Drug-coated ballon (DCB) endovascular therapy was found to be a reasonable treatment for femoropopliteal lesions in patients on hemodialysis, according to research published July 14 in JACC: Cardiovascular Interventions.

Yasutaka Yamauchi, MD, PhD, et al., evaluated restenosis risk in patients on hemodialysis undergoing DCB treatment with either Lutonix or IN.PACT Admiral for symptomatic femoropopliteal artery disease. Of the patients included from March 2018 to December 2019, there were 3,165 lesions and 991 were in patients on hemodialysis. The study's primary outcome was no restenosis.

At one year post procedure, lack of restenosis in the hemodialysis vs. non-hemodialysis cohort was 82% vs. 86%. At year three, lack of restenosis was 62% vs. 66%, respectively.

Among patients on hemodialysis, restenosis was observed in 363 lesions during a median follow-up of 16.2 months. Risk factors independently associated with three-year restenosis included no below-the-knee runoff, history of endovascular therapy, popliteal lesion, severe calcification, use of Lutonix and severe dissection.

"It is necessary to fully consider the patient's background and tolerance of surgery," write the authors. "Repeated [endovascular therapy] increases the physical burden on the patient and the cost of medical care."

In an accompanying editorial comment, Maxime Dubosq-Lebaz, MD, and Eric Alexander Secemsky, MD, FACC, add that "these results underline the multifactorial nature of restenosis in [hemodialysis] patients, where anatomical, procedural, and device-specific factors likely interact."

An additional JACC: Cardiovascular Interventions article, informed by data from PROMISE II and a pooled analysis of other PROMISE studies, found that transcatheter arterialization of the deep veins (TADV) using the LimFlow System resulted in reliable rates of amputation-free survival (AFS) and limb salvage in addition to progressive improvement in symptoms and wound healing at one year.

Mehdi H. Shishehbor, DO, MPH, PhD, FACC, et al., evaluated outcomes from 105 patients enrolled in PROMISE II and 137 patients from the pooled analysis who had Rutherford class 5/6 chronic limb-threatening ischemia (CLTI) and were identified as either ineligible or to have exhausted conventional lower extremity revascularization options.

Among PROMISE II participants, the rate of AFS was 54%, limb salvage was 69% and survival was 79% at one year after TADV with the LimFlow System. The pooled analysis showed the following rates at one year: 66%, 74% and 89%, respectively.

The authors note that "clinical symptoms and wound status showed improvement" throughout the one-year follow-up period. "This comprehensive analysis shows favorable rates of AFS, limb salvage, and overall survival in the largest cohort of no-option CLTI patients studied prospectively to date, highlighting the potential clinical benefits and improved patient outcomes with this treatment," they write.

An accompanying editorial comment from Michael S. Conte, MD, notes that "because these were single-arm, open-label trials lacking a comparator, there remains considerable uncertainty about the clinical effectiveness of [percutaneous deep venous arterialization] and which patients in particular might be likely to benefit."