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Background

Background. There is ongoing debate to identify the most effective drug-eluting stent between the two currently most used devices (ie, sirolimus- [SES] and paclitaxel-eluting stents [PES])

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Background

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  1. Background • There is ongoing debate to identify the most effective drug-eluting stent between the two currently most used devices (ie, sirolimus- [SES] and paclitaxel-eluting stents [PES]) • In order to overcome the limitations and apparently conflicting results of single randomized trials, direct1 and indirect2 comparison meta-analyses have been performed • Most recently, methods have been developed to combine direct and indirect meta-analyses,3 but to date they have been employed rarely ACC 2006 1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005; 3Bucher et al, J Clin Epidemiol 1997

  2. Rationale Direct comparison TREATMENT A TREATMENT B TREATMENT A TREATMENT B Indirect comparison TREATMENT C TREATMENT C Direct and indirect comparison meta-analyses can be then combined using a generic inverse variance approach1-3 ACC 2006 1Bucher et al, J Clin Epidemiol 1997; 2Song et al, BMJ 2003; 3Psaty et al, JAMA 2003

  3. Aim of the study • We aimed to search, appraise and then combine previously published direct and indirect comparison meta-analyses of SES vs PES • The goal was to maximize statistical precision and power, as well as increasing robustness and validity of such SES vs PES comparison1-3 ACC 2006 1Bucher et al, J Clin Epidemiol 1997; 2Song et al, BMJ 2003; 3Psaty et al, JAMA 2003

  4. Methods • Direct and indirect comparison meta-analyses of SES vs PES were systematically searched in electronic databases • Pertinent results for binary angiographic restenosis and target lesion revascularization at 6-12 months were abstracted and pooled by means of fixed effects generic inverse variance weighting • We then computed odds ratios (OR) with 95% confidence intervals, and inconsistency (I2) as a measure of statistical heterogeneity • Two-tailed statistical significance was set at the 0.05 level ACC 2006

  5. Results • We identified a full report of direct comparison meta-analysis,1 which pooled 6 head-to-head randomized clinical trials comparing SES vs PES in 3669 patients (1845 treated with SES and 1824 with PES) • We also retrieved an indirect comparison meta-analysis,2 which compared SES vs PES from 9 additional trials enrolling 2185 patients (1007 treated with SES and 1178 treated with PES), using as benchmark the bare-metal-stent control group for each study ACC 2006 1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005

  6. Results SES Pts PES Pts BMS Pts CORPAL ISAR-DESIRE ISAR-DIABETES REALITY SIRTAX TAXI C-SIRIUS E-SIRIUS RAVEL SES-SMART SIRIUS TAXUS I TAXUS II MR TAXUS II SR TAXUS IV TAXUS VI 331 100 125 684 503 102 50 175 120 129 533 - - - - - 321 100 125 669 509 100 - - - - - 31 135 131 662 219 - - - - - - 50 178 118 128 525 30 134 136 652 227 Trial DIRECT META-ANALYSIS INDIRECT META-ANALYSIS ACC 2006

  7. Results • Pooling these two systematic reviews, by means of a fixed effects generic inverse variance method lead to the inclusion of a total of 5854 patients (2852 treated with SES and 3002 with PES) • In this population the use of SES in comparison to PES was associated with significant reductions in binary angiographic restenosis (p<0.0001) and target lesion revascularization (p=0.0008), even if the former end-point was statistically inhomogeneous ACC 2006 1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005

  8. Binary angiographic restenosis ACC 2006

  9. Target lesion revascularization ACC 2006

  10. Conclusions • This review combining previous direct and indirect meta-analyses of SES vs PES definitively establish the superiority of SES in comparison to PES in patients undergoing percutaneous coronary intervention • These data, notwithstanding their inherent limitations, should be taken into account together with costs in clinical decision making ACC 2006

  11. For further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html ACC 2006

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