Current use and two-year outcomes of coronary lithotripsy: updates from the BENELUX-IVL registry

Background/introduction Intravascular lithotripsy (IVL) has emerged as percutaneous treatment option for coronary artery calcification (CAC). However, data on long-term outcomes remain limited. Purpose To evaluate the utilization patterns, safety, efficacy and two-year outcomes of IVL for CAC in an all-comers, real-world patient cohort. Methods Patients undergoing percutaneous coronary intervention (PCI) with IVL between May 2019 and September 2024 across nine centers in Belgium, Italy and the Netherlands were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints were device success (IVL balloon delivery and pulse administration without complications), technical success (residual stenosis <30% with final TIMI 3 flow) and procedural success (technical success without in-hospital major adverse cardiovascular events [MACE: cardiac death, non-fatal myocardial infarction, or clinically driven target vessel revascularization (TVR)]). Safety endpoints included procedural complications and MACE up to two-year follow-up. Results A total of 583 patients (mean age 73±9 years, 74% male) underwent IVL for 612 calcified lesions. The median IVL balloon size was 3.5mm (IQR: 3.0–4.0) with 80 (IQR: 60-80) pulses delivered. Clinical presentations included chronic coronary syndrome (n= 336, 58%) and acute coronary syndrome (n=247, 42%). Treated lesions included bifurcations (n=135, 22%), aorto-ostial lesions (n=148, 24%), in-stent lesions (n=185, 30%) and chronic total occlusions (45, 7%). Additional calcium modification techniques were used in 91 cases (15%), mostly pre-IVL (n=82, 13%), with rotational atherectomy performed in 75 (12%). Pre- and post-dilatation were performed in 82% of procedures. Intracoronary imaging was used in in 294 (48%) procedures. Stenting was performed in 476 (78%) and drug eluting balloons were used in 46 (8%) cases. Device, technical, and procedural success rates were 97%, 90%, and 89%, respectively. Complications occurred in 35 patients (6%), of which 7 (1%) were IVL-related. The median follow-up was 377 days (159–730), contributing to 695 patient-years of follow-up. Complete one-year follow-up data were available for 416 patients (71%), with MACE observed in 44 patients (11%). Two-year follow-up was available for 290 patients (50%), with an additional 9 events (3%) recorded. The cumulative incidence of MACE at two years was 53 events (8% per patient-year). Conclusion In this real-world cohort of patients treated with IVL, high success rates and low complication rates were observed. Importantly, these favorable outcomes were sustained over two years, with a cumulative MACE rate of 8% per patient-year.