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在急性冠状动脉综合征的高危 TWILIGHT 样患者中,确立 PCI 后 DAPT 的最佳持续时间。

Establishing the optimal duration of DAPT following PCI in high-risk TWILIGHT-like patients with acute coronary syndrome.

机构信息

Department of Cardiology, Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

State Key Laboratory of Cardiovascular Disease, Beijing, China.

出版信息

Catheter Cardiovasc Interv. 2022 Jan 1;99(1):98-113. doi: 10.1002/ccd.29741. Epub 2021 Apr 28.

DOI:10.1002/ccd.29741
PMID:33909311
Abstract

OBJECTIVES

To determine the association of extended-term (>12-month) versus short-term dual antiplatelet therapy (DAPT) with ischemic and hemorrhagic events in high-risk "TWILIGHT-like" patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) in clinical practice.

BACKGROUND

Recent emphasis on shorter DAPT regimen after PCI irrespective of indication for PCI may fail to account for the substantial residual risk of recurrent atherothrombotic events in ACS patients.

METHODS

All consecutive patients fulfilling the "TWILIGHT-like" criteria undergoing PCI were identified from the prospective Fuwai PCI Registry. High-risk patients (n = 8,358) were defined by at least one clinical and one angiographic feature based on TWILIGHT trial selection criteria. The primary ischemic endpoint was major adverse cardiac and cerebrovascular events at 30 months, composed of all-cause mortality, myocardial infarction, or stroke while BARC type 2, 3, or 5 bleeding was key secondary outcome.

RESULTS

Of 4,875 high-risk ACS patients who remained event-free at 12 months after PCI, DAPT>12-month compared with shorter DAPT reduced the primary ischemic endpoint by 63% (1.5 vs. 3.8%; HRadj: 0.374, 95% CI: 0.256-0.548; HRmatched: 0.361, 95% CI: 0.221-0.590). The HR for cardiovascular death was 0.049 (0.007-0.362) and that for MI 0.45 (0.153-1.320) and definite/probable stent thrombosis 0.296 (0.080-1.095) in propensity-matched analyses. Rates of BARC type 2, 3, or 5 bleeding (0.9 vs. 1.3%; HRadj: 0.668 [0.379-1.178]; HRmatched: 0.721 [0.369-1.410]) did not differ significantly between two groups.

CONCLUSIONS

Among high-risk ACS patients undergoing PCI, long-term DAPT, compared with shorter DAPT, reduced ischemic events without a concomitant increase in clinically meaning bleeding events, suggesting that prolonged DAPT can be considered in ACS patients who present with a particularly higher risk for thrombotic complications without excessive risk of bleeding.

摘要

目的

在临床实践中,确定接受经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征(ACS)高危“TWILIGHT 样”患者中,与短期双抗血小板治疗(DAPT)相比,延长 DAPT(>12 个月)与缺血和出血事件的相关性。

背景

最近强调 PCI 后无论 PCI 指征如何,都应采用更短的 DAPT 方案,但这可能无法解释 ACS 患者中复发性动脉血栓形成事件的大量残余风险。

方法

从前瞻性阜外 PCI 注册中心中确定符合“TWILIGHT 样”标准并接受 PCI 的所有连续患者。高危患者(n=8358)根据 TWILIGHT 试验选择标准,基于至少一个临床和一个血管造影特征来定义。主要缺血终点是 30 个月时的主要心脏和脑血管不良事件,由全因死亡率、心肌梗死或中风组成,而 BARC 类型 2、3 或 5 出血是关键次要结局。

结果

在接受 PCI 后 12 个月时仍无事件的 4875 例高危 ACS 患者中,与较短的 DAPT 相比,DAPT>12 个月可使主要缺血终点降低 63%(1.5% vs. 3.8%;HRadj:0.374,95%CI:0.256-0.548;HRmatched:0.361,95%CI:0.221-0.590)。在倾向匹配分析中,心血管死亡的 HR 为 0.049(0.007-0.362),心肌梗死的 HR 为 0.45(0.153-1.320),明确/可能的支架血栓形成的 HR 为 0.296(0.080-1.095)。在两组之间,BARC 类型 2、3 或 5 出血的发生率(0.9% vs. 1.3%;HRadj:0.668[0.379-1.178];HRmatched:0.721[0.369-1.410])无显著差异。

结论

在接受 PCI 的高危 ACS 患者中,与短期 DAPT 相比,长期 DAPT 可减少缺血事件,而不会增加临床意义上的出血事件,这表明对于存在特别高血栓并发症风险且出血风险无增加的 ACS 患者,可以考虑延长 DAPT。

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