A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization

Marie Claude Morice, Patrick W. Serruys, J. Eduardo Sousa, Jean Fajadet, Ernesto Ban Hayashi, Marco Perin, Antonio Colombo, G. Schuler, Paul Barragan, Giulio Guagliumi, Ferenc Molnàr, Robert Falotico

Research output: Contribution to journalArticlepeer-review


Background: The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization. Because sirolimus (rapamycin) inhibits the proliferation of lymphocytes and smooth-muscle cells, we compared a sirolimus-eluting stent with a standard uncoated stent in patients with angina pectoris. Methods: We performed a randomized, double-blind trial to compare the two types of stents for revascularization of single, primary lesions in native coronary arteries. The trial included 238 patients at 19 medical centers. The primary end point was in-stent late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months). Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis (luminal narrowing of 50 percent or more). We also analyzed a composite clinical end point consisting of death, myocardial infarction, and percutaneous or surgical revascularization at 1, 6, and 12 months. Results: At six months, the degree of neointimal proliferation, manifested as the mean (±SD) late luminal loss, was significantly lower in the sirolimus-stent group (-0.01±0.33 mm) than in the standard-stent group (0.80±0.53 mm, P

Original languageEnglish
Pages (from-to)1773-1780
Number of pages8
JournalNew England Journal of Medicine
Issue number23
Publication statusPublished - Jun 6 2002

ASJC Scopus subject areas

  • Medicine(all)


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