Shockwave Medical, a company which provides intravascular lithotripsy (IVL) to treat complex calcified cardiovascular disease, unveiled the results of the DISRUPT CAD II study, a European postmarket study of coronary IVL, in a High Impact Clinical Research session at Transcatheter Cardiovascular Therapeutics (TCT 2019; 24–29 September, San Francisco, USA).
A press release from the company outlines that DISRUPT CAD II was a prospective, nonrandomised, multicentre study 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 centres, enrolling 120 patients with de novo, calcified, stenotic, coronary artery disease at 15 European centres.
In the 120 patients enrolled, 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). 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 revascularisation.
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 1.7mm2. In 47 of the 120 patients in which concomitant optical coherence tomography (OCT) imaging was performed, calcium fractures were identified in 79% of lesions, averaging more than three fractures per lesion.
Simultaneously published in Circulation: Cardiovascular Interventions, DISRUPT CAD II outcomes confirmed the initial results from the DISRUPT CAD I study, says the press release—which are that IVL may be safely performed with high procedural success and minimal complications. Coronary IVL is a lesion preparation tool designed to fracture challenging calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion.
In the statement from the company, Carlo Di Mario (University of Florence, Florence, Italy), coprincipal investigator of CAD II and presenter at TCT, says: “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.”
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 USA they are limited to investigational use within the DISRUPT CAD III IDE Study.