A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease

Patrick W. Serruys, Peter De Jaegere, Ferdinand Kiemeneij, Carlos Macaya, Wolfgang Rutsch, Guy Heyndrickx, Håkan Emanuelsson, Jean Marco, Victor Legrand, Pierre Materne, Jorge Belardi, Ulrich Sigwart, Antonio Colombo, Jean Jacques Goy, Paul Van Den Heuvel, Juan Delcan, Marie Angèle Morel

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Balloon-expandable coronary-artery stents were developed to prevent coronary restenosis after coronary angioplasty. These devices hold coronary vessels open at sites that have been dilated. However, it is unknown whether stenting improves long-term angiographic and clinical outcomes as compared with standard balloon angioplasty. Methods. A total of 520 patients with stable angina and a single coronary-artery lesion were randomly assigned to either stent implantation (262 patients) or standard balloon angioplasty (258 patients). The primary clinical end points were death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for coronary- artery bypass surgery, or a second percutaneous intervention involving the previously treated lesion, either at the time of the initial procedure or during the subsequent seven months. The primary angiographic end point was the minimal luminal diameter at follow-up, as determined by quantitative coronary angiography. Results. After exclusions, 52 patients in the stent group (20 percent) and 76 patients in the angioplasty group (30 percent) reached a primary clinical end point (relative risk, 0.68; 95 percent confidence interval, 0.50 to 0.92; P = 0.02). The difference in clinical- event rates was explained mainly by a reduced need for a second coronary angioplasty in the stent group (relative risk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P = 0.005). The mean (±SD) minimal luminal diameters immediately after the procedure were 2.48±0.39 mm in the stent group and 2.05±0.33 mm in the angioplasty group; at follow-up, the diameters were 1.82±0.64 mm in the stent group and 1.73±0.55 mm in the angioplasty group (P = 0.09), which correspond to rates of restenosis (diameter of stenosis, ≥50 percent) of 22 and 32 percent, respectively (P = 0.02). Peripheral vascular complications necessitating surgery, blood transfusion, or both were more frequent after stenting than after balloon angioplasty (13.5 vs. 3.1 percent, P

Original languageEnglish
Pages (from-to)489-495
Number of pages7
JournalNew England Journal of Medicine
Volume331
Issue number8
DOIs
Publication statusPublished - Aug 25 1994

ASJC Scopus subject areas

  • Medicine(all)

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