Preclinical and early clinical experience with a biodegradable polymer-based, rapamycin-eluting, Indian drug-eluting coronary stent: the BIO-RAPID study.

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dc.contributor.authorBhargava, Balramen_US
dc.contributor.authorKarthikeyan, Ganesanen_US
dc.contributor.authorShankar, Pr Bhimaen_US
dc.contributor.authorSeth, Sandeepen_US
dc.contributor.authorSingh, Sandeepen_US
dc.contributor.authorPr, Umashankaren_US
dc.contributor.authorLal, Arthur Vijayanen_US
dc.contributor.authorMohanty, Miraen_US
dc.date.accessioned2008-05-26en_US
dc.date.accessioned2009-05-27T04:20:25Z
dc.date.available2008-05-26en_US
dc.date.available2009-05-27T04:20:25Z
dc.date.issued2008-05-26en_US
dc.description.abstractOBJECTIVE: To evaluate the performance of a biodegradable polymer based rapamycin-eluting coronary stent in a porcine model and demonstrate its safety and efficacy in the treatment of patients with de novo coronary stenosis. BACKGROUND: The indefinite presence of the polymer after the implantation of drug-eluting stents may initiate and sustain inflammation and contribute to the occurrence of late complications. METHODS: Seven study stents and 5 polymer-coated (control) stents were implanted in porcine carotid arteries. Histomorphometric analysis was performed 8 weeks after stent implantation. After establishing the safety of the stent in the animal model, a single-center, non-randomized study in patients with de novo coronary artery lesions was performed. Forty-nine stents were implanted in 43 patients. The 6-month clinical follow-up was 91% (39/43) and angiographic follow-up was 67% (29/43). The primary safety endpoint was the occurrence of 30-day major adverse cardiovascular events (MACE) and the principal efficacy endpoint was the 6-month angiographic late loss and binary restenosis rate. RESULTS: In the porcine model, the study stent showed acceptably low injury, inflammation and fibrin scores. There was a quantitative reduction in neointimal hyperplasia which was not statistically different from the control stent. However, in the first-in-man evaluation, there was significant suppression of intimal growth as evidenced by an angiographic late loss of 0.28 +/- 0.45 mm at 6 months. The restenosis rate was 10.3% (3/297). There was no death, stent thrombosis or myocardial infarction at 30 days or at 6 months. The 6-month target lesion revascularization rate was 3.47 percent; (1/29). CONCLUSION: This preclinical and early clinical experience demonstrates the safety and efficacy of a novel biodegradable polymer-based rapamycin-eluting coronary stent.en_US
dc.description.affiliationDepartment of Cardiology, All India Institute of Medical Sciences, New Delhi, India. balrambhargava@yahoo.comen_US
dc.identifier.citationBhargava B, Karthikeyan G, Shankar PB, Seth S, Singh S, Pr U, Lal AV, Mohanty M. Preclinical and early clinical experience with a biodegradable polymer-based, rapamycin-eluting, Indian drug-eluting coronary stent: the BIO-RAPID study. Indian Heart Journal. 2008 May-Jun; 60(3): 228-32en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/3738
dc.language.isoengen_US
dc.source.urihttps://indianheartjournal.comen_US
dc.subject.meshAbsorbable Implantsen_US
dc.subject.meshAnimalsen_US
dc.subject.meshAspirin --therapeutic useen_US
dc.subject.meshCoronary Restenosis --drug therapyen_US
dc.subject.meshCoronary Thrombosis --etiologyen_US
dc.subject.meshDrug-Eluting Stents --adverse effectsen_US
dc.subject.meshHumansen_US
dc.subject.meshImmunosuppressive Agents --adverse effectsen_US
dc.subject.meshIndiaen_US
dc.subject.meshInflammation --prevention & controlen_US
dc.subject.meshModels, Animalen_US
dc.subject.meshPlatelet Aggregation Inhibitors --therapeutic useen_US
dc.subject.meshPolymersen_US
dc.subject.meshRisk Factorsen_US
dc.subject.meshSirolimus --adverse effectsen_US
dc.subject.meshTiclopidine --analogs & derivativesen_US
dc.subject.meshTime Factorsen_US
dc.titlePreclinical and early clinical experience with a biodegradable polymer-based, rapamycin-eluting, Indian drug-eluting coronary stent: the BIO-RAPID study.en_US
dc.typeIn Vitroen_US
dc.typeJournal Articleen_US
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