Biondi-Zoccai Giuseppe G L, Lotrionte Marzia, Abbate Antonio, Valgimigli Marco, Testa Luca, Burzotta Francesco, Crea Filippo, Agostoni Pierfrancesco
Int J Cardiol. 2007 Jan 2;114(1):104-5. doi: 10.1016/j.ijcard.2005.11.019. Epub 2005 Dec 19.
There is ongoing debate to identify the most effective, safe and cost-beneficial drug-eluting stent, between the two currently approved and used devices, i.e. sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). To date, head-to-head comparison studies of SES vs PES have been however limited by relatively small sample sizes and the low number of events typically associated with these highly effective coronary devices. To overcome the drawbacks of single trials, direct and indirect comparison meta-analyses have been designed and conducted to thoroughly compare sirolimus- vs paclitaxel eluting-stents. This article provides results of a pooled analysis of such indirect and direct comparisons, definitively demonstrating across 5854 patients the superiority of SES in comparison to PES (odds ratio 0.62 [95% confidence interval 0.50-0.75], p<0.0001 for binary angiographic restenosis, and odds ratio 0.66 [0.52-0.84], p=0.0008 for target lesion revascularization). Indeed, such combination of direct and indirect comparisons should also be envisaged to soundly and timely appraise the next generation of drug-eluting stents.
在目前已获批使用的两种药物洗脱支架,即西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,对于确定哪种支架最有效、安全且具有成本效益仍存在争论。然而,迄今为止,SES与PES的直接对比研究受到样本量相对较小以及与这些高效冠状动脉器械相关的事件数量较少的限制。为克服单一试验的缺点,已设计并开展了直接和间接对比的荟萃分析,以全面比较西罗莫司洗脱支架与紫杉醇洗脱支架。本文提供了此类间接和直接对比的汇总分析结果,明确显示在5854例患者中,SES相较于PES具有优越性(二元血管造影再狭窄的优势比为0.62 [95%置信区间0.50 - 0.75],p<0.0001;靶病变血运重建的优势比为0.66 [0.52 - 0.84],p = 0.0008)。事实上,也应设想采用这种直接和间接对比相结合的方式,以便合理、及时地评估下一代药物洗脱支架。