Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO.
CPC Clinical Research Aurora CO.
J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.
Background Despite high female prevalence of peripheral artery disease (PAD), little is known about sex-based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported. Methods and Results In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low-dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER. Unplanned index limb revascularization was prespecified and prospectively ascertained. The primary safety outcome was Thrombolysis in Myocardial Infarction major bleeding. Analyses of outcomes and treatment effects by sex were performed using Cox proportional hazards models. Among 6564 randomly assigned patients followed for a median of 28 months, 1704 (26.0%) were women. Among patients administered placebo, women were at similar risk for the primary efficacy outcome (hazard ratio [HR], 0.90; [95% CI, 0.74-1.09]; =0.29) as men, while female sex was associated with a trend toward higher risk of unplanned index limb revascularization (HR, 1.18; [95% CI, 1.00-1.40]; =0.0499). Irrespective of sex, effects of rivaroxaban were consistent for the primary efficacy outcome (-interaction=0.22), unplanned index limb revascularization (-interaction=0.64), and bleeding (-interaction=0.61). Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03-1.25]; =0.0099). Conclusions Among >1700 women with PAD undergoing LER, women and men were at similar risk for the primary outcome, but a trend for greater risk of unplanned index limb revascularization among women was observed. Effects of rivaroxaban were consistent by sex, though women more often discontinued treatment. Better understanding of sex-based outcomes and treatment adherence following LER is needed. Registration URL: http://clinicaltrials.gov; Unique identifier: NCT02504216.
尽管女性外周动脉疾病（PAD）的患病率较高，但对于症状性 PAD 下肢血运重建（LER）后的性别相关结局知之甚少。利伐沙班在 LER 后的性别影响尚未得到充分报告。
在 VOYAGER PAD（ASA[乙酰水杨酸]联合利伐沙班治疗外周动脉疾病的血管结局研究）中，与安慰剂相比，低剂量利伐沙班联合阿司匹林可降低 PAD 患者接受 LER 后心血管和肢体事件的复合主要疗效终点。未计划的索引肢体血运重建是预先规定并前瞻性确定的。主要安全性结局是心肌梗死溶栓出血的主要出血。使用 Cox 比例风险模型对性别相关结局和治疗效果进行分析。在 6564 例随机分配的患者中，中位随访时间为 28 个月，其中 1704 例（26.0%）为女性。在接受安慰剂治疗的患者中，女性发生主要疗效结局的风险与男性相似（风险比[HR]，0.90；[95%置信区间，0.74-1.09]；=0.29），而女性性别与未计划索引肢体血运重建的风险呈上升趋势（HR，1.18；[95%置信区间，1.00-1.40]；=0.0499）。无论性别如何，利伐沙班对主要疗效结局（-交互作用=0.22）、未计划索引肢体血运重建（-交互作用=0.64）和出血（-交互作用=0.61）的影响一致。与男性相比，女性更有可能停止研究治疗（HR，1.13；[95%置信区间，1.03-1.25]；=0.0099）。
在 1700 多名接受 LER 的 PAD 女性中，女性和男性发生主要结局的风险相似，但女性未计划索引肢体血运重建的风险呈上升趋势。按性别划分，利伐沙班的疗效一致，但女性更常停止治疗。需要更好地了解 LER 后基于性别的结局和治疗依从性。
