Stettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P
Department of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Heart. 2006 May;92(5):650-7. doi: 10.1136/hrt.2005.070698. Epub 2005 Oct 26.
To examine whether polymer based coronary stents eluting sirolimus or paclitaxel are equally effective in patients with and without diabetes.
Systematic review and meta-analysis by indirect comparison of randomised controlled trials comparing stents eluting sirolimus or paclitaxel with conventional bare metal stents. The overall study population and patients with and without diabetes were analysed separately by using the ratio of incidence rate ratios (RIRR).
The analysis was based on 10 trials (six with sirolimus, four with paclitaxel), 4513 patients (1146 patients with diabetes), 5755 years of follow up, and 2464 events. In patients without diabetes sirolimus eluting stents were superior to paclitaxel eluting stents with respect to in-stent (RIRR 0.21, 95% confidence interval (CI) 0.10 to 0.48, p < 0.001) and in-segment restenosis (RIRR 0.47, 95% CI 0.24 to 0.92, p = 0.027), target lesion revascularisation (RIRR 0.54, 95% CI 0.30 to 0.99, p = 0.045), and major adverse cardiac events (RIRR 0.46, 95% CI 0.26 to 0.83, p = 0.010). In patients with diabetes the two drug eluting stents did not differ significantly in any of these end points. Meta-regression analysis showed a significant difference between patients with and without diabetes (tests for interaction for in-stent and in-segment restenosis, p = 0.036 and p = 0.016).
Indirect evidence indicates that sirolimus eluting stents are superior to paclitaxel eluting stents in patients without diabetes but not in patients with diabetes.
研究洗脱西罗莫司或紫杉醇的聚合物基冠状动脉支架在糖尿病患者和非糖尿病患者中是否具有同等疗效。
通过间接比较将洗脱西罗莫司或紫杉醇的支架与传统裸金属支架进行对比的随机对照试验,进行系统评价和荟萃分析。使用发病率比(RIRR)的比值分别对总体研究人群以及糖尿病患者和非糖尿病患者进行分析。
分析基于10项试验(6项使用西罗莫司,4项使用紫杉醇)、4513例患者(1146例糖尿病患者)、5755年的随访以及2464例事件。在非糖尿病患者中,洗脱西罗莫司的支架在支架内(RIRR 0.21,95%置信区间(CI)0.10至0.48,p<0.001)、节段内再狭窄(RIRR 0.47,95%CI 0.24至0.92,p = 0.027)、靶病变血管重建(RIRR 0.54,95%CI 0.30至0.99,p = 0.045)和主要不良心脏事件(RIRR 0.46,95%CI 0.26至0.83,p = 0.010)方面优于洗脱紫杉醇的支架。在糖尿病患者中,两种药物洗脱支架在这些终点中的任何一项上均无显著差异。荟萃回归分析显示糖尿病患者和非糖尿病患者之间存在显著差异(支架内和节段内再狭窄的交互作用检验,p = 0.036和p = 0.016)。
间接证据表明,洗脱西罗莫司的支架在非糖尿病患者中优于洗脱紫杉醇的支架,但在糖尿病患者中并非如此。