3. 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
1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005; 3Bucher et al, J Clin Epidemiol 1997
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4. Rationale Direct and indirect comparison meta-analyses can be
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
1Bucher et al, J Clin Epidemiol 1997; 2Song et al, BMJ 2003; 3Psaty et al, JAMA 2003
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5. 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
1Bucher et al, J Clin Epidemiol 1997; 2Song et al, BMJ 2003; 3Psaty et al, JAMA 2003
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6. 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
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7. 1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005
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
1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005
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8. Results Trial SES Pts PES Pts BMS Pts META-ANALYSIS DIRECT
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 - 31
135
131
662
219 - 50
178
118
128
525 30
134
136
652
227
META-ANALYSIS
DIRECT
META-ANALYSIS
INDIRECT
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9. 1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005
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
1Kastrati et al, JAMA 2005; 2Biondi-Zoccai et al, Int J Cardiol 2005
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10. Binary angiographic restenosis
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11. Target lesion revascularization
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12. 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
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13. For further slides on these topics please feel free to visit the metcardio.org website:
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