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ILLUMENATE: DCB for femoropoliteal artery disease safe, durable at 2 years
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A drug-coated balloon to inhibit restenosis in the superficial femoral and popliteal arteries showed safe and durable clinical outcomes at 2 years, according to the results of the ILLUMENATE first-in-human study.
Researchers evaluated the paclitaxel-coated DCB (Stellarex, Spectranetics) in 50 patients with 58 lesions in the first cohort that required predilatation with an uncoated balloon before the inflation of the DCB. The mean age of the cohort was 69 years, 38% were women, mean lesion length was 7.2 cm and mean stenosis at baseline was 75%.
The primary effectiveness endpoint was late lumen loss at 6 months. The major secondary endpoint was major adverse events, defined as CV death, amputation and/or ischemia-driven target lesion revascularization.
The trial had statistical power of 81% to detect a 0.65-mm difference in angiographic late lumen loss at 6 months between patients who received the DCB and a historical control group.
At 6 months, mean late lumen loss was 0.54 mm (95% CI, 0.28-0.81), significantly below the historical control of 1.1 mm, which meant that the primary endpoint was met.
The rate of major adverse events at 6 months was 4% (95% CI, 0.5-13.7). According to the researchers, the major secondary endpoint was met because the lower bound of the CI was below the prespecified objective performance criterion of 30%.
The primary patency rate was 89.5% at 12 months and 80.3% at 24 months.
“Stellarex DCB is the only drug-coated angioplasty balloon that has demonstrated 80.3% patency at 24 months,” Henrik Schroeder, MD, from the Center for Diagnostic Radiology and Minimally Invasive Therapy at The Jewish Hospital in Berlin, said in a press release. “We are very pleased with these promising results.”
The rate of freedom from clinically driven TLR was 90% at 12 months and 85.8% at 24 months.
No amputations or CV deaths were reported at 24 months.
“Treatment of atherosclerotic lesions with the Stellarex DCB is a safe and effective option that offers an important economic benefit due to the high patency rate and low TLR rate,” Schroeder and colleagues wrote.
The Stellarex DCB is not yet approved for use in the United States. – by Erik Swain
Disclosure: The study was supported by CV Ingenuity, Covidien and Spectranetics. Schroeder reports consulting for Spectranetics. Another researcher reports consulting for Spectranetics and formerly holding stock options in CV Ingenuity.
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