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Original Article
Volume 331:489-495 August 25, 1994 Number 8
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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, Hakan Emanuelsson, Jean Marco, Victor Legrand, Pierre Materne, Jorge Belardi, Ulrich Sigwart, Antonio Colombo, Jean Jacques Goy, Paul van den Heuvel, Juan Delcan, Marie-angele Morel, for The Benestent Study Group

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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<0.001). The mean hospital stay was significantly longer in the stent group than in the angioplasty group (8.5 vs. 3.1 days, P<0.001).

Conclusions Over seven months of follow-up, the clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty. However, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.


Source Information

From the University Hospital Rotterdam Dijkzigt, Thorax Center, Rotterdam, the Netherlands (P.W.S., P.J., M.A.M.); Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (F.K.); University Hospital San Carlos, Madrid, Spain (C.M.); Universitatsklinikum Rudolf Virchow, Charlottenburg, Berlin, Germany (W.R.); Onze Lieve Vrouwe Kliniek, Aalst, Belgium (G.H.); Sahlgrenska Hospital, Goteborg, Sweden (H.E.); Clinique Pasteur, Toulouse, France (J.M.); Sart-Tilman Centre Hospitalier Universitaire, Liege, Belgium (V.L.); Hopital de la Citadelle, Liege, Belgium (P.M.); Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina (J.B.); Royal Brompton National Heart and Lung Institute, London (U.S.); Centro Cuore Columbus, Milan, Italy (A.C.); Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (J.J.G.); Middelheim Ziekenhuis, Antwerp, Belgium (P.H.); and Gregorio Maranon, Madrid, Spain (J.D.). The remaining investigators in the Benestent Study Group are listed in the Appendix.

Address reprint requests to Dr. Serruys at the Catheterization Laboratory, Thorax Center, Erasmus University Rotterdam, P.O. Box 1738, 3000 DR Rotterdam, the Netherlands.

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Related Letters:

Coronary-Stent Placement Compared with Balloon Angioplasty
Bittl J. A., Schwartz L., Serruys P. W., The Benestent Investigators , Fischman D. L., Savage M. P., Goldberg S., Topol E. J.
Extract | Full Text  
N Engl J Med 1995; 332:536-538, Feb 23, 1995. Correspondence

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