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Stent thrombosis in randomized clinical trials of drug-eluting stents.
- Source :
-
The New England journal of medicine [N Engl J Med] 2007 Mar 08; Vol. 356 (10), pp. 1020-9. Date of Electronic Publication: 2007 Feb 12. - Publication Year :
- 2007
-
Abstract
- Background: Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner.<br />Methods: We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee.<br />Results: The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20; 95% confidence interval [CI], -0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal-stent group (P=0.24; 95% CI, -0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal-stent group (P=0.70; 95% CI, -1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal-stent group (P=0.52; 95% CI, -0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal-stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal-stent group.<br />Conclusions: The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.<br /> (Copyright 2007 Massachusetts Medical Society.)
- Subjects :
- Angioplasty, Balloon, Coronary
Brachytherapy
Combined Modality Therapy
Coronary Disease mortality
Coronary Restenosis epidemiology
Coronary Restenosis therapy
Coronary Thrombosis epidemiology
Drug Delivery Systems
Female
Follow-Up Studies
Humans
Incidence
Kaplan-Meier Estimate
Male
Middle Aged
Platelet Aggregation Inhibitors therapeutic use
Prosthesis Design
Prosthesis Failure
Randomized Controlled Trials as Topic
Coronary Disease therapy
Coronary Thrombosis etiology
Immunosuppressive Agents administration & dosage
Paclitaxel administration & dosage
Sirolimus administration & dosage
Stents adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 356
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 17296821
- Full Text :
- https://doi.org/10.1056/NEJMoa067731