Cargando…

Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project

Venous thromboembolism (VTE) is a major cause of death in the world. After the acute-phase treatment, the optimal duration of anticoagulation is still debatable. The latest guidelines suggest maintaining long-term anticoagulation in patients with cancer-associated thrombosis (CAT) or with unprovoked...

Descripción completa

Detalles Bibliográficos
Autores principales: Bortoluzzi, Cristiano, Bernardi, Enrico, Camporese, Giuseppe, Noventa, Franco, Ceccato, Davide, Tonello, Chiara, Vo Hong, Ngoc, Campello, Elena, Simion, Chiara, Imbalzano, Egidio, Di Micco, Pierpaolo, Callegari, Elena, Simioni, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9604582/
https://www.ncbi.nlm.nih.gov/pubmed/36295091
http://dx.doi.org/10.3390/life12101657
_version_ 1784817850270089216
author Bortoluzzi, Cristiano
Bernardi, Enrico
Camporese, Giuseppe
Noventa, Franco
Ceccato, Davide
Tonello, Chiara
Vo Hong, Ngoc
Campello, Elena
Simion, Chiara
Imbalzano, Egidio
Di Micco, Pierpaolo
Callegari, Elena
Simioni, Paolo
author_facet Bortoluzzi, Cristiano
Bernardi, Enrico
Camporese, Giuseppe
Noventa, Franco
Ceccato, Davide
Tonello, Chiara
Vo Hong, Ngoc
Campello, Elena
Simion, Chiara
Imbalzano, Egidio
Di Micco, Pierpaolo
Callegari, Elena
Simioni, Paolo
author_sort Bortoluzzi, Cristiano
collection PubMed
description Venous thromboembolism (VTE) is a major cause of death in the world. After the acute-phase treatment, the optimal duration of anticoagulation is still debatable. The latest guidelines suggest maintaining long-term anticoagulation in patients with cancer-associated thrombosis (CAT) or with unprovoked VTE and a low bleeding risk. Methods: The MAC Project is an ongoing prospective-cohort, multi-center, observational study in Italy. The project aims to collect real-life clinical information in unselected patients given oral anticoagulants for VTE over a 5-year follow-up period. There were no exclusion criteria, except for life expectancy <6 months and refusal to sign the informed consent form or to attend the planned follow-up visit. All patients were followed-up prospectively with clinical controls scheduled at 3, 6, and 12 months after the index event, and then annually for up to 5 years. The primary efficacy and safety outcomes were symptomatic recurrent VTE and major bleeding. Results: We analyzed 450 consecutive patients treated with rivaroxaban and referred them to the MAC Project database for unprovoked or recurrent VTE. Of these, 267 (55%) were unprovoked VTE, and 377 (87%) were symptomatic. We followed up with the patients for a mean of 22 months (Q1 10.7; Q3 37.4 months). Recurrent VTE occurred in 12 patients on rivaroxaban treatment (IR 1.7 per 100 person-years). Males had more recurrence than women. During the follow-up period, we recorded 13 (2.9%) major bleeding, 12 (2.7%) clinically relevant non-major bleeding, 8 minor bleeding, and no fatal bleeding events. Overall, bleeding events occurred in 33 (7.3%) patients, most occurring within the first 2 years of treatment. In addition, we observed a statistically significant higher incidence of bleeding in patients with a baseline HAS-BLED score of 3 to 4 compared with those with a score of 0 to 2, with most events occurring during the first 3 months of treatment (RR 5.9). Discussion: Rivaroxaban appears to be safe and effective for the long-term treatment of patients with recurrent or unprovoked VTE. Our results match previously published data, and we are confident that the continuation of the follow-up for up to 5 years will confirm these outcomes.
format Online
Article
Text
id pubmed-9604582
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-96045822022-10-27 Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project Bortoluzzi, Cristiano Bernardi, Enrico Camporese, Giuseppe Noventa, Franco Ceccato, Davide Tonello, Chiara Vo Hong, Ngoc Campello, Elena Simion, Chiara Imbalzano, Egidio Di Micco, Pierpaolo Callegari, Elena Simioni, Paolo Life (Basel) Communication Venous thromboembolism (VTE) is a major cause of death in the world. After the acute-phase treatment, the optimal duration of anticoagulation is still debatable. The latest guidelines suggest maintaining long-term anticoagulation in patients with cancer-associated thrombosis (CAT) or with unprovoked VTE and a low bleeding risk. Methods: The MAC Project is an ongoing prospective-cohort, multi-center, observational study in Italy. The project aims to collect real-life clinical information in unselected patients given oral anticoagulants for VTE over a 5-year follow-up period. There were no exclusion criteria, except for life expectancy <6 months and refusal to sign the informed consent form or to attend the planned follow-up visit. All patients were followed-up prospectively with clinical controls scheduled at 3, 6, and 12 months after the index event, and then annually for up to 5 years. The primary efficacy and safety outcomes were symptomatic recurrent VTE and major bleeding. Results: We analyzed 450 consecutive patients treated with rivaroxaban and referred them to the MAC Project database for unprovoked or recurrent VTE. Of these, 267 (55%) were unprovoked VTE, and 377 (87%) were symptomatic. We followed up with the patients for a mean of 22 months (Q1 10.7; Q3 37.4 months). Recurrent VTE occurred in 12 patients on rivaroxaban treatment (IR 1.7 per 100 person-years). Males had more recurrence than women. During the follow-up period, we recorded 13 (2.9%) major bleeding, 12 (2.7%) clinically relevant non-major bleeding, 8 minor bleeding, and no fatal bleeding events. Overall, bleeding events occurred in 33 (7.3%) patients, most occurring within the first 2 years of treatment. In addition, we observed a statistically significant higher incidence of bleeding in patients with a baseline HAS-BLED score of 3 to 4 compared with those with a score of 0 to 2, with most events occurring during the first 3 months of treatment (RR 5.9). Discussion: Rivaroxaban appears to be safe and effective for the long-term treatment of patients with recurrent or unprovoked VTE. Our results match previously published data, and we are confident that the continuation of the follow-up for up to 5 years will confirm these outcomes. MDPI 2022-10-20 /pmc/articles/PMC9604582/ /pubmed/36295091 http://dx.doi.org/10.3390/life12101657 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Communication
Bortoluzzi, Cristiano
Bernardi, Enrico
Camporese, Giuseppe
Noventa, Franco
Ceccato, Davide
Tonello, Chiara
Vo Hong, Ngoc
Campello, Elena
Simion, Chiara
Imbalzano, Egidio
Di Micco, Pierpaolo
Callegari, Elena
Simioni, Paolo
Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
title Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
title_full Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
title_fullStr Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
title_full_unstemmed Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
title_short Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project
title_sort safety and efficacy of rivaroxaban for extended-phase anticoagulation of patients with unprovoked or recurrent venous thromboembolism: real-life data from the mac project
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9604582/
https://www.ncbi.nlm.nih.gov/pubmed/36295091
http://dx.doi.org/10.3390/life12101657
work_keys_str_mv AT bortoluzzicristiano safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT bernardienrico safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT camporesegiuseppe safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT noventafranco safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT ceccatodavide safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT tonellochiara safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT vohongngoc safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT campelloelena safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT simionchiara safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT imbalzanoegidio safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT dimiccopierpaolo safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT callegarielena safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject
AT simionipaolo safetyandefficacyofrivaroxabanforextendedphaseanticoagulationofpatientswithunprovokedorrecurrentvenousthromboembolismreallifedatafromthemacproject