Acceptable six-month safety and patency with Absorb bioresorbable vascular scaffold below the knee

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Ramon Varcoe, Prince of Wales Hospital, Sydney, New South Wales, Australia and colleagues published the clinical and imaging outcomes obtained when they investigated a new bioresorbable vascular scaffold (Absorb, Abbott Vascular) for the treatment of focal tibial and distal popliteal lesions in the Journal of Endovascular Therapy (JEVT) in April 2015. They subsequently presented their first experience with the everolimus-eluting, bioresorbable scaffold for use in peripheral arteries below the knee at EUROPCR in Paris, France. The study was also published in EuroIntervention.

Varcoe told Interventional News: “As we all move away from permanent metallic implants after angioplasty, the world is searching for a non-permanent method of scaffolding the blood vessel and delivering antiproliferative drug to the site of vascular injury. This device offers the best of both worlds, satisfying the needs of both the ‘leave-nothing-behind’ and ‘need-for-scaffolding’ philosophies. Moreover, this early research points toward equivalence with drug-eluting stents and raises the potential for return of blood vessel contractility, once scaffold resorption has taken place.”

At EuroPCR, Varcoe told delegates that the restenosis rates after standard balloon-angioplasty for occlusive tibial arterial disease are reduced with the use of drug-eluting stents, but that the ongoing presence of a permanent metal scaffold could have deleterious effects on the local vessel.

The investigators reported in JEVT that midterm follow-up for a small pilot sample of 15 limbs in 14 patients demonstrates acceptable safety and patency results, together with freedom from all major adverse limb events, with the device below the knee. Seven (47%) of the limbs were treated for critical limb ischaemia and eight (53%) for severe claudication.

Varcoe and colleagues performed tibial and distal popliteal angioplasty in nine men, whose median age 82 years. The 18 lesions (mean length 22.2±14mm) were implanted with 22 everolimus-eluting bioresorbable scaffolds. They then evaluated the safety, midterm restenosis rate, and clinical improvement at one, three, six and 12 months clinically and using ultrasound.

The researchers found that immediate technical success was 100%, although a single limb suffered two scaffold thromboses on the first day. This was salvaged with repeat endovascular intervention, reported the authors.

They further wrote that all patients were available for surveillance examinations during a follow-up of 6.1±3.9 months and that no patients died. Of the 15 limbs in the analysis, 12 improved clinically and these included four of the seven critical limb ischaemia patients. There was no amputation, bypass surgery, or evidence of binary restenosis on follow-up sonographic examination.

 

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