PROMISE II: Deep venous arterialization boosts amputation-free survival in severe CLI
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In patients with severe critical limb ischemia treated with a transcatheter deep venous arterialization system, about two-thirds achieved amputation-free survival at 6 months, according to new data from the PROMISE II trial.
“The PROMISE II trial was a single-arm trial based on a highly researched group of reports regarding outcomes for these patients,” Daniel G. Clair, MD, chair of and professor in the department of vascular surgery at Vanderbilt University Medical Center, said during a presentation at VIVA 22. “This was a landmark trial for CLI in my view. We were able to achieve limb salvage and amputation-free survival that well exceeded what our target mark was.”
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The system (LimFlow) diverts arterial flow from the tibial artery to the tibial veins. As Healio previously reported, in the PROMISE I single-arm study of 32 patients, 70% of patients with severe CLI who were not candidates for surgical or endovascular revascularization, so called “no-option” CLI, achieved amputation-free survival at 1 year.
For the PROMISE II single-arm pivotal trial, 105 patients (mean age, 69 years; 69% men) with no-option CLI and Rutherford class 5 or 6 underwent deep venous arterialization. Stable patients on dialysis were eligible. The primary endpoint was amputation-free survival at 6 months, with a performance goal of 54% based on prior literature.
“This is a group of patients that I do not think have been studied well in any other trial,” Clair said during the presentation. “In my view, this is probably the sickest group of patients that has ever been enrolled in a lower-extremity pivotal trial.”
Technical success was achieved in 99% of procedures, he said.
The primary endpoint was met in 66% of patients (posterior mean, 0.66; 95% Bayesian CI, 0.565-0.745; P = .005), accounting for three patients who died of COVID-19 during the trial, and the probability that the performance goal was exceeded was 0.9931, better than the requirement of 0.977 to win, Clair said during the presentation.
At 6 months, the rate of limb salvage was 76% and the rate of overall survival was 87%, he said.
In a subgroup analysis, the only subgroup that did not meet the performance goal for the primary endpoint was patients on dialysis, he said, noting that “the primary reason that this group did not meet it is overall survival. This is obviously a very sick group of patients. If you have end-stage renal disease and have reached the point where your limb is not salvageable, there are probably major changes that we need to do in order to improve overall survival.”
Amputation-free survival at 6 months occurred in 75% of patients not on dialysis but 37% of patients on dialysis (P = .0012), while overall survival occurred in 95% of patients not on dialysis but 63% of patients on dialysis (P = .0001), he said.
“We have to find a new name for this group of patients,” he said.
Wound healing occurred in 75% of patients at 6 months, while pain scale score dropped from 5.3 at baseline to 3 at 6 months, Clair said.
Rutherford class improved over time, with almost 20% of patients achieving Rutherford class 0 or 1 at 6 months, while preliminary 1-year results indicate nearly 60% of patients achieved that goal, he said.
“The system with transcatheter arterialization is a teachable, reproducible procedure,” Clair said during the presentation. “Consistent patient follow-up to manage wound care is critical to success.”
The system is not yet approved for commercial use in the United States.
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Clair DG, et al. Late-Breaking Clinical Trials. Presented at: VIVA 22; Oct. 31-Nov. 3, 2022; Las Vegas (hybrid meeting).
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