REALITY Study to Evaluate Directional Atherectomy Plus DCB Treatment for PAD

November 2, 2015—Medtronic plc announced the initiation of the REALITY study to evaluate patient outcomes following adjunctive use of directional atherectomy and drug-coated balloon (DCB) treatment of patients with symptomatic peripheral arterial disease (PAD) in long, calcified superficial femoral (SFA) and/or popliteal artery lesions.

The study, which will have multidisciplinary representation in leadership, is sponsored and will be managed by VIVA Physicians, Inc. 

The new study was announced at VIVA 15, the 13th annual Vascular InterVentional Advances meeting, held November 2–5, 2015, at the Wynn in Las Vegas, Nevada.

The announcement describes the REALITY study is a multicenter, prospective, single-arm observational angiographic and duplex ultrasound core lab–adjudicated study that will enroll 250 patients at up to 20 sites across the United States. Primary patency will be assessed by duplex ultrasound at 12-months. Patients will be followed to 24 months to determine rates of clinically driven target lesion revascularization (CD-TLR). 

Medtronic’s directional atherectomy systems (HawkOne, TurboHawk, and SilverHawk) and its In.Pact Admiral DCB will be studied in REALITY. The study also involves several important core lab–adjudicated subanalyses including the intravascular ultrasound assessment of the efficiency of directional atherectomy to debulk various plaque morphologies including severe calcium in long lesions before DCB deployment and the validation of the Peripheral Arterial Calcium Scoring Scale, or PACSS, to assess the impact of severe vessel calcification on Major Adverse Clinical Events (MACE) from the procedure through 12 months. A health economics and Quality of Life assessment will also be included as part of REALITY.

Krishna Rocha-Singh, MD, who is on the Board of Directors of VIVA Physicians and is chief scientific officer of Prairie Heart Institute at St. John's Hospital in Springfield, Illinois, commented in Medtronic’s press release, “As standalone treatments for peripheral arterial disease, directional atherectomy and DCBs have demonstrated strong clinical results. However, challenges in treating long and severely calcified femoropopliteal lesions remain, including the associated provisional stent rate with DCB and reintervention rates with directional atherectomy over the long term. The REALITY study was driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address these challenges.” Dr. Rocha-Singh also serves on the Board of Directors of VIVA Physicians.

At VIVA 2014, the 1-year results from the DEFINITIVE AR pilot study were presented by Covidien (now Medtronic), and showed early promise in calcified and long lesions for PAD patients treated with directional atherectomy before DCB use.

“DEFINITIVE AR was the first, and only randomized pilot study to determine the outcome differences between patients who were treated with directional atherectomy and DCB and DCB alone,” stated Mark Turco, MD, who is medical director of the Aortic & Peripheral Vascular Business within Medtronic’s Cardiac and Vascular Group. “While the data demonstrated positive, early trends towards combination therapy in some lesion subsets, further investigation is needed to determine the effectiveness of debulking a lesion with directional atherectomy prior to DCB.”

Dr. Turco added, “It is an honor for Medtronic to partner with VIVA and a multidisciplinary team of clinicians in the study. We are pleased to support research in advancing therapy options for patients with PAD.”