ILLUMENATE: DCB yields durable treatment effect at 2 years

Marianne Brodmann

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.

Perspective from John H. Rundback, MD, FAHA, FSVM, FSIR

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

Reference:

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.

Perspective

John H. Rundback, MD, FAHA, FSVM, FSIR

These are the best 2-year results we have seen with a DCB, and are comparable only to those seen with the Eluvia DES (Boston Scientific). If that is sustained in long-term results, it will be a real differentiator. Generally, DCBs have changed how we treat these patients. We used to sit down with patients with SFA disease and tell them there was a one in four chance, often more, that they would need revascularization. Now, I tell them there is a one in 10 chance they will need revascularization. The impact to the patients, payers and physicians is dramatic.

I would like to know if the investigators will be parsing out those results by high-risk lesion features. How did the device perform in longer lesions, in occlusions vs. stenoses, in heavy calcification? Or was this a homogenous population? Of interest, the PTA group did very well, which suggests that lesion complexity may be the key driver of the very good results.

John H. Rundback, MD, FAHA, FSVM, FSIR

Medical Director, Interventional Institute

Holy Name Medical Center

Managing Partner

Advanced Interventional Radiology Services LLP

Teaneck, New Jersey

Disclosures: Rundback reports he has received honoraria from Abbott Vascular, Bard Peripheral Vascular, Cook Medical, Cardiovascular Systems Inc. and W.L. Gore and Associates; consulted for Abbott Vascular, Boston Scientific and Medtronic; held common stock in Eximo; and received research funding from Bayer, Bard Peripheral Vascular, Biomet, Cook Medical, Intact Vascular, Juventas and Mercator.