Spectranetics has announced that the final 12-month results of the Stellarex drug-coated balloon ILLUMENATE pivotal trial have been presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference (29 October–2 November, Washington, DC, USA). The ILLUMENATE trial’s co-principal investigators are Sean Lyden of the Cleveland Clinic, Cleveland, USA, who presented the data, and Prakash Krishnan, Mount Sinai, New York, USA.
Krishnan stated, “First-generation drug-coated balloons forced us to make a choice between top-tier clinical outcomes and the potential safety advantages of a lower drug dose. Based on the compelling Stellarex study results, we no longer need to compromise. In the most challenging patient population studied in a drug-coated balloon investigational device exemption trial (IDE), the next-generation Stellarex achieved remarkable clinical outcomes. I am very excited these results could be obtained given the high proportion of severely calcified lesions and co-morbidities.”
The ILLUMENATE pivotal trial enrolled 300 patients, all of whom were randomised to treatment with the Stellarex or a percutaneous transluminal angioplasty (PTA). This patient cohort represents the most complex patient population studied in a drug-coated balloon IDE trial, when considering co-morbidities for the drug-coated balloon arm included high rates of severe calcification (43.9%), diabetes (49.5%), renal insufficiency (18%), and cardiovascular disease (45%). The key results, per Kaplan-Meier survival estimates, at day 365 include:
- Primary patency of 82.3% for the Stellarex group and 70.9% for the PTA group
- Freedom from clinically-driven target lesion revascularisation (CD-TLR) was 93.6% for the Stellarex group and 87.3% for the PTA group.
- The trial met its primary safety and effectiveness endpoints and demonstrated superiority to PTA on both.
The ILLUMENATE pivotal trial is the second randomised controlled trial to study the Stellarex drug-coated balloon. The ILLUMENATE European randomised control trial reported a 12-month Kaplan-Meier primary patency rate of 89% for the drug-coated balloon arm vs. 65% in the PTA arm. When the drug-coated balloon cohort data from both randomised trials is pooled, the Kaplan-Meier primary patency rate is 86% and the CD-TLR rate is 94.2%.
“Severe calcification has been viewed as the Achilles heel of drug-coated balloons. Our US pivotal trial data provides compelling evidence that Stellarex achieves top-tier patency even in very complex patients. These outcomes are a significant step forward in our effort to improve patient care and lead the way in clinical science,” said Scott Drake, president and chief executive officer.