Behnood Bikdeli, Hannah Leyva, Alfonso Muriel, Zhenqiu Lin, Gregory Piazza, Candrika D Khairani, Rachel P Rosovsky, Ghazaleh Mehdipour, Michelle L O'Donoghue, Olga Madridano, Juan Bosco Lopez-Saez, Meritxell Mellado, Ana Maria Diaz Brasero, Elvira Grandone, Primavera A Spagnolo, Yuan Lu, Laurent Bertoletti, Luciano López-Jiménez, Manuel Jesús Núñez, Ángeles Blanco-Molina, Marie Gerhard-Herman, Samuel Z Goldhaber, Shannon M Bates, David Jimenez, Harlan M Krumholz, Manuel Monreal
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The few existing show conflicting results due to small sample size (type II error) and suboptimal methods (overreliance on <i>p</i>-value, which may detect differences of small clinical relevance).</p><p><strong>Methods: </strong>We assessed sex differences in anticoagulation and advanced therapies for PE in older adults, utilizing data from Registro Informatizado Enfermedad TromboEmbolica (RIETE), a large PE registry with predominant participation from Europe, and data from US Medicare beneficiaries. We prespecified a standardized difference (SRD) > 10% as clinically relevant. RIETE included 33,462 (57.7% female) and Medicare included 102,391 (55.0% female) older adults with PE.</p><p><strong>Results: </strong>In RIETE, there were no overall sex differences in the use of anticoagulation (median: 181 vs 180 days, SRD < 1%), fibrinolysis (SRD < 3%), thrombectomy (SRD < 2%), or inferior vena cava (IVC) filters (SRD: 4.4%). However, fibrinolytic therapy (systemic or catheter-based) was less often used in female than male patients with intermediate-risk PE (8.0% vs 12.1%, SRD: 13.6%). No sex differences were noted with advanced PE therapies in Medicare beneficiaries. In unadjusted analyses, fibrinolysis and IVC filter placement were more frequent in Medicare than RIETE participants regardless of sex (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>In a predominantly European PE registry and a US study of older adults, there were no overall sex differences in anticoagulation patterns or advanced therapy utilization. Future studies should determine if sex disparities in fibrinolytic therapy for intermediate-risk PE and greater use of advanced therapies in US older adults correlate with clinical outcomes.</p>","PeriodicalId":23604,"journal":{"name":"Vascular Medicine","volume":" ","pages":"1358863X241292023"},"PeriodicalIF":3.0000,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Sex differences in treatment strategies for pulmonary embolism in older adults: The SERIOUS-PE study of RIETE participants and US Medicare beneficiaries.\",\"authors\":\"Behnood Bikdeli, Hannah Leyva, Alfonso Muriel, Zhenqiu Lin, Gregory Piazza, Candrika D Khairani, Rachel P Rosovsky, Ghazaleh Mehdipour, Michelle L O'Donoghue, Olga Madridano, Juan Bosco Lopez-Saez, Meritxell Mellado, Ana Maria Diaz Brasero, Elvira Grandone, Primavera A Spagnolo, Yuan Lu, Laurent Bertoletti, Luciano López-Jiménez, Manuel Jesús Núñez, Ángeles Blanco-Molina, Marie Gerhard-Herman, Samuel Z Goldhaber, Shannon M Bates, David Jimenez, Harlan M Krumholz, Manuel Monreal\",\"doi\":\"10.1177/1358863X241292023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Sex differences exist in risk factors and comorbidities of older adults (aged ⩾ 65 years) with pulmonary embolism (PE). Clinically relevant sex-based treatment disparities for PE have not been adequately addressed. The few existing show conflicting results due to small sample size (type II error) and suboptimal methods (overreliance on <i>p</i>-value, which may detect differences of small clinical relevance).</p><p><strong>Methods: </strong>We assessed sex differences in anticoagulation and advanced therapies for PE in older adults, utilizing data from Registro Informatizado Enfermedad TromboEmbolica (RIETE), a large PE registry with predominant participation from Europe, and data from US Medicare beneficiaries. We prespecified a standardized difference (SRD) > 10% as clinically relevant. RIETE included 33,462 (57.7% female) and Medicare included 102,391 (55.0% female) older adults with PE.</p><p><strong>Results: </strong>In RIETE, there were no overall sex differences in the use of anticoagulation (median: 181 vs 180 days, SRD < 1%), fibrinolysis (SRD < 3%), thrombectomy (SRD < 2%), or inferior vena cava (IVC) filters (SRD: 4.4%). However, fibrinolytic therapy (systemic or catheter-based) was less often used in female than male patients with intermediate-risk PE (8.0% vs 12.1%, SRD: 13.6%). No sex differences were noted with advanced PE therapies in Medicare beneficiaries. In unadjusted analyses, fibrinolysis and IVC filter placement were more frequent in Medicare than RIETE participants regardless of sex (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>In a predominantly European PE registry and a US study of older adults, there were no overall sex differences in anticoagulation patterns or advanced therapy utilization. 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引用次数: 0
摘要
导言:患有肺栓塞(PE)的老年人(65 岁以上)在风险因素和合并症方面存在性别差异。与临床相关的基于性别的肺栓塞治疗差异尚未得到充分研究。由于样本量小(II 型误差)和方法不理想(过度依赖 p 值,可能检测出临床相关性较小的差异),现有的少数研究显示出相互矛盾的结果:我们评估了老年人PE抗凝和先进疗法的性别差异,利用的数据来自Registro Informatizado Enfermedad TromboEmbolica (RIETE),这是一个主要来自欧洲的大型PE登记处,数据来自美国医疗保险受益人。我们预设标准化差异(SRD)> 10%为临床相关性。RIETE 纳入了 33,462 名(57.7% 为女性)患有 PE 的老年人,Medicare 纳入了 102,391 名(55.0% 为女性)患有 PE 的老年人:在 RIETE 中,使用抗凝疗法(中位数:181 天 vs 180 天,SRD < 1%)、纤维蛋白溶解疗法(SRD < 3%)、血栓切除术(SRD < 2%)或下腔静脉 (IVC) 过滤器(SRD:4.4%)的总体性别差异不大。然而,女性中危 PE 患者使用纤溶疗法(全身或导管疗法)的比例低于男性(8.0% vs 12.1%,SRD:13.6%)。在医疗保险受益人中,高级 PE 治疗方法没有性别差异。在未经调整的分析中,无论性别如何,Medicare 参与者比 RIETE 参与者更常接受纤维蛋白溶解和 IVC 滤器置入治疗(P < 0.001):结论:在一项主要针对欧洲 PE 患者的登记和一项针对美国老年人的研究中,抗凝模式或先进疗法的使用总体上没有性别差异。未来的研究应确定中危 PE 纤维蛋白溶解疗法的性别差异以及美国老年人更多地使用先进疗法是否与临床结果相关。
Sex differences in treatment strategies for pulmonary embolism in older adults: The SERIOUS-PE study of RIETE participants and US Medicare beneficiaries.
Introduction: Sex differences exist in risk factors and comorbidities of older adults (aged ⩾ 65 years) with pulmonary embolism (PE). Clinically relevant sex-based treatment disparities for PE have not been adequately addressed. The few existing show conflicting results due to small sample size (type II error) and suboptimal methods (overreliance on p-value, which may detect differences of small clinical relevance).
Methods: We assessed sex differences in anticoagulation and advanced therapies for PE in older adults, utilizing data from Registro Informatizado Enfermedad TromboEmbolica (RIETE), a large PE registry with predominant participation from Europe, and data from US Medicare beneficiaries. We prespecified a standardized difference (SRD) > 10% as clinically relevant. RIETE included 33,462 (57.7% female) and Medicare included 102,391 (55.0% female) older adults with PE.
Results: In RIETE, there were no overall sex differences in the use of anticoagulation (median: 181 vs 180 days, SRD < 1%), fibrinolysis (SRD < 3%), thrombectomy (SRD < 2%), or inferior vena cava (IVC) filters (SRD: 4.4%). However, fibrinolytic therapy (systemic or catheter-based) was less often used in female than male patients with intermediate-risk PE (8.0% vs 12.1%, SRD: 13.6%). No sex differences were noted with advanced PE therapies in Medicare beneficiaries. In unadjusted analyses, fibrinolysis and IVC filter placement were more frequent in Medicare than RIETE participants regardless of sex (p < 0.001).
Conclusion: In a predominantly European PE registry and a US study of older adults, there were no overall sex differences in anticoagulation patterns or advanced therapy utilization. Future studies should determine if sex disparities in fibrinolytic therapy for intermediate-risk PE and greater use of advanced therapies in US older adults correlate with clinical outcomes.
期刊介绍:
The premier, ISI-ranked journal of vascular medicine. Integrates the latest research in vascular biology with advancements for the practice of vascular medicine and vascular surgery. It features original research and reviews on vascular biology, epidemiology, diagnosis, medical treatment and interventions for vascular disease. A member of the Committee on Publication Ethics (COPE)