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目的系统评价经皮冠状动脉介入术后≤12个月双联抗血小板治疗(DAPT)是否优于>12个月双联抗血小板治疗。方法计算机检索Pub Med、The Cochrane Library(2016年第2期)、EMbase、Web of Science、CBM、Wan Fang Data、VIP、CNKI数据库,搜集有关经皮冠状动脉介入术(PCI)后DAPT时限的随机对照试验,检索时间均从建库至2016年11月。检索采用Me SH主题词和自由词相结合的方式检索。筛选文献、提取资料、评价纳入研究偏倚风险后运用Rev Man 5.3软件进行Meta分析。结果最终纳入12个RCT,共41 728例患者,其中≤12个月DAPT治疗组20 768例,>12个月DAPT治疗组20 960例。Meta分析结果显示:PCI术后≤12个月DAPT与>12个月DAPT相比总死亡率明显降低,差异有统计学意义(RR=0.85,95%CI:0.74~0.97,P=0.02);主要出血风险明显降低,差异有统计学意义(RR=0.61,95%CI:0.42~0.90,P=0.01);支架内血栓形成风险明显升高,差异有统计学意义(RR=1.78,95%CI:1.19~2.67,P=0.005);心肌梗死的发生率明显增加,差异有统计学意义(RR=1.68,95%CI:1.48~1.91,P<0.00001);心源性死亡、卒中、靶血管再次血管重建术(TVR)和轻微出血风险未见明显增加,差异无统计学意义。结论短疗程(≤12个月)DAPT治疗可以降低PCI术后患者总死亡率和主要出血风险,但同时也增加了患者支架内血栓形成和心肌梗死的发生。短疗程(≤12个月)DAPT治疗较长疗程(>12个月)DAPT治疗相比并没有增加PCI术后患者心源性死亡、卒中、TVR和轻微出血的发生率。上述结论仍有待于更多高质量RCT加以验证。
Objective To evaluate whether dual antiplatelet therapy (DAPT) of ≤12 months after percutaneous coronary intervention is superior to> 12 months of dual antiplatelet therapy. Methods The database of Pub Med, The Cochrane Library (2016 Issue 2), EMbase, Web of Science, CBM, Wan Fang Data, VIP and CNKI was searched. The randomized controlled trials on DAPT after percutaneous coronary intervention Control trial, retrieval time from the building to November 2016. Search using Me SH keywords and free word combination of retrieval. The literature was screened, data were extracted and evaluated for inclusion in the risk of research bias using Meta-analysis of Rev Man 5.3 software. RESULTS: Twelve RCTs were eventually enrolled in 41 728 patients, with 20 768 in the DAPT group and 20 960 in the DAPT group> 12 months ≤12 months. The results of Meta analysis showed that the total mortality of DAPT was significantly lower than that of> 12 months after PCI (≤12 months), the difference was statistically significant (RR = 0.85, 95% CI: 0.74-0.97, P = 0.02). The risk of major bleeding was significantly lower (RR = 0.61, 95% CI: 0.42-0.90, P = 0.01). The risk of stent thrombosis was significantly increased with a statistically significant difference (RR = 1.78, 95% CI: 1.19-2.67, P = 0.005). The incidence of myocardial infarction was significantly increased with a statistically significant difference (RR = 1.68,95% CI: 1.48-1.91, P <0.00001); cardiac death, stroke, Vascular revascularization (TVR) and mild bleeding risk no significant increase, the difference was not statistically significant. Conclusions Short-course (≤12 months) DAPT can reduce the overall mortality and major bleeding risk after PCI, but also increase stent thrombosis and myocardial infarction. Short duration of treatment (≤12 months) DAPT did not increase the incidence of cardiac death, stroke, TVR, and minor bleeding in patients treated with DAPT over a longer duration of treatment (> 12 months). The above conclusion still needs to be verified by more high quality RCTs.