Comparison of Bleeding Risk between Rivaroxaban and Apixaban: a Pilot Feasibility Study
Notice bibliographique
Résumé
Introduction: The direct oral anticoagulants (DOACs) apixaban and rivaroxaban have simplified the treatment of acute venous thromboembolism (VTE). Phase III randomized controlled trials demonstrated each DOAC to have similar or better safety and efficacy profiles to vitamin K antagonists, while network meta-analyses suggest that apixaban might be associated with fewer bleeding events than rivaroxaban. Trial limitations and lack of direct comparison between these agents make it impossible to know which DOAC confers the best risk-benefit ratio. The COBRRA (COmparison of Bleeding Risk between Rivaroxaban and Apixaban) pilot feasibility study (NCT02559856) was designed to determine if it is feasible to conduct a large randomized multicenter trial comparing apixaban to rivaroxaban for the treatment of acute VTE. Methods: Adult patients with symptomatic acute VTE were eligible for randomization to apixaban or rivaroxaban in an open-label fashion. The exclusion criteria were: had received >72 hours of therapeutic anticoagulation; creatinine clearance 120 Kg; known Child-Pugh B or C liver disease; active bleeding; active malignancy; pregnancy/breastfeeding; and use of contraindicated medications. Patients were followed on anticoagulation for 3 or 6 months. The pilot trial was conducted in 4 Canadian centers that are part of the CanVECTOR network. Two sites are established Thrombosis research centers and the other 2 sites are emerging research centers with minimal established research infrastructure. The primary outcome was recruitment of at least 2 patients per month per site over a mean of 6 months recruitment. Secondary outcomes included major bleeding, clinically relevant non-major bleeding, and minor bleeding events; recurrent VTE; VTE related deaths; and all-cause mortality. Results: Seventy-two patients were enrolled with mean recruitment of 4 patients per month at experienced sites and 2 patients per month at new sites. Baseline clinical characteristics are available in Table 1. Thirty-four patients were randomized to apixaban with mean age 58 years; 37 patients were randomized to rivaroxaban and had mean age of 63 years. Follow up visits are ongoing at three participating sites and results will be available in October 2017. No patients have been lost to follow up. Conclusions: This pilot trial is the first direct comparison of rivaroxaban and apixaban for acute VTE treatment. Recruitment targets were met hence we demonstrated feasibility of the main trial. The sample size of the full study is estimated to be 2760 patients. With recruitment rates similar to those observed in this pilot study, we would need at least 10 experienced centers and 8 emerging sites to ensure enrolment is completed over 4 years. Secondary outcome reporting will be available for the 59th ASH Annual Meeting. Disclosures Castellucci: BMS: Honoraria; Bayer: Honoraria; Leo Pharma: Honoraria; Boehringer-Ingelheim: Honoraria; Pfizer: Honoraria. Le Gal: Bayer: Honoraria; BMS: Honoraria.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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 | 0,019 | 0,021 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,004 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,001 | 0,002 |
| Science ouverte | 0,002 | 0,002 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
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 ».