Jesus G. Ulloa MD, MBA, MSHPM , Olamide Alabi MD, MS , Katharine McGinigle MD, MPH , John Lane MD, MS , Gheorghe Doros PhD, MBA , Matthew Menard MD , Carla C. Moreira MD, PhD , Deja R. Judelson MD , Alik Farber MD , Michael S. Conte MD , Kenneth Rosenfeld MD , Mohammed Hamouda MD , Lee Kirksey MD, MBA , Michael B. Strong MA , Mahmoud Malas MD , Amber Kernodle MD, PhD , Vincent L. Rowe MD
{"title":"在BEST-CLI试验中接受开放式旁路手术的西班牙裔患者的结果。","authors":"Jesus G. Ulloa MD, MBA, MSHPM , Olamide Alabi MD, MS , Katharine McGinigle MD, MPH , John Lane MD, MS , Gheorghe Doros PhD, MBA , Matthew Menard MD , Carla C. Moreira MD, PhD , Deja R. Judelson MD , Alik Farber MD , Michael S. Conte MD , Kenneth Rosenfeld MD , Mohammed Hamouda MD , Lee Kirksey MD, MBA , Michael B. Strong MA , Mahmoud Malas MD , Amber Kernodle MD, PhD , Vincent L. Rowe MD","doi":"10.1016/j.jvs.2025.01.212","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><div>Hispanic patients have a higher prevalence of peripheral artery disease (PAD) risk factors, undergo revascularization at lower rates, and have higher rates of major amputation. This study compares outcomes after open surgical revascularization within the Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) Trial between Hispanic and non-Hispanic White patients.</div></div><div><h3>Methods</h3><div>In a secondary analysis of BEST-CLI, open surgical cohorts were combined (cohort 1, suitable single segment greater saphenous vein [n = 484]; cohort 2, lack of suitable single segment greater saphenous vein [n = 150]) and examined, by ethnicity, for the following 1-year outcomes: (1) above-ankle amputation, (2) major reintervention, (3) major adverse limb event (a composite of major amputation and major reintervention), and (4) survival. Cox regression models were constructed to determine the association between Hispanic ethnicity and selected endpoints after surgical bypass for patients enrolled in BEST-CLI.</div></div><div><h3>Results</h3><div>Of the 634 patients who underwent open surgical bypass, 528 (83.3%) were non-Hispanic White (White) and 106 (16.7%) were Hispanic. Compared with White patients, Hispanic patients were younger (64.6 ± 8.6 years vs 68.5 ± 9.6 years; <em>P</em> < .001), had a higher proportion of diabetes (91.5% vs 66.3%; <em>P</em> < .001), end-stage renal disease (15.1% vs 6.8%; <em>P</em> = .005), and were more often never smokers (44.3% vs 16.2%; <em>P</em> < .001). Preoperative ankle-brachial index was higher among Hispanic patients (0.7 ± 0.4 vs 0.5 ± 0.3; <em>P</em> < .001). After controlling for age, sex, diabetes, end-stage renal disease, smoking history, infrapopliteal disease, Wound Ischemia foot Infection stage, and previous lower extremity revascularization, Hispanic ethnicity was not significantly associated with major amputation (adjusted hazard ratio [aHR], 0.67; 95% confidence interval [CI], 0.30-1.48), major reintervention (aHR, 0.81; 95% CI, 0.35-1.87), major adverse limb event (aHR, 0.64; 95% CI, 0.34-1.21), or survival (aHR, 0.69; 95% CI, 0.42-1.13) 1 year after surgical bypass.</div></div><div><h3>Conclusions</h3><div>Disparities in limb-related outcomes were not observed for Hispanic patients undergoing open revascularization in BEST-CLI. Future PAD clinical trials should capture metrics of access to care, and timeliness of care for assessing risk of disparate outcomes among PAD populations thought to be at higher risk based on epidemiological and retrospective studies.</div></div>","PeriodicalId":17475,"journal":{"name":"Journal of Vascular Surgery","volume":"81 6","pages":"Pages 1420-1429"},"PeriodicalIF":3.6000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Outcomes for Hispanic patients undergoing open bypass in BEST-CLI\",\"authors\":\"Jesus G. Ulloa MD, MBA, MSHPM , Olamide Alabi MD, MS , Katharine McGinigle MD, MPH , John Lane MD, MS , Gheorghe Doros PhD, MBA , Matthew Menard MD , Carla C. Moreira MD, PhD , Deja R. Judelson MD , Alik Farber MD , Michael S. Conte MD , Kenneth Rosenfeld MD , Mohammed Hamouda MD , Lee Kirksey MD, MBA , Michael B. Strong MA , Mahmoud Malas MD , Amber Kernodle MD, PhD , Vincent L. Rowe MD\",\"doi\":\"10.1016/j.jvs.2025.01.212\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><div>Hispanic patients have a higher prevalence of peripheral artery disease (PAD) risk factors, undergo revascularization at lower rates, and have higher rates of major amputation. This study compares outcomes after open surgical revascularization within the Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) Trial between Hispanic and non-Hispanic White patients.</div></div><div><h3>Methods</h3><div>In a secondary analysis of BEST-CLI, open surgical cohorts were combined (cohort 1, suitable single segment greater saphenous vein [n = 484]; cohort 2, lack of suitable single segment greater saphenous vein [n = 150]) and examined, by ethnicity, for the following 1-year outcomes: (1) above-ankle amputation, (2) major reintervention, (3) major adverse limb event (a composite of major amputation and major reintervention), and (4) survival. Cox regression models were constructed to determine the association between Hispanic ethnicity and selected endpoints after surgical bypass for patients enrolled in BEST-CLI.</div></div><div><h3>Results</h3><div>Of the 634 patients who underwent open surgical bypass, 528 (83.3%) were non-Hispanic White (White) and 106 (16.7%) were Hispanic. Compared with White patients, Hispanic patients were younger (64.6 ± 8.6 years vs 68.5 ± 9.6 years; <em>P</em> < .001), had a higher proportion of diabetes (91.5% vs 66.3%; <em>P</em> < .001), end-stage renal disease (15.1% vs 6.8%; <em>P</em> = .005), and were more often never smokers (44.3% vs 16.2%; <em>P</em> < .001). Preoperative ankle-brachial index was higher among Hispanic patients (0.7 ± 0.4 vs 0.5 ± 0.3; <em>P</em> < .001). After controlling for age, sex, diabetes, end-stage renal disease, smoking history, infrapopliteal disease, Wound Ischemia foot Infection stage, and previous lower extremity revascularization, Hispanic ethnicity was not significantly associated with major amputation (adjusted hazard ratio [aHR], 0.67; 95% confidence interval [CI], 0.30-1.48), major reintervention (aHR, 0.81; 95% CI, 0.35-1.87), major adverse limb event (aHR, 0.64; 95% CI, 0.34-1.21), or survival (aHR, 0.69; 95% CI, 0.42-1.13) 1 year after surgical bypass.</div></div><div><h3>Conclusions</h3><div>Disparities in limb-related outcomes were not observed for Hispanic patients undergoing open revascularization in BEST-CLI. Future PAD clinical trials should capture metrics of access to care, and timeliness of care for assessing risk of disparate outcomes among PAD populations thought to be at higher risk based on epidemiological and retrospective studies.</div></div>\",\"PeriodicalId\":17475,\"journal\":{\"name\":\"Journal of Vascular Surgery\",\"volume\":\"81 6\",\"pages\":\"Pages 1420-1429\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Vascular Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0741521425002587\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Vascular Surgery","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0741521425002587","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/4 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
摘要
目的:西班牙裔患者外周动脉疾病(PAD)危险因素的患病率较高,接受血运重建术的比例较低,并且主要截肢的比例较高。本研究比较了西班牙裔和非西班牙裔白人重症肢体缺血患者在最佳血管内治疗和最佳手术治疗(Best - cli)试验中开放手术重建术的结果。方法:在BEST-CLI试验的二次分析中,开放手术队列被合并(队列1:合适的单段大隐静脉(SSGSV), N=484;队列2:缺乏合适的SSGSV, N=150),并按种族检查以下1年结果:1)踝关节以上截肢;2)重大再干预;3)肢体重大不良事件(MALE,主要截肢和主要再干预的复合事件);4)生存。构建Cox回归模型以确定西班牙裔种族与BEST-CLI试验患者旁路手术后选定终点之间的关系。结果:在634例接受开放旁路手术的患者中,528例(83.3%)为非西班牙裔白人(White), 106例(16.7%)为西班牙裔。与白人患者相比,西班牙裔患者更年轻(64.6±8.6 vs 68.5±9.6)。结论:在最佳- cli试验中,接受开放性血运重建术的西班牙裔患者未观察到肢体相关结局的差异。根据流行病学和回顾性研究,未来的PAD临床试验应该获得治疗的可及性指标和治疗的及时性,以评估PAD人群中被认为具有较高风险的不同结果的风险。
Outcomes for Hispanic patients undergoing open bypass in BEST-CLI
Objectives
Hispanic patients have a higher prevalence of peripheral artery disease (PAD) risk factors, undergo revascularization at lower rates, and have higher rates of major amputation. This study compares outcomes after open surgical revascularization within the Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) Trial between Hispanic and non-Hispanic White patients.
Methods
In a secondary analysis of BEST-CLI, open surgical cohorts were combined (cohort 1, suitable single segment greater saphenous vein [n = 484]; cohort 2, lack of suitable single segment greater saphenous vein [n = 150]) and examined, by ethnicity, for the following 1-year outcomes: (1) above-ankle amputation, (2) major reintervention, (3) major adverse limb event (a composite of major amputation and major reintervention), and (4) survival. Cox regression models were constructed to determine the association between Hispanic ethnicity and selected endpoints after surgical bypass for patients enrolled in BEST-CLI.
Results
Of the 634 patients who underwent open surgical bypass, 528 (83.3%) were non-Hispanic White (White) and 106 (16.7%) were Hispanic. Compared with White patients, Hispanic patients were younger (64.6 ± 8.6 years vs 68.5 ± 9.6 years; P < .001), had a higher proportion of diabetes (91.5% vs 66.3%; P < .001), end-stage renal disease (15.1% vs 6.8%; P = .005), and were more often never smokers (44.3% vs 16.2%; P < .001). Preoperative ankle-brachial index was higher among Hispanic patients (0.7 ± 0.4 vs 0.5 ± 0.3; P < .001). After controlling for age, sex, diabetes, end-stage renal disease, smoking history, infrapopliteal disease, Wound Ischemia foot Infection stage, and previous lower extremity revascularization, Hispanic ethnicity was not significantly associated with major amputation (adjusted hazard ratio [aHR], 0.67; 95% confidence interval [CI], 0.30-1.48), major reintervention (aHR, 0.81; 95% CI, 0.35-1.87), major adverse limb event (aHR, 0.64; 95% CI, 0.34-1.21), or survival (aHR, 0.69; 95% CI, 0.42-1.13) 1 year after surgical bypass.
Conclusions
Disparities in limb-related outcomes were not observed for Hispanic patients undergoing open revascularization in BEST-CLI. Future PAD clinical trials should capture metrics of access to care, and timeliness of care for assessing risk of disparate outcomes among PAD populations thought to be at higher risk based on epidemiological and retrospective studies.
期刊介绍:
Journal of Vascular Surgery ® aims to be the premier international journal of medical, endovascular and surgical care of vascular diseases. It is dedicated to the science and art of vascular surgery and aims to improve the management of patients with vascular diseases by publishing relevant papers that report important medical advances, test new hypotheses, and address current controversies. To acheive this goal, the Journal will publish original clinical and laboratory studies, and reports and papers that comment on the social, economic, ethical, legal, and political factors, which relate to these aims. As the official publication of The Society for Vascular Surgery, the Journal will publish, after peer review, selected papers presented at the annual meeting of this organization and affiliated vascular societies, as well as original articles from members and non-members.