Safety and Efficacy of a Novel Rotational Atherectomy System in Coronary Calcifications

BackgroundCalcified coronary lesions present challenges during percutaneous coronary intervention, often impeding successful stent delivery and expansion. Rotational atherectomy (RA) facilitates plaque modification in such cases. However, clinical performance of a novel RA system remains unclear. MethodsThis trial included 2 prospective phases, a first-in-human (FIH) study and a pivotal randomized controlled trial. In the FIH study, 15 patients underwent percutaneous coronary intervention with the novel RA system, and clinical success was assessed. In pivotal trial, 224 patients with calcified lesions were randomized to receive RA using either the novel (n = 111) or established (n = 113) system, followed by stenting. The primary endpoint was freedom from major adverse cardiovascular events (MACEs), a composite of cardiac death, myocardial infarction, and target vessel revascularization, at 30 days. Secondary endpoints included MACEs at 12 months and quantitative imaging analyses. ResultsAll FIH patients achieved clinical success. In pivotal study, the median follow-up time was 349.5 (IQR: 343, 359) days. Freedom from MACEs at 30 days was 97.3% (108 of 111 vs 110 of 113; 95% CI: 92.3%-99.4% vs 92.4%-99.5%) in both groups (P for noninferiority