Abstract
BACKGROUND: Calcified lesions represent a key challenge in percutaneous coronary intervention (PCI). In recent years, intravascular lithotripsy (IVL) has emerged as a safe and effective adjunctive therapy for severely calcified lesions before stenting implantation. In the present study, we investigated the safety and efficacy of a novel coronary IVL system in patients with severely calcified lesions. METHODS: The LEAD-FIM study was a prospective, multicenter, single-arm trial in China. Patients with severely calcified lesions and a clinical indication for PCI with vessel preparation for DES implantation using IVL. The primary endpoint was procedural success, which was defined as residual stenosis ≤ 30% following successful stent placement and the absence of major adverse cardiac event (MACE, including cardiac death, myocardial infarction, or target vessel revascularization) up to 7 days post-procedure. The primary endpoint assessed against performance goals derived from major published registries on Shockwave IVL. A subgroup analysis using optical coherence tomography was carried out to evaluate the morphology of calcification before and after IVL treatment, as well as post-stent. RESULTS: From February to April 2023, a total of 184 patients with severely calcified lesions at 11 sites were enrolled. The target lesions were predominantly in the left anterior descending artery (77.2%) and the mean diameter stenosis was 87.6%±6.6%. Procedure success was observed in 96.7% (178/184) of patients (95%CI: 94.2%-99.3%), which significantly surpassed the prespecified performance goal of 85.0% (p < 0.001). All patients met the criteria of angiographic success and 6 (3.3%) patients occurred in-hospital MACE event. The rate of 30-day and 180-day MACE was 3.8% (7/184) and 4.9% (9/184), respectively. In the OCT sub-study population, minimum lumen area increased after IVL by 1.22 ± 0.87 mm² and by an additional 2.54 ± 1.73 mm² post stenting with overall stent expansion of 85.3 ± 17.1% at the site of maximal calcification. No serious adverse events associated with the device were documented. The rates of target lesion failure at 1- and 6-month were 3.3% and 4.4%, respectively. CONCLUSIONS: The novel IVL system could promote stent delivery and achieve optimized stent expansion among patients with severely calcified coronary lesions. TRIAL REGISTRATION: This trial was registered in the clinicaltrials.gov (URL: https://www.clinicaltrials.gov; Unique identifier: NCT05649488) on 28th November 2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12872-025-05447-4.