Ramon Varcoe today announced positive five-year results of the ABSORB BTK trial at the 2019 Vascular Interventional Advances conference (VIVA) in Las Vegas, USA (4–7 November). Primary patency of the Absorb bioresorbable vascular scaffold (BVS) from Abbott achieved a 72.9% primary patency rate and 90.7% freedom from clinically-driven target lesion revascularisation (CD-TLR).
The ABSORB BTK trial is a prospective, nonrandomised, single-centre study designed to evaluate the novel bioresorbable, drug-eluting Absorb scaffold used for the treatment of peripheral artery disease below the knee. There were 71 scaffolds utilised in 55 limbs of 48 patients who fulfilled the inclusion criteria (72.7% with critical limb ischemia). Most scaffolds were implanted in arteries of the proximal half of the calf, and the mean lesion length was 20.1 mm (range, 5–50 mm). There was 100% procedural and technical success.
Over the 5-year follow-up period, 38% of patients had died, all from causes unrelated to the procedure or study device; 95% of patients had sustained clinical improvement. Complete wound healing occurred in 90% of those treated for tissue loss, with no major amputations and a limb salvage rate of 100%. No late or very late scaffold thromboses were observed.
This novel bioresorbable, drug-eluting scaffold has several inherent advantages over stents, related to its biological resorption. These results represent best-in-class durability for a stent-like device in this challenging vascular territory.