Deep venous arterialization continues to benefit patients with severe CLTI at 12 months
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Key takeaways:
- Most patients with severe chronic limb-threatening ischemia treated with a deep venous arterialization system were alive with intact limbs at 12 months.
- Those on dialysis did worse than those not on dialysis.
Most patients with severe chronic limb-threatening ischemia treated with a transcatheter deep venous arterialization system achieved limb salvage at 12 months, according to new data from the PROMISE II trial.
As Healio previously reported, in the main results of PROMISE II, about two-thirds of patients with no-option chronic limb-threatening ischemia (CLTI), also known as critical limb ischemia, achieved amputation-free survival at 6 months when treated with the system (LimFlow), which diverts arterial flow from the tibial artery to the tibial veins. The results led to the FDA approval of the system in September for treatment of patients with severe CLTI who are not candidates for endovascular or surgical revascularization. Daniel G. Clair, MD, professor and chair of the department of vascular surgery and section of surgical sciences at Vanderbilt University Medical Center, presented the 12-month results of PROMISE II at VIVA 23.
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The cohort included 105 patients with Rutherford class 5 or 6 (mean age, 69 years; 69% men; 15% Black; 28% Hispanic/Latino; 18% on dialysis) and the rate of technical success was 99%.
“These were patients who were felt by an independent adjudicated committee to have no surgical or interventional option for treatment of severe CLTI,” Clair said during a presentation. “They had to have wounds, they had to have a life expectancy of greater than 12 months and we excluded patients with severe heart failure and hepatic insufficiency, although renal failure was included in this trial.”
At 12 months, the rate of limb salvage was 69%, Clair said during the presentation.
“We saw, as has been noted before, a drop off after the first 3 months, but those who were able to keep their limbs to that point usually did significantly well over time,” he said.
Wounds were fully healed in 45% of the cohort and healed or healing in 92% at 12 months, whereas the average primary wound area fell from 6.8 cm2 at baseline to 0.2 cm2 at 12 months, he said.
On the pain scale of 0 to 10, the cohort improved from 5.3 at baseline to 1.4 at 12 months, Clair said.
More than half of patients achieved Rutherford class 0 or 1 at 12 months, he said.
Patients on dialysis fared worse than those not on dialysis, Clair said, noting the 12-month rates of amputation-free survival were 32% in those on dialysis and 61% in those not on dialysis (P = .0012), and the rates of overall survival were 55% in those on dialysis and 86% in those not on dialysis (P = .0001).
Clair also presented the results of a pooled analysis of the 137 patients from the PROMISE I single-arm study and PROMISE II; the cohorts were similar except that PROMISE I did not include patients on dialysis and did not count deaths from COVID-19.
In the pooled cohort, the rate of overall survival was 86%, the rate of limb salvage was 73% and the rate of amputation-free survival was 63% at 12 months, he said.
“The 12-month data ... shows that this is a durable, sustainable outcome,” Clair said during the presentation. “The outcomes are consistent even with interventionalists who are just learning the technique. The procedure is reproducible and generalizable. I continue to believe that as we gain more experience with this over time, we will learn more and do better as we move forward. I am happy with where we are headed with this complex group of patients.”
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Clair DG, et al. Late-breaking clinical trials. Presented at: VIVA 23; Oct. 30-Nov. 2, 2023; Las Vegas (hybrid meeting).
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