Prospective randomized comparison of early and late results of 4 different stent designs

Late results of interventional procedures using coronary stents are largely determined by the rate of restenosis. So far, few data are available addressing the effect of stent design on this crucial variable and on early and late adverse events after stent implantation. From 1996 through1998, a tota...

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Bibliographic Details
Published in:The American heart journal 2003-07, Vol.146 (1), p.134-141
Main Authors: Sick, Peter B, Thiele, Holger, Brosteanu, Oana, Hentschel, Bettina, Lauer, Bernward, Niebauer, Josef, Hambrecht, Rainer, Schuler, Gerhard
Format: Article
Language:English
Subjects:
Aged
Angioplasty
Biological and medical sciences
Cardiovascular disease
Coronary Disease - therapy
Coronary Restenosis - diagnostic imaging
Coronary Restenosis - etiology
Coronary Restenosis - pathology
Equipment Design
Female
Follow-Up Studies
Heart attacks
Humans
Male
Medical sciences
Middle Aged
Mortality
Multivariate Analysis
Radiography
Regression Analysis
Stents
Stents - adverse effects
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Surgery of the heart
Thrombosis
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Summary:Late results of interventional procedures using coronary stents are largely determined by the rate of restenosis. So far, few data are available addressing the effect of stent design on this crucial variable and on early and late adverse events after stent implantation. From 1996 through1998, a total of 965 lesions in 925 patients with coronary artery disease were randomized to treatment with 1 of 4 different stent designs (Micro stent II [M] AVE, Düsseldorf, Germany; Sito [S] Sitomed, Rangendingen, Germany; Pura Vario [PV], Devon, Hamburg, Germany; Inflow [ID] Inflow Dynamics, München, Germany). The primary end point of the study was the degree of diameter stenosis measured by quantitative coronary angiography 6 months after stent implantation. Diameter stenosis at 6 months follow-up was not different in the 4 study arms (M 40.3 ± 24.1, S 42.8 ± 27.0, PV 42.6 ± 26.9 and ID 42.3 ± 26.8, P = .7). No significant differences could be detected in net lumen gain and late lumen loss, resulting in comparable restenosis rates (≥50% diameter stenosis) at follow-up (M 26.0%, S 30.5%, PV 31.3%, and ID 28.7%, P = .7). Early adverse events like stent loss, stent thrombosis, periinterventional acute myocardial infarctions and emergency coronary artery bypass graft also showed no significant differences. Multivariate regression analyses revealed reference vessel diameter
ISSN:0002-8703
1097-6744
DOI:10.1016/S0002-8703(03)00113-3