The assessment of two year clinical outcomes after stent implantation for the treatment of coronary artery disease
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The sirolimus-eluting stent (Cypher) was the first approved drug- eluting stent by the Food and Drug Administration in April 2003. This is a stent that is based on a bare-metal stent and is coated with a layer of polymer incorporating sirolimus and releasing it by diffusion. Drug-eluting stents reduced risk of restenosis and repeat revascularization as compared with bare-metal stents. Clinical data has raised concerns that drug-eluting stents are associated with late untoward events. Objectives: The objective of this study was to test the hypothesis that stenting is safe and effective treatment for coronary artery disease. Methods and Results: Sirolimus-eluting stenting was performed in 30 patients with 34 coronary lesions. Detailed clinical follow-up data was collected by personal interview or telephone contact at 1, 6, 12 and 24 months. Patients were followed for 2 years for the occurrence of angina and cardiovascular events namely death, myocardial infarction, stent thrombosis and target lesion revascularization. The mean age of the cohort was 62.33±10.99 years; 83 percent were male, 6 percent were diabetic, 53 percent had hypertension. In spite of the overall patient and lesion complexity there were no incidences of major adverse cardiac events and all patients remained angina free out to two years. Dual antiplatelet therapy with aspirin and plavix varied from at least four weeks to one year. One patient had a bleeding event. Conclusions: Treatment of lesions with sirolimus-eluting stents is associated with a sustained clinical benefit two years after device implantation.