Benefit of Extended Maintenance Therapy for Venous Thromboembolism with Dabigatran Etexilate Is Maintained Over 1 Year of Post-Treatment Follow-up
Notice bibliographique
Résumé
Abstract Abstract 21 Background: The RE-SONATE trial compared 6 months of dabigatran etexilate (DE) 150 mg twice daily to placebo in patients at equipoise for needing additional oral anticoagulation following 6–18 months of anticoagulant therapy with a vitamin K antagonist. DE provided a 92% relative risk reduction for recurrent symptomatic VTE compared with placebo and a low risk of major bleeding. We present here the results of an extended observational follow-up period of 12 months following completion of study treatment, which was conducted to determine whether there was an increase in VTE recurrence following discontinuation of study treatment. Methods: RE-SONATE is an international, randomized, double-blind, event-driven, superiority study for efficacy. Patients were ≥ 18 years of age with creatinine clearance ≥ 30 mL/min. The primary efficacy endpoint (assessed by an independent adjudication committee blinded to treatment allocation) was symptomatic recurrent VTE (including symptomatic deep vein thrombosis, non-fatal and fatal pulmonary embolism) and unexplained death. The primary safety endpoint was major bleeding. Events were counted within the intended treatment period plus 3 days. A protocol amendment extended the post-treatment follow-up period from 1 month to 12 months. The extended follow-up population, used for the analysis of efficacy for patients who continued into this period, was a subset of the full analysis set, including patients who signed the consent form for the relevant protocol amendment. Results: In the initial double-blind treatment period of up to 6 months from randomization, recurrent symptomatic VTE or unexplained death occurred in 3 (0.4%) of 681 patients treated with DE and 37 (5.6%) of 662 patients treated with placebo (hazard ratio [HR] 0.08; 95% CI 0.02, 0.25%; P < 0.0001). Two patients had major bleeds (0.39%) on treatment with DE versus none in the placebo group. No unexplained deaths occurred in the DE group compared with one in the placebo group (Schulman et al. J Thromb Haem 2011 Supp 2 11–10626). In the extended follow-up analysis of 1323 patients, the cumulative incidences of recurrent symptomatic VTE and unexplained death at intermediate time points during the uncontrolled, post-treatment follow-up were (Table 1): at 40 days, 2.0% in the former DE group versus 5.7% in the former placebo group (p=0.0005); and at 6 months, 6.0% versus 10.2% (p=0.0060), respectively. These represent absolute risk differences of 3.7% and 4.3% after 40 days and 6 months of uncontrolled follow-up, respectively. At 1 year of follow-up (540 days after randomization), these events occurred in 7.8% in the former DE group compared with 11.6% in the former placebo group (p=0.0261), for a risk difference of 3.8% (95% CI 0.5%, 7.1%). Conclusions: The reduced risk of recurrent VTE associated with extending treatment with DE during the double-blind treatment period is preserved during 1 year of follow-up after discontinuation of study drug. However, the high rate of recurrent VTE, even in the former DE treatment group (7–8%), suggests that a longer duration of anticoagulant therapy may be warranted. Disclosures: Off Label Use: Dabigatran etexilate is an oral thrombin inhibitor under investigation for anticoagulant prophylaxis or treatment in venous and arterial thrombomebolism. Baanstra:Boehringer Ingelheim: Employment. Friedman:Boehringer Ingelheim: Employment.
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 | 0,004 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,000 | 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) | 0,003 | 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 ».