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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.
Risk of recurrence after discontinuing anticoagulation in patients with COVID-19- associated venous thromboembolism: a prospective multicentre cohort study
Jara-Palomares, Luis;Bikdeli, Behnood;Jiménez, David;Muriel, Alfonso;Demelo-Rodríguez, Pablo;Moustafa, Farès;Villalobos, Aurora;López-Miguel, Patricia;López-Jiménez, Luciano;Otálora, Sonia;Peris, María Luisa;Amado, Cristina;Chopard, Romain;Rivera-Cívico, Francisco;Monreal, Manuel;Adarraga, María Dolores;Conesa, Ana Alberich;Aibar, Jesús;Lozano, Alicia Alda;Alfonso, Joaquín;Carrillo, Jesús Alonso;Amado, Cristina;García, María Angelina;Arcelus, Juan Ignacio;Ballaz, Aitor;Barba, Raquel;Hernando, María Barca;Barbagelata, Cristina;Barrón, Manuel;Andrés, Belén Barrón;Chaib, Fahd Beddar;Blanco Molina, María Ángeles;Caballero, Juan Carlos;Castellanos, Gonzalo;Chasco, Leyre;Criado, Juan;de Ancos, Cristina;Toro, Jorge del;Rodríguez, Pablo Demelo;de Juana Izquierdo, Cristina;Díaz Brasero, Ana María;Díaz Peromingo, José Antonio;Silva, Álvaro Dubois;Escribano, Juan Carlos;Falgá, Concepción;Farfán Sedano, Ana Isabel;Aracil, Cleofe Fernández;Capitán, Carmen Fernández;Jiménez, Begoña Fernández;Fernández Reyes, José Luis;Fidalgo, María Ángeles;Francisco, Iria;Gabara, Cristina;Valle, Francisco Galeano;Bragado, Francisco García;Ortega, Alberto García;Sebastián, Olga Gavín;Gil de Gómez, María Allende;Díaz, Aída Gil;Cuervo, Covadonga Gómez;Munera, Adriana González;Grau, Enric;Guirado, Leticia;Gutiérrez, Javier;Blasco, Luis Hernández;Palomares, Luis Jara;Jaras, María Jesús;Jiménez, David;Jiménez, Rafael;Jou, Inés;Joya, María Dolores;Justo, Sara Lainez;Lalueza, Antonio;Lecumberri, Ramón;León Ramírez, José Manuel;Llamas, Pilar;Lobo, José Luis;Jiménez, Luciano López;Miguel, Patricia López;López Núñez, Juan José;Ruiz, Antonio López;López Sáez, Juan Bosco;Lorenzo, Alicia;Lumbierres, Marina;Madridano, Olga;Maestre, Ana;Marchena, Pablo Javier;Marcos, María;Martín del Pozo, Mar;Martos, Francisco Martín;Maza, Jorge Manuel;Mena, Elisabeth;Mercado, Maria Isabel;Moisés, Jorge;Monreal, Manuel;Morales, María del Valle;Navas, Maria Sierra;Nieto, José Antonio;Núñez Fernández, Manuel Jesús;Olid, Mónica;Ortega, Lucía Ordieres;Ortiz, María;Osorio, Jeisson;Otálora, Sonia;Otero, Remedios;Gómez, Nazaret Pacheco;Pagán, Javier;Palomeque, Andrea Catalina;Paredes, Ezequiel;Caballero, Pedro Parra;Pedrajas, José María;Ductor, Cristina Pérez;Pinar, Montserrat Pérez;Peris, María Luisa;Pesce, María Lourdes;Porras, José Antonio;Puchades, Ramón;Cívico, Francisco Rivera;Cobo, Ana Rodríguez;Rosa, Vladimir;Brugera, Marta Romero;Artacho, Pedro Ruiz;Giménez, Nuria Ruiz;Ruiz, Justo Ruiz;Salgueiro, Georgina;Sancho, Teresa;Sendín, Vanesa;Sigüenza, Patricia;Soler, Silvia;Fernández, Susana Suárez;Tirado, Raimundo;Vilar, Ana Torrents;Torres, María Isabel;Santos, Javier Trujillo;Uresandi, Fernando;Valle, Reina;Varona, José Felipe;Villalobos, Aurora;Villares, Paula;Ay, Cihan;Nopp, Stephan;Pabinger, Ingrid;Engelen, Matthias;Vanassche, Thomas;Verhamme, Peter;Bok Yoo, Hugo Hyung;Montenegro, Ana Cristina;Morales, Silvia Natalia;Roa, Jairo;Hirmerova, Jana;Malý, Radovan;Bertoletti, Laurent;Bura-Riviere, Alessandra;Catella, Judith;Chopard, Romain;Couturaud, Francis;Espitia, Olivier;Grange, Claire;Leclercq, Barbara;Le Mao, Raphael;Mahé, Isabelle;Moustafa, Farès;Plaisance, Ludovic;Bartoli, Gabrielle Sarlon;Suchon, Pierre;Versini, Edouard;Schellong, Sebastian;Brenner, Benjamin;Dally, Najib;Tzoran, Inna;Sadeghipour, Parham;Rashidi, Fahrid;Abenante, Alessia;Barillari, Giovanni;Basaglia, Manuela;Bilora, Franca;Bissacco, Daniele;Bortoluzzi, Cristiano;Brandolin, Barbara;Casana, Renato;Ciammaichella, Maurizio;Colaizzo, Donatella;Dentali, Francesco;Di Micco, Pierpaolo;Grandone, Elvira;Imbalzano, Egidio;Deliliers, Daniela Lambertenghi;Negro, Federica;Pesavento, Raffaele;Poz, Alessandra;Prandoni, Paolo;Scarinzi, Paolo;Siniscalchi, Carmine;Taflaj, Beldisa;Tufano, Antonella;Visonà, Adriana;Hong, Ngoc Vo;Zalunardo, Beniamino;Skride, Andris;Kigitovica, Dana;Fonseca, Samuel;Marques, Rafael;Meireles, José;Pinto, Sara Barbosa;Bosevsky, Marijan;Eftimova, Aleksandra;Zdraveska, Marijan;Bounameaux, Henri;Mazzolai, Lucia;Aujayeb, Avinash;Bikdeli, Behnood;Caprini, Joseph;Weinberg, Ido;Bui, Hanh My
2024-01-01
Abstract
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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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11383/2181293
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