DISRUPT CAD II European Postmarket Study Presented for Shockwave's Coronary IVL System

September 25, 2019—Shockwave Medical, Inc. announced that the results of the DISRUPT CAD II study were presented by coprincipal investigator Professor Carlo Di Mario, MD, in a High Impact Clinical Research session at TCT 2019, at the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25–29 in San Francisco, California. In conjunction with the presentation at TCT, the findings were published online by Ziad A. Ali, MD, et al in Circulation: Cardiovascular Interventions.

The DISRUPT CAD II study is a European postmarket study of the Shockwave coronary intravascular lithotripsy (IVL) system for the treatment of complex calcified cardiovascular disease. Coronary IVL is a lesion-preparation tool designed to fracture challenging calcium using sonic pressure waves to facilitate stent delivery, deployment, and optimal expansion. Shockwave C2 coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and other select countries. In the United States, the devices are limited to investigational use within the DISRUPT CAD III IDE study.

According to Shockwave, the prospective, nonrandomized, multicenter study was designed to confirm the safety and performance of the DISRUPT CAD I study that supported CE Mark approval of the Shockwave coronary IVL system. DISRUPT CAD II was a postmarket study intended to confirm the CAD I results in a larger number of patients and centers, enrolling 120 patients with de novo, calcified, stenotic, coronary artery disease at 15 European centers.

The company stated that the DISRUPT CAD II outcomes confirmed the initial results from the DISRUPT CAD I study that IVL may be safely performed with high procedural success and minimal complications.

As summarized by the company, 120 patients were enrolled in the CAD II study. In these patients, severe calcification by independent angiographic core lab analysis was observed in 94% of lesions, which were both concentric (72%) and eccentric (28%). The primary safety endpoint was met, with 94.2% of patients free from in-hospital major adverse cardiac events (MACE). MACE was driven entirely by seven non-Q-wave myocardial infarctions (MI).

Additionally, there were no reports of perforation, slow flow, no-reflow, or major dissections (defined as type D, E, or F) at any point in the study. At 30-day follow-up, the MACE rate remained low at 7.6%, with a single additional cardiac death, Q-wave MI, and target vessel revascularization.

Investigators were able to successfully deliver and use IVL in all 120 patients in the study. IVL facilitated successful stent delivery in all cases, which reduced stenoses in severely calcified coronary arteries to a residual of less than 8% with an acute gain of 1.7 mm². In 47 of the 120 patients in whom concomitant optical coherence tomography imaging was performed, calcium fractures were identified in 79% of lesions, averaging more than three fractures per lesion.

In the company's announcement, Prof. Di Mario commented, “The results of DISRUPT CAD II are remarkably consistent with those reported in the DISRUPT CAD I feasibility study, validating the safety and utility of coronary IVL. Based on these two studies, I believe IVL will set the bar for a new standard of safety associated with the treatment of challenging, heavily calcified lesions.”

Professor Jean Fajadet, MD, the study's other coprincipal investigator, added, “The excellent outcomes of the CAD II study not only verify the safety of coronary IVL, but they also highlight some of the technology’s more unique capabilities, including the ability to modify various types of calcium. With these benefits and the consistent clinical data we have generated so far, IVL has proven to be a feasible frontline tool for calcium modification.”