Clinical outcomes and predictors of complications after coronary intravascular lithotripsy

Abstract Background Intravascular lithotripsy (IVL) has emerged as a percutaneous treatment option for coronary artery calcification (CAC). Purpose This study aimed to evaluate the incidence of complications associated with IVL-therapy, to assess clinical outcomes and to identify predictors of complications in a real-world patient cohort. Methods Patients who underwent IVL between May 2019 and September 2024 were enrolled from an ongoing international, all-comers IVL-registry. Patients were categorized based on the presence or absence of complications following IVL and concomitant therapy. The primary endpoints were achievement of residual diameter stenosis 30% on quantitative coronary analysis (QCA) and the incidence of major adverse cardiovascular events (MACE) at one-year follow-up. MACE was defined as occurrence of cardiac death, non-fatal myocardial infarction, or clinically driven target vessel revascularization (TVR). Kaplan-Meier and binary logistic regression analyses were performed to compare outcomes and to identify predictors of complications. Results The study included 509 patients (73±9 years, 75% male). 219 (43%) patients presented with acute coronary syndrome and 290 (57%) with chronic coronary syndrome, and were comparable between groups (p=0.424). Complications occurred in 33 (6%), of which 6 (1%) were directly IVL-related. The most frequent complications were flow-limiting coronary dissections (n=9, 2%), hemodynamic instability (n=9, 2%) and coronary perforations (n=7, 1%). These were effectively managed with 30 interventions, leading to favorable procedural outcomes. Among patients with complications and available QCA data, residual diameter stenosis 30% was achieved in 28 of 29 lesions (97%). One-year cumulative MACE was 11% (39 patients) and was significantly higher in patients with complications (n=9, 43% vs. n=30, 9%; p0.001). This difference was primarily driven by in-hospital MACE, which occurred in 10 patients overall (2%); 6 (18%) in patients with complications and 4 (1%) in patients without complications (p0.001). Multivariate analysis identified larger pre-dilatation balloon diameters as a significant predictor of complications (p=0.032). Conclusion In this real-world registry, complications following IVL and concomitant therapy were uncommon, with an even lower rate of IVL-related complications. Patients with procedural complications had a significantly higher one-year MACE rate, primarily due to in-hospital events. Larger pre-dilatation balloon diameters were a significant predictor of complications.