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ILLUMENATE: DCB shows high 1-year patency rate

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A drug-coated balloon had a high 1-year patency rate, according to new data from the ILLUMENATE Global Study presented at the New Cardiovascular Horizons conference.

The prospective, multicenter, single-arm study of 371 patients was designed to determine the efficacy of the DCB (Stellarex, Spectranetics) in the superficial femoral and popliteal arteries, according to a press release issued by Spectranetics.

In a second interim analysis of 220 patients, the primary patency rate was 90.3% at 360 days and 86.5% at 365 days, while the rate of freedom from clinically driven target lesion revascularization was 93.9% at 360 days and 365 days. The results were consistent with the initial ILLUMENATE Global 12-month interim analysis, as well as the ILLUMENATE First-in-Human Study results, according to the release.

“The patency rates from this interim data are top-tier and compare well with the highest DCB patency rates in comparable clinical studies,” Prakash Krishnan, MD, from Mount Sinai Medical Center. “The fact that these results were achieved with a low-dose DCB is especially compelling.”

Prakash Krishnan

The first-in-human non-randomized, multicenter study, which enrolled 80 patients, showed the DCB had a primary patency rate of 89.5% at 12 months and 80.3% at 24 months, and patients were free from clinically driven TLR at a rate of 90% at 12 months and 85.8% at 24 months.

“This analysis supports the promising data generated in the First-In-Human study, and I look forward to seeing the randomized data later this year,” Krishnan said in the release.

The device is available in Europe but not in the United States. According to the release, Spectranetics expects the device to be commercially available in the United States in 2017 or shortly thereafter.

Reference:

Krishnan P, et al. Global Summit on Advanced Aortoiliac and Femoral Interventions for Peripheral Artery Disease Session III. Presented at: New Cardiovascular Horizons 17th Annual Conference; June 1-3, 2016; New Orleans.

Disclosure: Krishnan reports financial ties with Abbott, C.R. Bard, Medtronic and Spectranetics.