Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.
BACKGROUND
The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term.


RESULTS
This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months.


CONCLUSIONS
Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.
Fajadet
Jean
J
Clinique Pasteur, 45, Avenue du Lombez, 31300 Toulouse, France. fajadet@interv-cardiol-toul.com
Morice
Marie-Claude
MC
Bode
Christoph
C
Barragan
Paul
P
Serruys
Patrick W
PW
Wijns
William
W
Constantini
Constantino R
CR
Guermonprez
Jean-Léon
JL
Eltchaninoff
Hélène
H
Blanchard
Didier
D
Bartorelli
Antonio
A
Laarman
Gert-Jan
GJ
Perin
MarcoAntonio
M
Sousa
J Eduardo
JE
Schuler
Gerhard
G
Molnar
Ferenc
F
Guagliumi
Giulio
G
Colombo
Antonio
A
Ban Hayashi
Ernesto
E
Wülfert
Egon
E
D023903:Coronary Restenosis / Q000473:pathology; D023921:Coronary Stenosis / Q000601:surgery*; D003331:Coronary Vessels / Q000473:pathology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D020123:Sirolimus / Q000378:metabolism*; D015607:Stents; D013995:Time
D020123:Sirolimus