Sex differences in treatment strategies for pulmonary embolism in older adults: The SERIOUS-PE study of RIETE participants and US Medicare beneficiaries.

Autor: Bikdeli B; 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., Leyva H; 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., Muriel A; Respiratory Department, Hospital Ramón y Cajal and Medicine Department, Universidad de Alcalá (Instituto de Ramón y Cajal de Investigación Sanitaria), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain.; Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERESP: Universidad de Alcalá, Madrid, Spain., Lin Z; YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, CT, USA., Piazza G; 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., Khairani CD; Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Rosovsky RP; Department of Medicine, Division of Hematology/Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., Mehdipour G; Department of Radiology, Division of Nuclear Medicine, Montefiore Medical Center, New York, NY, USA., O'Donoghue ML; Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.; TIMI Study Group, Brigham and Women's Hospital, Boston, MA, USA., Madridano O; Department of Internal Medicine, Hospital Universitario Infanta Sofía, Madrid, Spain., Lopez-Saez JB; Department of Internal Medicine, Hospital Universitario de Puerto Real, Cádiz, Spain., Mellado M; Department of Angiology and Vascular Surgery, Hospital del Mar, Barcelona, Spain., Diaz Brasero AM; Department of Internal Medicine, Hospital Universitario de Guadalajara, Guadalajara, Spain., Grandone E; Thrombosis and Haemostasis Unit, Fondazione I.R.C.C.S. 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Foggia, Italy.; Department of Medical and Surgical Sciences, Institute of Obstetrics and Gynecology, University of Foggia, Foggia, Italy.; Department of Obstetrics, Gynecology and Perinatal Medicine, First Sechenov University, Moscow, Russia., Spagnolo PA; Department of Psychiatry, Mary Horrigan Connors Center for Women's Health & Gender Biology, Brigham and Women Hospital, Harvard Medical School, Boston, MA, USA., Lu Y; YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, CT, USA., Bertoletti L; Service de Médecine Vasculaire et Thérapeutique, CHU de Saint-Etienne, Saint-Etienne, France.; INSERM, UMR1059, Equipe Dysfonction Vasculaire et Hémostase, Université Jean-Monnet, Saint-Etienne, France.; INSERM, CIC-1408, CHU de Saint-Etienne, Saint-Etienne, France., López-Jiménez L; Department of Internal Medicine, Hospital Provincial Reina Sofía, Córdoba, Spain., Jesús Núñez M; Department of Internal Medicine, Complejo Hospitalario de Pontevedra, Pontevedra, Spain., Blanco-Molina Á; Department of Internal Medicine, Hospital Universitario Reina Sofía, Córdoba, Spain., Gerhard-Herman M; Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Goldhaber SZ; 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., Bates SM; Department of Medicine, Division of Hematology and Thromboembolism, McMaster University, Hamilton, ON, Canada., Jimenez D; Respiratory Department, Hospital Ramón y Cajal and Medicine Department, Universidad de Alcalá (Instituto de Ramón y Cajal de Investigación Sanitaria), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Madrid, Spain., Krumholz HM; YNHH/Yale Center for Outcomes Research and Evaluation (CORE), New Haven, CT, USA.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.; Department of Internal Medicine, Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA., Monreal M; Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, Murcia, Spain.
Jazyk: angličtina
Zdroj: Vascular medicine (London, England) [Vasc Med] 2024 Nov 26, pp. 1358863X241292023. Date of Electronic Publication: 2024 Nov 26.
DOI: 10.1177/1358863X241292023
Abstrakt: 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.
Competing Interests: Declaration of conflicting interestsOutside the submitted work, the authors disclosed the following. Dr Bikdeli is supported by a Career Development Award from the American Heart Association and VIVA Physicians (#938814) and the Heart and Vascular Center Junior Faculty Award from Brigham and Women’s Hospital. Dr Bikdeli is a member of the Medical Advisory Board for the North American Thrombosis Forum and serves in the Data Safety and Monitory Board of the NAIL-IT trial funded by the National Heart, Lung, and Blood Institute, and Translational Science. Dr Goldhaber reports research support from Bayer, BMS, Boston Scientific, Janssen, and the National Heart, Blood, and Lung Institute (NHBLI). Dr O’Donoghue reports grants from Amgen, Novartis, AstraZeneca, Merck, and Janssen, and consulting for Amgen, NovoNordisk, Janssen, Novartis, and AstraZeneca. Dr Rosovsky reports research support ( to the institution) from BMS and Janssen. She is an advisor/consultant to Abbott, BMS, Dova, Inari, Janssen, and Penumbra; national lead investigator for the Storm-PE trial funded by Penumbra; and President of the Pulmonary Embolism Response Team Consortium. Dr Piazza reports grants from BMS/Pfizer, Janssen, Bayer, Amgen, BSC, Esperion, and 1R01HL164717-01. He has an advisory role with BSC, Amgen, BCRI, PERC, NAMSA, BMS, Janssen, and Regeneron. Dr Bertoletti reports personal fees and nonfinancial support from Aspen, Bayer, BMS-Pfizer, Léo-Pharma, MSD, and Johnson & Johnson. Dr Bates receives unencumbered salary support from the Eli Lilly Canada/May Cohen Chair in Women’s Health at McMaster University. She reports honoraria from Léo Pharma Canada, Inc., ROVI, and Sanofi, as well as payment for work from Elsevier. Dr Krumholz is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare and Medicaid Services, Janssen, Johnson & Johnson Consumer, and Pfizer; is a recipient of grants from AHA, Agency for Healthcare Research and Quality, NIH, Centers for Disease Control and Prevention; is a consulting expert for Massachusetts Medical Society, EyeDentifeye, F-prime, UpToDate, and Ensight; serves on the Data Safety Monitoring Board for Element Science; holds stocks for Element Science and EyeDentifyeye; and is a cofounder of Refactor Health, Ensight AI, and Hugo Health. Dr Monreal received an unrestricted grant for research from Sanofi and Rovi laboratories to sponsor the RIETE registry. All other authors have no disclosures to report.
Databáze: MEDLINE