(Circulation. 2001;104:e111.)
© 2001 American Heart Association, Inc.
From St Lukes Episcopal Hospital, Texas Heart Institute, Baylor College of Medicine, University of Texas Health Science Center at Houston, Houston, Tex.
Reprint requests and correspondence to James J. Ferguson III, MD, Cardiology Research, MC 1-191, St. Lukes Episcopal Hospital/Texas Heart Institute, PO Box 20269, Houston, TX 77225. E-mail jferguson@heart.thi.tmc.edu
The following studies (Table) were presented at the XXIII Congress of the European Society of Cardiology, which was held in Stockholm, Sweden, on September 1 through 5, 2001.
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Interventional Cardiology
RAVEL
Presenter: Marie-Claude Maurice, MD, Hospitalier Jacque Cartier, Massy, France
The study: A randomized, double-blind, parallel-group trial comparing a stent coated with sirolimus (an immunosuppressive macrolide antibiotic; n=120) with a similar uncoated stent (BX Velocity; n=118) in patients undergoing stent implantation. Qualifying patients had to have de novo single-vessel disease in a native coronary artery that was <18 mm in length and 2.5 to 3.5 mm in diameter. The primary end point was in-stent lumen diameter loss measured at 6-month follow-up angiography.
The results: Mean reference vessel size was 2.6 mm; mean lesion length was 9.6 mm. Late loss in the control uncoated stent was 0.80±0.53 mm; late loss with the sirolimus-coated stent was 0.01±0.33 mm (P<0.001). The binary restenosis rate was 2.6% with the uncoated stents and 0% with the coated stents. Preliminary long-term clinical follow-up (to 210 days) showed a target lesion revascularization rate of 26% in the uncoated stent group versus 0% in the coated stent group (P<0.0001). Survival free from major adverse cardiovascular events was 73% in the uncoated stent group and 97% in the coated stent group (P<0.001) when used for the treatment of discrete lesions.
Summary: Sirolimus-coated stents seem to have virtually no restenosis (at 6 months) in native vessels that are 2.5
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