Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III
Sameer Nagpal1, S Elissa Altin1, Katharine McGinigle2
1Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT.
Insights
Intravascular lithotripsy (IVL) for peripheral artery disease (PAD) shows similar safety and effectiveness in women and men. This study found no significant sex-based differences in complications or outcomes for calcified PAD treatment.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Endovascular therapy for peripheral artery disease (PAD) historically has higher complication rates in women compared to men.
- Intravascular lithotripsy (IVL) has demonstrated favorable outcomes in coronary arteries regardless of sex, but data for peripheral PAD is limited.
- Investigating sex-specific outcomes in peripheral IVL is crucial for equitable treatment strategies.
Purpose of the Study:
- To evaluate the acute procedural safety and effectiveness of intravascular lithotripsy (IVL) for treating calcified lower extremity peripheral artery disease (PAD) differentiated by sex.
- To compare outcomes between women and men undergoing IVL for calcified PAD.
- To identify any sex-specific trends in complications or procedural success.
Main Methods:
- Secondary analysis of the multicenter Disrupt PAD III Observational Study.
- Inclusion of 1262 patients with symptomatic calcified lower extremity PAD treated with the Shockwave peripheral IVL system.
- Comparison of adjudicated acute safety and efficacy outcomes by sex using univariate statistical analysis (chi-squared or Fisher exact test).
Main Results:
- Women were older and had lower ankle-brachial index, smaller reference vessel size, and more severe stenosis at baseline compared to men.
- Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar between sexes.
- IVL significantly reduced residual stenosis in both groups (21.9% in women vs. 24.7% in men) with infrequent and similar serious angiographic complications (1.4% vs. 0.6%).
Conclusions:
- Intravascular lithotripsy (IVL) demonstrates favorable acute safety and effectiveness in treating calcified PAD in both women and men.
- No significant sex-based differences in acute procedural safety or effectiveness were observed.
- IVL is a viable treatment option for calcified PAD across both sexes.
Objective:
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.
Methods:
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 χ2 test or Fisher exact test, as appropriate.
Results:
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.
Conclusions:
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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