Mid-term outcome of de novo lesions vs. in stent restenosis treated by intravascular lithotripsy procedures: Insights from the French Shock Initiative

Abstract

Background: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion.

Methods: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately.

Results: A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group.

Conclusions: In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted.

Keywords: Coronary calcification; In-stent restenosis; Intravascular lithotripsy.