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FANTOM II: BVS effective in noncomplex CAD treatment at 6 months
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A novel coronary bioresorbable vascular scaffold showed favorable outcomes at 6 months, according to results published in JACC: Cardiovascular Intervention.
BVS can potentially improve long-term event-free survival in patients with CAD, but many first- generation BVS have important limitations vs. metallic drug-eluting stents, according to the researchers. They wrote that they developed a radiopaque sirolimus-eluting BVS (Fantom, Reva Medical) to address limitations including ease of placement, strut size and expansion capacity.
Alexandre Abizaid, MD, PhD, from the Instituto Dante Pazzanese de Cardiologia and Hospital Albert Einstein in São Paulo, and colleagues evaluated 117 patients from cohort A of the FANTOM II study with single de novo native coronary artery lesions up to 20 mm in length and reference vessel diameter 2.5 mm to 3.5 mm.
The study had a primary angiographic endpoint of mean late lumen loss at 6 months measured by quantitative coronary angiography.
Procedural outcomes were short-term technical success, short-term procedural success and clinical procedural success.
The primary clinical endpoint was MACE, a composite of cardiac death, MI or clinically driven target lesion revascularization (TLR), at 6 months.
The BVS achieved short-term technical success in 96.6% of patients, short-term procedural success in 99.1% and clinical procedural success in 99.1% in the 6-month follow-up.
At 6 months, there was an in-stent late lumen loss of 0.25 ± 0.4 mm (n = 100).
Binary restenosis was present in two patients (2%).
Three patients had an occurrence of MACE within 6 months (2.6%), including two MIs and two TLRs. There were no deaths.
Additionally, there was one occurrence of scaffold thrombosis (0.9%).
“The cohort A results from the FANTOM II study have demonstrated that the Fantom scaffold is capable of treating noncomplex de novo native coronary artery lesions with [late lumen loss] and MACE at 6 months,” Abizaid and colleagues wrote.
According to an accompanying editorial from Stephen G. Ellis, MD, of the department of cardiovascular medicine at the Cleveland Clinic, although the study reports encouraging results, the question is one of safety over time.
“In short, these results should provide impetus for a larger and more definitive study,” Ellis said. “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.” – by Dave Quaile
Disclosures: Abizaid reports he is a consultant for Reva Medical. Ellis reports he is a consultant for Abbott Vascular, Boston Scientific and Medtronic, and received research funding from Abbott Vascular and Boston Scientific.
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