ABSTRACT
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.
ABSTRACT
BACKGROUND: Primary pulmonary hypertension is a disorder with limited treatment options and poor outcome. Sildenafil, a pulmonary vasodilator, is likely to be beneficial in primary pulmonary hypertension. We studied the clinical efficacy of sildenafil in patients with primary pulmonary hypertension. METHODS AND RESULTS: A registry of patients with primary pulmonary hypertension has been maintained in our hospital since January 1999. Of a total of 60 patients. 29 (M:16, F:13) consented to try sildenafiL. New York Heart Association functional class, six-minute walk test and Doppler echocardiographic evaluation of pulmonary artery pressure was done before and after treatment with sildenafil. Sildenafil was initiated at a dose of 25 mg thrice a day and increased up to 100 mg thrice a day as tolerated. There was a significant improvement in the functional class. The six-minute walked distance increased from 297.07+/-130.69 m at baseline to 427.68+/-85.35 m after 3 months of sildenafil therapy (p<0.0003). The mean of the pulmonary artery systolic pressure before starting sildenaffil was 109.26+/-24.15 mmHg (mean+/-SD) and it decreased to 95.15+/-24.64 mmHg (p<0.008). While 19 of the 31 historical controls in whom sildenafil was not given died during follow-up (11-44 months), only 1 of the 29 patients given sildenafil died (in an accident) during follow-up (5-20 months). CONCLUSIONS: Sildenafil, a pulmonary vasodilator, has a beneficial effect in patients with primary pulmonary hypertension in improving the functional class, six-minute walked distance and in decreasing the pulmonary artery pressures.