ILLUMENATE: DCB yields durable treatment effect at 2 years
LAS VEGAS — New data from the ILLUMENATE EU randomized controlled trial demonstrate higher primary patency and a lower rate of clinically driven target lesion revascularization at 2 years after treatment with a drug-coated balloon, compared with percutaneous transluminal angioplasty.
Researchers for the trial randomly assigned 294 patients with symptomatic femoropopliteal disease on a 3:1 basis to receive the DCB (Stellarex, Spectranetics/Philips) or PTA. The DCB was approved by the FDA in July.
“Drug-coated balloons are becoming a front-line therapy for superficial femoral artery treatment. We know that 12-month primary patency rates are significantly higher [with DCBs] than uncoated balloons; this has been proven over several DCB trials,” Marianne Brodmann, MD, interim head of the clinical division of angiology, department of internal medicine, Medical University Graz, Austria, said during a presentation. “But long-term data on DCBs are limited and variable. The Stellarex balloon was confronted with the issue of [whether] a low-dose DCB [can] deliver enough drug to provide a durable treatment effect at 2 years.”
The mean age of the DCB group was 67 years and 72% were men. The mean age of the PTA group was 69 years and 68% were men. The groups were similar in lesion length, lesion type, calcification and other characteristics.
At 2 years, primary patency was 75.2% in the DCB group vs. 61.2% in the PTA group (log-rank P = .004), Brodmann said. The exact rates at 790 days were 75.9% in the DCB group and 61% in the PTA group (difference, 14.9%; 95% CI, 1.1-28.7; P = .025), she said.
Rates of freedom from clinically driven TLR at 2 years were 88.9% in the DCB group and 71.8% in the PTA group (log-rank P < .001), according to results presented here.
Major adverse events at 2 years were higher in the PTA group (14% vs. 31.7%; P = .002), driven by clinically driven TLR, she said.
“There was a significant treatment effect observed out to 2 years,” Brodmann said. “This treatment effect increased from 1 to 2 years. These impressive data for clinically driven TLR also corresponded with clinical and functional improvements” in Rutherford category and walking metrics.
Exact rates of core lab-adjudicated primary patency at 790 days were higher for the Stellarex DCB than for the IN.PACT Admiral DCB (Medtronic) and the Lutonix 035 DCB (Bard Peripheral Vascular; 75.9% vs. 69.2% vs. 53.8%, respectively), she said.
“The Stellarex balloon shows a durable treatment effect with no indication of late catch-up at 2 years,” Brodmann said. “There were 60% fewer reinterventions in the Stellarex cohort, and the Stellarex is the first low-dose DCB to demonstrate a statistically significant treatment effect at 2 years.” – by Erik Swain
Brodmann M, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 14-17, 2017; Las Vegas.
Disclosures: The study was funded by Spectranetics, now part of Royal Philips. Brodmann reports she received honoraria from Avinger, AstraZeneca, B. Braun, Bard Peripheral Vascular, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cagent, Daiichi Sankyo, Intact Vascular, Medtronic, Sanofi Aventis and VIVA Physicians.