SCAI Scientific Sessions: Shockwave IVL Maintains Superiority to Angioplasty in Calcified Peripheral Disease at Two Years

Randomized Disrupt PAD III Study Finds Superior Vessel Preparation Leads to Excellent Long-Term Outcomes and Preserved Future Treatment Options

SANTA CLARA, Calif., May 19, 2022 —  Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today 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 (PTA) 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 today in a featured clinical research session at the 2022 Scientific Sessions of the Society for Cardiovascular Angiography & Interventions (SCAI) 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 percent without flow-limiting dissection, prior to drug-coated balloon (DCB) or stent, 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 a reduction in frequency and severity of flow-limiting major dissections (1.4 percent vs. 6.8 percent, p=0.03), a reduction in stent implantation rate (4.6 percent vs 18.3 percent, p=0.001) and no distal embolization or perforation events.

These new long-term results found that the powered secondary endpoint of primary patency (defined as freedom from CD-TLR, restenosis determined by duplex ultrasound and provisional stenting) favored IVL over PTA at one year (80.5 percent vs. 68.0%, p>=0.017) and remained favorable through two years (Kaplan-Meier estimate: 74.4 percent vs. 57.7 percent, p=0.005), respectively.

“Prior to the PAD III study, there were limited long-term data available to provide treatment guidance for this challenging population since patients with severe calcification have historically been excluded from endovascular trials,” said William A. Gray, M.D., FACC, FSCAI, Co-Director of the Lankenau Heart Institute and System, Chief of the Division of Cardiovascular Disease at Main Line Health, Wynnewood, PA, and co-principal investigator of PAD III who presented the long-term results. “The primary end point at 30 days showed IVL to be a superior vessel preparation strategy by demonstrating stenosis resolution with significantly fewer complications including severe dissections and the subsequent need for bail-out stent implantation. Avoiding unplanned stent implantations allows interventionalists to preserve all their future treatment options should reintervention be necessary. These new long-term data show that vessel preparation with IVL followed by DCB result in excellent efficacy and durable patency out to two years, and taken together the acute and long-term results reinforce IVL as a preferred vessel preparation strategy for calcified femoropopliteal disease.”

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 percent 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.