Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial.
OBJECTIVE
This study examined the clinical outcomes at 5 years in RAVEL (A Randomized Comparison of a Sirolimus-Eluting Stent With a Standard Stent for Coronary Revascularization), the first controlled trial of drug-eluting stents.


BACKGROUND
The 6-month rate of angiographic coronary restenosis has been markedly lowered by sirolimus-eluting stents (SES). The long-term performance of drug-eluting stents, however, is under close scrutiny.


METHODS
The trial included 238 patients (mean age 60.7 +/- 10.4 years, 76% men) with a single, de novo native coronary artery lesion, randomly assigned to treatment with SES versus bare-metal stents (BMS). Rates of major adverse cardiac events (MACE), defined as all-cause mortality, myocardial infarction, and percutaneous or surgical revascularization up to 5 years of follow-up, and rates of stent thrombosis were compared between the 2 treatment groups.


RESULTS
Complete datasets were available in 92.5% of patients treated with SES and 89.1% of patients assigned to BMS. The 1-, 3-, and 5-year rates of survival free from target lesion revascularization (TLR) were, respectively, 99.2%, 93.8%, and 89.7% in the SES group versus 75.9%, 75.0%, and 74.0% in the control group (p < 0.001; log-rank). Rates of all MACE at 5 years were 25.8% in patients treated with SES versus 35.2% in patients assigned to BMS (p = 0.03; log-rank). Rates of stent thrombosis, per protocol or by the Academic Research Consortium definitions, were similar in both groups.


CONCLUSIONS
The 5-year rate of TLR associated with SES was significantly lower than that with BMS. There was no apparent adverse effect associated with the use of SES, although the trial was not powered to examine uncommon complications.
Morice
Marie-Claude
MC
Institut Cardiovasculaire Paris Sud, Massy, France. mc.morice@icps.com.fr
Serruys
Patrick W
PW
Barragan
Paul
P
Bode
Christoph
C
Van Es
Gerrit-Anne
GA
Stoll
Hans-Peter
HP
Snead
David
D
Mauri
Laura
L
Cutlip
Donald E
DE
Sousa
Eduardo
E
D000368:Aged; D000369:Aged, 80 and over; D001807:Blood Vessel Prosthesis; D023903:Coronary Restenosis / Q000517:prevention & control; D023921:Coronary Stenosis / Q000401:mortality / Q000628:therapy*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus