Intravascular Lithotripsy in Diabetic Patients Undergoing Percutaneous Coronary Intervention: Long-Term Outcomes from the BENELUX Registry
Year: 2025
Type: article
Study design: Observational Study
Abstract: Diabetes mellitus (DM) is associated with increased coronary calcification and adverse outcomes after percutaneous coronary intervention (PCI), yet the performance of intravascular lithotripsy (IVL) in this high-risk population remains insufficiently defined. This study, conducted within the all-comers BENELUX-IVL registry, evaluated the safety and efficacy of IVL-assisted PCI in patients with and without DM. The primary endpoint was major adverse cardiovascular events (MACE) at 1 and 2 years, defined as cardiovascular death, nonfatal myocardial infarction, or clinically driven target vessel revascularization. Secondary endpoints included procedural outcomes, complications, and all-cause mortality. A total of 574 patients were included, of whom 193 (33.6%) had DM and 381 (66.4%) did not. Procedural (87.0% vs 89.5%; p = 0.381) and device success (95.3% vs 97.9%; p = 0.087) were similar between groups. Post-PCI minimum lumen diameter (2.80 ± 0.59 vs 2.95 ± 0.70 mm; p = 0.027) and area (6.0 [4.80 to 7.75] vs 6.6 [4.98 to 8.90] mm²; p = 0.045) were smaller in patients with DM. Thirty-day MACE was higher among diabetics (3.1% vs 0.3%; p = 0.007), whereas 1- and 2-year MACE and mortality rates were comparable. Diabetes was not independently associated with mortality (adjusted OR 1.51; p = 0.17). In conclusion, IVL-assisted PCI is safe and effective in diabetic patients, with long-term outcomes comparable to those without diabetes, although the higher early MACE risk, particularly in type 1 DM, warrants careful procedural planning and follow-up.
Authors: Akshay A.S. Phagu, Martijn J.H. van Oort, Federico Oliveri, Brian O. Bingen, Valeria Paradies, Gianluca Mincione, Bimmer E.P.M. Claessen, Aukelien C. Dimitriu-Leen, Tessel N. Vossenberg, Joelle Kefer, Alessandro Mandurino-Mirizzi, Marios Sagris, Frank van der Kley, J. Wouter Jukema, Ibtihal Al Amri, Jose M. Montero-Cabezas
Institutions: Leiden University Medical Center, Maasstad Ziekenhuis, IRCCS Humanitas Research Hospital, Amsterdam UMC Location University of Amsterdam, Amsterdam University Medical Centers, Radboud University Nijmegen, Radboud University Medical Center, Medisch Centrum Leeuwarden, Frisius MC, Cliniques Universitaires Saint-Luc, University of Salento, Ospedale Vito Fazzi, National and Kapodistrian University of Athens, Hippocration General Hospital, Netherlands Heart Institute
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,380
OpenAlex ID: W4416758047
