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
Background Balloon-expandable coronary-artery stents were developedto prevent coronary restenosis after coronary angioplasty. Thesedevices hold coronary vessels open at sites that have been dilated.However, it is unknown whether stenting improves long-term angiographicand clinical outcomes as compared with standard balloon angioplasty.
Methods A total of 520 patients with stable angina and a singlecoronary-artery lesion were randomly assigned to either stentimplantation (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 percutaneousintervention involving the previously treated lesion, eitherat the time of the initial procedure or during the subsequentseven months. The primary angiographic end point was the minimalluminal diameter at follow-up, as determined by quantitativecoronary angiography.
Results After exclusions, 52 patients in the stent group (20percent) and 76 patients in the angioplasty group (30 percent)reached a primary clinical end point (relative risk, 0.68; 95percent confidence interval, 0.50 to 0.92; P = 0.02). The differencein clinical-event rates was explained mainly by a reduced needfor a second coronary angioplasty in the stent group (relativerisk, 0.58; 95 percent confidence interval, 0.40 to 0.85; P= 0.005). The mean (±SD) minimal luminal diameters immediatelyafter the procedure were 2.48 ±0.39 mm in the stent groupand 2.05 ±0.33 mm in the angioplasty group; at follow-up,the diameters were 1.82 ±0.64 mm in the stent group and1.73 ±0.55 mm in the angioplasty group (P = 0.09), whichcorrespond to rates of restenosis (diameter of stenosis, 50percent) of 22 and 32 percent, respectively (P = 0.02). Peripheralvascular complications necessitating surgery, blood transfusion,or both were more frequent after stenting than after balloonangioplasty (13.5 vs. 3.1 percent, P<0.001). The mean hospitalstay was significantly longer in the stent group than in theangioplasty group (8.5 vs. 3.1 days, P<0.001).
Conclusions Over seven months of follow-up, the clinical andangiographic outcomes were better in patients who received astent than in those who received standard coronary angioplasty.However, this benefit was achieved at the cost of a significantlyhigher risk of vascular complications at the access site anda 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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