Shockwave Medical’s Intravascular Lithotripsy System Evaluated in Three Published Studies

June 28, 2021—Shockwave Medical, Inc. announced the publication of evaluations of the safety, efficacy, and mechanism of the benefit of the company’s intravascular lithotripsy (IVL) for the treatment of coronary and peripheral artery disease (PAD). IVL received FDA approval for use in coronary arteries in February 2021. It has been cleared for the treatment of PAD in the United States since 2016, advised the company.

The articles published in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions include a pooled analysis of four studies involving coronary IVL, a randomized clinical trial involving peripheral IVL, and a mechanism-of-action paper.

Gunnar Tepe, MD, et al published the 30-day outcomes from the DISRUPT PAD III trial of IVL for peripheral artery calcification (2021;14:1351-1361).

According to the company, the DISRUPT PAD III randomized controlled trial is assessing the treatment of calcified lower extremity arterial lesions. It compares vessel preparation with peripheral IVL to percutaneous transluminal angioplasty (PTA) in patients receiving drug-coated balloon (DCB) treatment for PAD.

As summarized by the company, key findings include the following:

• Peripheral IVL was superior to PTA in the primary endpoint, procedural success, at 30-days. (Site reported, 90.1% vs 64.5%; P < .0001. Core lab reported, 65.8% vs 50.4%; P = .01)
• Vessel preparation was safely performed with IVL using a significantly lower maximum balloon inflation pressure relative to PTA and a lower rate of provisional or bail-out stenting.
• There was no distal embolization or perforation in the IVL group.
• Final residual stenosis following the definitive therapy, DCB and/or stent placement, was similar between the two groups, although the PTA group required more stents (P = .001).

Dr. Tepe et al concluded that IVL treatment required significantly less bail-out stenting to achieve a successful outcome, thereby facilitating a “leave-nothing-behind” approach in patients with severely calcified lower extremity arterial lesions.

In an editorial comment, Christopher J. White, MD, and Joshua A. Beckman, MD, noted that the objective of the study was to determine if IVL was able to prepare the vessel with a low residual stenosis and without severe dissections or the need for stents versus more narrowly focusing on only the residual stenosis at the end of the procedure (2021;14:1362–1363).

Dean J. Kereiakes, MD, et al reported findings from a patient-level pooled analysis of the four prospective DISRUPT CAD studies (DISRUPT CAD I, II, III, and IV) that analyzed the clinical outcomes of coronary IVL in severely calcified, stenotic de novo coronary arteries prior to stenting (2021;14:1337-1348).

According to Shockwave Medical, findings from the analysis, which was composed of a cohort of 628 patients treated with coronary IVL, included the following:

• Coronary IVL safely facilitated successful stent implantation and achieved high procedural success in one of the most severely calcified vessel cohorts reported for any percutaneous coronary intervention trial to date.
• Primary safety and effectiveness endpoints were achieved in almost all patients (92.7% and 92.4% respectively).
• Coronary IVL showed low rates of major adverse cardiovascular events and very low rates of severe angiographic complications in complex target lesions.
• Coronary IVL was consistently effective in achieving high acute gain and low residual stenosis.

In an accompanying editorial in JACC: Cardiovascular Interventions, Ajay J. Kirtane, MD, and Matthew T. Finn, MD, discussed the findings (2021;14:1349-1351). The DISRUPT CAD studies were designed to obtain regulatory approval for Shockwave C2 coronary IVL device in the European Union, United States, and Japan, noted the company.

In the state-of-the art review of the IVL mechanism of action, Dr. Kereiakes et al outlined the principles of the IVL system, procedure, energy distribution, and specific mechanisms for calcium modification (2021;14:1275-1292).

The company outlined the key points as follows:

• IVL fractures both superficial and deep calcium and minimizes the risk of vascular complications or thermal injury.
• In the treatment of severely calcified lesions, IVL offers several advantages compared to balloon-based and athero-ablative (atherectomy) technologies.
• IVL has very high levels of safety and effectiveness across multiple clinical studies involving severely calcified coronary and PAD.

Dr. Kereiakes, who served as Principal Investigator for the DISRUPT CAD III trial, commented in Shockwave Medical’s press release. “It is a tremendous accomplishment to have three separate publications in such a well-respected journal like JACC: Cardiovascular Interventions. These publications represent the most definitive evidence to date for safety and effectiveness of IVL as adjunctive therapy in vascular intervention. In addition, specific mechanisms of benefit from IVL are clearly defined. IVL represents a quantum step forward in our ability to safely treat patients with severely calcified arteries.” Dr. Kereiakes is President of The Christ Hospital Heart and Vascular Institute, Professor of Clinical Medicine, The Ohio State University in Cincinnati, Ohio.