小柯机器人

韩国首尔国立大学医院Hyo-Soo Kim团队比较了阿司匹林与氯吡格雷用于经皮冠状动脉介入术后长期维持单药治疗的效果。2021年5月16日，该成果发表在《柳叶刀》杂志上。

接受冠状动脉支架置入术的患者在慢性维持期的最佳抗血小板单药疗法尚不明确。

为了比较阿司匹林和氯吡格雷单药治疗该人群的疗效和安全性，研究组在韩国的37个研究机构进行了一项研究者发起、前瞻性、随机开放性、多中心试验。研究组招募年龄至少为20岁的患者，他们在使用药物洗脱支架（DES）经皮冠状动脉介入治疗后6-18个月内维持双重抗血小板治疗，且无临床事件。排除有任何缺血和严重出血并发症的患者。将参与者按1：1随机分配，分别接受氯吡格雷或阿司匹林单药治疗，持续24个月。在意向治疗人群中，主要终点是全因死亡、非致命性心肌梗死、中风、急性冠脉综合征再入院和出血学术研究会（BARC）出血类型3型及以上。

2014年3月26日至2018年5月29日，研究组共招募了5530名患者，将其中5438名（98.3%）随机分组，其中氯吡格雷组2710名，阿司匹林组2728名。5338名（98.2%）患者完成了主要终点的确定。在24个月的随访中，氯吡格雷组中有152例（5.7%）患者发生主要终点，阿司匹林组中有207例（7.7%），风险比为0.73。

研究结果表明，对于经皮冠状动脉介入术后需要无限期抗血小板单药治疗的患者，与阿司匹林单药治疗相比，氯吡格雷单药治疗可显著降低全因死亡、非致命性心肌梗死、中风、急性冠脉综合征再入院和3型及以上BARC出血的风险。

附：英文原文

Title: Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial

Author: Bon-Kwon Koo, Jeehoon Kang, Kyung Woo Park, Tae-Min Rhee, Han-Mo Yang, Ki-Bum Won, Seung-Woon Rha, Jang-Whan Bae, Nam Ho Lee, Seung-Ho Hur, Junghan Yoon, Tae-Ho Park, Bum Soo Kim, Sang Wook Lim, Yoon Haeng Cho, Dong Woon Jeon, Sang-Hyun Kim, Jung-Kyu Han, Eun-Seok Shin, Hyo-Soo Kim, Bon-Kwon Koo, Jeehoon Kang, Kyung Woo Park, Tae-Min Rhee, Heesun Lee, Han-Mo Yang, Ki-Bum Won, Seung-Woon Rha, Jang-Whan Bae, Nam Ho Lee, Seung-Ho Hur, Junghan Yoon, Tae-Ho Park, Bum Soo Kim, Sang Wook Lim, Yoon Haeng Cho, Dong Woon Jeon, Sang-Hyun Kim, Jung-Kyu Han, Eun-Seok Shin, Hyo-Soo Kim, Kyoo-Rok Han, Keon-Woong Moon, Seok Kyu Oh, Ung Kim, Moo-Yong Rhee, Doo-Il Kim, Song-Yi Kim, Sung-Yun Lee, Seung Uk Lee, Sang-Wook Kim, Seok Yeon Kim, Hui-Kyung Jeon, Kwang Soo Cha, Sang-Ho Jo, Jae Kean Ryu, Il-Woo Suh, Hyun-Hee Choi, Seoung-Il Woo, In-Ho Chae, Won-Yong Shin, Dae-Kyeong Kim, Ju Hyeon Oh, Myung Ho Jeong, Yong Hoon Kim

Issue&Volume: 2021-05-16

Abstract:

Background

Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population.

Methods

We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6–18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.

Findings

Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59–0·90]; p=0·0035).

Interpretation

Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.

DOI: 10.1016/S0140-6736(21)01063-1

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01063-1/fulltext

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