高出血风险患者经皮冠状动脉介入治疗后使用依维莫司洗脱支架行 1 个月双联抗血小板治疗。
One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.
机构信息
Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA (D.E.K.).
Department of Interventional Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital (A.J.K., T.N.).
出版信息
Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.
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% (<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.
背景
尽管药物洗脱支架后高出血风险（HBR）患者的双联抗血小板治疗（DAPT）持续时间缩短的治疗指南得到了认可，但支持这些建议的证据有限。本研究旨在研究经皮冠状动脉介入治疗后使用依维莫司洗脱支架的 HBR 患者接受 1 个月 DAPT 治疗的安全性和有效性。
方法
onyx ONE Clear 是一项前瞻性、多中心、非随机研究，评估了在经皮冠状动脉介入治疗中使用 Resolute Onyx 药物洗脱支架后，HBR 患者接受 1 个月 DAPT 后单药抗血小板治疗的安全性和有效性。在 Onyx ONE 美国/日本研究和 Onyx ONE 随机对照试验中，对 1 个月至 1 年内心脏死亡或心肌梗死的主要分析是在预先指定的 1 个月 clear 患者人群中进行的。1 个月 clear 定义为 DAPT 依从性良好，且在经皮冠状动脉介入治疗后第一个月内无重大不良事件。
结果
在 Onyx ONE 美国/日本（n=752）和 Onyx ONE 随机对照试验（n=1018）中入组的患者中，有 1506 例患者符合 1 个月 clear 标准。每位患者的平均 HBR 特征为 1.6，其中 44.7%有多种风险。分别在 2 个月和 1 年时，96.9%和 89.3%的患者服用单药抗血小板治疗。在 1 个月至 1 年内，主要终点的发生率为 7.0%。1 侧 97.5%CI 上限为 8.4%，低于 9.7%的性能目标（<0.001）。
结论
在 1 个月 DAPT 停药前无事件发生的 HBR 患者中，通过 1 年的随访，使用 Resolute Onyx 药物洗脱支架治疗可获得良好的安全性和有效性，支持经皮冠状动脉介入治疗后缩短 DAPT 持续时间的个体化治疗策略。注册：网址：https://www.clinicaltrials.gov；唯一标识符 NCT03647475。
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