TCT-163 Gender Differences in Outcomes of Intravascular Lithotripsy versus Mechanical Atherectomy for Severely Calcified Coronary Lesions: A ROLLING STONE Registry Sub-Analysis in Journal of the American College of Cardiology

2025
ASL Torino 3
ASL VCO
ASL Vercelli

Tipo pubblicazione

Conference Abstract

Autori/Collaboratori (32)Vedi tutti...

Pavani G
University of Turin, Turin, Chieri, Italy
Pavani M
San Luigi Gonzaga University Hospital/Rivoli Hospital, Turin, Turin, Italy
Cerrato E
Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Infermi Hospital, Rivoli, Turin, Italy, Turin, Turin, Italy

et alii...

Abstract

Background: Intravascular lithotripsy (IVL) and mechanical debulking are established coronary calcium modification techniques, but robust comparative data from real-world practice, especially concerning sex-specific outcomes, are lacking. This gap is largely due to the historical underrepresentation of women in pivotal cardiovascular trials. This analysis aimed to address this critical evidence gap by examining the relative performance of IVL vs mechanical debulking with orbital or rotational atherectomy (AT), in both women and men. Methods: This was a pre-specified sub-analysis of the prospective, multicenter ROLLING STONE registry (NCT05016726), which enrolled consecutive patients from 23 Italian centers. The present analysis included 888 patients (195 female, 693 male) requiring either IVL or AT for severely calcified coronary lesions. The primary safety endpoint was 30-day Major Adverse Cardiac Events (MACE), a composite of cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The primary efficacy endpoint was procedural success (successful stent delivery, final residual stenosis <30%, and no in-hospital MACE). A key secondary endpoint was 1-year MACE. Outcomes were analyzed using multivariate Cox proportional-hazards and logistic regression models, adjusted for potential confounders. A formal interaction analysis was performed to test for effect modification by sex on the treatment strategy. Results: Baseline characteristics differed significantly, with females being older, having a lower prevalence of smoking history, and presenting more frequently with acute coronary syndromes (ACS). Procedurally, females received radial access less often. A significant interaction between sex and treatment strategy was discovered for the primary efficacy endpoint of procedural success (interaction OR 0.15, 95% CI: 0.02-0.80; p=0.040), indicating a clear differential treatment effect. Subsequent stratified analyses revealed that IVL was a

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DOI : 10.1016/j.jacc.2025.09.238

Keywords

calcium; acute coronary syndrome; aged; atherectomy; calcification; cardiovascular disease; conference abstract; controlled study; female; follow up; heart death; heart infarction; human; lithotripsy; major adverse cardiac event; major clinical study; male; multicenter study; prevalence; rotational atherectomy; sex difference; smoking; target vessel revascularization; therapy effect;