A New Hope for Treatment of Chronic Limb-Threatening Ischemia

Patients with chronic limb-threatening ischemia (CLTI) have high rates of both limb loss and mortality, driven in part by low rates of sustained patency of both surgical and catheter-based revascularization for infrapopliteal peripheral artery disease (PAD). Although metallic drug-eluting coronary stents have shown benefit for these patients, there are concerns that the permanent scaffold may limit future treatment options. Resorbable vascular scaffolds have the potential to overcome the limitations of metallic drug-eluting stents by providing temporary scaffolding to treat elastic recoil and dissection after balloon angioplasty, allowing sustained local drug elution to limit neointimal proliferation and providing gradual resorption to facilitate future treatment.

In an industry-sponsored trial, investigators studied the efficacy and safety of a novel, investigational everolimus-eluting resorbable vascular scaffold device among 261 patients with CLTI and 1 or 2 stenotic or occlusive infrapopliteal lesions. Patients were randomized in a 2:1 ratio to undergo revascularization with the resorbable vascular scaffold or balloon angioplasty alone. At 1-year follow-up, the primary endpoint — freedom from above-ankle amputation of the target limb, target vessel occlusion, clinically driven repeat revascularization of the target lesion, and restenosis of the target lesion — was observed in a significantly greater proportion of the scaffold group compared with the angioplasty group (74% vs. 44%; absolute risk difference, 30%). Both treatments were safe; the rate of periprocedural death or major adverse limb events at 6 months was low.