This article is more than 5 years old. Information may no longer be current.
BVS in below-the-knee arteries safe, effective at 1 year
Click Here to Manage Email Alerts
At 1-year follow-up, treatment of focal tibial and distal popliteal lesions with an everolimus-eluting bioresorbable vascular scaffold demonstrated safety, patency and freedom from target lesion revascularization, according to new data published in JACC: Cardiovascular Interventions.
“Encouraging patency and freedom from [TLR] results at 12 months of follow-up, together with advantages related to its complete dissolution, suggest that it has significant potential to become the favored class of therapy in this group of patients,” Ramon L. Varcoe, MBBS, MS, PhD, from the department of vascular surgery at Prince of Wales Hospital, Sydney, Australia, and colleagues wrote.
The researchers evaluated mid-term performance of the bioresorbable vascular scaffold (Absorb, Abbott Vascular in 33 patients (38 limbs) who were treated from September 2013 to November 2015 at Prince of Wales Hospital in Sydney, Australia. Of those, 18 were men and the mean age was 82 years. More than 68% of patients received treatment for critical limb ischemia and more than 31% for severe claudication.
In total, the researchers used 50 scaffolds to treat 43 lesions. The mean lesion length was 19.2 mm.
The primary endpoint of the study was freedom from binary restenosis. Secondary endpoints included all-cause mortality and CV mortality, amputation, bypass surgery, clinically driven TLR and other morbidity events within 30 days after BVS implantation.
The researchers reported achievement of technical success in all patients. There were no cases of amputation, death or target-limb bypass surgery within the first 30 days after implantation.
Five patients died during the mean follow-up period of 1 year.
The rate of primary patency, defined as freedom from clinically driven TLR and binary restenosis, was 96% at 1 year and 84.6% at 2 years, according to Kaplan-Meier analysis. The rate of freedom from clinically driven TLR was 96% at both follow-up periods, according to Kaplan-Meier analysis.
No major amputations were required during follow-up. Sixty-four percent of patients treated for tissue loss experienced complete wound healing.
“This experience with the Absorb BVS is the first in the published research and provides a useful insight into the longer-term performance of the scaffold below the knee,” Varcoe and colleagues wrote. “Although our previous study found encouraging safety and technical feasibility parameters at a mean follow-up of 6.1 months, this more mature experience provides further insight into this novel technology with larger numbers and longer follow-up.”
One limitation of the study was inclusion of only patients with single short lesions. According to the researchers, because of this limitation, “these results cannot be generalized to a broader cohort with a variety of long and complex lesions.” – by Katie Kalvaitis
Disclosure: Varcoe is a consultant and advisory board member for Abbott Vascular and a consultant for Boston Scientific, Medtronic and W.L. Gore. Two other researchers report consulting for Abbott Vascular. The other researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts