DCB shows durable real-world effectiveness at 4 years
LAS VEGAS — In a real-world population with peripheral artery disease, nearly three-quarters of patients treated with a drug-coated balloon were free from clinically driven target lesion revascularization at 4 years, according to new data presented at VIVA 19.
Among the 1,406 patients treated with the DCB (IN.PACT Admiral, Medtronic) for lesions in the superficial femoral or popliteal arteries of at least 2 cm, 73.4% were free from clinically driven TLR at 4 years, a difference of 3.5% from the rate of 76.9% at 3 years, Thomas Zeller, MD, associate professor of angiology at Universitaets-Herzzentrum Freiburg, Bad Krozingen, Germany, said during a presentation on the IN.PACT Global single-arm registry. Healio previously reported on the 1-year and 2-year results.
Mean time to clinically driven TLR was 570.2 days, he said.
“The treatment of peripheral arterial disease in patients with multiple comorbidities is challenging and remains a global health concern,” Zeller said during the presentation. “Patients with complex lesions are usually excluded from randomized controlled trials [but] are reflected in real-world registries. Numerous randomized controlled trials and registries have demonstrated the superiority of drug-coated balloons over percutaneous transluminal angioplasty for the treatment of peripheral artery disease in real-world patients; however, long-term evidence in this complex group is still missing.”
At 4 years, major adverse events occurred in 39.1% of patients, with 15.1% having died, 27.5% having had clinically driven TLR, 1.1% having had major target limb amputation and 5.5% having had thrombosis, Zeller said.
The Kaplan-Meier estimate of freedom from all-cause death at 4 years was 83.5%, Zeller said, noting vital status data were available for 98% of patients.
Freedom from clinically driven TLR at 4 years was more common in claudicants than in those with critical limb ischemia (74.5% vs. 64.8%; log-rank P = .005), according to the researchers.
Zeller said independent predictors of clinically driven TLR at 4 years included bilateral disease (P < .001), baseline Rutherford class of 4 or more (P = .002), previous peripheral target limb revascularization (P = .006), moderate to severe or severe target limb calcification (P = .015) and chronic total occlusion (P = .016).
“The results demonstrate the durable effectiveness of the IN.PACT Admiral DCB through 4 years,” Zeller said during the presentation. “The long-term safety through 4 years demonstrated low amputation and thrombosis rates and a safety composite of 72%. Robust, real-world data continue to demonstrate durable results, indicating this DCB is a viable solution for the treatment of femoropopliteal disease, including the distal popliteal artery segments.”
Among the cohort, the mean age was 69 years, 68% were men, 39.9% had diabetes, mean ankle-brachial index was 0.678 and mean lesion length was 12.09 cm. – by Erik Swain
Zeller T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 19; Nov. 4-7, 2019; Las Vegas.
Disclosures: The study was funded by Medtronic. Zeller reports he has financial ties with Bayer, B. Braun Medical, Biotronik, Boston Scientific, Cardiovascular Systems Inc., Cook Medical, C.R. Bard, Intact Vascular, MedAlliance, Medtronic, Philips, Pluristem, QT Medical, Spectranetics, TriReme, Veryan, Vesper and W.L. Gore and Associates.