Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA.
Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Thromb Res. 2022 Jun;214:122-131. doi: 10.1016/j.thromres.2022.04.019. Epub 2022 May 4.
Sex is an important factor associated with pulmonary embolism (PE) disease presentation and outcomes, which may be related to pathobiological, social, and treatment-based differences. We are seeking to illuminate sex differences in pulmonary embolism presentation, care, and outcomes using an international registry and a national US database of people 65 years and older, the age group in which the majority of these events occur.
The Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism (SERIOUS-PE) study has been designed to address knowledge gaps in this area. This study will use data from the Registro Informatizado Enfermedad TromboEmbolica (RIETE) registry and the US Medicare Fee-For-Service beneficiaries. RIETE is a large international registry of patients with venous thromboembolism with data collected on PE presentation, risk factors, co-morbidities, drug and interventional therapies, as well as 30-day and 1-year outcomes (including recurrent VTE, major bleeding, and mortality). Data from US Medicare Fee-For-Service beneficiaries will be used to understand the sex differences in PE hospitalizations, advanced therapies, and outcomes at 30-day and 1-year follow-up. Assessment of outcomes in both databases will be performed in unadjusted models, as well as those adjusted for demographics, co-morbidities, and treatments, to understand whether the potential sex differences in outcomes are related to differences in risk factors and co-morbidities, potential disparities in treatment, or a plausible biological difference in women versus men. Linear trends will be assessed over time.
RIETE data from March 2001 through March 2021 include 33,462 elderly patients with PE, of whom 19,294 (57.7%) were women and 14,168 (42.3%) were men. In the Medicare Fee-For-Service database, between January 2001 and December 31, 2019, 1,030,247 patients were hospitalized with a principal discharge diagnosis of PE, of whom 599,816 (58.2%) were women and 430,431 (41.8%) were men.
Findings from the SERIOUS-PE study will help address important knowledge gaps related to sex differences in presentation and risk factors, treatment patterns, and outcomes of older adults with PE. The results may guide changes in prognostic prediction rules based on sex-specific findings, identify sex-based disparities in care delivery that should be addressed by quality improvement, or uncover potential differences in response to available therapies that warrant testing in dedicated randomized trials.
性别是与肺栓塞（PE）疾病表现和结局相关的重要因素，这可能与病理生物学、社会和治疗相关的差异有关。我们旨在使用国际登记处和美国全国 65 岁及以上人群的国家医疗保险费用数据库来阐明肺栓塞表现、护理和结局方面的性别差异，该年龄组发生了大多数此类事件。
“老年肺栓塞患者临床表现、危险因素、药物和介入治疗及结局的性别差异（SERIOUS-PE）”研究旨在解决该领域的知识空白。该研究将使用来自静脉血栓栓塞症登记处（RIETE）登记处和美国医疗保险费用数据库的数据。RIETE 是一个大型国际静脉血栓栓塞症患者登记处，收集了关于 PE 表现、危险因素、合并症、药物和介入治疗以及 30 天和 1 年结局（包括复发性 VTE、大出血和死亡率）的数据。美国医疗保险费用数据库的数据将用于了解 30 天和 1 年随访时 PE 住院、高级治疗和结局方面的性别差异。在未调整模型以及调整了人口统计学、合并症和治疗因素后，评估两个数据库中的结局，以了解结局方面的潜在性别差异是否与危险因素和合并症的差异、治疗方面的潜在差异或女性与男性之间的合理生物学差异有关。将评估随时间的线性趋势。
2001 年 3 月至 2021 年 3 月期间的 RIETE 数据包括 33462 名患有 PE 的老年患者，其中 19294 名（57.7%）为女性，14168 名（42.3%）为男性。在医疗保险费用数据库中，2001 年 1 月至 2019 年 12 月 31 日期间，有 1030247 名患者因主要出院诊断为 PE 而住院，其中 599816 名（58.2%）为女性，430431 名（41.8%）为男性。
“老年肺栓塞患者临床表现、危险因素、药物和介入治疗及结局的性别差异（SERIOUS-PE）”研究的结果将有助于解决与老年 PE 患者临床表现和危险因素、治疗模式以及结局方面的性别差异相关的重要知识空白。研究结果可能指导基于性别特异性发现的预后预测规则的改变，确定护理方面的性别差异，这些差异应通过质量改进加以解决，或揭示潜在的对现有治疗方法的反应差异，值得在专门的随机试验中进行测试。
