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Five-year Irish trial of CLI patients with TASC II type C/D lesions undergoing subintimal angioplasty or bypass

Sherif Sultan1, Niamh Hynes

  • 1Western Vascular Institute, Department of Vascular & Endovascular Surgery, University College Hospital, and The Galway Clinic, Galway, Ireland. mrsherif.sultan@gmail.com

Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists
|August 1, 2009
PubMed

Insights

Subintimal angioplasty (SIA) offers improved outcomes for critical limb ischemia (CLI) patients compared to bypass grafting (BG). SIA demonstrated reduced major adverse events and costs, enhancing quality-adjusted life years.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Health Economics

Background:

  • Critical limb ischemia (CLI) significantly impacts patient quality of life and limb salvage rates.
  • TASC II type C/D lesions in lower limb arteries present complex challenges for revascularization.
  • Subintimal angioplasty (SIA) and bypass grafting (BG) are established treatment options for CLI.

Purpose of the Study:

  • To compare the 5-year effectiveness of SIA versus BG for treating TASC II type C/D lower limb arterial lesions in CLI patients.
  • To evaluate secondary endpoints including major adverse events (MAE), restenosis, target lesion revascularization (TLR), and quality-adjusted life years (QALY).
  • To conduct a cost analysis comparing SIA and BG treatments.

Main Methods:

  • A 5-year observational parallel group study involving 190 patients undergoing SIA and 119 patients undergoing BG.
  • Patients presented with Rutherford classification 4-6 ischemia (rest pain and/or tissue loss).
  • Primary endpoints included survival free from amputation and sustained clinical improvement; secondary endpoints covered MAE, restenosis, TLR, Q-TWiST, and cost-effectiveness.

Main Results:

  • At 5 years, sustained clinical improvement was higher in the SIA group (82.8%) vs. BG group (68.2%).
  • All-cause survival and amputation-free survival were similar between groups.
  • SIA significantly reduced MAE (p<0.002) and hospital stay (p<0.0001), with improved Q-TWiST (p<0.001) and lower cost-per-QALY (p<0.002).

Conclusions:

  • SIA demonstrated a 20% enhanced 5-year freedom from MAE compared to BG.
  • SIA offers substantial cost reductions and improved quality-adjusted life years (Q-TWiST).
  • SIA represents a minimally invasive approach that enhances amputation-free and symptom-free survival, potentially shifting CLI management paradigms.
Abstract

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