冠状动脉支架置入术后阿司匹林与氯吡格雷的长期对比,按出血风险和手术复杂程度分类。

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Jeehoon Kang, Jaewook Chung, Kyung Woo Park, Jang-Whan Bae, Huijin Lee, Doyeon Hwang, Han-Mo Yang, Kyoo-Rok Han, Keon-Woong Moon, Ung Kim, Moo-Yong Rhee, Doo-Il Kim, Song-Yi Kim, Sung-Yun Lee, Seung Uk Lee, Sang-Wook Kim, Seok Yeon Kim, Jung-Kyu Han, Eun-Seok Shin, Bon-Kwon Koo, Hyo-Soo Kim
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引用次数: 0

摘要

重要性:对于高出血风险(HBR)患者和接受过复杂经皮冠状动脉介入治疗(PCI)的患者,在慢性维持治疗期间的抗血小板单药治疗尚未得到探讨:比较氯吡格雷与阿司匹林在高出血风险和/或复杂经皮冠状动脉介入治疗患者中的单药治疗效果:这项多中心 HOST-EXAM Extended 研究是一项开放标签试验,在韩国的 37 个研究机构进行,2014 年至 2018 年期间招募了患者,随访时间长达 5.9 年。分析时间为 2023 年 2 月至 11 月。纳入的患者均在PCI治疗后6至18个月内保持双联抗血小板疗法(DAPT)无事件发生:患者按 1:1 的比例随机接受氯吡格雷或阿司匹林治疗。对有足够数据评估HBR或复杂PCI的患者进行分析:主要终点为血栓性综合终点(心血管死亡、非致死性心肌梗死、中风、急性冠脉综合征再入院、明确/可能的支架血栓形成)和任何出血(出血学术研究联盟 2 至 5 型):在纳入的 3974 名患者中(平均 [SD] 年龄为 63.4 [10.7] 岁;2976 名男性 [74.9%]),866 名患者患有 HBR(21.8%),849 名患者接受了复杂 PCI(21.4%)。与阿司匹林相比,无论HBR和/或PCI复杂程度如何,氯吡格雷都能降低血栓和出血事件的发生率。就血栓复合终点而言,HBR 患者的危险比 (HR) 为 0.75(95% CI,0.53-1.04),而非 HBR 患者的危险比 (HR) 为 0.62(95% CI,0.48-0.80)(交互作用 P = 0.38);复杂 PCI 患者的危险比 (HR) 为 0.49(95% CI,0.32-0.77),而非复杂 PCI 患者的危险比 (HR) 为 0.74(95% CI,0.59-0.92)(交互作用 P = 0.12)。与阿司匹林相比,氯吡格雷减少出血的效果在 HBR 患者(HR,0.82;95% CI,0.56-1.21)和非 HBR 患者(HR,0.58;95% CI,0.40-0.85;交互作用 P = 0.12)中一致。85;交互作用的 P = 0.20),以及复杂 PCI 患者(HR,0.79;95% CI,0.47-1.33)与非复杂 PCI 患者(HR,0.68;95% CI,0.50-0.93;交互作用的 P = 0.62)之间的差异:在这项研究中,对于经历过PCI且在6至18个月的DAPT期间无事件发生的患者,无论出血风险和/或PCI复杂程度如何,氯吡格雷单药治疗对阿司匹林单药治疗的有利影响是一致的:试验注册:ClinicalTrials.gov Identifier:NCT02044250。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-Term Aspirin vs Clopidogrel After Coronary Stenting by Bleeding Risk and Procedural Complexity.

Importance: Antiplatelet monotherapy in the chronic maintenance period for patients with high bleeding risk (HBR) and those who have undergone complex percutaneous coronary intervention (PCI) has not yet been explored.

Objective: To compare clopidogrel vs aspirin monotherapy in patients with HBR and/or PCI complexity.

Design, setting, and participants: This post hoc analysis of the multicenter HOST-EXAM Extended study, an open-label trial conducted across 37 sites in South Korea, enrolled patients from 2014 to 2018 with up to 5.9 years of follow-up. The analysis was conducted from February to November 2023. Patients who maintained dual antiplatelet therapy (DAPT) event-free for 6 to 18 months following PCI were included.

Interventions: Patients were randomized to receive either clopidogrel or aspirin in a 1:1 ratio. Those with sufficient data to assess HBR or complex PCI were analyzed.

Main outcomes and measures: Coprimary end points were thrombotic composite end point (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding (Bleeding Academic Research Consortium type 2 to 5).

Results: Of 3974 patients included (mean [SD] age, 63.4 [10.7] years; 2976 male [74.9%]), 866 had HBR (21.8%), and 849 underwent complex PCI (21.4%). Clopidogrel as compared with aspirin was associated with lower rates of thrombotic and bleeding events regardless of HBR and/or PCI complexity. For the thrombotic composite end point, the hazard ratio (HR) was 0.75 (95% CI, 0.53-1.04) among HBR vs 0.62 (95% CI, 0.48-0.80) among patients without HBR (P for interaction = 0.38) and 0.49 (95% CI, 0.32-0.77) among patients with complex PCI vs 0.74 (95% CI, 0.59-0.92) among patients with noncomplex PCI (P for interaction = 0.12). The reduction in bleeding by clopidogrel compared with aspirin was consistent among both patients with HBR (HR, 0.82; 95% CI, 0.56-1.21) and patients without HBR (HR, 0.58; 95% CI, 0.40-0.85; P for interaction = 0.20) and among patients undergoing complex PCI (HR, 0.79; 95% CI, 0.47-1.33) vs noncomplex PCI (HR, 0.68; 95% CI, 0.50-0.93; P for interaction = 0.62).

Conclusions and relevance: In this study, in patients who experienced PCI and were event-free during 6 to 18 months of DAPT, the beneficial impact of clopidogrel monotherapy over aspirin monotherapy was consistent, regardless of bleeding risk and/or PCI complexity.

Trial registration: ClinicalTrials.gov Identifier: NCT02044250.

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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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