SS04 - Comparison of Long-term Outcomes between TADV versus Standard of Care Therapy for No-Option CLTI Patients

Objectives: 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 are not eligible for conventional revascularization techniques (“no-option”) and have a 1-year major amputation rate of up to 60%. Transcatheter arterialization of the deep veins (TADV) has shown encouraging early outcomes from several studies of no-option CLTI patients but there is a paucity of data regarding long term outcomes. Here we compare long-term outcomes in “no-option” CLTI patients who underwent TADV versus standard-of-care (SoC) treatment.

Methods: PROMISE I and II were single-arm, multicenter, prospective studies designed to evaluate the safety and efficacy of TADV in no-option CLTI patients, with assessments conducted by an independent committee. The CLariTI study, a concurrent natural history study, examined the standard of care (SoC) for no-option CLTI patients, who met the same enrollment criteria as those in the PROMISE studies. SoC was defined as the use of conventional treatment strategies, excluding TADV, at the discretion of the interventionalist. The study population included no-option chronic limb-threatening ischemia patients with inadequate popliteal, tibial, or pedal revascularization target, and Rutherford class 5 or 6. Outcomes from the TADV studies were pooled at the patient level for further analysis, with key endpoints including limb salvage (LS), amputation-free survival (AFS), and changes in Rutherford classification through 1 year, with additional 2-year outcomes available for the TADV cohort. Kaplan-Meier estimates were used for time-to-event analysis, and survival probabilities and p-values were derived from Fisher’s exact test or Cox proportional hazards models.

Results: A total of 137 TADV patients and 123 SoC patients were included. At 1 year, in patients treated with TADV vs SOC, LS rate was 71% (95% CI: 64–80%) vs 51% (95% CI: 42–62%) (p < 0.001) and AFS was 58% (95% CI: 51–67%) vs 34% (95% CI: 26–44%) (p < 0.001) (Figure). Of the surviving patients with limbs salvaged at 1 year, the proportion with a Rutherford classification ≤4 was 62% (95% CI: 49–73%) for TADV and 36% (95% CI: 17–59%) for SoC (p=0.049). The 2-year LS for TADV was 68% (95% CI: 60–77%).

Conclusions: TADV is associated with high rates of limb salvage and amputation-free survival through 1 year and these outcomes were sustained through 2 years.