Long-Term Risk for Major Bleeding During Extended Oral Anticoagulant Therapy for First Unprovoked Venous Thromboembolism

Khan, Faizan; Tritschler, Tobias; Kimpton, Miriam; Wells, Phillip S.; Kearon, Clive; Weitz, Jeffrey I.; Büller, Harry R.; Raskob, Gary E.; Ageno, Walter; Couturaud, Francis; Prandoni, Paolo; Palareti, Gualtiero; Legnani, Cristina; Kyrle, Paul A.; Eichinger, Sabine; Eischer, Lisbeth; Becattini, Cecilia; Agnelli, Giancarlo; Vedovati, Maria Cristina; Geersing, Geert‐Jan; Takada, Toshihiko; Cosmi, Benilde; Aujesky, Drahomir; Marconi, Letizia; Palla, Antonio; Siragusa, Sergio; Bradbury, Charlotte; Parpia, Sameer; Mallick, Ranjeeta; Lensing, Anthonie W. A.; Gebel, Martin; Grosso, Michael; Thavorn, Kednapa; Hutton, Brian; Gal, Grégoire Le; Fergusson, Dean; Rodger, Marc

doi:10.7326/m21-1094

Cited by 88 publications

(42 citation statements)

References 69 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…5 In a recent meta-analysis, we determined that the overall incidence of major bleeding during extended anticoagulation for a first unprovoked or weakly provoked VTE was 1.74 events per 100 person-years (95% CI, 1.34-2.20) with vitamin K antagonists (VKA) and 1.12 events per 100 person-years (95% CI, 0.72-1.62) with direct oral anticoagulants (DOACs), with case-fatality rates of 8.3% and 9.7% with VKAs and DOACs, respectively. 6 In contrast, precise estimates for the incidence of recurrent VTE during extended anticoagulation are lacking, and as a result, advising patients on what to expect while receiving extended anticoagulation and estimating the net clinical benefit of extended treatment to guide long-term management remain difficult.…”

Section: Introductionmentioning

confidence: 99%

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Khan

Tritschler

Kimpton

et al. 2021

Journal of Thrombosis and Haemostasis

Self Cite

View full text Add to dashboard Cite

Background The long‐term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain. Objectives To determine the incidence of recurrent VTE during extended anticoagulation of up to 5 years in patients with a first unprovoked VTE. Methods MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3 months of initial treatment. Unpublished data on number of recurrent VTE and person‐years, obtained from authors of included studies, were used to calculate study‐level incidence rate, and random‐effects meta‐analysis was used to pool results. Results Twenty‐six studies and 15 603 patients were included in the analysis. During 11 631 person‐years of follow‐up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person‐years was 1.41 (95% CI, 1.03–1.84) and 0.09 (0.04–0.16), with 5‐year cumulative incidences of 7.1% (3.0%–13.2%) and 1.2% (0.4%–4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77–1.44) with direct oral anticoagulants and 1.55 (1.01–2.20) with vitamin K antagonists. The case‐fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%–8.7%). Conclusions In patients with a first unprovoked VTE, the long‐term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long‐term management of unprovoked VTE.

show abstract

Section: Introductionmentioning

confidence: 99%

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Khan

Tritschler

Kimpton

et al. 2021

Journal of Thrombosis and Haemostasis

Self Cite

View full text Add to dashboard Cite

show abstract

“…In this regard, the overall rate of any bleeding in our cohort was 0.65% annually and the major bleeding rate was 0.97 events per 100 patient years. According to a recent published analysis, this rate of bleeding can be considered as low in comparison to the general population of patients treated with anticoagulants ( 37 ).…”

Section: Discussionmentioning

confidence: 99%

Patterns of Recurrent Thrombosis in Primary Antiphospholipid Syndrome—Multicenter, Real-Life Long-Term Follow-Up

et al. 2022

View full text Add to dashboard Cite

BackgroundAntiphospholipid syndrome (APS) is an acquired hypercoagulable condition associated with antiphospholipid antibody (aPL) presence. Data on re-thrombosis following APS-diagnosis are limited.MethodsThis is a retrospective analysis of new thrombotic events among primary APS (pAPS) patients followed for up to 15 years in three medical centers in Israel.ResultsAmong 312 primary-APS patients, 143 (46%) had new thrombotic event classified to three patterns: (1) Arterial—associated with heart valve disease (OR 7.24, 95% C.I. 2.26–24.6), hypertension (OR 3, 95% C.I. 1.44–6.25), elevated anti-B2-GPI IgM (OR 1.04, 95% C.I. 0.996–1.08), arterial thrombosis at presentation (OR 1.74 95% C.I. 0.992–3.26), and older age (41 vs. 34 years, p < 0.001). (2) Venous—linked with venous thrombosis at presentation (OR 12.9, 95% C.I. 5.27–31.6, p < 0.001), heart valve disease (OR 9.81 95% C.I. 1.82–52.9, p = 0.018), aGAPSS (OR 1.15 95% C.I. 1.02–1.29), and younger age (31 vs. 36.5 years, p = 0.001); and (3) Combined pattern—associated with heart valve disease (OR 40.5 95% C.I. 7.7–212) and pulmonary embolism (OR 7.47 95% C.I. 1.96–28.5). A 4th variant “the Breakthrough pattern” defined by re-thrombosis despite prophylactic therapy was observed in 100/143 (70%) patients and linked with heart valve disease (OR 8. 95% C.I. 2.43–26.3), venous thrombosis at presentation (OR 2.61 95% C.I. 1.47–4.66), leg ulcers (OR 12.2, 95% C.I. 1.4–107), hypertension (OR 1.99, 95% C.I. 0.92–4.34), and higher aGAPSS (OR 1.08, 95% C.I. 0.99–1.18).ConclusionIn this real-life observation, re-thrombosis was common among pAPS patients including in those recommended to receive prophylactic therapy. Different patterns of recurrence were identified and linked with presenting symptoms, specific serological markers, APS manifestations, and comorbidities. Studies that will address interventions to prevent recurrences of APS-related events are needed.

show abstract

“…According to a recent meta-analysis of 14 randomized controlled trials and 13 cohort studies, including 9982 patients who received a vitamin K antagonist and 7220 received a DOAC, it has been supported that the incidence of major bleeding was statistically significantly higher among those who had creatinine clearance less than 50 mL/min [ 42 ]. Accordingly, in the present study, we found a correlation between high serum creatinine levels and hemorrhagic complications, but the regression model did not prove that this variable was an independent predictor of hemorrhage.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Hemorrhagic Complications in Hospitalized Patients with Pulmonary Embolism

Pagkratis

Matsagas

Malli

et al. 2022

JPM

View full text Add to dashboard Cite

Background: The prevalence of anticoagulant therapy-associated hemorrhagic complications in hospitalized patients with pulmonary embolism (PE) has been scarcely investigated. Aim: To evaluate the prevalence of hemorrhages in hospitalized PE patients. Methods: The Information System “ASKLIPIOS™ HOSPITAL” implemented in the Respiratory Medicine Department, University of Thessaly, was used to collect demographic, clinical and outcome data from January 2013 to April 2021. Results: 326 patients were included. Males outnumbered females. The population’s mean age was 68.7 ± 17.0 years. The majority received low molecular weight heparin (LMWH). Only 5% received direct oral anticoagulants. 15% of the population were complicated with hemorrhage, of whom 18.4% experienced a major event. Major hemorrhages were fewer than minor (29.8% vs. 70.2%, p = 0.001). Nadroparin related to 83.3% of the major events. Hematuria was the most common hemorrhagic event. 22% of patients with major events received a transfusion, and 11% were admitted to intensive care unit (ICU). The events lasted for 3 ± 2 days. No death was recorded. Conclusions: 1/5 of the patients hospitalized for PE complicated with hemorrhage without a fatal outcome. The hemorrhages were mainly minor and lasted for 3 ± 2 days. Among LMWHs, nadroparin was related to a higher percentage of hemorrhages.

show abstract

Long-Term Risk for Major Bleeding During Extended Oral Anticoagulant Therapy for First Unprovoked Venous Thromboembolism

Abstract: Long-term risk for major bleeding during extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta-analysis / Khan, F.

Cited by 88 publications

References 69 publications

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Patterns of Recurrent Thrombosis in Primary Antiphospholipid Syndrome—Multicenter, Real-Life Long-Term Follow-Up

Prevalence of Hemorrhagic Complications in Hospitalized Patients with Pulmonary Embolism

Contact Info

Product

Resources

About