101. Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation.
- Author
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Ong AT, Hoye A, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PP, de Feyter P, van Domburg RT, and Serruys PW
- Subjects
- Aged, Cohort Studies, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease epidemiology, Coronary Artery Disease therapy, Coronary Thrombosis diagnostic imaging, Equipment Design, Female, Follow-Up Studies, Humans, Incidence, Male, Middle Aged, Multivariate Analysis, Paclitaxel administration & dosage, Postoperative Complications diagnostic imaging, Sirolimus administration & dosage, Sirolimus therapeutic use, Survival Analysis, Time Factors, Treatment Outcome, Antibiotics, Antineoplastic therapeutic use, Antineoplastic Agents, Phytogenic therapeutic use, Blood Vessel Prosthesis Implantation adverse effects, Coated Materials, Biocompatible therapeutic use, Coronary Thrombosis epidemiology, Coronary Thrombosis etiology, Paclitaxel adverse effects, Paclitaxel therapeutic use, Postoperative Complications epidemiology, Postoperative Complications etiology, Sirolimus adverse effects, Stents adverse effects
- Abstract
Objectives: We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation., Background: Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice., Methods: The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES., Results: In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST., Conclusions: The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.
- Published
- 2005
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