ShockWave Medical, Inc. announced that long-term data from the Disrupt PAD III trial found that superior vessel preparation with IVL led to excellent long-term outcomes out to two years with preservation of future treatment options compared to percutaneous transluminal angioplasty in the treatment of calcified peripheral artery disease. The final outcomes of the largest randomized trial of severely calcified peripheral lesions were presented by investigators in a featured clinical research session at the 2022 Scientific Sessions of the Society for Cardiovascular Angiography & Interventions and published simultaneously in JSCAI. As previously published, IVL at 30 days demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30% without flow-limiting dissection, prior to drug-coated balloon or stent, with a rate of 65.8% versus 50.4% as determined by an independent angiographic core lab.

Additionally, PAD III showed that IVL achieved a reduction in frequency and severity of flow-limiting major dissections, a reduction in stent implantation rate and no distal embolization or perforation events. These new long-term results found that the powered secondary endpoint of primary patency favored IVL over PTA at one year and remained favorable through two years, respectively. Disrupt PAD III was 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 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, 82.9 % of patients were classified by the angiographic core lab as having severe calcification, with an average calcified lesion length of 129.4 millimeters. Joining Dr. Gray as co-principal investigator of the study was Gunnar Tepe, M.D., Head of the Department of Diagnostic and Interventional Radiology, RoMed Clinic Rosenheim, Germany.