‘Excellent’ results but only in unusually focal lesions.

Implanting the Absorb bioresorbable vascular scaffold in focal below-the-knee lesions was safe and effective in the long run, investigators suggested.

Technical success was achieved in all cases. And the majority of tibial and distal popliteal lesions treated with the everolimus-eluting disappearing scaffold improved at 1 year (79%), Ramon L. Varcoe, MBBS, MS, PhD, of Australia’s Prince of Wales Private Hospital, and colleagues reported online in JACC: Cardiovascular Interventions.

On Kaplan-Meier analysis, primary patency was observed in 96% and 84.6% of lesions at 12 and 24 months, respectively; freedom from clinically-driven target lesion revascularization was 96% at both time points. There was a 6% rate of binary restenosis over follow-up, the authors found.
They concluded that the numbers “demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.”
“It has significant potential to become the favored class of therapy in this group of patients,” they wrote.
“We congratulate the authors for reporting the long-term clinical outcome of their experience with coronary scaffolds in below-the-knee interventions; their restenosis rate, together with the appropriate duration of clinical follow-up, actually represent a proof of concept of the great potential of vascular scaffolds in peripheral interventions,” Antonio Micari, MD, PhD, and Roberto Nerla, MD, both of Maria Cecilia Hospital in Italy, wrote in an accompanying editorial.
Varcoe’s study included 33 patients with critical limb ischemia (68.4%) or severe claudication (31.6%). Operators treated 43 lesions with 50 Absorb scaffolds in total; five patients died over the follow-up period, leaving 38 treated limbs available for analysis.

Importantly, the investigators selected highly focal lesions for their study. The average lesion clot was just 19.2 mm long.
“This makes it impossible to derive reliable considerations about the usefulness and the real impact (in clinical practice) of these devices on below-the-knee procedures, given that infrapopliteal disease is known to be more diffuse and complex in a real-world setting,” according to Micari and Nerla, who suggested that future studies include a broader population.