Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia

Ann Vasc Surg. 2024 Feb:99:50-57. doi: 10.1016/j.avsg.2023.08.010. Epub 2023 Oct 18.

Abstract

Background: Patients with no-option chronic limb-threatening ischemia (no-option CLTI) have limited therapeutic options. The PROMISE II study evaluated, transcatheter arterialization of deep veins (TADV) as a treatment option for no-option CLTI. In the current study patients from PROMISE II were compared to patients from a registry of untreated no-option CLTI patients (CLariTI: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia).

Methods: We used propensity matching to compare patients from the PROMISE II prospective study of the TADV intervention with simultaneously enrolled CLTI patients that were note candidates for PROMISE II but were enrolled in to CLariTI natural history registry. Untreated no-option CLTI (CLariTI) patients could either be no-option or patients who did not meet PROMISE II entry criteria. Risk difference between groups was calculated using common risk difference and P values were provided by propensity-score stratified Mantel-Haenszel test. The primary endpoint was amputation-free survival (AFS).

Results: Diabetes was present in over 75% of patients. All patients had tissue loss and 35-46% had extensive tissue loss (Rutherford 6). The unadjusted AFS at 6 months, was 66.1% by Kaplan-Meier estimate for PROMISE II patients (n = 105) compared to 39.1% in the no-option cohort of CLariTI (n = 121) and 44.0% in the full cohort (no-option and patients not meeting entry criteria combine, n = 180). The treatment group who underwent TADV for no-option CLTI had an absolute difference of 29% improved (P < 0.0001) propensity-adjusted risk difference in AFS and a relative event rate reduction of 45% compared to the no-option control patients.

Conclusions: Transcatheter arterialization of deep veins (TADV) resulted in improved 6 month AFS in no-option CLTI patients and appears to be a promising therapy in patients with no-option CLTI.

MeSH terms

  • Chronic Disease
  • Chronic Limb-Threatening Ischemia
  • Endovascular Procedures* / adverse effects
  • Humans
  • Ischemia / diagnostic imaging
  • Ischemia / surgery
  • Limb Salvage / methods
  • Peripheral Arterial Disease* / diagnostic imaging
  • Peripheral Arterial Disease* / therapy
  • Prospective Studies
  • Retrospective Studies
  • Risk Factors
  • Standard of Care
  • Treatment Outcome