Intravascular Lithotripsy in Diabetic Patients Undergoing Percutaneous Coronary Intervention: Long-Term Outcomes from the BENELUX Registry

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.