Coronary-Artery Stenting Compared with Balloon Angioplasty for Restenosis after Initial Balloon Angioplasty
Raimund Erbel, M.D., Michael Haude, M.D., Hans W. Höpp, M.D., Damian Franzen, M.D., Hans Jürgen Rupprecht, M.D., Bernd Heublein, M.D., Klaus Fischer, M.D., Peter de Jaegere, M.D., Patrick Serruys, M.D., Wolfgang Rutsch, M.D., Peter Probst, M.D., for The Restenosis Stent Study Group
Background Intracoronary stenting reduces the rate of restenosisafter angioplasty in patients with new coronary lesions. Weconducted a prospective, randomized, multicenter study to determinewhether intracoronary stenting, as compared with standard balloonangioplasty, reduces the recurrence of luminal narrowing inrestenotic lesions.
Methods A total of 383 patients who had undergone at least oneballoon angioplasty and who had clinical and angiographic evidenceof restenosis after the procedure were randomly assigned toundergo standard balloon angioplasty (192 patients) or intracoronarystenting with a Palmaz–Schatz stent (191 patients). Theprimary end point was angiographic evidence of restenosis (definedas stenosis of more than 50 percent of the luminal diameter)at six months. The secondary end points were death, Q-wave myocardialinfarction, bypass surgery, and revascularization of the targetvessel.
Results The rate of restenosis was significantly higher in theangioplasty group than in the stent group (32 percent as comparedwith 18 percent, P= 0.03). Revascularization of the target vesselat six months was required in 27 percent of the angioplastygroup but in only 10 percent of the stent group (P=0.001). Thisdifference resulted from a smaller mean (±SD) minimalluminal diameter in the angioplasty group (1.85±0.56mm) than in the stent group (2.04±0.66 mm), with a meandifference of 0.19 mm (P=0.01) at follow-up. Subacute thrombosisoccurred in 0.6 percent of the angioplasty group and in 3.9percent of the stent group. The rate of event-free survivalat 250 days was 72 percent in the angioplasty group and 84 percentin the stent group (P=0.04).
Conclusions Elective coronary stenting was effective in thetreatment of restenosis after balloon angioplasty. Stentingresulted in a lower rate of recurrent stenosis despite a higherincidence of subacute thrombosis.
Source Information
From the Department of Cardiology, University of Essen, Essen, Germany (R.E., M.H.); the Department of Medicine III, University of Cologne, Cologne, Germany (H.W.H., D.F.); the Medical Clinic II, University of Mainz, Mainz, Germany (H.J.R.); the Department of Cardiothoracic Surgery, Hannover Medical School, Hannover, Germany (B.H., K.F.); the Department of Cardiology, Thorax Center, Erasmus University, Rotterdam, the Netherlands (P.J., P.S.); the Department of Cardiology, University Clinic Charité, Berlin, Germany (W.R.); and the Department of Cardiology, University of Vienna, Vienna, Austria (P.P.).
Address reprint requests to Dr. Erbel at the Department of Cardiology, University of Essen, Hufelandstr. 55, 45122 Essen, Germany.
Antithrombotic Therapy after Coronary-Artery Stenting
Ferrer F., Moraleda J. M., Vicente V., LoGerfo F. W., Wohl V. R., Hecht E., Shaughnessy K., Leon M. B., Dangas G., Erbel R., Haude M., The Restenosis Stent Study Group , Topol E. J.
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N Engl J Med 1999;
340:1365-1368, Apr 29, 1999.
Correspondence
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