Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS.

AIMS: The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS AND RESULTS: We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96). CONCLUSION: Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02270242.

Low body mass index is associated with adverse cardiovascular outcomes following PCI in India: ACC-NCDR registry.

Objective: Registry-based prospective study was conducted to evaluate association of body mass index (BMI) with major adverse coronary events (MACE) following percutaneous coronary intervention (PCI). Methods: Successive patients undergoing PCI were enrolled from April'19 to March'22 and classified into five BMI categories (<23.0,23.0-24.9,25.0-26.9,27.0-29.9, and ≥30.0 kg/m2). Clinical, angiographic features, interventions and outcomes were obtained by in-person or telephonic follow-up. Primary endpoints were (a) MACE(cardiovascular deaths, acute coronary syndrome or stroke, revascularization, hospitalization and all-cause deaths) and (b)cardiovascular deaths. Cox-proportionate hazard ratios(HR) and 95 % confidence intervals(CI) were calculated. Results: The cohort included 4045 patients. Mean age was 60.3 ± 11y, 3233(79.7 %) were men. There was high prevalence of cardiometabolic risk factors. 90 % patients had acute coronary syndrome(STEMI 39.6 %, NSTEMI/unstable angina 60.3 %), 60.0 % had impaired ejection fraction(EF) and multivessel CAD. Lower BMI groups (<23.0 kg/m2) had higher prevalence of tobacco use, reduced ejection fraction(EF), multivessel CAD, stents, and less primary PCI for STEMI. There was no difference in discharge medications and in-hospital deaths. Median follow-up was 24 months (IQR 12-36), available in 3602(89.0 %). In increasing BMI categories, respectively, MACE was in 10.9,8.9,9.5,9.1 and 6.8 % (R2 = 0.73) and CVD deaths in 5.1,4.5,4.4,5.1 and 3.5 % (R2 = 0.39). Compared to lowest BMI category, age-sex adjusted HR in successive groups for MACE were 0.89,0.87,0.79,0.69 and CVD deaths 0.98,0.87,0.95,0.75 with overlapping CI. HR attenuated following multivariate adjustments. Conclusions: Low BMI patients have higher incidence of major adverse cardiovascular events following PCI in India. These patients are older, with greater tobacco use, lower EF, multivessel CAD, delayed STEMI-PCI, and longer hospitalization.