November 7, 2020

2-Year Outcomes of a Multi-Centre Study on Infrapopliteal Bioresorbable Vascular Scaffold

Presented by Steven Kum, MD

Chronic Limb Threatening Ischemia (CLTI) continues to plague many patients worldwide and is associated with complex comorbidities, poor vessel patency, and major lower extremity amputations. Plain balloon angioplasty is still the mainstay of treatment although metallic drug-eluting stents have shown promise. This multi-center pooled analysis investigates the mid-term outcomes of a drug-eluting Bioresorbable Vascular Scaffold (BVS) in the treatment of CLTI and represents the largest series analyzed in the infra-popliteal arteries.

Consecutive patients with de novo infra-popliteal lesions were treated with Absorb BVS (Abbott Vascular) at three centers (in Singapore, Chicago, and Sydney) between August 2012 and May 2017. 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).

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% 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.

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.

This study shows that Absorb BVS can be used for the treatment of CLTI patients in infra-popliteal arteries with no safety concerns and favorable patency, rates of re-interventions and amputations at a mid-term follow up of 24 months. The current LIFE-BTK randomized multi-center trial with the novel Esprit BTK drug-eluting resorbable scaffold (DRS) will help further assess the significance of our findings.

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