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Early data exhibit favorable results for polymer-free dual DES
The Bicare polymer-free, dual drug-eluting stent demonstrated feasibility and safety by the absence of early adverse events and favorable angiographic suppression of neointimal hyperplasia in preliminary results reported from a first-in-human trial.
Researchers in Beijing conducted a first-in-human feasibility study in patients with a single de novo native coronary stenosis less than 30 mm in length and with reference vessel diameter from 2.5 mm to 4 mm. Thirty-two patients (mean age, 55.7 years; 62.5% male; 18.8% had diabetes) underwent revascularization with the Bicare stent (Lepu Medical). The Bicare stent is a polymer-free, nanotechnology-based stent eluting sirolimus (Rapamune, Pfizer) and probucol (voluntarily removed from the market in the United States). Target lesion failure was the primary endpoint assessed at 30 days.
All of the patients were treated with a single stent with 100% procedural success. By 4 months, there was no occurrence of death, MI or stent thrombosis. Angiographic in-stent late loss was 0.14 ± 0.19 mm, and the in-stent binary restenosis rate was 3.1%.
At 18 months, target lesion failure occurred in three patients related to repeat revascularization. No adverse safety events were noted.
According to the researchers, imaging with optical coherence tomography was suggestive of early healing with extensive stent strut coverage and very low malapposition.
“These findings further inform comparison with alternative biopermanent polymer DES in larger studies to demonstrate clinical effectiveness and long-term safety,” the researchers concluded.
Disclosure: Yu reports no relevant financial disclosures.