Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Xiangya School of Medicine, Central South University, Changsha, Hunan, China.
BMJ. 2019 Jun 28;365:l2222. doi: 10.1136/bmj.l2222.
To evaluate the efficacy and safety of standard term (12 months) or long term (>12 months) dual antiplatelet therapy (DAPT) versus short term (<6 months) DAPT after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
Systematic review and network meta-analysis.
Relevant studies published between June 1983 and April 2018 from Medline, Embase, Cochrane Library for clinical trials, PubMed, Web of Science, ClinicalTrials.gov, and Clinicaltrialsregister.eu.
Randomised controlled trials comparing two of the three durations of DAPT (short term, standard term, and long term) after PCI with DES were included. The primary study outcomes were cardiac or non-cardiac death, all cause mortality, myocardial infarction, stent thrombosis, and all bleeding events.
17 studies (n=46 864) were included. Compared with short term DAPT, network meta-analysis showed that long term DAPT resulted in higher rates of major bleeding (odds ratio 1.78, 95% confidence interval 1.27 to 2.49) and non-cardiac death (1.63, 1.03 to 2.59); standard term DAPT was associated with higher rates of any bleeding (1.39, 1.01 to 1.92). No noticeable difference was observed in other primary endpoints. The sensitivity analysis revealed that the risks of non-cardiac death and bleeding were further increased for ≥18 months of DAPT compared with short term or standard term DAPT. In the subgroup analysis, long term DAPT led to higher all cause mortality than short term DAPT in patients implanted with newer-generation DES (1.99, 1.04 to 3.81); short term DAPT presented similar efficacy and safety to standard term DAPT with acute coronary syndrome (ACS) presentation and newer-generation DES placement. The heterogeneity of pooled trials was low, providing more confidence in the interpretation of results.
In patients with all clinical presentations, compared with short term DAPT (clopidogrel), long term DAPT led to higher rates of major bleeding and non-cardiac death, and standard term DAPT was associated with an increased risk of any bleeding. For patients with ACS, short term DAPT presented similar efficacy and safety with standard term DAPT. For patients implanted with newer-generation DES, long term DAPT resulted in more all cause mortality than short term DAPT. Although the optimal duration of DAPT should take personal ischaemic and bleeding risks into account, this study suggested short term DAPT could be considered for most patients after PCI with DES, combining evidence from both direct and indirect comparisons.
PROSPERO CRD42018099519.
评估药物洗脱支架(DES)经皮冠状动脉介入治疗(PCI)后标准疗程(12 个月)或长疗程(>12 个月)双联抗血小板治疗(DAPT)与短疗程(<6 个月)DAPT 的疗效和安全性。
系统评价和网络荟萃分析。
1983 年 6 月至 2018 年 4 月期间从 Medline、Embase、Cochrane 临床试验图书馆、PubMed、Web of Science、ClinicalTrials.gov 和 Clinicaltrialsregister.eu 检索的相关研究。
纳入比较三种 DAPT 疗程(短疗程、标准疗程和长疗程)中两种疗程(短疗程、标准疗程)的随机对照试验。主要研究结局为心脏或非心脏死亡、全因死亡率、心肌梗死、支架血栓形成和所有出血事件。
纳入 17 项研究(n=46864)。与短疗程 DAPT 相比,网络荟萃分析显示长疗程 DAPT 导致大出血(比值比 1.78,95%置信区间 1.27 至 2.49)和非心脏死亡(1.63,1.03 至 2.59)的风险增加;标准疗程 DAPT 与任何出血(1.39,1.01 至 1.92)的风险增加相关。其他主要结局未见明显差异。敏感性分析显示,与短疗程或标准疗程 DAPT 相比,≥18 个月的 DAPT 与非心脏死亡和出血风险进一步增加。在亚组分析中,与短疗程 DAPT 相比,长疗程 DAPT 在植入新一代 DES 的患者中导致全因死亡率更高(1.99,1.04 至 3.81);在急性冠脉综合征(ACS)患者和植入新一代 DES 的患者中,短疗程 DAPT 与标准疗程 DAPT 的疗效和安全性相似。汇总试验的异质性较低,使结果的解释更有信心。
在所有临床表现的患者中,与短疗程 DAPT(氯吡格雷)相比,长疗程 DAPT 导致大出血和非心脏死亡的风险增加,标准疗程 DAPT 与任何出血风险增加相关。对于 ACS 患者,短疗程 DAPT 与标准疗程 DAPT 的疗效和安全性相似。对于植入新一代 DES 的患者,长疗程 DAPT 导致的全因死亡率高于短疗程 DAPT。尽管 DAPT 的最佳持续时间应考虑个人的缺血和出血风险,但本研究提示对于大多数 DES 经皮冠状动脉介入治疗后的患者,可考虑短期 DAPT,这是基于直接和间接比较的证据。
PROSPERO CRD42018099519。