1. Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry
- Author
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Jacques, Machecourt, Nicolas, Danchin, Jean Marc, Lablanche, Jean Marie, Fauvel, Jean Louis, Bonnet, Stephanie, Marliere, Alison, Foote, Jean Louis, Quesada, Hélène, Eltchaninoff, and Gérald, Vanzetto
- Subjects
Male ,Sirolimus ,Antibiotics, Antineoplastic ,Coronary Disease ,Thrombosis ,Middle Aged ,Disease-Free Survival ,Blood Vessel Prosthesis Implantation ,Drug Delivery Systems ,Treatment Outcome ,Risk Factors ,Case-Control Studies ,Humans ,Insulin ,Female ,Stents ,Prospective Studies ,Registries ,Angioplasty, Balloon, Coronary ,Diabetic Angiopathies ,Aged - Abstract
We sought to assess the frequency and causes of stent thrombosis in diabetic and nondiabetic patients after implantation of sirolimus-eluting stents.Safety concerns about late stent thrombosis have been raised, particularly when drug-eluting stents are used in less highly selected patients than in randomized trials.The EVASTENT study is a matched multicenter cohort registry of 1,731 patients undergoing revascularization exclusively with sirolimus stents; for each diabetic patient included (stratified as single- or multiple-vessel disease), a nondiabetic patient was subsequently included. Patients were treated with aspirin + clopidogrel for at least 3 months and were followed for 465 (range 0 to 1,062) days (1-year follow-up in 98.5%). The primary end point was a composite of stent thrombosis (according to Academic Research Consortium definitions), cardiovascular death, and nonfatal myocardial infarction (major adverse cardiac events [MACE]).During follow-up, MACE occurred in 78 patients (4.5%), cardiac death in 35 (2.1%), and stent thrombosis in 45 (2.6%): 30 definite, 23 subacute, and 22 late, including 9 at6 months. In univariate analysis, the 1-year stent thrombosis rate was 1.8 times higher in diabetic than in nondiabetic patients (3.2% vs. 1.7%; log rank p = 0.03), with diabetic patients with multiple-vessel disease experiencing the highest rate and nondiabetic single-vessel disease patients the lowest (4.3% vs. 0.8%; p0.001). In multivariate analysis, in addition to the interruption of antithrombotic treatment, independent stent thrombosis predictors were previous stroke, renal failure, lower ejection fraction, calcified lesion, length stented, and insulin-requiring diabetes.The risk of sirolimus stent thrombosis is higher for multiple-vessel disease diabetic patients.
- Published
- 2006