Commentary: Bioresorbable Drug-Eluting Scaffold for Peripheral Artery Disease: The Best of Two Worlds or Unnecessary?

Abstract

Bioresorbable vascular scaffolds (BVS) were developed in the 1990s and have been in testing ever since. 1 Tamai et al 2 reported the first human use in coronary arteries in 2000. The first use in peripheral artery disease (PAD) was reported in 2009 3 using a biodegradable magnesium stent; however, poly-l-lactic acid (PLLA) has been the backbone of most endovascular scaffolds.In the August 2020 issue of the JEVT, Kum et al 4 report a single-center, retrospective study focusing on 41 patients from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) Registry with chronic limb-threatening ischemia (CLTI) due to de novo infrapopliteal lesions. All patients were in the advanced Rutherford categories 5 and 6, 90% were diabetic, and a quarter had severe vessel wall calcification, making it a challenging group of patients. The study device was the balloon-expandable Absorb BVS (Abbott Vascular, Santa Clara, CA, USA) developed for the coronary arteries. Its PLLA scaffold is coated with a polymer [poly(d-l-lactide)] that elutes the antiproliferative drug everolimus. The device was implanted without complications in 53 lesions. The median radiological follow-up by duplex ultrasound examination was 23 months (maximum 4 years). Angiography was performed only on suspicion of a clinically relevant restenosis. Clinical follow-up was performed at least monthly until complete wound healing occurred.The 86% 12-month per-scaffold patency rate was somewhat lower compared with the 92% to 96% patency rates in previous BVS studies, [5][6][7] but this study did include a group of patients with advanced CLTI. Freedom from imagingdefined occlusion and clinically-driven target lesion revascularization (TLR) estimates at 12 months were both 93%. Freedom from major amputation was 98% after 1 year. Wound healing was achieved in 24 of the 39 Rutherford category 5/6 patients (62%) at 6 months and in 31 patients (79%) at 12 months, which compares well with other BVS studies (64% at 1 year). 6 Median time to wound healing was 4 months.

Bioresorbable Scaffolds for Below-the-Knee Arterial Disease: A Literature Review of New Developments

“…These findings have raised concerns about the use of DCBs in below-the-knee (BTK) lesions, particularly due to the significant narrowing of arteries after the lumen has been expanded, which poses a challenge to the resistance of the DCBs. Though DCBs have effectively replaced standard balloon angioplasty, post-dilation dissection, elastic recoil, or incomplete lumen expansion due to calcification may still occur [ 33 ]. Therefore, concern exists over the failure of balloons to provide calcification lumen with enough short-term mechanical support.…”