Abstract：
BACKGROUND: The effects of aspirin-free strategy on bleeding and cardiovascular events in patients undergoing percutaneous coronary intervention with oral anticoagulation (OAC) have not been fully elucidated.
RESULTS: We conducted the prespecified subgroup analysis based on the use of OAC, including vitamin K antagonist and direct oral anticoagulants, within 7 days before percutaneous coronary intervention in the STOPDAPT-3 (Short and Optimal Duration of Dual Antiplatelet Therapy-3) trial, which randomly compared prasugrel monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The coprimary end points were major bleeding events (Bleeding Academic Research Consortium types 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. Among 5966 study patients, there were 530 patients (8.9%) with OAC (no aspirin: N=248, and DAPT: N=282) and 5436 patients (91.1%) without OAC (no aspirin: N=2736, and DAPT: N=2700). Regardless of the use of OAC, the effects of no aspirin compared with DAPT were not significant for the bleeding end point (OAC: 4.45% and 4.27%, hazard ratio [HR], 1.04 [95% CI, 0.46-2.35]; no-OAC: 4.47% and 4.75%, HR, 0.94 [95% CI, 0.73-1.20]; P for interaction=0.82), and for the cardiovascular end point (OAC: 4.84% and 3.20%, HR, 1.53 [95% CI, 0.64-3.62]; no-OAC: 4.06% and 3.74%, HR, 1.09 [95% CI 0.83-1.42]; P for interaction =0.46).
CONCLUSIONS: The no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of the use of OAC. There was a numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events in patients with OAC.
RESULTS: We conducted the prespecified subgroup analysis based on the use of OAC, including vitamin K antagonist and direct oral anticoagulants, within 7 days before percutaneous coronary intervention in the STOPDAPT-3 (Short and Optimal Duration of Dual Antiplatelet Therapy-3) trial, which randomly compared prasugrel monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The coprimary end points were major bleeding events (Bleeding Academic Research Consortium types 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. Among 5966 study patients, there were 530 patients (8.9%) with OAC (no aspirin: N=248, and DAPT: N=282) and 5436 patients (91.1%) without OAC (no aspirin: N=2736, and DAPT: N=2700). Regardless of the use of OAC, the effects of no aspirin compared with DAPT were not significant for the bleeding end point (OAC: 4.45% and 4.27%, hazard ratio [HR], 1.04 [95% CI, 0.46-2.35]; no-OAC: 4.47% and 4.75%, HR, 0.94 [95% CI, 0.73-1.20]; P for interaction=0.82), and for the cardiovascular end point (OAC: 4.84% and 3.20%, HR, 1.53 [95% CI, 0.64-3.62]; no-OAC: 4.06% and 3.74%, HR, 1.09 [95% CI 0.83-1.42]; P for interaction =0.46).
CONCLUSIONS: The no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of the use of OAC. There was a numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events in patients with OAC.
摘要：
背景：无阿司匹林策略对接受口服抗凝治疗（OAC）的经皮冠状动脉介入治疗患者出血和心血管事件的影响尚未完全阐明。
结果：我们根据OAC的使用进行了预设的亚组分析，包括维生素K拮抗剂和直接口服抗凝剂，STOPDAPT-3（双重抗血小板治疗-3的短期和最佳持续时间）试验的经皮冠状动脉介入治疗前7天内，随机比较普拉格雷单药治疗（2984例）与普拉格雷和阿司匹林双联抗血小板治疗（DAPT）（2982例）在急性冠脉综合征或高出血风险患者中的应用。主要终点是大出血事件（出血学术研究联盟类型3或5）和心血管事件（心血管死亡的复合，心肌梗塞,明确的支架血栓形成，或缺血性中风）在1个月时。在5966名研究患者中，有530例患者(8.9%)接受OAC(无阿司匹林:N=248,DAPT:N=282)和5436例患者(91.1%)未接受OAC(无阿司匹林:N=2736,DAPT:N=2700).不管使用OAC，与DAPT相比，无阿司匹林对出血终点的影响不显著(OAC:4.45%和4.27%，危险比[HR]，1.04[95%CI，0.46-2.35]；无OAC：4.47%和4.75%，HR,0.94[95%CI，0.73-1.20]；相互作用的P=0.82)，和心血管终点(OAC：4.84%和3.20%，HR,1.53[95%CI，0.64-3.62]；无OAC：4.06%和3.74%，HR,1.09[95%CI0.83-1.42]；相互作用的P=0.46）。
结论：与DAPT策略相比，无阿司匹林策略未能减少大出血事件，而与使用OAC无关。在OAC患者中，相对于DAPT策略，无阿司匹林策略在心血管事件方面存在数值上的超额风险。
结果：我们根据OAC的使用进行了预设的亚组分析，包括维生素K拮抗剂和直接口服抗凝剂，STOPDAPT-3（双重抗血小板治疗-3的短期和最佳持续时间）试验的经皮冠状动脉介入治疗前7天内，随机比较普拉格雷单药治疗（2984例）与普拉格雷和阿司匹林双联抗血小板治疗（DAPT）（2982例）在急性冠脉综合征或高出血风险患者中的应用。主要终点是大出血事件（出血学术研究联盟类型3或5）和心血管事件（心血管死亡的复合，心肌梗塞,明确的支架血栓形成，或缺血性中风）在1个月时。在5966名研究患者中，有530例患者(8.9%)接受OAC(无阿司匹林:N=248,DAPT:N=282)和5436例患者(91.1%)未接受OAC(无阿司匹林:N=2736,DAPT:N=2700).不管使用OAC，与DAPT相比，无阿司匹林对出血终点的影响不显著(OAC:4.45%和4.27%，危险比[HR]，1.04[95%CI，0.46-2.35]；无OAC：4.47%和4.75%，HR,0.94[95%CI，0.73-1.20]；相互作用的P=0.82)，和心血管终点(OAC：4.84%和3.20%，HR,1.53[95%CI，0.64-3.62]；无OAC：4.06%和3.74%，HR,1.09[95%CI0.83-1.42]；相互作用的P=0.46）。
结论：与DAPT策略相比，无阿司匹林策略未能减少大出血事件，而与使用OAC无关。在OAC患者中，相对于DAPT策略，无阿司匹林策略在心血管事件方面存在数值上的超额风险。
