LimFlow System’s 6-Month Outcomes Presented From the PROMISE II US Pivotal Trial

November 4, 2022—Six-month results from the PROMISE II United States pivotal trial of transcatheter arterialization of the deep veins with the LimFlow system (LimFlow, Inc.) showed that outcomes were better than expected and reproducible, and that the study’s “no-option” patient population can significantly benefit from this procedure. The outcomes were similar to what has previously been published with this technique.

The trial was a multisite, single-arm, prospective study designed with a composite primary endpoint of amputation-free survival (AFS). The study included patients with chronic limb-threatening ischemia who were felt to have no option for arterial revascularization into the foot. The lack of option was confirmed by an independent review committee of vascular surgeons.

Daniel Clair, MD presented the findings in the second of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, the trial enrolled 105 patients with a mean age of 69 years, 69% of whom were male; 75% of patients were diabetic; and 18% had end-stage renal disease and were on dialysis.

The investigators compared the primary endpoint to a performance goal of 54% AFS based on an extensive literature search for outcomes in this complex group of patients.

Dr. Clair reported that technical success for the procedure in the entire group was 99%, with the majority of procedures being performed to the posterior tibial vessels (75%) and the others connecting the peroneal or tibioperoneal trunk vessels.

AFS for the entire group at 6 months was 66%, which was well above the previously identified performance goal, and limb salvage was 76%. More than 75% of wounds were either healed or healing at 6 months, and Rutherford class and pain scores improved over 6 months.

The investigators found that there was a large difference in outcomes for dialysis versus nondialysis patients, which was driven primarily by the increased mortality in the dialysis group. AFS in the nondialysis group was 75%, while AFS in the dialysis group was 37%.

Overall survival in nondialysis patients at 6 months was 95%, while survival in the dialysis population was only 63%, stated the VIVA Foundation press release.