Dabigatran versus Vitamin-K-Antagonisten bei Vorhofflimmern in der klinischen Praxis: Endergebnisse der Phase III des GLORIA-AF-Registers

BACKGROUND: Prospectively collected, routine clinical practice-based data on antithrombotic therapy in non-valvular atrial fibrillation (AF) patients are important for assessing real-world comparative outcomes. The objective was to compare the safety and effectiveness of dabigatran versus vitamin K antagonists (VKAs) in patients with newly diagnosed AF. METHODS AND RESULTS: GLORIA-AF is a large, prospective, global registry program. Consecutive patients with newly diagnosed AF and CHA2DS2-VASc scores ≥ 1 were included and followed for 3 years. To control for differences in patient characteristics, the comparative analysis for dabigatran versus VKA was performed on a propensity score (PS)-matched patient set. Missing data were multiply imputed. Proportional-hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Between 2014 and 2016, 21,300 eligible patients were included worldwide: 3839 patients were prescribed dabigatran and 4836 VKA with a median age of 71.0 and 72.0 years, respectively; > 85% in each group had a CHA2DS2-VASc-score ≥ 2. The PS-matched comparative analysis for dabigatran and VKA included on average 3326 pairs of matched initiators. For dabigatran versus VKAs, adjusted HRs (95% confidence intervals) were: stroke 0.89 (0.59-1.34), major bleeding 0.61 (0.42-0.88), all-cause death 0.78 (0.63-0.97), and myocardial infarction 0.89 (0.53-1.48). Further analyses stratified by PS and region provided similar results. CONCLUSIONS: Dabigatran was associated with a 39% reduced risk of major bleeding and 22% reduced risk for all-cause death compared with VKA. Stroke and myocardial infarction risks were similar, confirming a more favorable benefit-risk profile for dabigatran compared with VKA in clinical practice. Clinical trial registration https://www. CLINICALTRIALS: gov . NCT01468701, NCT01671007.

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Im prospektiven GLORIA-AF-Register wurden weltweit 21 300 Patienten mit neu diagnostiziertem Vorhofflimmern (CHA2DS2-VASc ≥ 1) 3 Jahre nachverfolgt. Dabigatran (n = 3839) und Vitamin-K-Antagonisten (n = 4836) wurden nach Propensity-Score-Matching (im Mittel 3326 Paare) verglichen; die adjustierten Hazard Ratios betrugen 0,89 (Schlaganfall), 0,61 (schwere Blutung), 0,78 (Gesamtmortalität) und 0,89 (Myokardinfarkt). Dabigatran war mit einem um 39 % verringerten Risiko schwerer Blutungen und einem um 22 % verringerten Gesamtmortalitätsrisiko assoziiert, bei ähnlichen Risiken für Schlaganfall und Myokardinfarkt.

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