Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry

J Endovasc Ther. 2020 Aug;27(4):616-622. doi: 10.1177/1526602820922524. Epub 2020 May 29.

Abstract

Purpose: To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (Drug Impregnated Bioresorbable Stent in Asian Population Extremity Arterial Revascularization) registry. Materials and Methods: A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Results: Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. Conclusion: The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

Keywords: amputation; bioresorbable vascular scaffold; chronic limb-threatening ischemia; diabetes; infrapopliteal arteries; patency; peripheral arterial disease; stent; target lesion revascularization; wound healing.

Publication types

  • Observational Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Amputation, Surgical
  • Asian People
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Chronic Disease
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Female
  • Humans
  • Ischemia / diagnostic imaging
  • Ischemia / ethnology
  • Ischemia / therapy*
  • Limb Salvage
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / ethnology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prosthesis Design
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Singapore
  • Time Factors
  • Treatment Outcome
  • Vascular Patency
  • Wound Healing

Substances

  • Cardiovascular Agents
  • Everolimus