Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis.
OBJECTIVE
To evaluate the effect of drug-eluting vs. bare metal stents for the treatment of coronary artery disease on overall, cardiac, and non-cardiac mortalities.


RESULTS
We conducted a systematic literature search to identify all randomized controlled trials comparing sirolimus or paclitaxel-eluting stents with bare metal stents and reporting mortality data after at least 1 year of follow-up. Trial data were reviewed and extracted independently by two investigators in an unblinded standardized manner. Seventeen trials including a total of 8221 patients were analysed. Peto's odds ratios (ORs) for total mortality after 1 (n=8221), 2 (n=4631), 3 (n=4105), and 4 (n=1293) years of follow-up were 0.94 [95% confidence interval (CI) 0.66-1.34], 1.11 (95% CI 0.76-1.61), 1.25 (95% CI 0.91-1.73), and 1.46 (95% CI 0.92-2.31), respectively. Corresponding ORs for non-cardiac mortality were 1.07 (95% CI 0.64-1.80), 1.72 (95% CI 1.01-2.94), 1.45 (95% CI 0.93-2.25), and 1.65 (95% CI 0.89-3.10). There was no difference in OR for cardiac mortality among all trials. In sensitivity analyses, sirolimus- but not paclitaxel-eluting stents were associated with an increase in non-cardiac mortality at 2 and 3 years of follow-up.


CONCLUSIONS
Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices.
Nordmann
Alain Joel
AJ
Basel Institute for Clinical Epidemiology, University Hospital Basel, Hebelstrasse 10, 4031 Basel, Switzerland. nordmanna@uhbs.ch
Briel
Matthias
M
Bucher
Heiner Claudins
HC
D000368:Aged; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D004343:Drug Implants; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D012680:Sensitivity and Specificity; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D050257:Tubulin Modulators / Q000008:administration & dosage*
D004343:Drug Implants; D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D017239:Paclitaxel; D020123:Sirolimus