Powell RJ, Clair D, Shishehbor M, Pietzsch JB, Schneider PA, Dua A, Zayed H. One-Year Clinical Outcomes and Long-term Cost-Effectiveness using Propensity-Score Matching of Pooled PROMISE Studies and the CLariTI Registry for No-Option CLTI Patients. TCT 2024 Washington DC, Oct. 29, 2024.

Background: Patients with chronic limb-threatening ischemia (CLTI) can present with non-healing ischemic ulcerations and gangrene. It has been reported that up to 20% of these patients would not eligible for conventional revascularization techniques (“no-option”) and have a one-year major amputation rate up to 60%. Transcatheter arterialization of the deep veins (TADV) has shown encouraging 1-year outcomes from several studies of no-option CLTI patients. Propensity matching was used to compare outcomes and cost-effectiveness in a pooled cohort of patients who underwent TADV with the LimFlow System (Inari Medical, Irvine, CA) in the PROMISE I, II, and UK studies with patients from the CLariTI study, a concurrent natural history registry of untreated no-option CLTI patients.

Methods: PROMISE I, II, and UK were single-arm, multicenter, prospective studies evaluating the safety and effectiveness of TADV for no-option CLTI patients, as assessed by an independent committee. Eligibility criteria for all 3 TADV studies and CLariTI included Rutherford class 5/6. Propensity score matching was performed on 165 TADV patients and 180 CLariTI patients using 5 baseline variables: age, sex, diabetes, dialysis, and Rutherford classification. Outcomes assessed through 1 year included limb salvage, amputation-free survival, and overall survival using Cox regression models. Lifetime cost-effectiveness, measured as the incremental cost-effectiveness ratio (ICER) in $ per quality-adjusted life year (QALY) gained, was estimated by Markov model with contemporary U.S. cost data including the new technology add-on payment granted for TADV.

Results: A total of 278 patients (139 matched pairs) from 38 global sites were identified through propensity-score matching (Panel A). At 1 year, in patients treated with TADV vs matched patients from CLariTI, amputation-free survival was 60.9% vs 39.5% (p=0.0004, Panel B), limb salvage rate was 73.7% vs 56.7% (p=0.0046), and survival rate was 82.6% vs 69.7% (p=0.0353). Over a patient’s lifetime, TADV added 0.77 QALYs (1.88 vs 1.11) with a resulting ICER of $42,698 per QALY gained (Panel C). The total projected survival gain with TADV was 1.51 life years.

Conclusion: TADV was associated with significantly beder limb salvage, survival, and amputation-free survival at 1 year compared to untreated no-option CLTI patients, confirming the global generalizability and consistency of the procedure. These outcome improvements with TADV can be achieved at an incremental cost that renders it a cost-effective, high value intervention in a model-based analysis.