Preclinical and early clinical experience with a biodegradable polymer-based, rapamycin-eluting, Indian drug-eluting coronary stent: the BIO-RAPID study.
Indian Heart J
;
2008 May-Jun; 60(3): 228-32
Article
in English
| IMSEAR
| ID: sea-3738
ABSTRACT
OBJECTIVE:
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.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Polymers
/
Time Factors
/
Coronary Thrombosis
/
Ticlopidine
/
Humans
/
Platelet Aggregation Inhibitors
/
Aspirin
/
Risk Factors
/
Sirolimus
/
Absorbable Implants
Type of study:
Controlled clinical trial
/
Etiology study
/
Prognostic study
/
Risk factors
Country/Region as subject:
Asia
Language:
English
Journal:
Indian heart j
Year:
2008
Type:
Article
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