根据P2Y12抑制剂类型，冠状动脉支架置入术后的P2Y12抑制剂单药治疗

P2Y12 inhibitor monotherapy after coronary stenting according to type of P2Y12 inhibitor.

作者信息

Kim Juwon, Jang Woo Jin, Lee Wang Soo, Choi Ki Hong, Lee Joo Myung, Park Taek Kyu, Yang Jeong Hoon, Choi Jin-Ho, Song Young Bin, Choi Seung-Hyuk, Gwon Hyeon-Cheol, Lee Sang Hoon, Oh Ju-Hyeon, Chun Woo Jung, Park Yong Hwan, Im Eul-Soon, Jeong Jin-Ok, Cho Byung Ryul, Oh Seok Kyu, Yun Kyeong Ho, Cho Deok-Kyu, Lee Jong-Young, Koh Young-Youp, Bae Jang-Whan, Choi Jae Woong, Yoon Hyuck Jun, Lee Seung Uk, Cho Jang Hyun, Choi Woong Gil, Rha Seung-Woon, Hahn Joo-Yong

机构信息

Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).

Division of Cardiology, Department of Internal Medicine, Ewha Womans University College of Medicine Seoul Hospital, Seoul, Korea (the Republic of).

出版信息

Heart. 2021 Jun 11;107(13):1077-1083. doi: 10.1136/heartjnl-2020-318821.

DOI:10.1136/heartjnl-2020-318821

PMID:33758008

Abstract

OBJECTIVE

To compare P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) with 12-month DAPT according to the type of P2Y12 inhibitor in patients undergoing percutaneous coronary intervention (PCI).

METHODS

The Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Antiplatelet Therapy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents (SMART-CHOICE) randomised trial compared 3-month DAPT followed by P2Y12 inhibitor monotherapy with 12-month DAPT. In this trial, 2993 patients undergoing successful PCI with drug-eluting stent were enrolled in Korea. As a prespecified analysis, P2Y12 inhibitor monotherapy after 3-month DAPT versus 12-month DAPT were compared among patients receiving clopidogrel and those receiving potent P2Y12 inhibitor (ticagrelor or prasugrel), respectively. The primary endpoint was a composite of all-cause death, myocardial infarction or stroke at 12 months after the index procedure.

RESULTS

Among 2993 patients (mean age 64 years), 58.2% presented with acute coronary syndrome. Clopidogrel was prescribed in 2312 patients (77.2%) and a potent P2Y12 inhibitor in 681 (22.8%). There were no significant differences in the primary endpoint between the P2Y12 inhibitor monotherapy group and the DAPT group among patients receiving clopidogrel (3.0% vs 3.0%; HR: 1.02; 95% CI 0.64 to 1.65; p=0.93) as well as among patients receiving potent P2Y12 inhibitors (2.4% vs 0.7%; HR: 3.37; 95% CI 0.77 to 14.78; p=0.11; interaction p=0.1). Among patients receiving clopidogrel, P2Y12 inhibitor monotherapy compared with DAPT showed consistent treatment effects across various subgroups for the primary endpoint. Among patients receiving potent P2Y12 inhibitors, the rate of bleeding (Bleeding Academic Research Consortium types 2- 5) was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (1.5% vs 5.0%; HR: 0.33; 95% CI 0.12 to 0.87; p=0.03).

CONCLUSIONS

Compared with 12-month DAPT, clopidogrel monotherapy after 3-month DAPT showed comparable cardiovascular outcomes in patients undergoing PCI.

TRIAL REGISTRATION NUMBER

NCT02079194.

摘要

目的

根据经皮冠状动脉介入治疗（PCI）患者使用的P2Y12抑制剂类型，比较3个月双联抗血小板治疗（DAPT）后P2Y12抑制剂单药治疗与12个月DAPT的疗效。

方法

智能血管成形术研究团队：冠状动脉药物洗脱支架植入患者中P2Y12拮抗剂单药治疗与双联抗血小板治疗的比较（SMART-CHOICE）随机试验比较了3个月DAPT后序贯P2Y12抑制剂单药治疗与12个月DAPT的疗效。在该试验中，韩国2993例成功接受药物洗脱支架PCI的患者入组。作为一项预先设定的分析，分别比较了接受氯吡格雷和强效P2Y12抑制剂（替格瑞洛或普拉格雷）的患者中，3个月DAPT后P2Y12抑制剂单药治疗与12个月DAPT的疗效。主要终点为首次手术后12个月时全因死亡、心肌梗死或卒中的复合终点。

结果

在2993例患者（平均年龄64岁）中，58.2%表现为急性冠状动脉综合征。2312例患者（77.2%）使用氯吡格雷，681例患者（22.8%）使用强效P2Y12抑制剂。接受氯吡格雷治疗的患者中，P2Y12抑制剂单药治疗组与DAPT组的主要终点无显著差异（3.0%对3.0%；HR：1.02；95%CI 0.64至1.65；p=0.93）；接受强效P2Y12抑制剂治疗的患者中，两组间主要终点也无显著差异（2.4%对0.7%；HR：3.37；95%CI 0.77至14.78；p=0.11；交互作用p=0.1）。在接受氯吡格雷治疗的患者中，P2Y12抑制剂单药治疗与DAPT相比，在各亚组中对主要终点均显示出一致的治疗效果。在接受强效P2Y12抑制剂治疗的患者中，P2Y12抑制剂单药治疗组的出血率（出血学术研究联盟2-5型）显著低于DAPT组（1.5%对5.0%；HR：0.33；95%CI 0.12至0.87；p=0.03）。