A Novel 2-Hz Coronary Intravascular Lithotripsy Catheter for Calcified Coronary Artery Disease: One-Year Outcomes of the DISRUPT CAD Duo Trial.

BACKGROUND: Intravascular lithotripsy (IVL) modifies vascular calcification to enhance vessel compliance and optimize coronary stent deployment. A novel 2-Hz coronary IVL catheter was developed to improve procedural efficiency by shortening treatment time. Non-inferiority of the 2-Hz catheter for early safety and effectiveness has been previously reported, but there are no data on longer-term outcomes. METHODS: The DISRUPT CAD Duo IDE was a multicenter, prospective, single arm study. Patients with de novo, severely calcified coronary lesions were treated with the 2-Hz IVL catheter. The primary safety endpoint was freedom from 30-day MACE (cardiac death, MI, or TVR) and the primary effectiveness outcome was procedural success (stent delivery with ≤30% residual stenosis, and no in-hospital MACE). Additional patient-level outcomes, including mortality, MI, revascularization, stent thrombosis, and anginal status were evaluated through 1-year follow-up. RESULTS: Of 145 enrolled patients, 143 were eligible for and 140 (97.9%) completed 1-year follow-up (non-eligible patients included: 1 non-cardiac death and 1 consent withdrawal). Through 1 year, 3 patients had MI, 2 of which were attributable to a target vessel; 5 patients required TVR, including 3 ischemia-driven TLR. The overall MACE rate was 5.6% (8/142) with no cardiac deaths or stent thrombosis. One non-cardiac death was reported. Compared with 14.5% of patients at baseline, 77.1% of patients reported having no angina symptoms at 1 year. CONCLUSIONS: The 2-Hz coronary IVL catheter, when used in patients with calcified coronary artery lesions, demonstrated sustained low rates of MACE alongside high rates of improvement in anginal symptoms through 1 year.