EClinicalMedicine (Jul 2024)

Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort studyResearch in context

  • Luis Jara-Palomares,
  • Behnood Bikdeli,
  • David Jiménez,
  • Alfonso Muriel,
  • Pablo Demelo-Rodríguez,
  • Farès Moustafa,
  • Aurora Villalobos,
  • Patricia López-Miguel,
  • Luciano López-Jiménez,
  • Sonia Otálora,
  • María Luisa Peris,
  • Cristina Amado,
  • Romain Chopard,
  • Francisco Rivera-Cívico,
  • Manuel Monreal,
  • María Dolores Adarraga,
  • Ana Alberich Conesa,
  • Jesús Aibar,
  • Alicia Alda Lozano,
  • Joaquín Alfonso,
  • Jesús Alonso Carrillo,
  • Cristina Amado,
  • María Angelina García,
  • Juan Ignacio Arcelus,
  • Aitor Ballaz,
  • Raquel Barba,
  • María Barca Hernando,
  • Cristina Barbagelata,
  • Manuel Barrón,
  • Belén Barrón Andrés,
  • Fahd Beddar Chaib,
  • María Ángeles Blanco Molina,
  • Juan Carlos Caballero,
  • Gonzalo Castellanos,
  • Leyre Chasco,
  • Juan Criado,
  • Cristina de Ancos,
  • Jorge del Toro,
  • Pablo Demelo Rodríguez,
  • Cristina de Juana Izquierdo,
  • Ana María Díaz Brasero,
  • José Antonio Díaz Peromingo,
  • Álvaro Dubois Silva,
  • Juan Carlos Escribano,
  • Concepción Falgá,
  • Ana Isabel Farfán Sedano,
  • Cleofe Fernández Aracil,
  • Carmen Fernández Capitán,
  • Begoña Fernández Jiménez,
  • José Luis Fernández Reyes,
  • María Ángeles Fidalgo,
  • Iria Francisco,
  • Cristina Gabara,
  • Francisco Galeano Valle,
  • Francisco García Bragado,
  • Alberto García Ortega,
  • Olga Gavín Sebastián,
  • María Allende Gil de Gómez,
  • Aída Gil Díaz,
  • Covadonga Gómez Cuervo,
  • Adriana González Munera,
  • Enric Grau,
  • Leticia Guirado,
  • Javier Gutiérrez,
  • Luis Hernández Blasco,
  • Luis Jara Palomares,
  • María Jesús Jaras,
  • David Jiménez,
  • Rafael Jiménez,
  • Inés Jou,
  • María Dolores Joya,
  • Sara Lainez Justo,
  • Antonio Lalueza,
  • Ramón Lecumberri,
  • José Manuel León Ramírez,
  • Pilar Llamas,
  • José Luis Lobo,
  • Luciano López Jiménez,
  • Patricia López Miguel,
  • Juan José López Núñez,
  • Antonio López Ruiz,
  • Juan Bosco López Sáez,
  • Alicia Lorenzo,
  • Marina Lumbierres,
  • Olga Madridano,
  • Ana Maestre,
  • Pablo Javier Marchena,
  • María Marcos,
  • Mar Martín del Pozo,
  • Francisco Martín Martos,
  • Jorge Manuel Maza,
  • Elisabeth Mena,
  • Maria Isabel Mercado,
  • Jorge Moisés,
  • Manuel Monreal,
  • María del Valle Morales,
  • Maria Sierra Navas,
  • José Antonio Nieto,
  • Manuel Jesús Núñez Fernández,
  • Mónica Olid,
  • Lucía Ordieres Ortega,
  • María Ortiz,
  • Jeisson Osorio,
  • Sonia Otálora,
  • Remedios Otero,
  • Nazaret Pacheco Gómez,
  • Javier Pagán,
  • Andrea Catalina Palomeque,
  • Ezequiel Paredes,
  • Pedro Parra Caballero,
  • José María Pedrajas,
  • Cristina Pérez Ductor,
  • Montserrat Pérez Pinar,
  • María Luisa Peris,
  • María Lourdes Pesce,
  • José Antonio Porras,
  • Ramón Puchades,
  • Francisco Rivera Cívico,
  • Ana Rodríguez Cobo,
  • Vladimir Rosa,
  • Marta Romero Brugera,
  • Pedro Ruiz Artacho,
  • Nuria Ruiz Giménez,
  • Justo Ruiz Ruiz,
  • Georgina Salgueiro,
  • Teresa Sancho,
  • Vanesa Sendín,
  • Patricia Sigüenza,
  • Silvia Soler,
  • Susana Suárez Fernández,
  • Raimundo Tirado,
  • Ana Torrents Vilar,
  • María Isabel Torres,
  • Javier Trujillo Santos,
  • Fernando Uresandi,
  • Reina Valle,
  • José Felipe Varona,
  • Aurora Villalobos,
  • Paula Villares,
  • Cihan Ay,
  • Stephan Nopp,
  • Ingrid Pabinger,
  • Matthias Engelen,
  • Thomas Vanassche,
  • Peter Verhamme,
  • Hugo Hyung Bok Yoo,
  • Ana Cristina Montenegro,
  • Silvia Natalia Morales,
  • Jairo Roa,
  • Jana Hirmerova,
  • Radovan Malý,
  • Laurent Bertoletti,
  • Alessandra Bura-Riviere,
  • Judith Catella,
  • Romain Chopard,
  • Francis Couturaud,
  • Olivier Espitia,
  • Claire Grange,
  • Barbara Leclercq,
  • Raphael Le Mao,
  • Isabelle Mahé,
  • Farès Moustafa,
  • Ludovic Plaisance,
  • Gabrielle Sarlon Bartoli,
  • Pierre Suchon,
  • Edouard Versini,
  • Sebastian Schellong,
  • Benjamin Brenner,
  • Najib Dally,
  • Inna Tzoran,
  • Parham Sadeghipour,
  • Fahrid Rashidi,
  • Alessia Abenante,
  • Giovanni Barillari,
  • Manuela Basaglia,
  • Franca Bilora,
  • Daniele Bissacco,
  • Cristiano Bortoluzzi,
  • Barbara Brandolin,
  • Renato Casana,
  • Maurizio Ciammaichella,
  • Donatella Colaizzo,
  • Francesco Dentali,
  • Pierpaolo Di Micco,
  • Elvira Grandone,
  • Egidio Imbalzano,
  • Daniela Lambertenghi Deliliers,
  • Federica Negro,
  • Raffaele Pesavento,
  • Alessandra Poz,
  • Paolo Prandoni,
  • Paolo Scarinzi,
  • Carmine Siniscalchi,
  • Beldisa Taflaj,
  • Antonella Tufano,
  • Adriana Visonà,
  • Ngoc Vo Hong,
  • Beniamino Zalunardo,
  • Andris Skride,
  • Dana Kigitovica,
  • Samuel Fonseca,
  • Rafael Marques,
  • José Meireles,
  • Sara Barbosa Pinto,
  • Marijan Bosevsky,
  • Aleksandra Eftimova,
  • Marijan Zdraveska,
  • Henri Bounameaux,
  • Lucia Mazzolai,
  • Avinash Aujayeb,
  • Behnood Bikdeli,
  • Joseph Caprini,
  • Ido Weinberg,
  • Hanh My Bui

Journal volume & issue
Vol. 73
p. 102659

Abstract

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Summary: Background: The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE. Methods: A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued. Findings: Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3–20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5–4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2–4.2). No patient died of recurrent PE (0%, 95% CI: 0–7.6%). Subgroup analyses showed that patients with diagnosis in 2021–2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45–5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19–4.49) had significantly higher rates of VTE recurrences. Interpretation: In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings. Funding: Sanofi and Rovi, Sanofi Spain.

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