Clinical Impact of Bleeding in Patients Taking Oral Anticoagulant Therapy for Venous Thromboembolism

Linkins, Lori‐Ann; Choi, P.; Douketis, James D.

doi:10.7326/0003-4819-139-11-200312020-00007

Cited by 704 publications

(476 citation statements)

References 63 publications

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“…Interestingly and despite the fact that XALIA was an observational study with less strict selection criteria than the phase 3 trials with DOACs, these incidences of major bleeding compare well to those observed in the RE‐COVER trials (0·54% and 1·0% per 6 months for dabigatran and warfarin, respectively) and HOKUSAI study (0·82% and 1·0% per 3–12 months for edoxaban and warfarin, respectively) (Schulman et al , 2009, 2014; Hokusai VTE Investigators 2013; Klok et al , 2016, 2017). Even so, considering the 1·1% incidence of major bleeding in the sensitivity analysis on warfarin treatment, the incidences of major bleeding in XALIA do seem representative in the perspective of the established yearly 2·7% incidence‐rate of major bleeding in patients on long‐term vitamin K antagonist treatment (Linkins et al , 2003). The strength of VTE‐BLEED in this ‘real‐world’ cohort of patients thus lies predominantly in the identification of the majority of patients with a very low risk of major bleeding, in whom anticoagulants could be continued safely beyond the first 3 months.…”

Section: Discussionmentioning

confidence: 99%

Predictive value of venous thromboembolism (VTE)‐BLEED to predict major bleeding and other adverse events in a practice‐based cohort of patients with VTE: results of the XALIA study

et al. 2018

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SummaryVenous thromboembolism (VTE)‐BLEED, a decision tool for predicting major bleeding during chronic anticoagulation for VTE has not yet been validated in practice‐based conditions. We calculated the prognostic indices of VTE‐BLEED for major bleeding after day 30 and day 90, as well as for recurrent VTE and all‐cause mortality, in 4457 patients enrolled in the international, prospective XALIA study. The median at‐risk time was 190 days (interquartile range 106–360). The crude hazard ratio (HR) for major bleeding after day 30 was 2·6 [95% confidence interval (CI) 1·3–5·2] and the treatment‐adjusted HR was 2·3 (95% CI 1·1–4·5) for VTE‐BLEED high (versus low) risk patients: the corresponding values for major bleeding after day 90 were 3·8 (95% CI 1·6–9·3) and 3·2 (95% CI 1·3–7·7), respectively. The predictive value of VTE‐BLEED was similar in selected patients with unprovoked VTE or those treated with rivaroxaban. High VTE‐BLEED score was associated with higher incidence of all‐cause mortality (treatment‐adjusted HR 11, 95% CI 4·8–23), but not evidently with recurrent VTE (treatment‐adjusted HR 1·5; 95% CI 0·85–2·7). These results confirm the predictive value of VTE‐BLEED in practice‐based data in patients treated with rivaroxaban or conventional anticoagulation, supporting the hypothesis that VTE‐BLEED may be useful for making management decisions on the duration of anticoagulant therapy.

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Section: Discussionmentioning

confidence: 99%

Predictive value of venous thromboembolism (VTE)‐BLEED to predict major bleeding and other adverse events in a practice‐based cohort of patients with VTE: results of the XALIA study

et al. 2018

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“…O principal risco da anticoagulação oral é a hemorragia 1,26,27 . Em nosso estudo, foram observados 15,4% (38,8 por 100 pacientes/ano) de eventos hemorrágicos nos 136 pacientes acompanhados, sendo a grande maioria destes de intensidade leve (13,2%) ou moderada (2,2%).…”

Section: Discussionunclassified

“…A incidência de complicações hemorrágicas não é homogênea na literatura 1,18,27 . Para o TEV, a incidên-cia de episódios de sangramento maior varia de 0,4 a 12,8%, sendo a maioria dos dados tirados de trabalhos prospectivos em que a warfarina foi comparada com diferentes tipos e regimes de heparinas de baixo peso molecular 18,27,28 .…”

Section: Discussionunclassified

“…Um aspecto que tem sido discutido por vários autores é de não haver uma uniformidade nos critérios de definição dos graus de hemorragia 18,27,37 . A maioria dos autores divide o sangramento em maior e menor 20 .…”

Section: Discussionunclassified

“…Em pacientes tratados por TEV com warfarina, em ensaios clínicos controlados randomizados, a mortalidade também foi baixa, próxima a zero na maioria dos trabalhos 18,38 . Metaná-lise realizada por Linkins et al 27 , reunindo 10.757 pacientes (4.374 pacientes/ano) tratados com AVK por TEV, em ensaios randomizados ou coortes prospectivos, mostrou uma incidência de 1,15 casos por 100 pacientes/ano de hemorragia intracraniana. Essa incidência parece ser maior ainda em pacientes com fibrilação atrial, infarto do miocárdio, válvulas prostéticas cardíacas e acidente vascular encefálico, onde tem variado de 0,2 a 2,9% [39][40][41][42] .…”

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Complicações da terapia anticoagulante com warfarina em pacientes com doença vascular periférica: estudo coorte prospectivo

et al. 2006

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194 ResumoObjetivo: Estudar prospectivamente a freqüência de complicações em pacientes tratados com warfarina e acompanhados no Ambulatório de Anticoagulação da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista.Métodos: Pacientes sorteados entre os agendados para consulta de junho de 2002 a fevereiro de 2004. Na primeira consulta, foi preenchida ficha com dados de identificação e clínicos. A cada retorno, ou quando o paciente procurou o hospital por intercorrência, foi preenchida ficha com a razão normatizada internacional, existência e tipo de intercorrência e condições de uso dos antagonistas da vitamina K.Resultados: Foram acompanhados 136 pacientes (61 homens e 75 mulheres), 99 com tromboembolismo venoso e 37 com doença arterial; 59 pacientes eram de Botucatu, e 77, de outros municípios. Foram registradas 30 intercorrências: nove não relacionadas ao uso da warfarina e 21 complicações hemorrágicas (38,8 por 100 pacientes/ ano). Uma hematêmese foi considerada grave (1,9 por 100 pacientes/ ano). As demais foram consideradas moderadas ou leves. Não houve óbitos, hemorragia intracraniana ou necrose cutânea. A única associação significante foi da freqüência de hemorragia com nível médio de razão normatizada internacional.Conclusão: Nossos resultados mostram a viabilidade desse tratamento em pacientes vasculares em nosso meio, mesmo em população de baixo nível socioeconômico, quando tratados em ambulatório especializado.Palavras-chave: Anticoagulantes, warfarina, efeitos adversos, doenças vasculares, trombose venosa, embolia pulmonar. AbstractObjective: To prospectively study the frequency of complications in patients treated with warfarin followed at Botucatu Medical School.Methods: Patients randomly selected among those with appointments scheduled from June 2002 to February 2004. At the first appointment, a protocol was filled with identification and clinical data. At every return or when the patient went to the hospital due to clinical events, another form was filled with the international normalized ratio, existence and type of clinical event and the conditions of use of vitamin K antagonists.Results: A total of 136 patients (61 men and 75 women), were followed; 99 patients with venous thromboembolism and 37 with arterial disease; 59 were from Botucatu and 77 were from other municipalities. Thirty clinical events were registered: nine of them were not related to the use of warfarin and 21 were hemorrhagic complications (38.8 per 100 patients-year). One hematemesis was considered severe (1.9 per 100 patients-year). The others were considered moderate or mild. There were no deaths, intracranial hemorrhage or cutaneous necrosis. The only significant association was frequency of hemorrhage and average international normalized ratio level.Conclusion: Our results demonstrate the feasibility of this treatment in vascular patients in our country, even in socially and economically poor populations, when treated in specialized clinics.

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Anticoagulation in Acute Pulmonary Embolism

Kelly¹,

Rudd²,

Hunt³

et al. 2002

Archives of Internal Medicine

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Clinical Impact of Bleeding in Patients Taking Oral Anticoagulant Therapy for Venous Thromboembolism

Abstract: The clinical impact of anticoagulant-related major bleeding in patients with venous thromboembolism is considerable, and clinicians should take this into account when deciding whether to continue long-term oral anticoagulant therapy in an individual patient.

Cited by 704 publications

References 63 publications

Predictive value of venous thromboembolism (VTE)‐BLEED to predict major bleeding and other adverse events in a practice‐based cohort of patients with VTE: results of the XALIA study

Predictive value of venous thromboembolism (VTE)‐BLEED to predict major bleeding and other adverse events in a practice‐based cohort of patients with VTE: results of the XALIA study

Complicações da terapia anticoagulante com warfarina em pacientes com doença vascular periférica: estudo coorte prospectivo

Anticoagulation in Acute Pulmonary Embolism

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