November 7, 2020
Treatment of Chronic Limb-Threatening Ischemia With Abbott's Absorb BVS Evaluated at 2 Years
November 7, 2020—A multicenter pooled analysis investigated the midterm outcomes of an infrapopliteal drug-eluting bioresorbable vascular scaffold (BVS) in the treatment of chronic limb-threatening ischemia (CLTI).
The study included consecutive patients with de novo infrapopliteal lesions who were treated with Absorb BVS (Abbott Vascular) at three centers in Singapore, Chicago, Illinois, and Sydney, Australia between August 2012 and May 2017.
Steven Kum, MD, presented the results of the analysis in a late-breaking clinical trial session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6–8, 2020.
As summarized in the VIVA announcement, a total of 121 patients with 161 lesions were treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years; 57% of patients had diabetes; and 75% of patients had tissue loss.
Of the 161 lesions treated, 63% were calcified and 22% were occlusions. Median lesion length was 21 mm (4–88 mm). Successful deployment was achieved with all scaffolds.
Restenosis was defined on color-flow doppler examination with a sensitive peak systolic velocity (PSV) ratio > 2.0 or PSV > 2 m/s (equivalent to > 50% stenosis).
Dr. Kum reported that there was no mortality in 30 days. Primary patency was 90.3% and 86.6%, and freedom from clinically driven target lesion revascularization (CD-TLR) was 97.2% and 96.6% at 12 and 24 months respectively. Major amputation occurred in 1.6% of the limbs. Overall survival was 85.8% at 24 months.
The study concluded that Absorb BVS can be used for the treatment of CLTI patients in infrapopliteal arteries with no safety concerns and favorable patency, rates of reinterventions and amputations at a midterm follow-up of 24 months. The current LIFE-BTK randomized multicenter trial with the Esprit BTK drug-eluting resorbable scaffold (Abbott Vascular) will help further assess the significance of our findings, noted the investigators in the VIVA announcement.
"This is the first multicenter, 24-month analysis of a drug-eluting scaffold in the BTK arteries," summarized Dr. Kum in comments to Endovascular Today. "This data demonstrates the potential of this unique therapy that has the ability to deliver drug with a scaffold, providing temporary support that resorbs over time. This concept is being further studied in the upcoming pivotal LIFE-BTK trial of the new drug-eluting resorbable scaffold (DRS)."