As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices.
In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary bioresorbable vascular scaffold succeeded after six months. The device was designed to address challenges like strut size and expansion capacity, the researchers wrote.
The sirolimus-eluting device was studied with 117 patients with single de novo native coronary artery lesions. The primary angiographic endpoint was mean late lumen loss at six months. The study’s primary clinical endpoint was major adverse cardiac events at six months, including cardiac death, myocardial infarction or clinically driven target lesion revascularization.
Short-term technical success, short-term procedural success and clinical procedural success was met in 96.6%, 99.1% and 99.1% of participants, the authors reported. The mean in-stent late lumen loss was 0.25 millimeters (+/- 0.40) after six months. The team reported observing binary restenosis in two patients.
Major adverse cardiac events happened in three patients within the six-month study period, including two myocardial infarctions and two target lesion revascularizations.
Scaffold thrombosis was seen in one patient, the team added.
“The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease,” the researchers wrote.
In an accompanying editorial, Dr. Stephen Ellis from the Cleveland Clinic cautioned that the real question surrounding the BVS is long-term safety, pointing towards Abbott‘s (NYSE:ABT) 1-year trial of its Absorb BVS.
“In short, these results should provide impetus for a larger and more definitive study,” Ellis wrote. “In the meanwhile, the 1-year ABSORB IV study results will likely either provide a death knell or new life for that device, and perhaps the long-term findings from earlier ABSORB trials will tell us if the long-term value proposition of [BVS] remains worth pursuing.”