Shockwave Medical announces plans for “largest ever” calcified peripheral artery disease study

Shockwave Medical has announced plans for DISRUPT PAD III—what is claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified peripheral artery disease. Previous DISRUPT PAD studies utilised Lithoplasty as primary therapy, demonstrating safe, effective and consistent revascularisation of calcified lesions while maintaining future treatment options. To date, the potential benefit of combination therapy in these patients has not yet been evaluated.

DISRUPT PAD III will study use of the Shockwave Medical Lithoplasty system in combination with drug-coated balloon therapy to assess short- and long-term outcomes compared to those achievable using traditional balloon angioplasty prior to drug-coated balloon in a calcified patient population.

“Most contemporary randomised studies in peripheral artery disease have excluded calcified lesions. The available data on this difficult-to-treat patient cohort largely comes from post-hoc, subset analyses of single-arm registries. DISRUPT PAD III will be an important study because it will provide physicians foundational Level I evidence to guide treatment of this difficult-to-treat patient cohort,” said William Gray, principal investigator of DISRUPT PAD III and system chief, Division of Cardiovascular Disease at Main Line Health and president, Lankenau Heart Institute, Wynnewood, USA. “Today, there is no clear standard of care for interventional treatment of calcified peripheral artery disease.”

“Modifying calcium is the first step in any successful treatment of this patient cohort,” said Daniel Hawkins, chief executive officer of Shockwave Medical. Lithoplasty technology has been shown to effectively and consistently modify calcium, enabling successful revascularisation of these patients while keeping subsequent treatment options open. With the multiple treatment approaches being used in peripheral artery disease intervention today, and the absence of a consistent standard, understanding the benefits of using Lithoplasty in combination with other therapies is important to advancing the data on the treatment of calcified peripheral artery disease.”