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Columbia / CRF DES vs. BMS Meta-Analysis

Columbia / CRF DES vs. BMS Meta-Analysis. Kirtane et al, Circ 2009;119: 3198-3206. DES Studies: Data Synthesis. In order to synthesize the existing data, we performed a systematic review and meta-analysis of all DES vs. BMS studies through 2/08

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Columbia / CRF DES vs. BMS Meta-Analysis

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  1. Columbia / CRFDES vs. BMS Meta-Analysis Kirtane et al, Circ 2009;119: 3198-3206

  2. DES Studies: Data Synthesis In order to synthesize the existing data, we performed a systematic review and meta-analysis of all DES vs. BMS studies through 2/08 To derive summary estimates of all-cause mortality, MI, and TVR in studies with ≥1 year of follow-up To specifically assess differences between on-label / off-label use, and between RCT and observational data Kirtane et al, Circ 2009;119: 3198-3206

  3. Methods: Inclusion Criteria English language RCTs or registries which reported a direct comparison of DES (commercialized formulations of SES and PES only) vs. BMS up through February 2008 Criteria for each study: ≥100 patients total Mortality reported (± MI and/or TVR) ≥1 year of cumulative follow-up reported, with the outcome assessed at the same time point in both comparator arms Kirtane et al, Circ 2009;119: 3198-3206

  4. Study Flow Diagram Pubmed search thru 2/08: stent AND bare AND (eluting OR sirolimus OR paclitaxel) 834 articles 221 review articles or editorials 115 no/unclear clinical outcomes described 104 sub-studies/more recent papers 81 no BMS/DES comparison 100 basic science or non-approved device 84 with <1 year f/u or <100 pts 92 case reports, meta-analyses, non-coronary studies, or other 37 articles AHA (3/246), TCT (9/206), ESC (4/243), ACC (0/468) abstracts and reference searches 16 abstracts met criteria 3 articles met criteria EuroIntervention search (146 articles) 56 studies RCT studies: 22 (9,470 patients) Registry studies: 34 (182,901 patients) Kirtane et al, Circ 2009;119: 3198-3206

  5. All-Cause Mortality: All RCTs 8,867 patients, 21 trials, mean F/U 2.9 years 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 Kirtane et al, Circ 2009;119: 3198-3206

  6. All-Cause Mortality: RCT’s (Off-Label) 4,049 patients, 12 trials, mean F/U 1.5 years 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 Kirtane et al, Circ 2009;119: 3198-3206

  7. MI: All RCTs 8,850 patients, 20 trials , mean F/U 2.9 years Estimate (95% CI) Weight (%) Random Effects *Fixed Effects (I2=3.0%) 0.94 (0.78,1.13) 0.95 (0.79,1.13), p=0.54 Favors DES Favors BMS Kirtane et al, Circ 2009;119: 3198-3206

  8. MI: RCT’s (Off Label) 4,532 patients, 12 trials , mean F/U 1.5 years 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 Kirtane et al, Circ 2009;119: 3198-3206

  9. TVR: All RCTs 7,291 patients, 16 trials , mean F/U 3.2 years 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 Kirtane et al, Circ 2009;119: 3198-3206

  10. TVR: RCTs (Off Label) 2,673 patients, 8 trials , mean F/U 1.6 years 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 Kirtane et al, Circ 2009;119: 3198-3206

  11. TVR: RCTs Meta-Regression on Percent Angiographic F/U p=0.73 *Hazard Ratio Percentage of Patients with Angiographic F/U *log(HR) regressed on percentage of pts with angiographic f/u; figure displayed on exponentiated scale

  12. All-Cause Mortality: All Registries 169,595 patients, 31 registries, mean F/U 2.5 years Weight (%) Estimate (95% CI) *Random Effects (I2=71%) Fixed Effects 0.78 (0.71,0.86), p<0.001 0.81 (0.78,0.85) Favors DES Favors BMS Kirtane et al, Circ 2009;119: 3198-3206

  13. All-Cause Mortality: Adjusted Registries 136,558 patients, 19 registries , mean F/U 2.7 years Estimate (95% CI) Weight (%) *Random Effects (I2=76%) Fixed Effects 0.79 (0.71,0.89), p<0.001 0.82 (0.79,0.86) Favors DES Favors BMS Kirtane et al, Circ 2009;119: 3198-3206

  14. MI: All Registries 130,191 patients, 25 registries , mean F/U 2.5 years Estimate (95% CI) Weight (%) 0.87 (0.78,0.97), p=0.01 0.95 (0.91,1.00) *Random Effects (I2=60%) Fixed Effects Favors DES Favors BMS Kirtane et al, Circ 2009;119: 3198-3206 *MI is QWMI in Washington Hospital Center, RESTEM

  15. TVR: All Registries 74,154 pts, 18 registries , mean F/U 2.2 years Estimate (95% CI) Weight (%) *Random Effects (I2=70%) Fixed Effects 0.54 (0.48,0.61), p<0.001 0.57 (0.54,0.60) Favors DES Favors BMS Kirtane et al, Circ 2009;119: 3198-3206

  16. Summary: DES vs. BMSTreatment Effect Estimates <1.0  DES better Kirtane et al, Circ 2009;119: 3198-3206

  17. 14 Subsequent DES vs. BMS Registries Published 2/08-9/08 (N=176,777 pts)* Malenka et al (JAMA) excluded for DES era/BMS era comparison; 4 additional studies reported cardiac death only *Studies already included in meta-analysis in unpublished format not listed

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