Cause of death with bare metal and sirolimus-eluting stents.
OBJECTIVE
Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents.


RESULTS
An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6+/-0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently.


CONCLUSIONS
At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.
Holmes
David R
DR
Division of Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
Moses
Jeffrey W
JW
Schofer
Joachim
J
Morice
Marie-Claude
MC
Schampaert
Erick
E
Leon
Martin B
MB
D000368:Aged; D002423:Cause of Death; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000401:mortality; D016757:Death, Sudden, Cardiac / Q000209:etiology; D005260:Female; D006333:Heart Failure / Q000209:etiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents
D007166:Immunosuppressive Agents; D020123:Sirolimus