Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Lancet. 2020 May 9;395(10235):1487-1495. doi: 10.1016/S0140-6736(20)30315-9.
Antiplatelet therapy is recommended among patients with established atherosclerosis. We compared monotherapy with a P2Y inhibitor versus aspirin for secondary prevention.
In this systematic review and meta-analysis, all randomised trials comparing P2Y inhibitor with aspirin monotherapy for secondary prevention in patients with cerebrovascular, coronary, or peripheral artery disease were evaluated for inclusion. On Dec 18, 2019, we searched PubMed, Embase, BioMedCentral, Google Scholar, and the Cochrane Central Register of Controlled Trials. Additionally, we reviewed references from identified articles and searched abstracts from 2017 to 2019 presented at relevant scientific meetings. Data about year of publication, inclusion and exclusion criteria, sample size, baseline patients' features including the baseline condition determining study inclusion (ie, cerebrovascular, coronary, or peripheral artery disease), P2Y inhibitor type and dosage, aspirin dosage, endpoint definitions, effect estimates, follow-up duration, and percentage of patients lost to follow-up were collected. Odds ratios (ORs) and 95% CIs were used as metric of choice for treatment effects with random-effects models. Co-primary endpoints were myocardial infarction and stroke. Key secondary endpoints were all-cause death and vascular death. Heterogeneity was assessed with the I index. This study is registered with PROSPERO (CRD42018115037).
A total of nine randomised trials were identified and included in this study, and 42 108 patients randomly allocated to a P2Y inhibitor (n=21 043) or aspirin (n=21 065) were included in our analyses. Patients who received a P2Y inhibitor had a borderline reduction for the risk of myocardial infarction compared with those who received aspirin (OR 0·81 [95% CI 0·66-0·99]; I=10·9%). Risks of stroke (OR 0·93 [0·82-1·06]; I=34·5%), all-cause death (OR 0·98 [0·89-1·08]; I=0%), and vascular death (OR 0·97 [0·86-1·09]; I=0%) did not differ between patients who received a P2Y inhibitor and those who received aspirin. Similarly, the risk of major bleeding (OR 0·90 [0·74-1·10]; I=3·9%) did not differ between patients who received a P2Y inhibitor and those who received aspirin. The number needed to treat to prevent one myocardial infarction with P2Y inhibitor monotherapy was 244 patients. Findings were consistent regardless of the type of P2Y inhibitor used.
Compared with aspirin monotherapy, P2Y inhibitor monotherapy is associated with a risk reduction for myocardial infarction and a comparable risk of stroke in the setting of secondary prevention. The benefit of P2Y inhibitor monotherapy is of debatable clinical relevance, in view of the high number needed to treat to prevent a myocardial infarction and the absence of any effect on all-cause and vascular mortality.
Italian Ministry of Education.
抗血小板治疗推荐用于已确诊动脉粥样硬化的患者。我们比较了 P2Y 抑制剂单药治疗与阿司匹林用于二级预防的效果。
在这项系统评价和荟萃分析中，我们评估了所有比较 P2Y 抑制剂与阿司匹林单药治疗用于脑血管、冠状动脉或外周动脉疾病患者二级预防的随机试验，以确定是否纳入。于 2019 年 12 月 18 日，我们检索了 PubMed、Embase、BioMedCentral、Google Scholar 和 Cochrane 对照试验中心注册库。此外，我们还查阅了已确定文章的参考文献，并检索了 2017 年至 2019 年在相关科学会议上提交的摘要。收集的数据包括出版年份、纳入和排除标准、样本量、纳入研究的基线患者特征（即脑血管、冠状动脉或外周动脉疾病）、P2Y 抑制剂类型和剂量、阿司匹林剂量、终点定义、效应估计、随访时间以及失访患者的百分比。使用随机效应模型，选择比值比（OR）和 95%置信区间（CI）作为治疗效果的度量指标。主要共同终点为心肌梗死和卒中。关键次要终点为全因死亡和血管性死亡。使用 I 指数评估异质性。本研究已在 PROSPERO（CRD42018115037）上注册。
共确定了 9 项随机试验，并将其纳入本研究，共有 420108 例患者被随机分配至 P2Y 抑制剂（n=21043）或阿司匹林（n=21065）组，纳入我们的分析。与接受阿司匹林治疗的患者相比，接受 P2Y 抑制剂治疗的患者心肌梗死风险略有降低（OR 0.81 [95%CI 0.66-0.99]；I=10.9%）。卒中风险（OR 0.93 [0.82-1.06]；I=34.5%）、全因死亡风险（OR 0.98 [0.89-1.08]；I=0%）和血管性死亡风险（OR 0.97 [0.86-1.09]；I=0%）在接受 P2Y 抑制剂治疗的患者和接受阿司匹林治疗的患者之间无差异。同样，接受 P2Y 抑制剂治疗的患者和接受阿司匹林治疗的患者之间大出血风险（OR 0.90 [0.74-1.10]；I=3.9%）也无差异。使用 P2Y 抑制剂单药治疗预防心肌梗死的需要治疗人数为 244 人。无论使用何种 P2Y 抑制剂，结果均一致。
与阿司匹林单药治疗相比，P2Y 抑制剂单药治疗与心肌梗死风险降低相关，且在二级预防中与卒中风险相当。鉴于需要治疗人数来预防心肌梗死的人数较高，且对全因和血管死亡率无任何影响，因此 P2Y 抑制剂单药治疗的获益具有一定的临床相关性。
意大利教育部。
