Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.
First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.
JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.
The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists.
To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI).
DESIGN, SETTING, AND PARTICIPANTS: This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure.
The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin.
The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction.
Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004).
Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI.
ClinicalTrials.gov identifier: NCT01813435.
在新型强效 P2Y12 拮抗剂的背景下，需要明确阿司匹林在急性冠脉综合征（ACS）的抗血小板治疗方案中的作用。
评估 ACS 患者经皮冠状动脉介入治疗（PCI） 1 个月后，加用替格瑞洛与单独使用替格瑞洛相比，阿司匹林的获益和风险。
设计、环境和参与者：这是一项对 GLOBAL LEADERS 研究的非预设、事后分析，该研究是一项比较 2 种抗血小板治疗策略的随机、开放标签优效性试验。该试验纳入了来自不同国家的 130 家二级/三级保健医院的 15991 例稳定型冠状动脉疾病或 ACS 行 PCI 的患者。患者在指数治疗后 1、3、6、12、18 和 24 个月进行门诊随访。
实验组接受阿司匹林加替格瑞洛治疗 1 个月，然后接受替格瑞洛单药治疗 23 个月；对照组接受阿司匹林加氯吡格雷（稳定型冠状动脉疾病）或替格瑞洛（ACS）治疗 12 个月，然后接受阿司匹林单药治疗 12 个月。在本次分析中，我们观察了随机分组后 31 天至 365 天之间发生的临床结局，具体为在此时间范围内，被分配单独使用替格瑞洛或替格瑞洛和阿司匹林的 ACS 患者。
主要结局是全因死亡或新发 Q 波心肌梗死的复合终点。
在 15968 例参与者中，有 7487 例 ACS 患者入选；其中 3750 例患者被分配至实验组，3737 例患者被分配至对照组。在随机分组后 31 天至 365 天期间，实验组有 55 例（1.5%）患者发生主要结局，对照组有 75 例（2.0%）患者发生主要结局（风险比[HR]，0.73；95%CI，0.51-1.03；P=0.07）；研究者报告的 Bleeding Academic Research Consortium 定义的 3 型或 5 型出血，实验组有 28 例（0.8%）患者发生，对照组有 54 例（1.5%）患者发生（HR，0.52；95%CI，0.33-0.81；P=0.004）。
在 ACS 患者 PCI 后 1 个月至 12 个月期间，阿司匹林与出血风险增加相关，且似乎不能增加替格瑞洛对缺血事件的获益。这些发现应被视为探索性和产生假说的结果；然而，它们为进一步评估 PCI 后无阿司匹林抗血小板治疗策略的试验铺平了道路。
ClinicalTrials.gov 标识符：NCT01813435。
