Abstract
Intravascular lithotripsy (IVL) is a promising therapy for calcified coronary lesions. This study evaluated the safety and effectiveness of a novel IVL system. The COronary CAlcified Lesion Lithotripsy Procedure (COCALP) study (No. ChiCTR2300073280) was a prospective, multicenter, single-arm trial involving 266 patients with severely calcified coronary lesions. The primary endpoint was procedural success, defined as successful stent implantation with ≤30% residual stenosis and no in-hospital major adverse cardiovascular events (MACE). In a subgroup, calcium morphology was evaluated by optical coherence tomography (OCT) assessment. A total of 266 patients were included. The procedural success rate was 97.4% (95% confidence interval [CI]: 0.947-0.989), with the lower limit of the CI exceeding the prespecified performance goal (p < 0.001). No MACE occurred intraoperatively. During hospitalization, MACE occurred in five patients (1.9%), all of which were myocardial infarctions. MACE rates at 1 and 6 months were 2.3 and 3.4%, respectively. In the OCT subgroup (n = 76), IVL induced a 76.8% rate of calcification fracture. The minimal lumen area increased from 1.77 ± 0.72 to 2.59 ± 1.11 mm(2) following IVL (p < 0.001), and further expanded to 5.22 ± 1.69 mm(2) poststenting (p < 0.001). The novel IVL system demonstrated high effectiveness and safety, supporting its use for treating severely calcified coronary lesions and enhancing stent implantation success.