Johan Bennett, Bas Hamer, Valeria Paradies, Pim Tonino, Yoann Bataille, and Stefan Verheye
doi/10.1016/j.jacc.2024.09.435
Abstract
Background
LithiX Hertz Contact Intravascular Lithotripsy (LithiX HC-IVL) is a novel technology designed to fragment calcium during PCI, with low delivery profile and without the need for capital equipment. The PINNACLE I clinical trial demonstrated promising 30-day outcomes of LithiX HC-IVL. The primary safety endpoint of major adverse cardiovascular events (MACE) through 30 days and primary effectiveness and safety endpoint of clinical success (residual stenosis <50% with no evidence of in-hospital MACE) were met. We now report on the 6-month safety and effectiveness results of the LithiX HC-IVL.
Methods
PINNACLE I is a prospective multicenter study of 60 patients requiring PCI in up to 2 de novo coronary artery lesions with angiographic moderate to severe calcification. Angiographic imaging was performed in all subjects at baseline, after LithiX treatment, and at the end of procedure after stent deployment. In addition, optical coherence tomography (OCT) imaging was performed in a subgroup of 32 subjects at baseline, after LithiX treatment, and at the end of procedure after stent deployment. All angiographic and OCT images were analyzed by an independent imaging core laboratory. Clinical follow-up is planned through 6 months after the procedure. All potential endpoint events were adjudicated by an independent clinical events committee.
Results
Sixty patients with 63 lesions were enrolled by March 1, 2024. Patients were 72.1 ± 6.8 years old, 81.7% presented with chronic coronary syndrome, and 18.3% presented with acute coronary syndrome. Data collections are underway, and the 6-month outcomes of the study will be available for first-time presentation at TCT 2024.
Conclusions
PINNACLE I assessed the safety and effectiveness of LithiX HC-IVL for treatment of moderately to severely calcified coronary artery lesions. The 6-month outcomes will provide additional insights on the promise of the LithiX HC-IVL in calcium fragmentation for optimizing stent implantation.
