Department of Cardiovascular Medicine, Saga University, Saga, Japan.
Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
PLoS One. 2020 Mar 25;15(3):e0227612. doi: 10.1371/journal.pone.0227612. eCollection 2020.
There has been no previous prospective study evaluating 3-month dual antiplatelet therapy (DAPT) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in patients with acute coronary syndrome (ACS). The STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration in all-comer population after CoCr-EES implantation. Among 1525 study patients enrolled from 58 Japanese centers, the present study compared the 1-year clinical outcomes between ACS patients (N = 487) and stable coronary artery disease (CAD) patients (N = 1038). In the ACS group, 228 patients (47%) had unstable angina and 259 patients (53%) had myocardial infarction. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding. Thienopyridine was discontinued within 4-month in 455 patients (94.0%) in the ACS group and 977 patients (94.3%) in the stable CAD group. Cumulative 1-year incidence of and the adjusted risk for the primary endpoint were not significantly different between the ACS and stable CAD groups (2.3% vs. 3.0%, P = 0.42, and HR 0.94, 95%CI 0.44-1.87, P = 0.87). In the 3-month landmark analysis, cumulative incidence of the primary endpoint was also not significantly different between the ACS and stable CAD groups (1.3% vs. 2.4%, P = 0.16). There was no definite/probable ST through 1-year in both groups. In the propensity matched analysis, the cumulative 1-year incidence of the primary endpoint were similar between the ACS and stable CAD groups (2.3% versus 2.1%, P = 0.82). In conclusion, stopping DAPT at 3 months after CoCr-EES implantation in patients with ACS including 47% of unstable angina was as safe as that in patients with stable CAD.
此前，尚无前瞻性研究评估在急性冠状动脉综合征（ACS）患者中植入钴铬依维莫司洗脱支架（CoCr-EES）后 3 个月的双联抗血小板治疗（DAPT）。STOPDAPT 试验是一项前瞻性多中心单臂研究，评估了所有患者在植入 CoCr-EES 后的 3 个月 DAPT 持续时间。在从 58 家日本中心招募的 1525 名研究患者中，本研究比较了 ACS 患者（N=487）和稳定型冠状动脉疾病（CAD）患者（N=1038）的 1 年临床结局。在 ACS 组中，228 例患者（47%）为不稳定型心绞痛，259 例患者（53%）为心肌梗死。主要终点是心血管死亡、心肌梗死、卒中和确定的支架血栓形成（ST）和 TIMI 主要/次要出血的复合终点。在 ACS 组中，455 例患者（94.0%）在 4 个月内停用噻吩吡啶，1038 例稳定型 CAD 患者（94.3%）停用噻吩吡啶。ACS 组和稳定型 CAD 组 1 年累积主要终点发生率和调整后的风险无显著差异（2.3% vs. 3.0%，P=0.42，HR 0.94，95%CI 0.44-1.87，P=0.87）。在 3 个月的里程碑分析中，ACS 组和稳定型 CAD 组的主要终点累积发生率也无显著差异（1.3% vs. 2.4%，P=0.16）。两组均无明确/可能的 ST 至 1 年。在倾向匹配分析中，ACS 组和稳定型 CAD 组 1 年累积主要终点发生率相似（2.3% vs. 2.1%，P=0.82）。总之，在包括 47%不稳定型心绞痛患者的 ACS 患者中，在植入 CoCr-EES 后 3 个月停止 DAPT 与在稳定型 CAD 患者中一样安全。
