Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies

Abstract

<h2>Abstract</h2><h3>Background</h3> Coronary artery calcification increases the procedural complexity of percutaneous coronary intervention and is associated with worse outcomes, especially in women. Intravascular lithotripsy (IVL) has been demonstrated to be safe and effective for vessel preparation in severely calcified stenotic lesions before stent implantation. Sex-based outcomes of IVL-facilitated stenting have not been defined. <h3>Methods</h3> We performed a patient-level pooled analysis of the 4 prospective, single-arm Disrupt CAD studies that evaluated the safety and efficacy of IVL-facilitated stenting. Patient baseline and procedural characteristics and clinical outcomes were examined based on sex. The primary safety end point was 30-day major adverse cardiovascular events, defined as the composite of cardiac death, myocardial infarction, or target vessel revascularization. The primary efficacy end point was procedural success, defined as stent delivery with residual in-stent stenosis вүӨ30% without in-hospital major adverse cardiovascular events. <h3>Results</h3> A total of 628 patients were included, of which 144 (22.9%) were women. Women were older (<i>P</i> < .001) and more likely to have hyperlipidemia (<i>P</i> = .03), renal insufficiency (<i>P</i> = .05), and prior myocardial infarction (<i>P</i> = .05). Women had smaller mean reference vessel diameter (2.7В вҖӢ ВұВ вҖӢ0.4В вҖӢmm vs 3.0В вҖӢ ВұВ вҖӢ0.5В вҖӢmm, <i>P</i> < .001), shorter lesion length (22.4В вҖӢ ВұВ вҖӢ10.3В вҖӢmm vs 25.0В вҖӢ ВұВ вҖӢ11.7В вҖӢmm, <i>P</i> = .01), and less side branch involvement (22.9% vs 32.4%, <i>P</i> = .03). Severe coronary calcification defined by angiography, stent delivery success, lesion predilatation, post-IVL dilatation, and poststent dilatation was similar between groups. There were no significant differences between women and men in the primary safety end point (8.3% vs 7.1%, <i>P</i> = .61; adjusted odds ratio 1.66; 95% confidence interval 0.78, 3.34; <i>P</i> = .17) or the primary efficacy end point (91.7% vs 92.6%, <i>P</i> = .72; adjusted odds ratio 0.58; 95% confidence interval 0.29, 1.24; <i>P</i> = .15). Post-IVL serious angiographic complications (flow-limiting dissection, perforation, abrupt closure, slow flow, no reflow) were similar for women and men (1.6% vs 2.3%, <i>P</i> = .75). <h3>Conclusions</h3> Despite more comorbidities and smaller vessel size, IVL-facilitated stenting of severely calcified lesions achieves similar safety and efficacy in women and men.