LAS VEGAS — Use of a drug-coated balloon conferred positive outcomes in more than four of five patients with symptomatic femoropopliteal disease, according to findings presented at VIVA 17.
The DCB (IN.PACT Admiral, Medtronic) was evaluated in 1,406 real-world patients (mean age, 69 years; 68% men) with symptomatic femoropopliteal disease, defined as Rutherford class 2 to 4, some of whom had de novo in-stent restenosis, lesions longer than 15 cm and/or chronic total occlusion. One-year results were presented at VIVA in September 2016. Thomas Zeller, MD, PhD, director of the department of angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany, presented 2-year results here.
While randomized controlled trial results are considered the highest level of evidence, “we learned that these can be translated only to a very limited, selected patient cohort,” Zeller said during a press conference. “This is the reason for supplementing the randomized study with the IN.PACT Global study, which is more or less an all-comers study.”
Among 1,773 target lesions treated, mean lesion length was 12.1 cm, 18% had in-stent restenosis, 35.5% were total occlusions and 68.7% were calcified, Zeller said.
“We included the worst of the worst patients,” he said.
At 2 years, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 83.3%, Zeller said.
More patients in this cohort had clinically driven TLR at 2 years than in the DCB arm of the IN.PACT SFA randomized controlled trial (16.9% vs. 9.1%), but the IN.PACT Global cohort had longer lesion length (12.09 cm vs. 8.94 cm), a higher rate of in-stent restenosis (18% vs. 0%) and a higher rate of chronic total occlusions (35.5% vs. 25.8%) compared with the randomized trial cohort, according to Zeller.
The primary safety endpoint, defined as freedom from device- and procedure-related mortality at 30 days and freedom from clinically driven TLR and major target limb amputation at 2 years, was met by 81.7% of patients, according to findings presented.
Major target limb amputation occurred in 0.7% of the cohort and thrombosis occurred in 4.5% at 2 years, he said.
“Considering the patient population, I personally consider the reintervention rate a very good outcome,” Zeller said during the press conference. “It clearly showed there is an ongoing benefit of using drug-coated balloons long-term. The results demonstrate a durable treatment effect with the DCB. This is a robust dataset that continues to confirm the safety and strong performance of the IN.PACT DCB in this cohort of real-world patients.” – by Erik Swain
Zeller T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
Disclosures: The study was funded by Medtronic. Zeller reports he receives honoraria from 480 Biomedical, Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Shockwave Medical, Spectranetics, Veryan/Novate, Volcano and W.L. Gore and Associates; consults for Boston Scientific, Medtronic, Spectranetics, Veryan/Novate and W.L. Gore and Associates; holds common stock in QT Medical and Veryan/Novate; and receives research funding from 480 Biomedical, Bard Peripheral Vascular, B. Braun International, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Gardia Medical, Intact Vascular, MedAlliance, Medtronic, Plurestem, Philips, Shockwave Medical, Spectranetics, VIVA Physicians and Volcano.