Shockwave Medical’s IVL Compared to PTA in DISRUPT PAD III at 2 Years

May 19, 2022—Shockwave Medical, Inc. announced long-term data from the DISRUPT PAD III trial evaluating the company’s intravascular lithotripsy (IVL) in the treatment of severely calcified cardiovascular disease.

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 percutaneous transluminal angioplasty (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 mm.

William A. Gray, MD, and Gunnar Tepe, MD, are Coprincipal Investigators of DISRUPT PAD III. Dr. Gray is Co-Director of the Lankenau Heart Institute and System and Chief of the Division of Cardiovascular Disease at Main Line Health in Wynnewood, Pennsylvania. Dr. Tepe is Head of the Department of Diagnostic and Interventional Radiology at RoMed Clinic in Rosenheim, Germany.

According to the company, DISRUPT PAD III found that vessel preparation with IVL led to excellent long-term outcomes out to 2 years, with preservation of future treatment options, compared to PTA in the treatment of calcified peripheral artery disease.

Dr. Gray presented the final outcomes of the large randomized trial in a featured clinical research session of the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 scientific session held May 19-22 in Atlanta, Georgia. The findings were published simultaneously by Dr. Tepe et al online in JSCAI: Journal of the Society for Cardiovascular Angiography & Interventions.

The long-term results presented at SCAI 2022 found that the powered secondary endpoint of primary patency favored IVL over PTA at 1 year (80.5% vs 68%; P = .017) and remained favorable through 2 years (Kaplan-Meier estimate: 74.4% vs 57.7%; P = .005). Primary patency was defined as freedom from clinically driven target lesion revascularization, restenosis determined by duplex ultrasound, and provisional stenting.

According to the company, previously published data demonstrated the superiority of IVL versus PTA at 30 days in the primary endpoint analysis—defined as procedural success with residual stenosis ≤ 30% without flow-limiting dissection, before DCB or stent—with a rate of 65.8% versus 50.4% (P = .0065) as determined by an independent angiographic core lab. Additionally, DISRUPT PAD III showed that IVL achieved a reduction in frequency and severity of flow-limiting major dissections (1.4% vs 6.8%; P = .03), a reduction in stent implantation rate (4.6% vs 18.3%; P < .001), and no distal embolization or perforation events.

“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,” commented Dr. Gray in Shockwave’s press release. “The primary endpoint 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.”

Dr. Gray continued, “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 results in excellent efficacy and durable patency out to 2 years, and, taken together, the acute and long-term results reinforce IVL as a preferred vessel preparation strategy for calcified femoropopliteal disease.”