Abstract of the Year No. 3: One-Year Clinical and Lifetime Cost-Effectiveness Outcomes of Transcatheter Arterialization for No-Option CLTI in the U.S.
Presentation: Wednesday, April 2, at 8 a.m.
Transcatheter arterialization of the deep veins (TADV) for no-option patients with chronic limb-threatening ischemia (CLTI) is both a clinically and cost-effective therapy, according to a recent cost-analysis study.
An option for the no-option patient
Up to 20% of patients with CLTI are considered “no-option” because they are ineligible for traditional endovascular treatments and are thus at a higher risk for amputation. Without amputation or treatment, patients may suffer with non-healing ulcers, gangrene or both. However, TADV has shown promising results for these patients in terms of limb salvage and amputation-free survival.
Nicholas Petruzzi, MD, FSIR
According to Nicholas Petruzzi, MD, FSIR, lead author and one of the investigators in the upcoming PROMISE III Trial, TADV offers an entirely different way of thinking about CLTI management.
“Often when it comes to PAD or CLTI, scientific advances are in the realm of finding a new way to blow up calcium,” Dr. Petruzzi said. “TADV is a paradigm shift in how you treat the disease. With this approach, we take the atherosclerotic plaque completely out of the equation. We’re not finding a new way to drill through or smash something—we’re using the veins to fully bypass the arteries.”
While there is still much to learn about TADV, including from a histological perspective, Dr. Petruzzi says that the current data indicates that not only does TADV work, but it saves lives and limbs.
“It’s not going anywhere,” he said. “It’s only becoming more widespread; in fact, TADV was included in a 2024 multi-specialty consensus guideline as a consideration for CLTI patients who have no other below-the-knee bypass targets or endovascular revascularization options.”
The cost of limb salvage
But while the data shows that TADV may work, Dr. Petruzzi and his team wanted to ask a larger question: is it worth the cost?
“One-Year Clinical and Lifetime Cost-Effectiveness Outcomes of Transcatheter Arterialization for No-Option CLTI in the U.S.”, one of the SIR 2025 Abstracts of the Year, utilizes data from PROMISE I and II, single-arm, multicenter, prospective studies that investigated the safety and efficacy of TADV in no-option CLTI patients and compares it to patient data from the CLariTI natural history registry to determine both cost-effectiveness and overall quality of life value.
“We performed propensity matching between the PROMISE Trial data and the CLariTI data and then calculated the overall incremental cost-effectiveness ratios and quality adjusted life year (QALY) rate, and then we compared between the two,” Dr. Petruzzi said.
Researchers looked at the 1-year outcomes—including limb salvage, overall survival and amputation-free survival—of 228 patients, or 114 matched pairs. TADV patients had a 1-year limb salvage rate of almost 75%, compared to 58% from the CLariTI patients. Survival rates were more comparable, at 86% to 71.1%, while TADV patients had an amputation-free survival rate of 64.9% compared to 39.1%.
Utilizing the most recent cost and reimbursement data, Dr. Petruzzi and his team found that over a patient’s lifetime, TADV added 1.09 QALYs, with an overall incremental cost effectiveness ratio of approximately $33,000. The total survival gain with TADV is projected to be 2.18 life years.
“When we look at that, compared to several standard-of-care treatment strategies, TADV in general had a favorable cost-effectiveness ratio,” Dr. Petruzzi said.
According to guidelines published in the American Journal of Cardiology, which evaluate QALY rates to determine what is favorable or not, a procedure can be considered high value if its cost comes in under $50,000.
“TADV came out at $33,000, which is lower than a lot of standard practices,” Dr. Petruzzi said. “Yes, it may seem like you’re spending a lot up front. But on the back end, you’re really getting a great value for these patients, who are living longer and not having to undergo major amputation.”
Patient selection
While TADV has shown promising clinical and cost-effectiveness outcomes, Dr. Petruzzi said that there are still many unanswered questions—some of which he hopes to answer through PROMISE III.
“Selection criteria were further refined in PROMISE III, in part because of what we learned from the previous two trials,” he said.
One of the key goals of PROMISE III will be to better determine which patients will be ideal candidates for TADV.
“When you have a treatment that maybe helpful for someone with no other options, you always want to offer it—but it may not be best suited for that patient,” he said. “The worst thing you can do is put a patient through a high-cost procedure and then end up amputating their leg.”
