Marianne Brodmann, Medical University Graz, Austria, presented the final 12-month results of the ILLUMENATE European randomised clinical trial at the Amputation Prevention Symposium in Chicago, USA.
The low-dose drug-coated balloon significantly outperformed standard angioplasty and delivered top-tier outcomes, a press release from Spectranetics stated.
ILLUMENATE enrolled 328 patients, 295 of whom were randomised to treatment with the Stellarex drug-coated balloon or percutaneous transluminal angioplasty. The key results at one-year include:
Primary patency, using Kaplan-Meier survival estimates, was 89% for the drug-coated balloon group and 65% for the plain balloon angioplasty group.
Freedom from clinically-driven target lesion revascularisation, using Kaplan-Meier survival estimates, was 94.8% for the drug-coated balloon group and 85.3% for the plain balloon angioplasty group group.
Henrik Schöder, the trial’s national principal investigator from Jewish Hospital in Berlin, Germany, said: “The Stellarex drug-coated balloon produced outstanding results in this rigorous trial, validating its earlier first-in-human and interim ILLUMENATE Global studies. These consistent, high quality outcomes are achieved with a low dose drug balloon, making this device especially compelling. Physicians now have a powerful tool to prevent restenosis and improve their patients’ quality of life.”
ILLUMENATE was conducted with the highest level of rigour to ensure accuracy and reliability of the data. Independent, blinded third parties included a clinical events committee and angiographic and duplex ultrasound core laboratories to assess diagnostic images and outcomes, the press release adds.
“While results clearly show a highly significant gain compared to percutaneous transluminal angioplasty, they favourably match the highest rates of primary patency with a low drug dose,” said Brodmann. “It is very encouraging for us physicians to observe such a tremendous evolution in drug-coated balloon technologies and appreciate how low-dose and highly stable coatings such as Stellarex can achieve and beat such high clinical performance benchmarks while offering excellent deliverability and tractability.”
The Stellarex drug-coated balloon is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. Spectranetics launched the device in Europe in January 2015, with US commercialisation anticipated in the 2017 timeframe. The Stellarex DCB uses EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site.
There are five clinical studies evaluating the safety and efficacy of the Stellarex drug-coated balloon platform. These support USA and Canadian regulatory filings. There are four ILLUMENATE clinical studies in addition to the ILLUMENATE randomised trial described above:
- The ILLUMENATE first-in-human study was a non-randomised, multicentre study that enrolled 80 patients. In the pre-dilatation arm (n=50), the primary patency rate at was 89.5% at 12 months and 80.3% at 24 months.
- The ILLUMENATE pharmacokinetic study measured the paclitaxel drug levels in the blood of 25 patients enrolled at two sites.
- The ILLUMENATE pivotal study is a prospective, randomised controlled, multicentre trial with 300 patients enrolled at 43 sites to support US FDA approval. Results are expected to be released later this year.
- The ILLUMENATE Global study is a prospective, multicentre, single-arm study with 371 patients enrolled. Interim data on the first 220 subjects showed a primary patency rate of 86.5% at 12 months. Final data are expected to be released in early 2017.