Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT.
Division of Vascular Surgery, Department of Surgery, University of North Carolina School of Medicine, Chapel Hill, NC.
J Vasc Surg. 2024 Feb;79(2):358-365. doi: 10.1016/j.jvs.2023.10.058. Epub 2023 Nov 2.
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 test or Fisher exact test, as appropriate.
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.
与男性相比，下肢外周动脉疾病（PAD）的血管内治疗与更高的并发症发生率和更差的预后相关。虽然血管内碎石术（IVL）在钙化的冠状动脉中显示出对男性和女性同样有利的结果，但没有发表过按性别区分的外周 IVL 的安全性和有效性数据。本研究旨在评估 IVL 治疗钙化性 PAD 后的性别特异性急性程序安全性和有效性。
我们对多中心 Disrupt PAD III 观察性研究进行了二次分析，该研究评估了使用 Shockwave 外周 IVL 系统治疗有症状的钙化性下肢 PAD 的患者的短期程序结局。使用 χ2 检验或 Fisher 确切检验（视情况而定）对性别进行了单变量分析，比较了经裁定的急性安全性和疗效结局。
共纳入 1262 例患者（29.9%为女性），其中超过 85%有中重度病变钙化。女性年龄更大（74 岁 vs 71 岁；P <.001），踝肱指数更低（0.7 vs 0.8；P <.001），参考血管直径更小（5.3 毫米 vs 5.6 毫米；P <.001），基线时狭窄更严重（82.3% vs 79.8%；P <.012）。两组的糖尿病、肾功能不全、慢性肢体威胁性缺血、病变长度和旋切术使用率相似。两组单独使用 IVL 后残余狭窄均显著减少。女性最终残余狭窄率为 21.9%，男性为 24.7%（P <.001）。严重的血管造影并发症在两组中均很少见且相似（1.4% vs 0.6%；P <.21），在任何程序中均无急性血管闭塞、远端栓塞或血栓事件。
在这个观察性登记处，使用 IVL 治疗钙化性 PAD 显示出良好的急性安全性和有效性，在女性和男性中均如此。
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