Hamana Tomoyo, Sawada Takahiro, Fujimoto Wataru, Osue Tsuyoshi, Tsukiyama Yoshiro, Uzu Kenzo, Takaya Tomofumi, Yasaka Yoshinori, Kawai Hiroya
Division of Cardiovascular Medicine, Hyogo Prefectural Himeji Cardiovascular Center Himeji Japan.
Circ Rep. 2020 Dec 23;3(1):55-65. doi: 10.1253/circrep.CR-20-0126.
In this study we investigated the efficacy and safety of very short duration (1-month) dual antiplatelet therapy (DAPT) followed by prasugrel monotherapy. In particular, we compared intrastent conditions using optical coherence tomography (OCT) after second-generation drug-eluting stent implantation between standard-duration and 1-month DAPT followed by prasugrel monotherapy. Between May 2015 and February 2018, 120 consecutive patients who underwent elective Resolute zotarolimus-eluting stent implantation were enrolled and divided into those receiving standard-duration or 1-month (1M) DAPT followed by prasugrel monotherapy; 47 patients (n=55 stents) and 46 patients (n=54 stents) in the standard and 1M groups, respectively, completed the protocol. The primary endpoint was the prevalence of abnormal intrastent tissue at the 9-month examination, as observed by OCT. The secondary endpoint was the presence of composite adverse events, including all-cause death, myocardial infarction, stent thrombosis, target lesion and vessel revascularization, and major and minor bleeding. The prevalence of abnormal intrastent tissue was similar between the standard and 1M groups (1.6% vs. 1.5%, respectively; non-inferiority P<0.01). There was a tendency for fewer composite events in the 1M than standard group at the 30-month follow-up examination (28.3% vs. 44.7%, respectively; P=0.41). In conclusion, 1M DAPT followed by prasugrel monotherapy after second-generation drug-eluting stent implantation was not inferior to standard-duration DAPT in terms of intrastent thrombus formation and composite adverse events.
在本研究中,我们调查了极短疗程(1个月)的双联抗血小板治疗(DAPT)继以普拉格雷单药治疗的疗效和安全性。具体而言,我们比较了第二代药物洗脱支架植入术后,标准疗程DAPT组与1个月DAPT继以普拉格雷单药治疗组,使用光学相干断层扫描(OCT)观察到的支架内情况。2015年5月至2018年2月,连续纳入120例行择期雷帕霉素洗脱支架植入术的患者,并将其分为接受标准疗程DAPT或1个月(1M)DAPT继以普拉格雷单药治疗的两组;标准组和1M组分别有47例患者(55枚支架)和46例患者(54枚支架)完成了研究方案。主要终点是OCT观察到的9个月检查时支架内异常组织的发生率。次要终点是复合不良事件的发生情况,包括全因死亡、心肌梗死、支架血栓形成、靶病变和血管再血管化,以及严重和轻微出血。标准组和1M组支架内异常组织的发生率相似(分别为1.6%和1.5%;非劣效性P<0.01)。在30个月的随访检查中,1M组的复合事件有少于标准组的趋势(分别为28.3%和44.7%;P=0.41)。总之,第二代药物洗脱支架植入术后1M DAPT继以普拉格雷单药治疗,在支架内血栓形成和复合不良事件方面不劣于标准疗程DAPT。