Frampton Jennifer, Kearney Kathleen E, Abbott J Dawn, Kereiakes Dean J, Di Mario Carlo, Saito Shigeru, Cristea Ecaterina, Riley Robert F, Fajadet Jean, Shlofmitz Richard A, Ali Ziad A, Klein Andrew J, Price Matthew J, Hill Jonathan M, Stone Gregg W, Lansky Alexandra J
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
University of Washington, Seattle, Washington.
J Soc Cardiovasc Angiogr Interv. 2023 Nov 7;2(6Part A):101069. doi: 10.1016/j.jscai.2023.101069. eCollection 2023 Nov-Dec.
Intravascular lithotripsy (IVL) for calcified lesion preparation prior to drug-eluting stent placement has high procedural success and safety, especially in women, whereas other atheroablative approaches are associated with increased procedural complications. We sought to investigate long-term sex-based outcomes of IVL-facilitated stenting.
We performed a patient-level pooled analysis of the single-arm Disrupt CAD III and IV studies. Patient baseline, procedural characteristics, and outcomes were examined according to sex at 30 days and 1 year. The primary end point was major adverse cardiac events (a composite of cardiac death, all myocardial infarction, or target vessel revascularization). Target lesion failure was defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
A total of 448 patients, 106 (24%) women, were included. Women were older and less likely to be smokers. Women had smaller reference vessel diameters (2.8 mm vs 3.1 mm), shorter lesion length (23.6 mm vs 27.1 mm), and shorter total calcified length (44.4 mm vs 49.3 mm) compared with men. Post-IVL angiographic outcomes and complications were similar between women and men. At 1 year, major adverse cardiac event rates (12.3% vs 13.2%, = .52) were not different between women and men. There were no differences between women and men (10.4% vs 11.2%; = .43) in target lesion failure at 1 year.
Use of IVL in the treatment of severely calcified lesions is associated with low rates of adverse clinical events and with similar safety and effectiveness in women and men at 1 year.
在药物洗脱支架置入前,采用血管内碎石术(IVL)来处理钙化病变具有较高的手术成功率和安全性,尤其是在女性患者中,而其他粥样斑块消融方法则与手术并发症增加相关。我们旨在研究IVL辅助支架置入的长期性别差异结局。
我们对单臂Disrupt CAD III和IV研究进行了患者层面的汇总分析。根据性别在30天和1年时检查患者的基线、手术特征和结局。主要终点是主要不良心脏事件(心脏死亡、所有心肌梗死或靶血管血运重建的复合事件)。靶病变失败定义为心脏死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建。
共纳入448例患者,其中106例(24%)为女性。女性年龄更大,吸烟的可能性更小。与男性相比,女性的参考血管直径更小(2.8毫米对3.1毫米),病变长度更短(23.6毫米对27.1毫米),总钙化长度更短(44.4毫米对49.3毫米)。女性和男性在IVL术后的血管造影结局和并发症相似。在1年时,女性和男性的主要不良心脏事件发生率(12.3%对13.2%,P = 0.52)无差异。在1年时,女性和男性的靶病变失败率(10.4%对11.2%;P = 0.43)无差异。
使用IVL治疗严重钙化病变与不良临床事件发生率低相关,且在1年时女性和男性的安全性及有效性相似。