直接支架术与预扩张支架术治疗冠心病的Meta分析

Direct Coronary Stenting vs.Conventional Stenting in Treating Coronary Heart Disease:A Meta-Analysis

目的系统评价冠脉内直接支架术和需球囊的预扩张支架术两种介入方法的安全及有效性。方法采用Cochrane系统评价方法,计算机检索PubMed、EMbase、Cochrane Library(2011年第3期)、CBMdisc、VIP、CNKI,检索时间从建库截至2011年4月,纳入中外文关于冠脉内直接支架术和球囊预扩张后支架术的RCT。由两名评价者独立评价纳入研究质量、提取资料并交叉核对后,采用RevMan 5.0软件进行Meta分析。结果共纳入24个RCT,6 666例患者。结果显示:与预扩张支架术相比,直接支架术手术时间短[MD=–3.36,95%CI(–4.41,–2.30),P<0.000 01],但在手术过程中急性管腔获得[MD=–0.01,95%CI(–0.04,0.02),P=0.64]、随访6个月时的主要心脏不良事件率[OR=0.89,95%CI(0.69,1.14),P=0.35]、再狭窄率[OR=1.02,95%CI(0.82,1.26),P=0.88]方面,两组差异无统计学意义。结论当前证据表明,直接支架术并不优于预扩张支架术。今后的临床研究仍需开展大规模设计良好的随机对照试验和尽可延长随访时间。

Objective To assess the safety and effectiveness of direct stenting （DS） versus conventional stenting （CS） with predilation in clinical practice. Methods Such databases as PubMed, EMbase, The Cochrane Library （Issue 3, 2011）, CBM, VIP and CNKI were searched from the date of their establishment to April 2011, to collect the randomized controlled trials （RCTs） on DS vs. CS. The quality of RCTs was critically appraised, and the data were extracted and crosschecked by two reviewers independently. Meta-analyses were conducted using RevMan 5.0 software. Results A total of 24 RCTs involving 6 666 patients were included, qhe results of Meta-analyses showed that DS took shorter operative time compared with CS （MD=-3.36, 95%CI -4.41 to -2.30, P〈0.000 01） with acute gain （luminal diameter） during operation （MD=-0.01, 95%CI -0.04 to 0.02, P=0.64）. But there were no significant differences in the incidence of major adverse cardiac events during six-month follow-up （OR=0.89, 95%CI 0.69 to 1.14, P=0.35） and restenosis （OR=l.02, 95%CI 0.82 to 1.26, P=0.88）. Conclusion Current evidence shows that DS is not superior to CS. This conclusion still needs to be further proved by well-designed and large scale RCTs with longer follow-up duration.