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Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries

Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries. Ajay J. Kirtane, M.D., S.M. Gregg W. Stone, M.D. Conflict of Interest Disclosure. Ajay J. Kirtane Past honorarium from Boston Scientific Corporation (modest)

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Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries

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  1. Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries Ajay J. Kirtane, M.D., S.M. Gregg W. Stone, M.D.

  2. Conflict of Interest Disclosure • Ajay J. Kirtane • Past honorarium from Boston Scientific Corporation (modest) • Consultant/Speaker: Medtronic Vascular, Abbott Vascular (modest) • Gregg W. Stone • Research grants from Boston Scientific and Abbott Vascular

  3. Persistent Questions: DES vs. BMS • While some of the alarm generated after ESC 2006 has been mitigated by analyses of patient-level data from the “on-label” RCTs*, there remains concern regarding DES outcomes in “off-label” patients and lesions, and with uncontrolled use • Are DES safe in higher risk off-label pts and in the unregulated environment of real-world use? • Are the benefits of DES in reducing TVR as robust in the real-world as in the RCTs, given the impact of routine angio FU and the oculostenotic reflex in many RCTs? *Stone et al, Kastrati et al, Spaulding et al, Mauri et al N Engl J Med 2007; 356(10).

  4. Methods: Goals and Objectives (1) • We therefore sought to perform a systematic review and meta-analysis from all high quality DES vs. BMS studies • To derive summary estimates of all-cause mortality, MI, and TVR in studies with ≥1 year of follow-up • To specifically assess differences between RCT and registry safety and effiacy with regard to these endpoints

  5. Methods: Inclusion Criteria • English language RCTs or registries which reported a direct comparison of DES (commercialized formulations of SES and PES only) vs. BMS. • Pre-specified criteria for each study: • ≥100 patients total • Mortality reported (± MI and/or TVR) • ≥1 year of follow-up reported, with the outcome assessed at the same time point in both comparator arms

  6. Methods: Statistical Analysis • All analyses were performed at The Cardiovascular Research Foundation/Columbia University • Models (both reported): • Fixed effects (Inverse-Variance weighted) • Random effects (DerSimonian and Laird)* • Fixed effects model was considered the primary model if significant heterogeneity was not present; otherwise random effects was considered primary • Formal heterogeneity testing was performed using the I2 statistic; heterogeneity was defined as I2 ≥ 25% *Weights displayed in figures are based upon the primary model used

  7. All-Cause Mortality: All RCTs 8,867 patients, 21 trials Weight (%) Estimate (95% CI) Random Effects *Fixed Effects (I2=0.0%) 0.97 (0.81,1.15) 0.97 (0.81,1.15), p=0.72 Favors DES Favors BMS Mean f/u 2.9 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  8. All-Cause Mortality: RCTs (On-Label) 4,818 patients, 10 trials Weight (%) Estimate (95% CI) Random Effects *Fixed Effects (I2=0.0%) 1.05 (0.84,1.30) 1.05 (0.84,1.30), p=0.69 Favors DES Favors BMS Mean f/u 4.0 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  9. All-Cause Mortality: RCT’s (Off-Label) 4,049 patients, 12 trials Weight (%) Estimate (95% CI) Random Effects *Fixed Effects (I2=0.0%) 0.84 (0.62,1.13) 0.84 (0.62,1.13), p=0.24 Favors DES Favors BMS Mean f/u 1.5 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  10. All-Cause Mortality: All Registries 161,232 patients, 28 registries Weight (%) Estimate (95% CI) *Random Effects (I2=70.1%) Fixed Effects 0.80 (0.72,0.88), p<0.001 0.83 (0.79,0.86) Favors DES Favors BMS Mean f/u 2.5 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  11. MI: All RCTs 8,850 patients, 20 trials Estimate (95% CI) Weight (%) Random Effects *Fixed Effects (I2=3.0%) 0.94 (0.78,1.13) 0.94 (0.79,1.13), p=0.54 Favors DES Favors BMS Mean f/u 2.9 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  12. MI: RCTs (On Label) 4,318 patients, 9 trials Estimate (95% CI) Weight (%) Random Effects *Fixed Effects (I2=0.0%) 1.03 (0.81,1.30) 1.03 (0.81,1.30), p=0.82 Favors DES Favors BMS Mean f/u 4.4 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  13. MI: RCT’s (Off Label) 4,532 patients, 12 trials Estimate (95% CI) Weight (%) 0.77 (0.54,1.10) 0.83 (0.62,1.10), p=0.19 Random Effects *Fixed Effects (I2=25.5%) Favors DES Favors BMS Mean f/u 1.5 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  14. MI: All Registries 129,955 patients, 24 registries Estimate (95% CI) Weight (%) 0.89 (0.80,0.98), p=0.023 0.96 (0.91,1.01) *Random Effects (I2=57.9%) Fixed Effects *MI is QWMI in Washington Hospital Center, RESTEM Favors DES Favors BMS Mean f/u 2.5 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  15. TVR: All RCTs 7,291 patients, 16 trials Estimate (95% CI) Weight (%) *Random Effects (I2=53.2%) Fixed Effects 0.45 (0.37,0.54), p<0.001 0.51 (0.45,0.57) Favors DES Favors BMS Mean f/u 3.2 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  16. TVR: RCTs (On Label) 4,618 patients, 9 trials Estimate (95% CI) Weight (%) *Random Effects (I2=48.8%) Fixed Effects 0.53 (0.43,0.65), p<0.001 0.54 (0.47,0.62) Favors DES Favors BMS Mean f/u 4.2 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  17. TVR: RCTs (Off Label) 2,673 patients, 8 trials Estimate (95% CI) Weight (%) *Random Effects (I2=47.8%) Fixed Effects 0.38 (0.27,0.52), p<0.001 0.42 (0.34,0.52) Favors DES Favors BMS Mean f/u 1.6 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  18. TVR: All Registries 73,819 patients, 17 registries Estimate (95% CI) Weight (%) *Random Effects (I2=71.2%) Fixed Effects 0.53 (0.47,0.61), p<0.001 0.57 (0.54,0.60) Favors DES Favors BMS Mean f/u 2.2 yrs Ajay J. Kirtane and Gregg W. Stone, 2008

  19. Summary: DES vs. BMSTreatment Effect Estimates <1.0  DES better

  20. Conclusions (1) • In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for ≥1 yr, DES resulted in: • Non significant 3% and 6% reductions in mortality and MI respectively • A highly significant 55% reduction in TVR • In 30 registries in which 174,302 pts were treated with either DES or BMS and followed for ≥1 yr, DES resulted in: • A highly significant 20% reduction in mortality • A significant 11% reduction in MI • A highly significant 47% reduction in TVR

  21. Conclusions (2) The favorable results of DES from the RCT and registry analysis populations were robust and consistent for both on-label and off-label use, and for clinical f/u extending to 3-4 years These findings, derived from more than 180,000 pts treated in 52 studies, strongly suggest that DES are safe for both on-label and off-label use, and have comparable efficacy in both RCTs and in the “real-world”

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