Background: The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts. Methods: The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. Results: Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31–0.99]; P =0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33–1.46]; P =0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points. Conclusions: Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02270242.
Objectives To evaluate the impact of extended dual antiplatelet therapy (DAPT) beyond 12 months in acute coronary syndrome (ACS) patients with intermediate‐risk to high‐risk of developing ischemia according to the Global Acute Coronary Event Registration (GRACE) score. Background The duration of optimal DAPT remains controversial in patients at higher risk of developing ischemia. Methods Overall, 9,309 ACS patients in the Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease (OPT‐CAD) study were stratified as low‐risk ( n = 5,112) or intermediate‐risk to high‐risk (n = 4,197) according to the GRACE score on hospital discharge. Clinical outcomes at 12–24 months in patients with intermediate‐to‐high risk who completed 1‐year DAPT without any adverse events were analyzed. The primary endpoint was 24‐month net adverse clinical events (NACEs). Results Patients at intermediate‐to‐high‐risk had significantly higher incidence of NACE (10.2 vs. 4.9%, p < .01) and ischemic events (8.3 vs. 3.8%, p < .01) than low‐risk patients at 24 months. For patients at intermediate‐to‐high‐risk, extended DAPT beyond 12 months was associated with lower risk of NACE (3.0 vs. 5.1%, p = .012), all‐cause death (1.1 vs. 2.6%, p = .01), and cardiac death (0.6 vs. 1.8%, p = .01), without excessive risk of major bleeding events (0.3 vs. 0.5%, p = .47). Clinical outcomes in the propensity‐matched cohort were consistent. Conclusions ACS patients with intermediate‐risk or high‐ischemic risk may benefit from extended DAPT beyond 1 year, an outcome than requires further confirmation in large‐scale randomized trials.
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