Anemia and bleeding in patients receiving anticoagulant therapy for venous thromboembolism: comment

Gaboreau, Yoann; Zenatti, Nora; Vermorel, Céline; Imbert, Patrick; Bosson, Jean‐Luc; Pernod, Gilles

doi:10.1007/s11239-018-1668-4

Cited by 4 publications

(1 citation statement)

References 12 publications

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“…Such findings confirm what was recently reported by a meta-analysis of all trials investigating direct anticoagulant use for VTE treatment [ 19 ], although the follow-up in the latter was limited to 12 months. They are also in line with observations from the RIETE Registry, although in patients treated only with VKA [ 15 , 20 , 21 , 22 , 23 ].…”

Section: Discussionsupporting

confidence: 90%

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

Bernardi²,

Camporese³

et al. 2022

Life

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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.

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Section: Discussionsupporting

confidence: 90%

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

Bernardi²,

Camporese³

et al. 2022

Life

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Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study)

Gaboreau,

Frappé,

Vermorel

et al. 2024

Family Practice

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Background To assess bleeding risk of patients treated by oral anticoagulants, several scores have been constructed to assist physicians in the evaluation of the benefit risk. Most of these scores lack a strong enough level of evidence for use in family practice. Objective To assess the predictive prognostic accuracy of 13 scores designed to assess the risk of major or clinically relevant non-major (CRNM) bleeding events in a French ambulatory cohort receiving Vitamin-K antagonists (VKA) or direct oral anticoagulants (DOACs) in a family practice setting. Methods CACAO (Comparison of Accidents and their Circumstances with Oral Anticoagulants) was a multicentre prospective cohort of ambulatory patients prescribed oral anticoagulants. We selected patients from the cohort who had received an oral anticoagulant because of non-valvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE) to be followed during one year by their GP. The following scores were calculated: mOBRI, Shireman, Kuijer, HEMORR2HAGES, ATRIA, HAS-BLED, RIETE, VTE-BLEED, ACCP score, Rutherford, ABH-Score, GARFIEL-AF, and Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT). Prognostic accuracy was assessed by using receiver operating characteristic curves and c-statistics. Results During 1 year, 3,082 patients were followed. All of the scores demonstrated only poor to moderate ability to predict major bleeding or CRNM in NVAF patients on DOACs (c-statistic: 0.41–0.66 and 0.45–0.58), respectively. The results were only slightly better for patients prescribed VKA (0.47–0.66 and 0.5–0.55, respectively) in this indication. The results were also unsatisfactory in patients treated for VTE. Conclusion None of the scores demonstrated satisfactory discriminatory ability when used in family practice. Clinical Trial Registration ClinicalTrials.gov NCT02376777

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Patients treated with vitamin K oral anticoagulants in family practice: a new approach to bleeding risk assessment. An ancillary study by the CACAO prospective general practice cohort

Gaboreau,

Frappé,

Vermorel

et al. 2024

Family Practice

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Background The ability of bleeding risk scores to predict major bleeding (MB) or clinically relevant nonmajor bleeding (CRNMB) remains a topic of contention, particularly in nonselected patients in family practice. In addition, the capacity to predict bleeding risk using simple variables has yet to be established. Objectives The main objective was to confirm that severe anemia was the most predictive factor for the estimation of bleeding risk in patients treated with vitamin K antagonists (VKAs). Secondary objectives were to test the capacity of different bleeding scores to detect high-risk patients. Subsequently, the impact of functional decline on bleeding incidence was explored. Methods The CACAO study was a multicenter prospective cohort study of patients who, due to nonvalvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE), had been prescribed an oral anticoagulant by their general practitioner (GP) as a prophylactic measure. Patient characteristics were collected at the time of inclusion by GPs, who then monitored them in accordance with standard practice for one year. MB and CRNMB were the main outcomes for one year. By applying this approach, a total of 13 scores were analyzed. Results Aaemia was found to be strongly associated with MB (HR: 2.77, 95% CI: 1.2–6.36), with a particularly pronounced association observed in cases of severe anemia (HR: 12.9, 95% CI: 2.76–60.35). Twelve out of 27 MB cases were not identified by at least half of the scores. By contrast, functional decline was identified as a novel factor associated with MB (HR: 2.45, 95% CI: 1.13–5.31). Conclusions Preexisting anemia is a major prognostic factor associated with the occurrence of bleeding. It seems relevant to suggest that functional decline should be considered by GPs when assessing bleeding risk.

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Anemia and bleeding in patients receiving anticoagulant therapy for venous thromboembolism: comment

Cited by 4 publications

References 12 publications

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

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

Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study)

Patients treated with vitamin K oral anticoagulants in family practice: a new approach to bleeding risk assessment. An ancillary study by the CACAO prospective general practice cohort

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