药物球囊与药物支架治疗支架内再狭窄的Meta分析

Meta-analysis on drug-eluting balloons versus drug-eluting stents in treatment of in-stent restenosis

目的系统评价药物球囊与药物支架治疗冠状动脉支架内再狭窄的有效性。方法计算机系统检索Medline、Embase、Cochrane、万方、维普、中国知网等数据库,辅以其他检索方式,检索所有有关药物球囊对比药物支架治疗支架内再狭窄的随机临床试验(RCT)。应用RevMan 5.3进行统计学分析。结果最终纳入6项随机对照试验,总体上在最小管腔直径(标准均数差为0.12,95%CI为-0.20^-0.05)两组间差异有统计学意义(P=0.002),但其余指标无明显统计学差异;在亚组分析中,紫杉醇支架亚组和依维莫司支架亚组在最小管腔直径(标准均数差为-0.25,95%CI为-0.36^-0.14,P<0.0001)、再狭窄发生率(相对危险度为1.79,95%CI为1.08~2.99,P=0.03)、靶血管血运重建(相对危险度为0.05,95%CI为0.01~0.10,P=0.03)差异有统计学意义。结论在治疗支架内再狭窄方面,药物球囊并不劣于药物支架,但依维莫司支架似乎是更好的选择。

Objective To evaluate efficacy of drug-eluting balloon versus drug-eluting stents in treatment of patients with in-stent restenosis. Methods A Meta-analysis was conducted by searching Medline, Embase, Cochrane, and VIP, China National Knowledge and other databases, supplemented by other search methods to recieve all relevant randomized clinical trial （RCT） of drug-eluting stent and drug-eluting balloons in treatment of in-stent restenosis. Statistical analysis was per- formed by RevMan 5.3. Results The final included six randomized controlled trials, There was statistically significant at a minimum lumen diameter （standardized mean difference [SMD] = - 0.12,95 % CI - 0.20--0.05, P = 0. 002） between the two groups, but the rest of analysis indicators had no statistically significant difference. There was statistically signifi- cant of lumen diameter （SMD= -0.25, 95% CI -0.36--0.14, P=0. 001）, binary restenosis （relative risk [RR] = 1.79,95% CI 1.08-2.99, P=0.03）, target lession revascularization （RR=0.05, 95% CI 0.01-0.10 , P=0. 03） be- tween the everolimus-eluting stents subgroup and paclitaxel-eluting stent subgroup. Conclusion Overall, in terms of the treatment of in-stent restenosis, the drug balloon is not inferior to the stent, but everolimus-eluting stent seems to be a bet- ter choice.