Intravascular lithotripsy in diabetic patients undergoing percutaneous coronary intervention: long-term outcomes from an all-comers 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, non-fatal 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 [4.80–7.75] vs. 6.6 [4.98–8.90] 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.