Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Harvard Medical School (retired), Boston, MA.
J Vasc Surg. 2023 Sep;78(3):711-718.e5. doi: 10.1016/j.jvs.2023.05.006. Epub 2023 May 17.
The use of optimal medical therapy (OMT) in patients with chronic limb-threatening ischemia (CLTI) has not been well-studied. The Best Endovascular vs Best Surgical Therapy in Patients with CLTI study (BEST-CLI) is a multicenter, randomized, controlled trial sponsored by the National Institutes of Health comparing revascularization strategies in patients with CLTI. We evaluated the use of guideline-based OMT among patients with CLTI at the time of their enrollment into the trial.
A multidisciplinary committee defined OMT criteria related to blood pressure and diabetic management, lipid-lowering and antiplatelet medication use, and smoking status for patients enrolled in BEST-CLI. Status reports indicating adherence to OMT were provided to participating sites at regular intervals. Baseline demographic characteristics, comorbid medical conditions, and use of OMT at trial entry were evaluated for all randomized patients. A linear regression model was used to identify the relationship of predictors to the use of OMT.
At the time of randomization (n = 1830 total enrolled), 87% of patients in BEST-CLI had hypertension, 69% had diabetes, 73% had hyperlipidemia, and 35% were currently smoking. Adherence to four OMT components (controlled blood pressure, not currently smoking, use of one lipid-lowering medication, and use of an antiplatelet agent) was modest. Only 25% of patients met all four OMT criteria; 38% met three, 24% met two, 11% met only one, and 2% met none. Age ≥80 years, coronary artery disease, diabetes, and Hispanic ethnicity were positively associated, whereas Black race was negatively associated, with the use of OMT.
A significant proportion of patients in BEST-CLI did not meet OMT guideline-based recommendations at time of entry. These data suggest a persistent major gap in the medical management of patients with advanced peripheral atherosclerosis and CLTI. Changes in OMT adherence over the course of the trial and their impact on clinical outcomes and quality of life will be assessed in future analyses.
慢性肢体威胁性缺血（CLTI）患者的最佳药物治疗（OMT）尚未得到充分研究。由美国国立卫生研究院（National Institutes of Health）赞助的 CLTI 患者最佳血管内治疗与最佳手术治疗研究（BEST-CLI）是一项多中心、随机、对照试验，比较了 CLTI 患者的血管重建策略。我们评估了在该试验入组时 CLTI 患者的循证 OMT 应用情况。
一个多学科委员会为 BEST-CLI 患者定义了与血压和糖尿病管理、降脂和抗血小板药物使用以及吸烟状况相关的 OMT 标准。定期向参与站点提供表明 OMT 依从性的状态报告。对所有随机患者的基线人口统计学特征、合并症和试验入组时的 OMT 使用情况进行了评估。使用线性回归模型来确定预测因素与 OMT 使用的关系。
在随机分组时（共 1830 名入组患者），BEST-CLI 患者中 87%有高血压，69%有糖尿病，73%有高脂血症，35%正在吸烟。对四项 OMT 组成部分（控制血压、不吸烟、使用一种降脂药物和使用一种抗血小板药物）的依从性适度。只有 25%的患者符合所有四项 OMT 标准；38%符合三项，24%符合两项，11%符合一项，2%符合零项。年龄≥80 岁、冠心病、糖尿病和西班牙裔与 OMT 的使用呈正相关，而黑人种族与 OMT 的使用呈负相关。
BEST-CLI 中的相当一部分患者在入组时不符合 OMT 循证推荐。这些数据表明，在晚期外周动脉粥样硬化和 CLTI 患者的医学管理方面仍然存在重大差距。在试验过程中对 OMT 依从性的变化及其对临床结局和生活质量的影响将在未来的分析中进行评估。
