Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents : Three-year results of the RAVEL trial

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. This multic...

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Published in:Circulation (New York, N.Y.) N.Y.), 2005-03, Vol.111 (8), p.1040-1044
Main Authors: FAJADET, Jean, MORICE, Marie-Claude, BARTORELLI, Antonio, LAARMAN, Gert-Jan, PERIN, Marcoantonio, SOUSA, J. Eduardo, SCHULER, Gerhard, MOLNAR, Ferenc, GUAGLIUMI, Giulio, COLOMBO, Antonio, BAN HAYASHI, Ernesto, WÜLFERT, Egon, BODE, Christoph, BARRAGAN, Paul, SERRUYS, Patrick W, WIJNS, William, CONSTANTINI, Constantino R, GUERMONPREZ, Jean-Léon, ELTCHANINOFF, Hélène, BLANCHARD, Didier
Format: Article
Language:English
Subjects:
Biological and medical sciences
Blood and lymphatic vessels
Cardiology. Vascular system
Cardiovascular system
Coronary heart disease
Coronary Restenosis - pathology
Coronary Stenosis - surgery
Coronary Vessels - pathology
Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous
Double-Blind Method
Female
Follow-Up Studies
Heart
Humans
Male
Medical sciences
Middle Aged
Myocardial Revascularization
Pharmacology. Drug treatments
Sirolimus - metabolism
Stents
Time
Vasodilator agents. Cerebral vasodilators
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Summary: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. 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
ISSN:0009-7322
1524-4539
DOI:10.1161/01.CIR.0000156334.24955.B2