Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data

Eline Huizing*, Steven Kum, Jetty Ipema, Ramon L. Varcoe, Atman P. Shah, Jean-Paul P. M. de Vries, Cagdas Unlu

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Previous studies on everolimus-eluting bioresorbable vascular scaffolds (BVS) have shown promising 1-year primary patency rates in infrapopliteal arteries. Literature from large cohorts on long-term outcomes with the infrapopliteal Absorb BVS (Abbott Vascular) is lacking. The aim of this study is to pool published and unpublished data to provide a more precise estimate of the 24-month outcomes of Absorb BVS for the treatment of infrapopliteal disease. For the pooled analysis, updated original and newly collected data from three cohorts on treatment with the Absorb BVS for de novo infrapopliteal lesions were combined. The primary endpoint was freedom from restenosis. Secondary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR), major amputation and survival. The pooled analysis included a total of 121 patients with 161 lesions, treated with 189 Absorb BVS in 126 limbs. The mean age of the patients was 73 years, 57% had diabetes mellitus, and 75% were classified as Rutherford-Becker class 5 or 6. Of the 161 lesions, 101 (63%) were calcified and 36 (22%) were occlusions. Successful deployment was achieved with all scaffolds. Freedom from restenosis was 91.7% and 86.6% at 12 and 24 months, respectively, and freedom from CD-TLR was 97.2% and 96.6%. Major amputation occurred in 1.6% of the limbs. Overall survival was 85% at 24 months. In conclusion, this pooled analysis represents the largest reported analysis of mid-term results of the Absorb BVS for the management of chronic limb-threatening ischemia. At 24 months, the Absorb BVS was safe with promising clinical outcomes for the treatment of infrapopliteal disease.

Original languageEnglish
Pages (from-to)195-199
Number of pages5
JournalVascular medicine
Volume26
Issue number2
Early online date28-Jan-2021
DOIs
Publication statusPublished - Apr-2021

Keywords

  • below-the-knee disease
  • bioresorbable vascular scaffold
  • chronic limb-threatening ischemia (CLTI)
  • infrapopliteal artery
  • patency
  • peripheral artery disease (PAD)

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