Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
BMJ Open. 2019 Jun 16;9(6):e022271. doi: 10.1136/bmjopen-2018-022271.
Dual antiplatelet therapy (DAPT) is routinely given to patients after percutaneous coronary intervention (PCI) with stenting; however, there is ongoing debate about the optimal duration, especially in specific patient groups. In the proposed systematic review, we intend to assess the optimal duration of DAPT following PCI with stenting, with a focus on clinically relevant patient subgroups.
We will perform a comprehensive search of the published literature for randomised controlled trials (RCTs) assessing the benefits and harms of extended DAPT (>12 months) compared with short-term DAPT (6-12 months) following PCI with stenting (bare metal or drug eluting). ClinicalTrials.gov and ICTRP will also be searched to identify ongoing and completed clinical trials. Two independent reviewers will select studies for inclusion, and the risk of bias will be assessed by use of Cochrane's Risk of Bias tool. The primary outcome of interest is death (all-cause, cardiovascular, non-cardiovascular). Secondary outcomes are bleeding (major, minor, gastrointestinal), urgent target vessel revascularisation, major adverse cardiovascular events, myocardial infarction, stroke and stent thrombosis. Subgroup data will be sought for patients with prior myocardial infarction, acute coronary syndrome at presentation and diabetes, and based on smoking status and age group. Data will be analysed by random-effects meta-analysis, and separate analyses will be performed for patient subgroups. Bayesian network meta-analysis will be performed to investigate the effect of individual P2Y12 inhibitors at different DAPT durations longer than 6 months.
This review will provide a comprehensive overview of the available evidence of the benefits and harms associated with extending DAPT beyond 12 months following PCI with stenting and the effects on clinically important subgroups. The results of this review will inform clinical and policy decisions regarding the optimal treatment duration of DAPT following PCI with stenting.
PROSPERO no. CRD42018082587.
经皮冠状动脉介入治疗（PCI）后，双联抗血小板治疗（DAPT）常规用于患者；然而，关于最佳持续时间，特别是在特定患者群体中，仍存在争议。在拟议的系统评价中，我们旨在评估 PCI 后接受支架置入术的患者 DAPT 的最佳持续时间，重点关注具有临床意义的患者亚组。
我们将全面搜索已发表的文献，以评估与 PCI 后接受支架置入术（裸金属或药物洗脱）的短期 DAPT（6-12 个月）相比，延长 DAPT（>12 个月）的获益和危害。还将搜索 ClinicalTrials.gov 和 ICTRP 以识别正在进行和已完成的临床试验。两名独立评审员将选择纳入的研究，使用 Cochrane 偏倚风险工具评估偏倚风险。主要观察结果为死亡（全因、心血管、非心血管）。次要结局为出血（主要、次要、胃肠道）、紧急靶血管血运重建、主要不良心血管事件、心肌梗死、卒中和支架血栓形成。将根据既往心肌梗死、就诊时急性冠脉综合征和糖尿病，以及吸烟状况和年龄组，寻求患者亚组数据。将采用随机效应荟萃分析进行数据分析，并针对患者亚组进行单独分析。贝叶斯网络荟萃分析将用于研究在 PCI 后支架置入术 6 个月以上的不同 DAPT 持续时间内，单独使用 P2Y12 抑制剂的效果。
本综述将全面概述 PCI 后支架置入术超过 12 个月延长 DAPT 与获益和危害相关的现有证据，以及对具有临床重要性的亚组的影响。本综述的结果将为 PCI 后支架置入术的 DAPT 最佳治疗持续时间的临床和政策决策提供信息。
PROSPERO 编号 CRD42018082587。
