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...
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MDPI AG
2022-10-01
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| Series: | Life |
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| Online Access: | https://www.mdpi.com/2075-1729/12/10/1657 |
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| author | Cristiano Bortoluzzi Enrico Bernardi Giuseppe Camporese Franco Noventa Davide Ceccato Chiara Tonello Ngoc Vo Hong Elena Campello Chiara Simion Egidio Imbalzano Pierpaolo Di Micco Elena Callegari Paolo Simioni |
| author_facet | Cristiano Bortoluzzi Enrico Bernardi Giuseppe Camporese Franco Noventa Davide Ceccato Chiara Tonello Ngoc Vo Hong Elena Campello Chiara Simion Egidio Imbalzano Pierpaolo Di Micco Elena Callegari Paolo Simioni |
| author_sort | Cristiano Bortoluzzi |
| collection | DOAJ |
| 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. <b>Methods:</b> 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. <b>Results</b>: 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). <b>Discussion:</b> 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. |
| first_indexed | 2024-03-09T19:55:52Z |
| format | Article |
| id | doaj.art-4f8748782b6a4ab48c413358f7429357 |
| institution | Directory Open Access Journal |
| issn | 2075-1729 |
| language | English |
| last_indexed | 2024-03-09T19:55:52Z |
| publishDate | 2022-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Life |
| spelling | doaj.art-4f8748782b6a4ab48c413358f74293572023-11-24T00:57:59ZengMDPI AGLife2075-17292022-10-011210165710.3390/life12101657Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC ProjectCristiano Bortoluzzi0Enrico Bernardi1Giuseppe Camporese2Franco Noventa3Davide Ceccato4Chiara Tonello5Ngoc Vo Hong6Elena Campello7Chiara Simion8Egidio Imbalzano9Pierpaolo Di Micco10Elena Callegari11Paolo Simioni12UO Internal Medicine San Giovanni e Paolo Hospital, 30121 Venice, ItalyEmergency Department ULSS2 “Marca Trevigiana”, 31100 Treviso, ItalyGeneral Medicine, Azienda Ospedaliera, 35100 Padova, ItalyQUOVADIS No-Profit Association, 35139 Padova, ItalyUO Angiology, Azienda Ospedaliera, 35122 Padova, ItalyUO Angiology, Azienda Ospedaliera, 35122 Padova, ItalyUO Internal Medicine San Giovanni e Paolo Hospital, 30121 Venice, ItalyThromboembolic Disease Unit Azienda Ospedaliera, 35128 Padova, ItalyThromboembolic Disease Unit Azienda Ospedaliera, 35128 Padova, ItalyDepartment of Clinical and Experimental Medicine, Polyclinic Hospital University of Messina, 98124 Messina, ItalyInternal Medicine, ASL NA2 Nord-“A. Rizzoli” Polyclinic Hospital, Ischia, 80122 Napoli, ItalyInternal Medicine, Ca’ Foncello Hospital, 31100 Treviso, ItalyThromboembolic Disease Unit Azienda Ospedaliera, 35128 Padova, ItalyVenous 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. <b>Methods:</b> 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. <b>Results</b>: 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). <b>Discussion:</b> 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.https://www.mdpi.com/2075-1729/12/10/1657venous thromboembolismlong-term anticoagulationrivaroxaban |
| spellingShingle | Cristiano Bortoluzzi Enrico Bernardi Giuseppe Camporese Franco Noventa Davide Ceccato Chiara Tonello Ngoc Vo Hong Elena Campello Chiara Simion Egidio Imbalzano Pierpaolo Di Micco Elena Callegari Paolo Simioni Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project Life venous thromboembolism long-term anticoagulation rivaroxaban |
| 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 | venous thromboembolism long-term anticoagulation rivaroxaban |
| url | https://www.mdpi.com/2075-1729/12/10/1657 |
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