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


CONCLUSIONS
This preclinical and early clinical experience demonstrates the safety and efficacy of a novel biodegradable polymer-based rapamycin-eluting coronary stent.
Bhargava
Balram
B
Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India. balrambhargava@yahoo.com
Karthikeyan
Ganesan
G
Shankar
Pr Bhima
PB
Seth
Sandeep
S
Singh
Sandeep
S
Pr
Umashankar
U
Lal
Arthur Vijayan
AV
Mohanty
Mira
M
D020341:Absorbable Implants; D000818:Animals; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000628:therapy; D003328:Coronary Thrombosis / Q000209:etiology* / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D066298:In Vitro Techniques; D007194:India; D007249:Inflammation / Q000517:prevention & control; D023421:Models, Animal; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; D012307:Risk Factors; D020123:Sirolimus / Q000009:adverse effects* / Q000627:therapeutic use; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors
D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus