Background:The benefit of clopidogrel monotherapy after 1-month dual antiplatelet therapy (DAPT) compared with 12-month DAPT with aspirin and clopidogrel was demonstrated in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2), but not in the STOPDAPT-2 acute coronary syndrome (ACS); however, both trials were underpowered based on the actual event rates.Methods:We obtained the prespecified pooled population of 5997 patients as the STOPDAPT-2 total cohort (STOPDAPT-2: N=3009/STOPDAPT-2 ACS: N=2988; ACS: N=4136/chronic coronary syndrome [CCS]: N=1861), comprising 2993 patients assigned to 1-month DAPT followed by clopidogrel monotherapy, and 3004 patients assigned to 12-month DAPT with aspirin and clopidogrel after percutaneous coronary intervention. The primary end point was the composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or any stroke) or bleeding (Thrombolysis in Myocardial Infarction major/minor) end points at 1 year.Results:One-month DAPT was noninferior to 12-month DAPT for the primary end point (2.84% versus 3.04%; hazard ratio [HR], 0.94 [95% CI, 0.70–1.27]; P_{noninferiority}=0.001; P_superiority=0.68). There was no significant risk-difference for the cardiovascular end point between the 1- and 12-month DAPT groups (2.40% versus 1.97%; HR, 1.24 [95% CI, 0.88–1.75]; P_{noninferiority}=0.14; P_superiority=0.23). There was a lower risk of the bleeding end point with 1-month DAPT relative to 12-month DAPT (0.50% versus 1.31%; HR, 0.38 [95% CI, 0.21–0.70]; P_superiority=0.002). One-month DAPT relative to 12-month DAPT was associated with a lower risk for major bleeding regardless of ACS or CCS (ACS: HR, 0.46 [95% CI, 0.23–0.94]; P=0.03, and CCS: HR, 0.26 [95% CI, 0.09–0.79]; P=0.02; P_interaction=0.40), while it was associated with a numerical increase in cardiovascular events in ACS patients, but not in CCS patients, although not statistically significant and without interaction (ACS: HR, 1.50 [95% CI, 0.99–2.27]; P=0.053, and CCS: HR, 0.74 [95% CI, 0.38–1.45]; P=0.39; P_interaction=0.08).Conclusions:Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT with aspirin and clopidogrel had a benefit in reducing major bleeding events without being associated with increase in cardiovascular events.Registration:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02619760, NCT03462498.

中文翻译：

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经皮冠状动脉介入治疗中 1 个月双重抗血小板治疗后的氯吡格雷单药治疗：来自 STOPDAPT-2 总队列


背景：与阿司匹林和氯吡格雷联合使用 12 个月的 DAPT 相比，1 个月双重抗血小板治疗 (DAPT) 后氯吡格雷单药治疗的益处已在 STOPDAPT-2（依维莫司洗脱钴铬后双重抗血小板治疗的短期和最佳持续时间）中得到证实。 Stent-2），但不适用于 STOPDAPT-2 急性冠状动脉综合征（ACS）；然而，根据实际事件发生率，这两项试验的功效均不足。 方法：我们获得了预先指定的 5997 名患者的汇总人群作为 STOPDAPT-2 总队列（STOPDAPT-2：N=3009/STOPDAPT-2 ACS：N=2988；ACS ：N=4136/慢性冠状动脉综合征[CCS]：N=1861），其中包括 2993 名患者接受为期 1 个月的 DAPT，随后接受氯吡格雷单药治疗，以及 3004 名患者在经皮冠状动脉介入治疗后接受为期 12 个月的 DAPT，联合阿司匹林和氯吡格雷治疗。主要终点是 1 年时心血管（心血管死亡、心肌梗死、明确支架内血栓形成或任何中风）或出血（心肌梗死主要/次要溶栓）终点的复合终点。 结果：1 个月 DAPT 不劣于主要终点为 12 个月 DAPT（2.84% 对比 3.04%；风险比 [HR]，0.94 [95% CI，0.70–1.27]； P_非劣效性=0.001； P_优效性=0.68）。 1 个月和 12 个月 DAPT 组之间的心血管终点没有显着风险差异（2.40% 与 1.97%；HR，1.24 [95% CI，0.88–1.75]； P_非劣效性=0.14； P_优效性= 0.23）。与 12 个月 DAPT 相比，1 个月 DAPT 的出血终点风险较低（0.50% 对比 1.31%；HR，0.38 [95% CI，0.21–0.70]； P_优效性=0.002）。 无论 ACS 还是 CCS，1 个月 DAPT 相对于 12 个月 DAPT 均与较低的大出血风险相关（ACS：HR，0.46 [95% CI，0.23–0.94]； P = 0.03，CCS：HR，0.26 [95% CI，0.09–0.79]； P = 0.02； P_交互作用= 0.40），虽然它与 ACS 患者心血管事件的数量增加相关，但与 CCS 患者无关，尽管没有统计学意义且没有交互作用（ACS） ：HR，1.50 [95% CI，0.99–2.27]； P = 0.053，CCS：HR，0.74 [95% CI，0.38–1.45]； P = 0.39； P_相互作用= 0.08）。与阿司匹林和氯吡格雷联合使用 12 个月的 DAPT 相比，1 个月的 DAPT 有利于减少大出血事件，且不会增加心血管事件的发生。唯一标识符：NCT02619760、NCT03462498。