PROMISE III: 6-Month Clinical and Quality of Life Outcomes in CLTI Patients Treated with Transcatheter Arterialization of the Deep Veins
Presenter
Mehdi H. Shishehbor, D.O., MPH, PhD, FSCAI, University Hospitals Harrington Heart & Vascular Institute, Cleveland, OH
Mehdi H. Shishehbor, D.O., MPH, PhD, FSCAI, University Hospitals Harrington Heart & Vascular Institute, Cleveland, OH and Daniel G. Clair, MD, Vanderbilt University Medical Center, Nashville, TN
Keywords: Critical Limb Ischemia/Chronic Limb-threatening Ischemia (CLT/CLTI) and Peripheral Artery Disease (PAD)
Background
Approximately 10% of patients with chronic limb-threatening ischemia (CLTI) have lacked viable options for conventional endovascular or surgical revascularization treatment options and face poor outcomes, including high major amputation rates. Transcatheter arterialization of the deep veins (TADV) with the purpose-built LimFlow System has demonstrated positive outcomes in no-option CLTI patients. We report the 6-month clinical and quality of life (QoL) outcomes from the PROMISE III trial.
Methods
The PROMISE III trial is a prospective, multicenter, single-arm study. All enrolled patients had Rutherford class 5/6 disease and were independently confirmed as no-option. The primary endpoint was 6-month amputation-free survival (AFS).
Other endpoints included limb salvage, survival, wound healing, pain, and QoL through 6 months.
Results
A total of 100 patients (103 limbs) underwent TADV. All included limbs had non-healing ulcers or gangrene with 74.8% Rutherford class 5 and 25.2% class 6. At 6 months, the primary endpoint of AFS was 80.7%. Limb salvage was 86.5% and survival was 93.8%. Approximately 80% of wounds were completely healed or healing. The median pain score was 2.0 at 6 months, significantly decreased from 6.0 at baseline (P<0.0001). Significant improvements were seen in QoL metrics at 6 months versus baseline (concerns about poor circulation, ability to participate in social activities, ability to fall or stay asleep, and feeling burdened by the wound; Figure).
Conclusions
Treatment with the LimFlow System was associated with clinical and QoL improvements in no-option CLTI patients.
