (PCI) in women undergoing transcatheter aortic valve replacement (TAVR). Background: Although women display a specific risk-profile for both PCI and TAVR, the impact of CAD and PCI in the setting of TAVR in women is unclear. Methods: The multinational Women's International Transcatheter Aortic Valve implantation registry enrolled consecutive female patients undergoing contemporary TAVR in 19 centers between 2013 and 2015. Patients with available coronary angiography or CT scan in the pre-operative assessment of TAVR were categorized as without CAD, with CAD but no recent PCI and CAD and recent PCI (≤30 days). All events were adjudicated according to the VARC-2 criteria. Results: A total of 787 patients were included in this analysis, among whom 459 (58.3%) had no CAD, 247 (31.4%) had CAD without recent PCI and 81 (10.3%) underwent recent PCI (≤ 30 days before TAVR). After multivariable adjustment, both groups of CAD patients, without and with recent PCI, presented with higher risk of death, myocardial infarction or stroke, compared with patients without CAD (adjHR 1.56, 95%CI 1.03–2.39, P = 0.038 and adjHR 1.96, 95% CI 1.1–3.5, P =.021, respectively). Patients with recent PCI had increased risk of all-cause death (adjHR 1.89, 95% CI 1.0–3.5, P = 0.04) and stroke (adjHR 3.7, 95% CI 1.0–13.5, P = 0.046) compared with patients without CAD. Conclusion: The presence of CAD in women undergoing TAVR, with or without recent PCI, was associated with long-term poorer outcomes.

Background: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group. Objectives: The objective of this article was to perform an economic evaluation of the SENIOR trial. Methods: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping. Results: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from (sic)13 752 to (sic)20 511/MACCE avoided and from (sic)42 835 to (sic)68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of (sic)50000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries. Conclusion: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.

Background and objectives Whether prolonged dual antiplatelet therapy (DAPT) is more protective in patients with CKD and drug-eluting stents compared with shorter DAPT is uncertain. The purpose of this meta-analysis was to examine whether shorter DAPT in patients with drug-eluting stents and CKD is associated with lower mortality or major adverse cardiovascular event rates compared with longer DAPT. Design, setting, participants, & measurements A Medline literature research was conducted to identify randomized trials in patients with drug-eluting stents comparing different DAPT duration strategies. Inclusion of patients with CKD was also required. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or stent thrombosis (definite or probable). Major bleeding was the secondary outcome. The risk ratio (RR) was estimated using a random-effects model. Results Five randomized trials were included (1902 patients with CKD). Short DAPT (≤6 months) was associated with a similar incidence of the primary outcome, compared with 12-month DAPT among patients with CKD (48 versus 50 events; RR, 0.93; 95% confidence interval [95% CI], 0.64 to 1.36; P=0.72). Twelve-month DAPT was also associated with a similar incidence of the primary outcome compared with extended DAPT (≥30 months) in the CKD subgroup (35 versus 35 events; RR, 1.04; 95% CI, 0.67 to 1.62; P=0.87). Numerically lower major bleeding event rates were detected with shorter versus 12-month DAPT (9 versus 13 events; RR, 0.69; 95% CI, 0.30 to 1.60; P=0.39) and 12-month versus extended DAPT (9 versus 12 events; RR, 0.83; 95% CI, 0.35 to 1.93; P=0.66) in patients with CKD. Conclusions Short DAPT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents. Because of imprecision in estimates (few events and wide confidence intervals), no definite conclusions can be drawn with respect to stent thrombosis.

Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion.The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36).Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels.URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

Objectives The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). Background The clinical correlates and the prognostic significance of CAC in women undergoing percutaneous coronary intervention with DES remain unclear. Methods Patient-level data from female participants in 26 randomized trials of DES were pooled. Study population was categorized according to the presence of moderate or severe versus mild or no target lesion CAC, assessed through coronary angiography. Co–primary endpoints of interest were the composite of death, myocardial infarction (MI), or target lesion revascularization and death, MI, or stent thrombosis at 3-year follow-up. Results Among 11,557 women included in the pooled dataset, CAC status was available in 6,371 women. Of these, 1,622 (25.5%) had moderate or severe CAC. In fully adjusted models, independent correlates of CAC were age, hypertension, hypercholesterolemia, smoking, previous coronary artery bypass graft surgery, and worse left ventricular and renal function. At 3 years, women with CAC were at higher risk for death, MI, or target lesion revascularization (18.2% vs. 13.1%; adjusted hazard ratio: 1.56; 95% confidence interval: 1.33 to 1.84; p < 0.0001) and death, MI, or stent thrombosis (12.7% vs. 8.6%; adjusted hazard ratio: 1.48; 95% confidence interval: 1.21 to 1.80; p = 0.0001). The adverse effect of CAC on ischemic outcomes appeared to be consistent across clinical and angiographic subsets of women, including new-generation DES. Conclusions Women undergoing PCI of calcified lesions tend to have worse clinical profile and remain at increased ischemic risk, irrespective of new-generation DES.

Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Background Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. Methods The WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.

BACKGROUND Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. METHODS AND RESULTS We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25). CONCLUSIONS Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc.

Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. Methods We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Results Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. Conclusions Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.

Objectives This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD). Background The prevalence and effect of CKD in women undergoing PCI with DES is unclear. Methods We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl)

Background There are no data available on specific causes of death from randomized trials that have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI). Objectives The purpose of this study was to investigate specific causes of death, and its predictors, after revascularization for complex coronary disease in patients. Methods An independent Clinical Events Committee consisting of expert physicians who were blinded to the study treatment subclassified causes of death as cardiovascular (cardiac and vascular), noncardiovascular, or undetermined according to the trial protocol. Cardiac deaths were classified as sudden cardiac, related to myocardial infarction (MI), and other cardiac deaths. Results In the randomized cohort, there were 97 deaths after CABG and 123 deaths after PCI during a 5-year follow-up. After CABG, 49.4% of deaths were cardiovascular, with the greatest cause being heart failure, arrhythmia, or other causes (24.6%), whereas after PCI, the majority of deaths were cardiovascular (67.5%) and as a result of MI (29.3%). The cumulative incidence rates of all-cause death were not significantly different between CABG and PCI (11.4% vs. 13.9%, respectively; p = 0.10), whereas there were significant differences in terms of cardiovascular (5.8% vs. 9.6%, respectively; p = 0.008) and cardiac death (5.3% vs. 9.0%, respectively; p = 0.003), which were caused primarily by a reduction in MI-related death with CABG compared with PCI (0.4% vs. 4.1%, respectively; p Conclusions During a 5-year follow-up, CABG in comparison with PCI was associated with a significantly reduced rate of MI-related death, which was the leading cause of death after PCI. Treatments following PCI should target reducing post-revascularization spontaneous MI. Furthermore, secondary preventive medication remains essential in reducing events post-revascularization. (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

BACKGROUND Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI. METHODS AND RESULTS The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057). CONCLUSIONS In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.

BACKGROUND Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. RESULTS We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated–stent group and in 154 patients (12.9%) in the bare-metal–stent group (risk difference, −3.6 percentage points; 95% confi dence interval [CI], −6.1 to −1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P

Backgrounds To facilitate the learning process of transcatheter aortic valve implantation (TAVI) in Japan, unique supporting systems (e.g., on-site proctor and web-based screening systems) have been developed. Nevertheless, little is known about real-world clinical outcomes after TAVI in Japan compared with their European counterparts. Methods From the optimized catheter valvular intervention (OCEAN-TAVI, Japan) and the Institut Cardiovasculaire Paris Sud (Massy, France) registries, we evaluated a total of 134 and 178 patients, respectively, who underwent transfemoral TAVI during the same time period. Results Among the French cohort, about half of the patients (N = 81, 45.5%) were treated with the Edwards SAPIEN XT. Body surface area was significantly smaller in the Japanese cohort, although operative risks for both cohorts were almost the same. A greater percentage of patients in the Japanese cohort were implanted with 23 mm valves compared with the French cohort (73.1% vs. 23.0%, P

Background Several clinical and procedural factors determine outcomes after transcatheter aortic valve replacement (TAVR), but data are scarce on the impact of post-TAVR discharge disposition on long-term outcomes. We sought to analyse whether discharge location after TAVR is associated with 1-year outcomes in women undergoing contemporary TAVR. Methods The Women’s INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry is the first all-female TAVR registry to study the safety and performance of contemporary TAVR in women (n = 1019). Information on discharge location was available in 817 patients (80.2%). We compared women discharged home vs those discharged to another location (nursing home, rehabilitation, or other hospital). One-year outcomes were adjusted using multivariable Cox regression methods with discharge home as the reference group. Results Of the study subjects, 75.2% (n = 614) were discharged home and 24.8% (n = 203) to another location. Women discharged to other locations were older with a greater prevalence of severe lung disease requiring home oxygen and renal failure on dialysis but were less frequently considered frail or at high surgical risk compared with women discharged home. After multivariable adjustment, non-home discharge was associated with greater hazard for 1-year Valve Academic Research Consortium 2 efficacy (21.3% vs 10.8%, hazards ratio [HR] 1.9, 95% confidence interval [CI] 1.2-2.9) and safety endpoints (31.5% vs 15.2%, HR 2.1, 95% CI 1.5-3.0), cardiovascular death (12.7% vs 5.5%, HR 2.0, 95% CI 1.1-3.6), and stroke (6.5% vs 0.8%, HR 8.5, 95% CI 2.9-25.6). Conclusions In women undergoing contemporary TAVR, discharge disposition significantly affects 1-year risk of outcomes even after adjustment for recorded baseline differences. This might suggest the necessity of considering additional factors beyond comorbidities in the TAVR decision-making process.

In the EXCEL trial, periprocedural major adverse events (MAE) were more frequent after coronary artery bypass graft (CABG) versus percutaneous coronary intervention (PCI) for treatment of left main (LM) disease. The association between composite and individual MAE after LM revascularization and long

The American and European practice guidelines are discordant regarding the preferred type of coronary stent (bare-metal vs. drug-eluting stent) to be used in patients with a planned noncardiac surgery (NCS) shortly after percutaneous coronary intervention (PCI). In this post hoc analysis of the

Final kissing balloon inflation (FKBI) after percutaneous coronary intervention (PCI) of bifurcation lesions has been advocated based on bench tests and computer simulations; however, the impact of FKBI on long-term clinical outcomes remains controversial. The study aims to determine the impact of

Prior studies of patients with noncomplex coronary artery disease have demonstrated safety of percutaneous coronary intervention (PCI) performed in the outpatient setting. The angiographic finding of left main coronary artery disease (LMCAD) usually prompts hospital admission for rapid

The COMPARE-ABSORB trial has shown noninferiority between the bioresorbable vascular scaffold (BVS) and the metallic everolimus-eluting stents (EES) at 1 year in composite safety and effectiveness outcomes, although BVS carries a higher device thrombosis rate than EES. Several studies indicated an

There is little data on long-term outcomes in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for left main coronary artery disease. In the EXCEL trial, 1,905 patients with left main coronary artery disease and low or

Vascular closure devices (VCD) provide rapid hemostasis and enable early mobilization of patients undergoing percutaneous coronary intervention (PCI) with transfemoral access (TFA); however, the safety and efficacy of VCD use continues to be debated. The authors analyzed data from the multicenter

Patients undergoing revascularization for left main coronary artery disease (LMCAD) may develop non–periprocedural-related myocardial infarction (MI) during long-term follow-up. There is limited information regarding the relative rate and prognostic impact of such spontaneous MI after percutaneous

The aim of this study was to determine whether high-risk patients with left main coronary artery disease (LMCAD) and prior cerebrovascular disease (CEVD) preferentially benefit from revascularization by percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG).Patients with known CEVD requiring revascularization are often referred to PCI rather than CABG. There is a paucity of data regarding the impact of CEVD in patients with LMCAD undergoing revascularization.In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with LMCAD and low or intermediate SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) scores were randomized to PCI with everolimus-eluting stents versus CABG. The effects of prior CEVD, defined as prior stroke, transient ischemic attack, or carotid artery disease, on 30-day and 3-year event rates were assessed.Prior CEVD was present in 233 of 1,898 patients (12.3%). These patients were older and had higher rates of comorbidities, including hypertension, diabetes, peripheral vascular disease, anemia, chronic kidney disease, and prior PCI, compared with those without prior CEVD. Patients with prior CEVD had higher rates of stroke at 30 days (2.2% vs. 0.8%; p = 0.05) and 3 years (6.4% vs. 2.2%; p = 0.0003) and higher 3-year rates of the primary endpoint of all-cause death, stroke, or myocardial infarction (25.0% vs. 13.6%; p 0.0001). The relative effects of PCI versus CABG on the 30-day and 3-year rates of stroke (pPatients with LMCAD and prior CEVD compared with those without CEVD have higher rates of stroke and reduced event-free survival after revascularization. Data from the EXCEL trial do not a priori support a preferential role of PCI over CABG in patients with known CEVD.

Background: Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion. Methods and Results: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35–0.88; P =0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P =0.01) and myocardial infarction (7.7% versus 12.8%, P =0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P =0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P =0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P =0.36). Conclusions: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

Aim In current device trials, the values of angiographic late lumen loss (LLL) have become extremely low and the relationship between LLL and clinical endpoints has not been recently re-evaluated. The impact of LLL on target lesion revascularization (TLR) in a patient- and study-level analysis of contemporary coronary devices was investigated. Methods and results We performed a patient-level meta-analysis of seven randomized controlled trials including 2426 patients treated with first- and second-generation drug-eluting stents (DES) and a study-level meta-analysis of 40 studies including 19 199 patients treated with CE-marked DES. In the patient-level analysis, the probability regression curve showed an exponential relationship between in-stent LLL and 2-year incidence of TLR. The optimal cut-off value of LLL based on Youden's index for 2-year TLR event was 0.50 mm. In the Cox proportional hazard model, LLL >0.50 mm was independently associated with an increased incidence of TLR up to 4 years after angiographic follow-up {adjusted hazard ratio (HR) 6.62 [95% confidence interval (95% CI) 4.67-9.39], P 0.50 mm (R2 = 0.44, P 0.50 mm was. Low LLL in contemporary device trials may not be a sufficiently discriminating parameter for the comparative evaluation of devices.

Pre-existing atrial fibrillation (AF) is common among patients who underwent transcatheter aortic valve implantation (TAVI) and has been associated with adverse outcomes. The specific impact of AF at baseline in women who underwent TAVI, however, remains unknown. The Women's International Transcatheter Aortic Valve Implantation is a prospective, multinational registry evaluating the safety and performance of contemporary TAVI in women in 19 centers between January 2013 and December 2015. Patients with available electrocardiogram at baseline were compared according to the presence of AF. All events were adjudicated according to the Valve Academic Research Consortium 2 criteria. Associations between AF and outcomes were tested using multivariate Cox regression model. Of the 993 women with available baseline electrocardiogram included in the study, 200 (20.1%) presented with AF. Patients with AF at baseline had higher Euroscore I score values and more frequently had chronic kidney disease or prior stroke. Patients without AF more frequently had coronary artery disease. There was no difference regarding in-hospital events between the two groups aside from longer length of stay for patients with AF (13.3 ± 11 vs 11.5 ± 7.1 days, p = 0.01). In multivariate analysis, AF at baseline was associated with an increase of all-cause and cardiovascular death at 12 months (adjHR 1.67 95%CI 1.11 to 2.50, p = 0.013 and adjHR 1.85 95%CI 1.19 to 2.86, p = 0.006 respectively). In conclusion, in this prospective registry of women who underwent contemporary TAVI, the presence of AF at baseline was associated with significantly increased 12-month mortality.

Several expert documents on sex-based differences in interventional outcomes are now available; however, this is the first position paper from the EAPCI Women Committee discussing the potential influence of sex in the percutaneous treatment of coronary and structural heart disease. Despite the misconception that coronary artery disease is a “man's disease”, contemporary data show a growing incidence in women. However, women are under-represented in randomised coronary clinical trials (~25%). The generalisation of such studies is, therefore, problematic in decision making for females undergoing coronary intervention. Differences in pathophysiology between sexes exist, highlighting the need for greater awareness amongst healthcare professionals to enable best evidence-based therapies for women as well as for men. Reassuringly, women represent half of the population included in transcatheter aortic valve implantation clinical trials and may actually benefit more. Growing evidence is also emerging for other interventional atrial procedures which may well be advantageous to women. Awareness of sex disparities is increasing, and we must all work collaboratively within our profession to ensure that we provide effective care for all patients with heart disease. The EAPCI Women Committee aims to highlight such issues through this position paper and through visibility within the interventional community.

Background Morphine is commonly used to treat chest pain during myocardial infarction, but its effect on cardiovascular outcome has never been directly evaluated. The aim of this study was to examine the effect and safety of morphine in patients with acute anterior ST ‐segment elevation myocardial infarction followed up for 1 year. Methods and Results We used the database of the CIRCUS (Does Cyclosporine Improve Outcome in ST Elevation Myocardial Infarction Patients) trial, which included 969 patients with anterior ST ‐segment elevation myocardial infarction, admitted for primary percutaneous coronary intervention. Two groups were defined according to use of morphine preceding coronary angiography. The composite primary outcome was the combined incidence of major adverse cardiovascular events, including cardiovascular death, heart failure, cardiogenic shock, myocardial infarction, unstable angina, and stroke during 1 year. A total of 554 (57.1%) patients received morphine at first medical contact. Both groups, with and without morphine treatment, were comparable with respect to demographic and periprocedural characteristics. There was no significant difference in major adverse cardiovascular events between patients who received morphine compared with those who did not (26.2% versus 22.0%, respectively; P =0.15). The all‐cause mortality was 5.3% in the morphine group versus 5.8% in the no‐morphine group ( P =0.89). There was no difference between groups in infarct size as assessed by the creatine kinase peak after primary percutaneous coronary intervention (4023±118 versus 3903±149 IU/L; P =0.52). Conclusions In anterior ST ‐segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention, morphine was used in half of patients during initial management and was not associated with a significant increase in major adverse cardiovascular events at 1 year.

The aim of the present study was to assess outcomes after coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) according to sex in a large randomized trial of patients with unprotected left main disease.In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, sex had a significant interaction effect with revascularization strategy, and women had an overall higher mortality when treated with PCI than CABG.The EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial was a multinational randomized trial that compared PCI with everolimus-eluting stents and CABG in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction, or stroke at 3 years.Of 1,905 patients randomized, 1,464 (76.9%) were men and 441 (23.1%) were women. Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score 24.2 vs. 27.2, p 0.001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR]: 1.10; 95% confidence interval [CI]: 0.82 to 1.48; p = 0.53) or all-cause death (HR: 1.39; 95% CI: 0.92 to 2.10; p = 0.12) at 3 years. At 30 days, all-cause death, myocardial infarction, or stroke had occurred in 8.9% of woman treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (p for interaction = 0.003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (p for interaction = 0.06). These differences were driven by higher periprocedural rates of myocardial infarction in women after PCI and in men after CABG.In patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease.

There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD).This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes.In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization.Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004).In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was common after CABG but extremely rare after PCI. The development of NOAF was strongly associated with subsequent death and stroke in CABG-treated patients. Further studies are warranted to determine whether prophylactic strategies to prevent or treat atrial fibrillation may improve prognosis in patients with LMCAD who are undergoing CABG. (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

The optimal duration of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor antagonist after percutaneous coronary intervention (PCI) and stenting of the left main coronary artery (LMCA) remains uncertain, especially considering the catastrophic complications of stent thrombosis (ST)

International audience; BACKGROUND: Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS: In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS: A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS: In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.)