Marianne Brodmann of Medical University Graz, Austria, has presented the final 12-month results of the Stellarex (Spectranetics) ILLUMENATE drug-coated balloon European randomised clinical trial (EU RCT) at the Amputation Prevention Symposium (AMP; 10–13 August, Chicago, USA). The EU RCT Trial enrolled 328 patients, 295 of whom were randomised to treatment with the Stellarex drug-coated balloon (DCB) or a percutaneous transluminal angioplasty (PTA).
Brodmann told delegates that the key results at day 365 include:
- Primary patency, per Kaplan-Meier survival estimates, was 89% for the DCB group and 65% for the PTA group
- Freedom from clinically-driven target lesion revascularisation per Kaplan-Meier survival estimates was 94.8% for the DCB group and 85.3% for the PTA group.
Henrik Schöder, the trial’s national principal investigator from Jewish Hospital in Berlin, Germany, said, “The Stellarex DCB 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.”
A Spectranetics press release states that the EU RCT study was “conducted with the highest level of rigor 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.
“While results clearly show a highly significant gain compared to PTA, 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 DCB 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 DCB 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 2017.