Potent P2Y12 Inhibitor Monotherapy vs DAPT After PCI in Patients With and Without STEMI: The NEO-MINDSET Substudy.

This prespecified analysis from the NEO-MINDSET trial evaluated whether treatment effects of early aspirin discontinuation differ between ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation ACS (NSTE-ACS; defined as unstable angina or non-ST-segment elevation myocardial infarction).

NEO-MINDSET试验的这一预先设定的分析评估了早期停用阿司匹林的效果在ST段抬高型心肌梗死（STEMI）和非ST段抬高型ACS（NSTE-ACS；定义为不稳定型心绞痛或非ST段抬高型心肌梗死）之间是否存在差异。

Methods

NEO-MINDSET randomized ACS patients to potent P2Y12 inhibitor monotherapy initiated within 4 days of hospitalization vs standard dual antiplatelet therapy (DAPT) with aspirin and a potent P2Y12 inhibitor for 12 months.

NEO-MINDSET 研究将急性冠脉综合征（ACS）患者随机分为两组，一组在入院后 4 天内开始使用强效 P2Y12 抑制剂单药治疗，另一组则接受标准的双重抗血小板治疗（DAPT），包括阿司匹林和强效 P2Y12 抑制剂，持续 12 个月。

Co-primary outcomes were: 1) the composite of all-cause death, myocardial infarction, stroke, and urgent target vessel revascularization (ischemic outcome); and 2) Bleeding Academic Research Consortium types 2, 3, or 5 bleeding (bleeding outcome).

主要共研究终点为：1) 全因死亡、心肌梗死、中风和紧急靶血管血运重建的复合终点（缺血性结果）；以及 2) 出血学术研究联合会（BARC）类型 2、3 或 5 出血（出血结果）。

Results

Of the 3,410 participants included, 2,119 (62.1%) presented with STEMI and 1,291 (37.9%) with NSTE-ACS.

在纳入的3410名参与者中，有2119名（62.1%）表现为STEMI，1291名（37.9%）表现为NSTE-ACS。

Among STEMI patients, an early aspirin-free strategy was associated with a higher rate of the co-primary ischemic composite outcome compared with DAPT at 1 year (8.2% vs 5.2%, respectively; HR: 1.60; 95% CI: 1.14-2.24), whereas among those with NSTE-ACS, ischemic event rates were similar between monotherapy and DAPT (5.1% vs 6.0%, respectively; HR: 0.84; 95% CI: 0.53-1.35; P for interaction = 0.030).

在STEMI患者中，早期无阿司匹林策略与1年时双联抗血小板治疗（DAPT）相比，联合主要缺血性复合终点的发生率更高（分别为8.2%和5.2%；HR: 1.60；95%置信区间：1.14-2.24），而在NSTE-ACS患者中，单药治疗与DAPT的缺血事件发生率相似（分别为5.1%和6.0%；HR: 0.84；95%置信区间：0.53-1.35；交互作用P值=0.030）。

The co-primary bleeding outcome was lower with monotherapy than with DAPT in both STEMI (HR: 0.37; 95% CI: 0.22-0.61) and NSTE-ACS (HR: 0.45; 95% CI: 0.23-0.86) populations (P for interaction = 0.650).

在ST段抬高型心肌梗死（STEMI）和非ST段抬高型急性冠脉综合征（NSTE-ACS）人群中，与双联抗血小板治疗（DAPT）相比，单药治疗的联合主要出血结果较低（STEMI：风险比[HR] 0.37；95% 置信区间[CI] 0.22-0.61；NSTE-ACS：HR 0.45；95% CI 0.23-0.86）（交互作用P值=0.650）。

Conclusions

In patients with STEMI treated with percutaneous coronary intervention, early aspirin withdrawal may be harmful, because it increases the risk of ischemic events.

在接受经皮冠状动脉介入治疗（PCI）的ST段抬高型心肌梗死（STEMI）患者中，早期停用阿司匹林可能会增加缺血事件的风险。

Conversely, in NSTE-ACS, potent P2Y12 inhibitor monotherapy may be a viable therapeutic option: Ischemic event rates were similar and bleeding was reduced compared with DAPT.

相反，在非ST段抬高型急性冠状动脉综合征（NSTE-ACS）中，强效P2Y12抑制剂单药治疗可能是一个可行的治疗选择：缺血事件的发生率与双联抗血小板治疗（DAPT）相似，而出血事件有所减少。

(Percutaneous Coronary Intervention Followed by Antiplatelet Monotherapy in the Setting of Acute Coronary Syndromes [NEOMINDSET]; NCT04360720).

(经皮冠状动脉介入治疗后在急性冠状动脉综合征背景下进行抗血小板单药治疗的研究[NEOMINDSET]; NCT04360720)。