1-Year Outcomes of Transcatheter Arterialization of Deep Veins: PROMISE II and Pooled PROMISE Studies.

BACKGROUND

Up to 20% of patients with chronic limb-threatening ischemia (CLTI) are ineligible or have exhausted conventional options of lower extremity revascularization ("no-option") and face high rates of major amputation and death.

OBJECTIVES

The authors present the 1-year outcomes of the pivotal PROMISE II trial and a patient-level pooled analysis combined with PROMISE I and PROMISE UK, comprising the largest cohort of prospectively studied patients following transcatheter arterialization of the deep veins (TADV) with the LimFlow System.

METHODS

The single-arm, multicenter prospective PROMISE II study included patients with Rutherford class 5/6 CLTI and independently assessed no-option status. Amputation-free survival (AFS), limb salvage, and survival were assessed through 1 year. Clinical outcomes included Rutherford classification, pain scores, and wound healing.

RESULTS

In PROMISE II, 105 enrolled patients had a median age of 70 years, 68.6% (72/105) were men, and the prevalence of comorbidities was high, including 77.1% (81/105) with diabetes. At 1 year, AFS was 54.2% (95% CI: 45.2-65.1%), limb salvage was 68.7% (95% CI: 59.8-78.9%), and survival was 79.0% (95% CI: 70.2-88.8%). The pooled analysis included 137 patients from PROMISE I, II, and UK and showed 1-year AFS of 66.1% (95% CI: 58.4-74.9%), limb salvage of 74.4% (95% CI: 67.1-82.5%), and survival of 88.9% (95% CI: 82.9-95.2%). Clinical symptoms and wound status showed improvement through 1 year.

CONCLUSIONS

1-year outcomes following TADV with the LimFlow System demonstrated durable AFS and limb salvage rates, and improvement in clinical symptoms in no-option CLTI patients who often face major amputation or palliative care.