在ELEGANCE注册表中实施方法,以增加临床研究的多样性
Eric A Secemsky1, Jay Giri2, Marianne Brodmann3
1Department of Vascular Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
Journal of vascular surgery
|September 24, 2023
概括
ELEGANCE注册表强调了不同患者群体中外围动脉疾病 (PAD) 呈现和特征的显著差异,强调了需要量身定制的护理策略的需要. 这项研究强调了PAD的性别和种族/种族差异.
科学领域:
- 心血管研究研究心血管研究
- 血管医学 血管医学
- 健康差异 在健康上的差异
背景情况:
- 周围动脉疾病 (PAD) 不成比例地影响女性和代表性不足的少数群体 (URM).
- 与非西班牙裔白人男性相比,这些人口群体对PAD治疗的反应不同.
- 在现有的PAD研究中,女性和URM的代表性明显不足.
研究的目的:
- 在接受外周动脉疾病 (PAD) 治疗的多元人群中评估基线疾病特征.
- 评估 ELEGANCE 登记册的招生策略,以实现女性和 URM 的代表性.
- 为了确定在不同性别和种族/民族群体的PAD呈现和治疗指示的潜在差异.
主要方法:
- ELEGANCE注册表是一个全球性的,前性的,多中心的,市场后研究.
- 它的目标是注册至少40%的女性和40%的代表性不足的少数民族 (URM).
- 包括标准包括年龄≥18岁和使用波士顿科学药物释放装置治疗外周病变的治疗.
主要成果:
- 目前,有750名患者注册,其中43.2%是女性,47.3%是URM.
- 在拉瑟福分类按性别 (P=.019) 和按种族/种族 (P=.003) 的治疗指示 (P=.003) 中观察到显著差异.
- 慢性肢体威胁性缺血在黑人和西班牙裔/拉丁裔患者中更为普遍,而de-novo狭窄症在亚洲患者中更为普遍.
结论:
- 根据ELEGANCE注册数据显示,基于性别和种族/种族的PAD基线特征存在差异.
- 这些差异可能源于诸如延迟诊断,未经管理的并发症和获得护理的不平等等因素.
- 需要进一步的研究来解决这些差异,并优化所有患者群体的PAD管理.
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