TCT 2016: Drug-coated balloon outperforms angioplasty procedures in research

New research presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference on a drug-coated balloon (DCB) provided good news for cardiologists concerned with ensuring controlled drug delivery to a patient’s treatment site during an endovascular procedure.

The balloon, branded the Stellarex, is made by Spectranetics and is designed to treat peripheral arterial disease. It is coated in the company’s EnduraCoat technology, a durable coating that prevents drug loss during transit and controls drug delivery to the treatment site.

The study, ILLUMENATE, was led by Sean Lyden, MD, the chair of vascular surgery at the Cleveland Clinic, and Prakash Krishnan, MD, a cardiologist at Mount Sinai in New York.

The trial followed 300 patients who were randomly treated with either the Stellarex DCB or a percuntaneous transluminal angioplasty (PTA).

One-year results showed that primary patency was 82.3 percent for patients with the DCB and 70.9 percent for patients with PTA.

“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,” Krishnan said in a statement. “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 co-morbidities.”