HEROES-DCB Trial to Compare Lutonix and In.Pact Drug-Coated Balloons

May 11, 2016—Advocate Heart Institute of Oak Lawn, Illinois announced the initiation of the HEROES-DCB trial to evaluate the efficacy of the Lutonix (Bard Peripheral Vascular) and In.Pact (Medtronic) drug-coated balloons (DCBs) with respect to patient outcomes. 

HEROES-DCB is a prospective, randomized clinical trial to determine if there is a difference in clinical outcomes between US Food and Drug Administration-approved DCBs to treat peripheral artery disease (PAD). The clinical trial is sponsored by Advocate Heart Institute and supported by the Advocate Department of Research & Innovation. The trial enrolled its first patient at Advocate Christ Medical Center in Oak Lawn, Illinois.

Jaafer Golzar, MD, is National Principal Investigator for the HEROES-DCB trial. In the announcement, Dr. Golzar commented, “Such head-to-head trials advance endovascular therapies and improve patient outcomes. We will eagerly await the results of the trial to understand if there is a difference in the current technologies, or if improvement in outcomes are a class effect.”

According to Advocate Heart Institute, HEROES-DCB is an investigator-initiated, multicenter, prospective, randomized, core-lab adjudicated trial that will enroll 275 patients at multiple sites across the United States. Primary patency with be evaluated by duplex ultrasound at 12 months. The study will provide significant clinical value to patients with PAD.

Other participating sites will include Advocate Illinois Masonic Medical Center, Advocate Good Samaritan Hospital, Advocate Lutheran General Hospital, and Advocate South Suburban Hospital, as well as Detroit Medical Center, Cleveland Clinic, Baylor Medical Center, Munster Community Hospital, St. Joseph Hospital, and Alexian Brothers Medical Center.