Effectiveness and Safety of Rivaroxaban Versus Warfarin for Treatment of Venous Thromboembolism in Patients with Known Primary Hypercoagulable States
Notice bibliographique
Résumé
Background: The efficacy and safety of rivaroxaban versus enoxaparin/vitamin K antagonist (VKA) for treatment and secondary prevention of venous thromboembolism (VTE) was demonstrated in the EINSTEIN clinical trial program. As screening for primary hypercoagulable states was not required as part of the EINSTEIN trial program protocol, fewer than 500 total patients with a known primary hypercoagulable state were identified. Objective: To assess the effectiveness and safety of rivaroxaban versus warfarin for treatment and secondary prevention of VTE in patients with a known primary hypercoagulable state in a large, real-world population. Methods: US MarketScan claims data from January 2012-September 2015 were utilized. We identified adult patients with a primary International Classification of Diseases-9th Revision (ICD-9) discharge diagnosis code for deep vein thrombosis (DVT) (ICD-9=451.1, 451.2, 453.40, 453.41, 453.42, 453.8, 453.9) or pulmonary embolism (PE)(ICD-9=415.1x), diagnosed during a hospitalization or emergency department visit (the index event), with ≥180-days of continuous medical and prescription benefits prior to the index event (baseline), a documented diagnosis for a primary hypercoagulable state (ICD-9=289.81) during baseline or the index VTE encounter and newly-initiated on rivaroxaban or warfarin within 30-days of the index VTE event. Patients with a claim for an anticoagulant before the index event were excluded. Effectiveness and safety endpoints included recurrent VTE, any major bleeding (identified per the Cunningham algorithm), intracranial hemorrhage (ICH) and gastrointestinal bleeding (GIB). Patients were followed for a maximum of 12-months from the index event or until occurrence of an endpoint, switch or discontinuation (14-day permissible gap) of index oral anticoagulation or insurance disenrollment. Rivaroxaban users were 1:1 propensity-score matched to warfarin users. Balance between cohorts was evaluated by inspecting standardized differences for baseline covariates (differences >0.1 indicating imbalance). Cox regression was performed and results reported as hazard ratios (HRs) with 95% confidence intervals (CIs). Results: We matched 403 rivaroxaban and 403 warfarin users with a known primary hypercoagulable state and experiencing a VTE. Mean±standard deviation (SD) duration of patient follow-up was 0.5±3 years. All baseline covariates had a standardized difference Conclusion: Our study results suggest rivaroxaban9s relative effectiveness and safety versus warfarin is maintained when treating VTE patients with known primary hypercoagulable states in routine practice. These real-world study findings are consistent with that of the overall EINSTEIN clinical trial program and its subgroup analysis of patients with primary hypercoagulable states. Disclosures Coleman: Boehringer Ingelheim: Consultancy, Honoraria; Janssen Pharmaceuticals: Consultancy, Honoraria, Research Funding; Bayer AG: Consultancy, Honoraria, Research Funding. Turpie: Bayer HealthCare Pharmaceuticals: Consultancy; Janssen Research and Development: Consultancy, Honoraria. Beyer-Westendorf: Pfizer: Honoraria, Research Funding; Daiichi-Sankyo: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; Boehringer-Ingelheim: Honoraria, Research Funding.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,011 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».