Clinical Evaluation of an Indigenous Paclitaxel-Eluting Stent in De NovoCoronary Artery Stenosis.

BACKGROUND, Drug-eluting stents have enabled considerable reduction in restenosis in patients subjected to angioplasty. However, in view of high cost of drug-eluting stents, efforts to develop medicated stents at reduced cost using alternative polymers in Indian setting are imperative. Hence a multi-center study was undertaken to evaluate the safety and efficacy of the indigenously developed paclitaxel-eluting RELEASE-T stent. METHODS, The study included 100 patients (male:86, Female:14) who were undergoing angioplasty for various indications at four centres viz. Delhi, Hyderabad, Pune and Warangal. The age range was 29 - 76 years; 37 patients were diabetic. All patients were pre-treated with aspirin 150-325 mg plus clopidogrel 75 mg daily four days before procedure or clopidogrel alone. Aspirin was continued indefinitely. RESULTS, Direct stenting ws done in majority of patients. One patient, in whom stent could not be delivered, received only baloon angioplasty. Sixty-four patients had stenting of left anterior descending artery. The stent diameter ranged from 2.5 to 3.5 mm, and the length, 15 to 20 mm. All patients were followed up at 1,3 and 6 months. There was two deaths: one had subacute thrombosis on both stents, and the other (who was HIV positive) had sudden cardiac death. The 6-month rate of major adverse cardiac events was 4% and target lesion revascularization rate ws 2%. CONCLUSION, This ulti-locational study brings out that the use of indigenously developed paclitaxel-eluting stent is safe and clinically efficacious.