Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy.

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.

Correction to: Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.

In the original article, t.

Dual Antiplatelet Therapy Duration in Medically Managed Acute Coronary Syndrome Patients: Sub-Analysis of the OPT-CAD Study.

INTRODUCTION: Optimal dual antiplatelet therapy (DAPT) duration for medically managed acute coronary syndrome (ACS) (MMACS) patients is still unknown. We explored the efficacy and safety of ≥ 12-month DAPT among MMACS patients. METHODS: In this sub-analysis of the optimal antiplatelet therapy for Chinese Patients with Coronary Artery Disease study (NCT01735305), clinical outcomes among MMACS patients were compared between the < 12-month and ≥ 12-month DAPT groups. The primary efficacy endpoint was a composite of cardiac death, myocardial infarction, and stroke. Safety endpoints included the Bleeding Academic Research Consortium (BARC) 2-5, BARC 3-5, and all bleeding events. Propensity score matching (PSM) was used to compare baseline characteristics between the < 12-month and ≥ 12-month DAPT groups. RESULTS: In this cohort of ACS patients (n = 10,016), MMACS patients (n = 2967) were less likely to use DAPT at 12 (31.64% vs. 67.47%, P < 0.0001) and 24 (13.82% vs. 18.71%, P < 0.0001) months and experienced more ischemic events at 12 (4.55% vs. 3.40%, P = 0.006) and 24 (6.88% vs. 5.08%, P = 0.0004) months than those treated with percutaneous coronary intervention (n = 7049). Among MMACS patients, the rate of primary efficacy endpoint occurring within the second year was significantly higher in the < 12-month DAPT group than in the ≥ 12-month group both before (2.88% vs. 1.60%, P = 0.040) and after (3.19% vs. 1.71%, P = 0.045) PSM. After PSM, no significant differences in all bleeding, BARC 2-5, and BARC 3-5 bleeding were found between the groups. CONCLUSION: MMACS patients with insufficient DAPT management experienced relatively more ischemic events. DAPT for at least 1 year may be beneficial to this special population without significantly increasing the bleeding risks. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01735305.

Impact of extended dual antiplatelet therapy on clinical prognosis in acute coronary syndrome patients with intermediate or high ischemic risk defined by the GRACE score.

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.