Disrupt PAD III is Largest Randomized Study of Complex Patients Typically Excluded from Clinical Trials
SANTA CLARA, CALIF. — November 7, 2020 — Shockwave Medical, Inc., offering Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, reported today that investigators unveiled data from the Disrupt PAD III study, which showed IVL to be superior to percutaneous transluminal angioplasty (PTA) on the primary endpoint of procedural success. The largest randomized trial of severely calcified peripheral lesions, Disrupt PAD III found that IVL was also associated with a statistically significant reduction in diameter stenosis, arterial dissections and bail-out stenting versus PTA. The results were presented earlier today in a late-breaking clinical trial session at VIVA20.
Disrupt PAD III is a prospective, multicenter, randomized study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a drug-coated balloon (DCB) or stent. The study enrolled 306 patients randomized between IVL and PTA at 45 sites in the United States, Germany, Austria and New Zealand. In the IVL arm, 83 percent of patients were classified by the angiographic core lab as having severe calcification, with an average calcified lesion length of 129 millimeters. The co-principal investigators of the study were William A. Gray, M.D., FACC, FSCAI, Chief of the Division of Cardiovascular Disease at Main Line Health, Wynnewood, Penn., and Gunnar Tepe, M.D., Head of the Department of Diagnostic and Interventional Radiology, RoMed Clinic Rosenheim, Germany.
“Until the Shockwave PAD III trial, there have been few data available to provide treatment guidance for this challenging population, as patients with severe calcification have historically been excluded from endovascular treatment trials,” said Dr. Gray, who presented the PAD III results. “IVL superiority over PTA in acute procedural success establishes the new standard in safety and effectiveness, and we now have Level I evidence to help inform our lesion preparation strategy.”
IVL demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30 percent without flow-limiting dissection (greater or equal to Grade D), prior to DCB or stenting, with a rate of 65.8 percent versus 50.4 percent (p=0.0065) as determined by an independent angiographic core lab. Additionally, PAD III showed that IVL achieved more atraumatic treatment based on the following findings:
- Reduction in frequency and severity of major arterial dissections (Grade C and Grade D, both p=0.03)
- Reduction in the need for bail-out stenting (75% relative risk reduction) and stent implantation rate (4.6% vs 18.3%, p=0.0002)
- Lower balloon maximum inflation pressure (6.3 atm vs 11.3 atm, p<0.0001)
- Reduction in categorical percent diameter stenosis after treatment with IVL versus PTA (p=0.02)
“I would like to compliment the physicians, clinical coordinators and institutions who worked diligently to generate this new Level I evidence in a difficult-to-treat patient population,” said Keith D. Dawkins, M.D., Chief Medical Officer of Shockwave Medical. “The acute safety and effectiveness of IVL in the PAD III core lab adjudicated randomized clinical trial are remarkably consistent with the excellent outcomes published earlier this year from a meta-analysis of previous studies across different peripheral arterial vessel beds, including the concurrent PAD III ‘real-world’ registry.”
About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.