Drug-coated balloon strategy following intravascular lithotripsy to treat coronary de novo lesion: mid-term clinical outcomes of a preliminary experience.

Objectives: The management of patients with calcified de novo lesions remains a major clinical challenge even in the era of drug-eluting stents (DES). Drug-coated balloon (DCB) therapy has emerged as an alternative to DES to treat de novo lesions. Nevertheless, the management of calcified lesions using intravascular lithotripsy (IVL) combined with DCB to treat de novo lesions has not been investigated. The authors report the short-term results of our preliminary experience with this novel approach.

Methods: The authors conducted a multicenter retrospective study of 14 patients who underwent percutaneous coronary intervention for de novo lesions treated with IVL followed by DCB in 3 centers between September 2023 and July 2024.

Results: The mean age of the patients was 69 years, and 71% were male. At 30 days, 1 patient experienced non-cardiac death. No lesion site thrombosis, target lesion revascularization (TLR), or cardiac death occurred at the 30-day follow-up. At the 6-month follow-up, 2 (14.3%) patients experienced TLR.

Conclusions: This real-world data using IVL followed by DCB (in cases of acceptable lesion preparation) in patients with de novo calcified coronary lesions suggest that this strategy is feasible and appears to have an acceptable target lesion failure rate at mid-term follow-up. This proof of concept could be hypothesis-generating for larger studies.