ILLUMENATE Pivotal Trial Results Presented for Spectranetics' Stellarex Drug-Coated Balloon

November 2, 2016—The Spectranetics Corporation announced that the final 12-month results of the ILLUMENATE pivotal trial for the company’s Stellarex drug-coated balloon (DCB) were presented by Sean P. Lyden, MD, at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Dr. Lyden and Prakash Krishnan, MD, serve as coprincipal investigators of ILLUMENATE. 

The ILLUMENATE pivotal trial enrolled 300 patients who were randomized to treatment with the Stellarex DCB or a percutaneous transluminal angioplasty (PTA). The patient population was described as a complex cohort with comorbidities in the DCB arm that included high rates of severe calcification (43.9%), diabetes (49.5%), renal insufficiency (18%), and cardiovascular disease (45%).

The key results included primary patency rates at day 365 (per Kaplan-Meier estimates) of 82.3% for the DCB group and 70.9% for the PTA group. The rate of freedom from clinically driven target lesion revascularization (CD-TLR) was 93.6% for the DCB group and 87.3% for the PTA group. Additionally, the trial met its primary safety and effectiveness endpoints and demonstrated superiority to PTA on both.

“First-generation DCBs forced us to make a choice between top-tier clinical outcomes and the potential safety advantages of a lower drug dose," commented Dr. Krishnan in the company’s press release. "Based on the compelling Stellarex DCB study results, we no longer need to compromise. In the most challenging patient population studied in a DCB investigational device exemption trial, the next-generation Stellarex DCB achieved remarkable clinical outcomes. I am very excited these results could be obtained given the high proportion of severely calcified lesions and comorbidities.”

Spectranetics noted that the ILLUMENATE pivotal trial was conducted with independent, blinded third parties that included a clinical events committee and angiographic and duplex ultrasound core laboratories to assess diagnostic images and outcomes. It is the second randomized controlled trial to evaluate the Stellarex DCB; the ILLUMENATE European randomized control trial previously demonstrated a 12-month Kaplan-Meier primary patency rate of 89% for the DCB arm versus a 65% rate in the PTA arm. When the DCB cohort data from both randomized trials is pooled, the Kaplan-Meier primary patency rate is 86% and the CD-TLR rate is 94.2%, the company said. 

Spectranetics launched the Stellarex DCB device in Europe in January 2015. It is not available for sale in the United States, where commercialization is anticipated in the second half of 2017. With the presentation of the ILLUMENATE data, the company also announced it has submitted a premarket approval application for Stellarex to the US Food & Drug Administration.