1. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.
- Author
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Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, and Stone GW
- Subjects
- Aged, Aged, 80 and over, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Drug Administration Schedule, Female, Hemorrhage chemically induced, Humans, Japan, Male, Middle Aged, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors adverse effects, Prospective Studies, Prosthesis Design, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Sirolimus administration & dosage, Time Factors, Treatment Outcome, United States, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Drug-Eluting Stents, Dual Anti-Platelet Therapy adverse effects, Percutaneous Coronary Intervention instrumentation, Platelet Aggregation Inhibitors administration & dosage, Sirolimus analogs & derivatives
- Abstract
Background: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients., Methods: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention., Results: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% ( P <0.001)., Conclusions: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.
- Published
- 2020
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