[en] 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, > or = 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.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Serruys, P. W.
de Jaegere, P.
Kiemeneij, F.
Macaya, C.
Rutsch, W.
Heyndrickx, G.
Emanuelsson, H.
Marco, J.
Legrand, Victor ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie
Materne, P.
Language :
English
Title :
A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group.
Publication date :
1994
Journal title :
New England Journal of Medicine
ISSN :
0028-4793
eISSN :
1533-4406
Publisher :
Massachusetts Medical Society, United States - Massachusetts
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987; 316: 701-706
de Jaegere PPT, Hermans WR, Rensing BJ, Strauss BH, de Feyter PJ, Serruys PW Matching based on quantitative coronary angioplasty as a surrogate for randomized studies: comparison between stent implantation and balloon angioplasty of native coronary artery lesions. Am Heart J 1993; 125: 310-319
Fischman DL, Savage MP, Ellis SG, et al. Restenosis after Palmaz-Schatz stent implantation. In: Serruys PW, Strauss BH, King SB III, eds. Restenosis after intervention with new mechanical devices. Vol. 131 of Developments in cardiovascular medicine. Dordrecht, the Netherlands: Kluwer Academic, 1992:191-205.
Schatz RA, Baim DS, Leon M, Clinical experience with the Palmaz-Schatz coronary stent: initial results of a multicenter study. Circulation 1991; 83: 148-161
Serruys PW, Strauss BH, Beatt KJ, Angiographic follow-up after placement of a self-expanding coronary-artery stent. N Engl J Med 1991; 324: 13-17
de Jaegere PPT, de Feyter PJ, van der Giessen WJ, Serruys PW Endovascular stents: preliminary clinical results and future developments. Clin Cardiol 1993; 16: 369-378
Serruys PW, Foley DP, de Feyter PJ, eds. Quantitative coronary angiography in clinical practice. Dordrecht, the Netherlands: Kluwer Academic, 1994.
Blackburn H, Keys A, Simonson E, Rautaharju P, Punsar S The electrocardiogram in population studies: a classification system. Circulation 1960; 21: 1160-1175
The TIMI Study Group. The thrombolysis in myocardial infarction (TIMI) trial: Phase 1 findings. N Engl J Med 1985; 312: 932-936
Pocock SJ Interim analyses for randomized clinical trials: the group sequential approach. Biometrics 1982; 38: 153-162
Greenland S, Robins JM Estimation of a common effect parameter from sparse follow-up data. Biometrics 1985; 41: 55-68
Hermans WRM, Rensing BJ, Foley DP, Therapeutic dissection after successful coronary balloon angioplasty: no influence on restenosis or on clinical outcome in 693 patients. J Am Coll Cardiol 1992; 20: 767-780
Ambrose JA, Winters SL, Stern A, Angiographic morphology and the pathogenesis of unstable angina pectoris. J Am Coll Cardiol 1985; 5: 609-616
Ellis SG, Roubin GS, King SB III, Douglas JS Jr, Cox WR Importance of stenosis morphology in the estimation of restenosis risk after elective percutaneous transluminal coronary angioplasty. Am J Cardiol 1989; 63: 30-34
Dorros G, Cowley MJ, Simpson J, Percutaneous transluminal coronary angioplasty: report of complications from the National Heart, Lung, and Blood Institute PTCA Registry. Circulation 1983; 67: 723-730
de Jaegere P, de Feyter P, Serruys PW Intracoronary stenting. Curr Rev Interv Cardiol 1993; 8: 1-17
Cohen DJ, Breall JA, Ho KK, Economics of elective coronary revascularization: comparison of costs and charges for conventional angioplasty, directional atherectomy, stenting and bypass surgery. J Am Coll Cardiol 1993; 22: 1052-1059
Cohen DJ, Breall JA, Ho KK, Evaluating the potential cost-effectiveness of stenting as a treatment for symptomatic single-vessel coronary disease: use of a decision-analytic model. Circulation 1994; 89: 1859-1874
Hirshfeld JW, Schwartz SS, Jugo R, Restenosis after coronary angioplasty: a multivariate statistical model to relate lesion and procedure variables to restenosis. J Am Coll Cardiol 1991; 18: 647-656
Ellis SG, Roubin GS, Wilentz J, Douglas JS Jr, King SB III Effect of 18- to 24-hour heparin administration for prevention of restenosis after uncomplicated coronary angioplasty. Am Heart J 1989; 117: 777-782
Perin EC, Turner SA, Ferguson JJ Relationship between the response to heparin and restenosis following PTCA. Circulation 1990; 82: Suppl III: III-497 abstract.
Faxon D, Spiro T, Minor S, Enoxaparin, a low molecular weight heparin, in the prevention of restenosis after angioplasty: result of a double blind randomized trial. J Am Coll Cardiol 1992; 19: Suppl A: 258A-258A abstract.
Thornton MA, Gruentzig AR, Hollman J, King SB III, Douglas JS Coumadin and aspirin in prevention of recurrence after transluminal coronary angioplasty: a randomized study. Circulation 1984; 69: 721-727
Urban P, Buller N, Fox K, Shapiro L, Bayliss J, Rickards A Lack of effect of warfarin on the restenosis rate or on clinical outcome after balloon coronary angioplasty. Br Heart J 1988; 60: 485-488
Rensing BJ, Hermans WR, Beatt KJ, Quantitative angiographic assessment of elastic recoil after percutaneous transluminal coronary angioplasty. Am J Cardiol 1990; 66: 1039-1044