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2020年日本心脏病学会(JCS)指南重点更新后日本经皮冠状动脉介入治疗的抗栓治疗趋势及临床结局:SAKURA PCI2抗栓注册研究结果

Trends in antithrombotic therapy and clinical outcomes for percutaneous coronary intervention in Japan following the 2020 JCS guideline focused update: findings from the SAKURA PCI2 Antithrombotic Registry.

作者信息

Arai Riku, Murata Nobuhiro, Kojima Keisuke, Matsumoto Michiaki, Matsumoto Naoya, Morikawa Tomoyuki, Atsumi Wataru, Tachibana Eizo, Haruta Hironori, Kogo Takaaki, Ebuchi Yasunari, Nomoto Kazumiki, Arai Masaru, Arima Ken, Mineki Takashi, Koyama Yutaka, Oiwa Koji, Okumura Yasuo

机构信息

Division of Cardiology, Department of Internal Medicine, Nihon University School of Medicine Itabashi Hospital, 30-1 Ohyaguchi-Kamicho, Itabashi-ku, Tokyo, 173-8610, Japan.

Division of Cardiology, Nihon University Hospital, Tokyo, Japan.

出版信息

Heart Vessels. 2025 Jul;40(7):612-628. doi: 10.1007/s00380-024-02493-4. Epub 2024 Dec 6.

Abstract

In April 2020, the Japanese Circulation Society updated guidelines recommending shortened dual antiplatelet therapy (DAPT) for patients at Japanese Version of the High Bleeding Risk (J-HBR), but the impact remains unclear. We conducted a prospective multicenter registry (SAKURA PCI2 Antithrombotic Registry) starting June 2020 (n = 1136), enrolling patients who underwent percutaneous coronary intervention (PCI). Planned DAPT duration, defined as short if less than 3 months, was based on patient background post-PCI and physicians' discretion. Planned short DAPT was used in 55.2% of patients, with a similar incidence of J-HBR (68.3% vs. 66.6%, p = 0.55) and a shorter actual DAPT duration (97 vs. 229 days, p < 0.001) compared with Planned non-short DAPT. Primary endpoints, major adverse cardiovascular and cerebrovascular events (MACCE) including all-cause death, non-fatal myocardial infarction, stent thrombosis, and stroke, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (BARC-3/5), occurred similarly across groups (MACCE: 6.5% vs. 7.3%, p = 0.66; BARC-3/5: 3.7% vs. 2.2%, p = 0.14). Independent predictors of MACCE included age ≥ 75, Clinical Frailty Scale ≥ 4, and hemoglobin < 11. Age ≥ 75, severe chronic kidney disease, hemoglobin < 11, and platelets < 100,000 were linked to BARC-3/5. Among BARC 3/5 patients, 41.2% experienced bleeding after switching to single antiplatelet therapy. Planned short DAPT was implemented in 55.2% of patients, showing comparable thrombotic and bleeding outcomes to non-short DAPT.

摘要

2020年4月,日本循环学会更新了指南,建议对日本版高出血风险(J-HBR)患者缩短双联抗血小板治疗(DAPT),但其影响仍不明确。我们于2020年6月启动了一项前瞻性多中心注册研究(SAKURA PCI2抗栓注册研究)(n = 1136),纳入接受经皮冠状动脉介入治疗(PCI)的患者。计划的DAPT持续时间,如果少于3个月则定义为短疗程,其依据是PCI术后患者背景和医生的判断。55.2%的患者采用了计划短疗程DAPT,与计划非短疗程DAPT相比,J-HBR发生率相似(68.3%对66.6%,p = 0.55),实际DAPT持续时间更短(97天对229天,p < 0.001)。主要终点,包括全因死亡、非致命性心肌梗死、支架血栓形成和中风的主要不良心血管和脑血管事件(MACCE),以及出血学术研究联盟(BARC)3型或5型出血(BARC-3/5),在各组中的发生率相似(MACCE:6.5%对7.3%,p = 0.66;BARC-3/5:3.7%对2.2%,p = 0.14)。MACCE的独立预测因素包括年龄≥75岁、临床衰弱量表≥4分和血红蛋白<11。年龄≥75岁、严重慢性肾脏病、血红蛋白<11和血小板<100,000与BARC-3/5相关。在BARC 3/5患者中,41.2%在改用单一抗血小板治疗后发生出血。55.2%的患者实施了计划短疗程DAPT,其血栓形成和出血结局与非短疗程DAPT相当。

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