Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study.

Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

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Copyright © 2023. Published by Elsevier Inc.

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Disclosures S.N. reports consultant for Cardinal Health, Haemonetics, and Veryan Medical. K.M. reports speaker fees from Shockwave Medical and Penumbra Inc. S.S.M. reports speaker fees from Shockwave Medical. G.A. reports consultant for education and research for Shockwave Medical. N.W.S. reports research and educational grants from Bard, AngioDynamics, and Boston Scientific; consultant for Abbott, Shockwave Medical, and VentureMed Group; and speaker bureau for Janssen, Boehringer Ingelheim, Merck, Amgen, and Bayer. A.M. reports speaker fees from Shockwave Medical; and speaker and training fees from Abbott. P.S. reports institutional grant support from W.L. Gore, Boston Scientific, Contego Medical, Endologix, InspireMD, MicroMedical Solutions, Philips, and Shockwave Medical. B.B. reports speaker fees from Shockwave Medical. A.J.L. reports speaker fees from Shockwave Medical.