Direct Oral Anticoagulant- or Warfarin-Related Major Bleeding

Xu, Yan; Schulman, Sam; Dowlatshahi, Dar; Holbrook, Anne; Simpson, Christopher S.; Shepherd, Lois E.; Wells, Philip S.; Giulivi, Antonio; Gomes, Tara; Mamdani, Muhammad; Khuu, Wayne; Frymire, Eliot; Johnson, Ana

doi:10.1016/j.chest.2017.02.009

Cited by 77 publications

(35 citation statements)

References 27 publications

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“…The accuracy of major hemorrhagic events diagnosis was the cornerstone of the SACHA study; in the majority of previous studies, no medical validation was made (33) and there were few real-life studies with medical diagnosis validation (47)(48)(49)(50).…”

Section: Discussionmentioning

confidence: 99%

French administrative health care database (SNDS): The value of its enrichment

et al. 2019

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SNIIRAM/SNDS, the French administrative health care database, covers around 99 % of the population. Its main limitation is the absence of clinical information and biological results. This report exposes the value of SNIIRAM/SNDS enrichment by external databases, and the linkage issues. It is illustrated by examples: the well-known population-based cohort CONSTANCES created to answer to epidemiological research questions with a specific interest on occupational and social factors, chronic diseases, and aging; the CANARI study, a regional-based study that collected Gleason score in all pathology laboratories in Brittany and then, linked pathology results to an ad hoc extraction from SNIIRAM database; the goal was to investigate the risk of high grade prostate cancer in patients treated by 5-alphareductase inhibitors for a symptomatic benign prostatic hyperplasia; the SACHA study, that identified and medically validated major bleeding event referred to emergency wards, then linked those clinical data to SNIIRAM; the goal was to minimize misclassification bias when estimating bleeding risk in patients who were prescribed antithrombotic drugs; the ISO-PSY study linked the SNIIRAM with the national cause of death registry (CépiDc) and the nationwide emergency department surveillance system (OSCOUR® Network) to investigate the potential link between isotretinoin and suicidal risk; the EFEMERIS cohort that assesses drugs prescriptions in French pregnant women who delivered in the Haute-Garonne region; the EPI-GETB-AM study that derived a SNIIRAM/SNDS-based algorithm to identify venous thromboembolism and linked SNIIRAM/SNDS to the EPI-GETBO-III survey for validation. Another perspective of SNDS enrichment is clinical trials' data for medico-economic assessment, and extended follow-up without attrition bias. Linkage is not straightforward. Apart from regulatory approbation and authorized data center issues, which could be solved by the Health Data Hub Initiative, a multidisciplinary team with medical, pharmacological and methodological knowledge, as well as with technical skills is essential to handle the whole process.

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Section: Discussionmentioning

confidence: 99%

French administrative health care database (SNDS): The value of its enrichment

et al. 2019

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“…96 Analysis of 460 bleeds observed in patients on NOACs showed that almost 20% of those patients received vitamin K, which is useless in such clinical situations. 94 It has absolutely no possibility of any effect, but was given probably because many of these patients had a prolonged INR due to rivaroxaban. 97 Tranexamic acid, an antifibrinolytic agent effective in trauma or postpartum hemorrhages, acts as a lysine analog that impairs plasminogen activation on fibrin.…”

Section: Specific Atrial Fibrillation Patient Populations At Risk Of mentioning

confidence: 99%

“…Fresh frozen plasma is ineffective in patients bleeding on NOACs but was used in about 10% of patients reported by Xu Y et al 94 Fresh frozen plasma may be used as a plasma volume expander in patients following transfusions; however, its shortcomings are numerous, including risk of transfusion reactions, and acute heart failure.…”

Section: Specific Atrial Fibrillation Patient Populations At Risk Of mentioning

confidence: 99%

“…A dose of 50 U/kg of PCC or activated PCC is recommend in patients treated with rivaroxaban or apixaban if life -threatening bleeding occurs. 16,19 A prospective multicenter observational study showed that in the real world, 94 reversal strategies in bleeding patients on rivaroxaban or apixaban differ largely. A Swedish case series of 84 bleeding patients (75% with AF) who required reversal of factor Xa inhibition after 9 to 16 hours since the last dose of the anticoagulant showed that in most cases (70% ICB and 16% GI bleeds), PCC at a dose of 2000 units was used in patients with body weight of 65 kg or more, while 1500 units were administered in patients weighted below 65 kg.…”

Section: Specific Atrial Fibrillation Patient Populations At Risk Of mentioning

confidence: 99%

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Bleeding in anticoagulated patients with atrial fibrillation: practical considerations

Undas¹,

Drabik²,

Potpara³

2020

Kardiologia Polska

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or higher, but they are safer and more convenient. 7,8 In a meta-analysis of pivotal phase 3 AF randomized controlled trials (RCTs), NOACs reduced the risk of stroke or SE by 19% compared with warfarin (relative risk [RR], 0.81; 95% CI, 0.73-0.91), largely due to a markedly lower rate of hemorrhagic strokes (RR 0.49, 95% CI, 0.38-0.64) and intracranial bleeding (ICB) (RR, 0.48; 95% CI, 0.39-0.59). 9 However, the use of NOACs (in particular, full-dose dabigatran and rivaroxaban) was significantly associated with an increased risk of gastrointestinal (GI) bleeding (RR, 1.25; 95% CI, 1.01-1.55). 7 Of note, the differences between baseline stroke and bleeding risks among different NOAC trials could have affected the reported bleeding rates (FIGURE 1). Residual incidence of stroke or SE despite NOAC use among patients with AF is estimated at 1.5% to 2.5% per year and that of major bleeding at 2% to 4% per year. 9 As compared with warfarin, NOACs slightly reduced all-cause mortality (RR

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“…В исследовании RE-LY (рандомизированная оценка долгосрочной антикоагулянтной терапии) сравнивали эффекты дабигатрана с варфарином у пациентов с ФП и предшествующим инсультом или транзиторной ишемической атакой (ТИА) [26]. Были сделаны выводы, что по сравнению с варфарином, дабигатран в дозе 110 мг не уступал, а в дозе 150 мг превосходил варфарин в профилактике инсульта или системной эмболии.…”

Section: частота значительных кровотечений при применении пероральныхunclassified

The effect of warfarin, heparin, and modern directly acting oral anticoagulants (dabigatran etexilate, rivaroxaban, apixaban) on the level of coagulation factors: V, VII, VIII, IX, XII, WF

Gulyaikhina

Евгеньевна²

2019

HERALD of North-Western State Medical University named after I.

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Heparin is common initial therapy administered to subjects with acute venous thromboembolism. Routine clinical practice in this case consists of immediate heparin therapy initiation and administration of warfarin sodium within 24 hours; administration of heparin is usually finished in 5 days. Patients with CF-LVAD (continuous flow left ventricular assist device) are also administered intravenous unfractionated heparin. Heparin mainly serves as anticoagulant via catalyzing antithrombin, which leads to factor II (thrombin), factor X inhibition, with smaller effect on IX, XI, XII. During the last 50 years warfarin has been the most common anticoagulant from vitamin K antagonists group which is used to treat patients with high risk of developing arterial and venous thrombosis. It has narrow therapeutic window due to unfavorable pharmacokinetics, thus requiring frequent monitoring, and it’s affected by interaction with concomitant medications and foods. Apart from this, effect of warfarin is not limited to the influence on hemostasis; it also has impact on all vitamin K-related proteins. Warfarin shows its anticoagulant effect through decreasing functional levels of vitamin K-related factors II, VII, IX and X. Synthesis of two physiologic anticoagulants — C and S proteins — is blocked at the same time. Warfarin competes with vitamin K, thus blocking vitamin K effects. Modern directly acting oral anticoagulants: direct thrombin inhibitor dabigatran and Xa factor inhibitors — rivaroxaban and apixaban, were developed as an alternative to warfarin. They also show non-hemostatic vascular effects via protease activated receptors (PARs).

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Direct Oral Anticoagulant- or Warfarin-Related Major Bleeding

Cited by 77 publications

References 27 publications

French administrative health care database (SNDS): The value of its enrichment

French administrative health care database (SNDS): The value of its enrichment

Bleeding in anticoagulated patients with atrial fibrillation: practical considerations

The effect of warfarin, heparin, and modern directly acting oral anticoagulants (dabigatran etexilate, rivaroxaban, apixaban) on the level of coagulation factors: V, VII, VIII, IX, XII, WF

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