The Stellarex drug-coated balloon (DCB; Spectranetics Corporation) improved primary patency and freedom from clinically-driven target lesion revascularization (TLR) compared to percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral arterial disease, according to ILLUMENATE trial results, presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting.

The Stellarex DCB is a novel paclitaxel-coated angioplasty balloon (2mcg/mm2) platform designed to treat peripheral arterial disease.

At 1 year, primary patency was 82.3% for the DCB group vs 70.9% for the PTA group. Freedom from clinically-driven TLR was 93.6% for the DCB group vs 87.3% for the PTA group. More than 3 in 4 patients (76.3%) achieved the primary efficacy end point: absence of restenosis and freedom from clinically-driven TLR though 1 year, compared with 57.6% of the PTA group.


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“There’s always been a concern about what would happen when you start adding [people with diabetes], when you start adding more calcified vessels, what happens if you have people [with] disease runoff in the subset,” said Sean Lyden, MD, chair of vascular surgery at Cleveland Clinic in Ohio, said in an interview with Cardiology Advisor. Dr Lyden presented the results at the TCT meeting in Washington, DC. “The study shows clinically superior results despite that challenging subset.”

Eligible patients had Rutherford class 2-4 symptoms, superficial femoral artery (SFA) and/or popliteal arterial stenoses. The study arm included high rates of severe calcification (43.9%), diabetes (49.5%), renal insufficiency (18.0%), and cardiovascular disease (45.0%).

In this study (ClinicalTrials.gov identifier: NCT01927068), conducted at 43 sites in the United States and European Union, 200 patients were assigned to Stellarex and 100 to PTA.

Dr Lyden said these results affirm previous findings from the ILLUMENATE First-in-Human study and the ILLUMENATE EU randomized trial. On the same day he presented these findings, Spectranetics Corporation submitted the results to the US Food and Drug Administration for approval.

“Hopefully in the near future we’ll have [the Stellarex DCB] approved for use in the US market,” Dr Lyden said.

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Reference

Lyden SP, Krishnan P. ILLUMENATE pivotal Stellarex DCB IDE study—12 month results. Presented at Transcatheter Cardiovascular Therapeutics 2016 scientific symposium. October 30-November 2, 2016; Washington, DC.