Article Synopsis
- Up to 20% of patients with chronic limb-threatening ischemia are ineligible for traditional revascularization methods and have high amputation and mortality rates.
- The PROMISE II trial, along with data from PROMISE I and PROMISE UK, studied the 1-year outcomes of transcatheter arterialization of the deep veins using the LimFlow System in a large cohort of patients.
- Results showed that after one year, the trial reported significant rates of amputation-free survival (54.2%), limb salvage (68.7%), and overall survival (79.0%), with overall clinical improvement in symptoms and wound healing across the pooled data.
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Article Abstract
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.
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| http://dx.doi.org/10.1016/j.jcin.2025.05.004 | DOI Listing |
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