Carlo Di Mario
SAN FRANCISCO — An intravascular lithotripsy device used for vessel preparation for stenting in patients with severely calcified coronary lesions was safe and effective, according to results from the DISRUPT CAD II study presented at TCT 2019.
The primary endpoint of in-hospital MACE, defined as cardiac death, MI or target vessel revascularization, occurred in 5.8% of the 120 patients enrolled in the single-arm study, Carlo Di Mario, MD, PhD, interventional cardiologist at Careggi University Hospital in Florence, Italy, said during a presentation, noting that all seven events were non-Q-wave MIs.
Efficacy and safety of the lithotripsy device (Shockwave C2 Coronary IVL catheter, Shockwave Medical) had been demonstrated in the small DISRUPT CAD I study, but “these results had to be confirmed in a larger group with more centers enrolling,” Di Mario told Healio. “I think this is what we managed to achieve, since this study showed the same safety and efficacy data as the first trial.”
The procedure was technically successful in all patients, and acute luminal gain after lithotripsy was 0.83 mm, Di Mario said.
Residual diameter stenosis was 32.7% after lithotripsy and 7.8% after implantation of a drug-eluting stent, according to the researchers.
There were no cases of angiographic complications such as dissections, perforations, abrupt closures, slow flow or no reflow, Di Mario said.
In a substudy of 47 patients who underwent OCT after the procedure, the researchers observed calcium fracture in 78.7% of lesions (3.4 fractures per lesion).
“We could see that the lesions were in fact highly calcific ... and around 80% of the lesions responded with visible fractures, and often multiple fractures, ” Di Mario told Healio.
Patients from the substudy had gains in lumen area (P < .0001) and reductions in calcium angle (P < .0001) and maximum calcium thickness (P = .004), Di Mario said during the presentation.
“This study shows that you can treat highly calcified stenoses without taking on risk of perforations, low flow and major CV events, as only a limited number of patients had non-Q-wave MI at the end of the trial,” Di Mario told Healio. “I think that is very different from what you achieve with alternative technologies such as atherectomy devices.”
The device is not yet available for commercial use in the United States but in September received a breakthrough device designation from the FDA. A pivotal trial, DISRUPT CAD III, commenced in January. – by Erik Swain
Di Mario C, et al. High-Impact Clinical Research III: Pharmacotherapy Strategies and
Calcified Lesions. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Ali ZA, et al. Circ Cardiovasc Interv. 2019;doi:10.1161/CIRCINTERVENTIONS.119.008434.
Disclosures: The study was funded by Shockwave Medical. Di Mario reports he received institutional research grants from Shockwave Medical. Please see the study for all other authors’ relevant financial disclosures.