Sidhu S, Shafiq N, Malhotra S, Pandhi P, Grover A
Department of Pharmacology, PGIMER, Chandigarh, India.
Br J Clin Pharmacol. 2006 Jun;61(6):720-6. doi: 10.1111/j.1365-2125.2006.02614.x.
Drug-eluting stents have been shown to be superior to bare metal stents in reducing restenosis rates. Recently head-to-head trials comparing sirolimus-eluting stents and paclitaxel-eluting stents have been reported. An early combined analysis of these comparative trials is needed. The present meta-analysis was carried out to compare the effects of sirolimus-eluting stents with paclitaxel-eluting stents on the restenosis rate, major adverse cardiac events and late loss of arterial lumen diameter in patients with obstructive coronary artery disease.
Electronic (Medline, Cochrane and Embase) and manual search (Index Medicus and cross references of retrieved articles) were carried out for all the relevant articles up till March 2005. Only randomized trials with adequate data for calculation of odds ratio for restenosis rates and major adverse cardiac events using the method of DerSimonian & Laird and standardized mean difference for late loss of arterial lumen diameter were included.
Four studies were found to be eligible for inclusion in the meta-analysis. Restenosis rate and late loss of arterial lumen diameter were significantly reduced by sirolimus-eluting stents as compared with paclitaxel-eluting stents (OR 0.598, 95% CI 0.400, 0.893, pooled mean difference -0.414, 95% CI -0.492, 0.336, respectively). The incidence of major adverse cardiac events was less with sirolimus-eluting stents as compared with paclitaxel-eluting stents (OR 0.727, 95% CI 0.518-1.018) but the results were not statistically significant.
Sirolimus-eluting stents are superior to paclitaxel-eluting stents in decreasing restenosis rate and late loss of arterial lumen diameter. However, no statistically significant difference in major adverse cardiac events was noted between the two stents.
药物洗脱支架在降低再狭窄率方面已被证明优于裸金属支架。最近有报道称进行了西罗莫司洗脱支架和紫杉醇洗脱支架的直接对比试验。需要对这些对比试验进行早期综合分析。本荟萃分析旨在比较西罗莫司洗脱支架和紫杉醇洗脱支架对阻塞性冠状动脉疾病患者再狭窄率、主要不良心脏事件及动脉管腔直径后期丢失的影响。
通过电子检索(医学文献数据库、考克兰系统评价数据库和荷兰医学文摘数据库)和手工检索(医学索引及检索文章的交叉参考文献),检索截至2005年3月的所有相关文章。仅纳入那些有足够数据、采用DerSimonian & Laird方法计算再狭窄率和主要不良心脏事件比值比以及计算动脉管腔直径后期丢失标准化均数差的随机试验。
发现四项研究符合纳入荟萃分析的条件。与紫杉醇洗脱支架相比,西罗莫司洗脱支架显著降低了再狭窄率和动脉管腔直径后期丢失(比值比分别为0.598,95%可信区间0.400,0.893;合并均数差为-0.414,95%可信区间-0.492,0.336)。与紫杉醇洗脱支架相比,西罗莫司洗脱支架的主要不良心脏事件发生率较低(比值比0.727,95%可信区间0.518 - 1.018),但结果无统计学意义。
西罗莫司洗脱支架在降低再狭窄率和动脉管腔直径后期丢失方面优于紫杉醇洗脱支架。然而,两种支架在主要不良心脏事件方面未发现统计学显著差异。