■经皮冠状动脉介入治疗(PCI)后1个月内双重抗血小板治疗(DAPT)的出血率在临床实践中仍然很高,特别是在急性冠脉综合征或高出血风险患者中。无阿司匹林策略可能导致PCI术后早期出血减少,而不会增加心血管事件。但其有效性和安全性尚未在随机试验中得到证实.
■我们将6002例急性冠脉综合征或高出血风险患者在PCI术前随机分配给普拉格雷(3.75mg/天)单药治疗或服用阿司匹林(81-100mg/天)和普拉格雷(3.75mg/天)。主要终点是大出血(出血学术研究联盟3或5)的优势和心血管事件(心血管死亡的复合,心肌梗塞,明确的支架血栓形成,或中风),具有相对50%的边缘。
■完整的分析集人群包括5966名患者(无阿司匹林组,2984例;DAPT组,2982名患者;年龄,71.6±11.7岁;男性,76.6%;急性冠脉综合征,75.0%)。在随机化前7天内,仅阿司匹林,阿司匹林与P2Y12抑制剂,口服抗凝剂,静脉肝素输注占21.3%,6.4%,8.9%,和24.5%,分别。两组在1个月时对方案指定的抗血小板治疗的依从性为88%。在1个月,无阿司匹林组的联合出血终点并不优于DAPT组(4.47%和4.71%;风险比,0.95[95%CI,0.75-1.20];P优=0.66)。无阿司匹林组的副主要心血管终点不劣于DAPT组(4.12%和3.69%;风险比,1.12[95%CI,0.87-1.45];伪劣=0.01)。净不良临床结局和共同主要心血管终点的每个组成部分没有差异。无计划的冠状动脉血运重建过多(1.05%和0.57%;风险比,1.83[95CI,1.01-3.30])和亚急性明确或可能的支架血栓形成(0.58%和0.17%;风险比,与DAPT组相比,无阿司匹林组3.40[95%CI,1.26-9.23])。
■与DAPT策略相比,使用低剂量普拉格雷的无阿司匹林策略未能证明PCI后1个月内大出血的优势,但PCI后1个月内心血管事件的优势不明显。然而,无阿司匹林策略与提示冠状动脉事件过度的信号相关.
■URL:https://www。clinicaltrials.gov;唯一标识符:NCT04609111。
Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials.
We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin.
The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; Psuperiority=0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; Pnoninferiority=0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group.
The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.