Twelve-month clinical and imaging outcomes from among patients treated with the everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular) in tibial arteries showed high rates of freedom from binary restenosis and target lesion revascularization.
“This current experience with the Absorb BVS [bioresorbable vascular scaffold] in tibial arteries has once again demonstrated that it may be implanted safely and with high rates of technical success,” wrote Ramon L. Varcoe, MD and colleagues in their paper published in JACC: Cardiovascular Interventions.
“Encouraging patency and freedom from target lesion revascularization results at 12 months of follow-up, together with advantages related to its complete dissolution, suggest that it has significant potential to become the favored class of therapy in this group of patients.”
From September 2013 and November 2015, Dr Varcoe of Prince of Wales Hospital in Sydney, Australia and colleagues evaluated the bioresorbable vascular scaffold in patients with chronic lower limb ischemia (Rutherford-Becker classes 3-6) from de novo stenotic lesions. Lesions were >60% of the tibila or distal popliteal arterias with length ≤5 cm and vessel diameters of 2.5-4.0 mm in which significant inflow stenoses had been successfully treated.
To be included in the study, patients also had to have ≥1 single-vessel outflow to the foot, including that distal to the target lesion.
Researchers implanted stents in 38 limbs (33 patients; mean age: 81.8 ± 7.9 years).
At 12 months, 28 patients were alive and all others were available for predetermined clinical and ultrasound follow-up. All patients had technical success and no patient experienced any amputation, death, or target limb bypass surgery within 30 days of implantation.
Researchers estimated freedom from clinically driven target lesion revascularization to be 96% at 6, 12, and 24 months. Primary patency rate was 96% at 6 and 12 months, and 84.6% at 24 months. All binary restenoses were in the 50% to 75% range. One binary restenosis resulted in clinical deterioration requiring revascularization 26 months after scaffold implantation.
Based on wound status and patient symptoms, researchers noted 79% of limbs improved clinically, 18% were unchanged, and 2.6% were worse.
Nearly three-quarters of patients73%) with more serious ischemia (Rutherford-Becker categories 4-6) saw improvement. Two-thirds (64%) of patients with ischemic tissue loss had completely healed during the follow-up period.
Disclosures: Dr Varcoe is a consultant and advisory board member for Abbott Vascular as well as a consultant for Medtronic, Boston Scientific, and WL Gore. Drs Thomas and Lennox are also consultants for Abbott Vascular.
Varcoe RL, Schouten O, Thomas SD, Lennox AL. Experience with the Absorb everolimus-eluting bioresorbable vascular scaffold in arteries below the knee:12-month clinical and imaging outcomes. JACC Cardiovasc Interv. 2016;9(16):1721-1728. doi:10.1016/j.jcin.2016.06.005.