真实世界中达比加群酯和华法林在心房颤动患者中的疗效和安全性：一项前瞻性国家范围内的队列研究

Objective
To assess the efficacy and safety in an ‘everyday clinical practice’ population of anticoagulant-naïve patients with atrial fibrillation (AF) treated with dabigatran etexilate following its post-approval availability in Denmark, compared to warfarin.
Background
Concerns have been raised about an excess of bleeding events or myocardial infarction amongst patients treated with the new oral direct thrombin inhibitor, dabigatran etexilate.
Methods
From the Danish Registry of Medicinal Product Statistics, we identified a dabigatran-treated group and a 1:2 propensity matched warfarin-treated group of n=4978and n=8936, respectively. Comparisons on efficacy and safety outcomes were made based on Cox-proportional hazards models stratified on propensity match groups.
Results
Stroke and systemic embolism were not significantly different between warfarin and dabigatran treated patients. Adjusted mortality was significantly lower with both dabigatran doses (110mg BID: propensity match group stratified HR (aHR): 0.79, 95% CI: 0.65-0.95, 150mg BID:aHR: 0.57, 95%CI: 0.40-0.80), when compared to warfarin. Pulmonary embolism was lower compared to warfarin for both doses of dabigatran.
Less intracranial bleeding was seen with both dabigatran doses (110mg BID: aHR: 0.24 95% CI: 0.08-0.56, 150mg BID: aHR: 0.08, 95%CI: 0.01-0.40). The incidence of myocardial infarction was lower with both dabigatran doses (110mg BID, aHR: 0.30,95% CI: 0.18-0.49; 150mg BID, aHR: 0.40,95%CI: 0.21-0.70). Gastrointestinal bleeding was lower with dabigatran 110mg BID (aHR: 0.60, 95%CI: 0.37-0.93) compared to warfarin, but not dabigatran 150mg BID. The main findings were broadly consistent in a subgroup analysis of dabigatran users with ≥1 year’s followup (median followup 13.9 months (IQR: 12.6-15.3)).
Conclusions
In this ‘everyday clinical practice’ post-approval nationwide clinical cohort, there were similar stroke/systemic embolism, and major bleeding rates with dabigatran (both doses) compared to warfarin. Mortality, intracranial bleeding, pulmonary embolism, and myocardial infarction were lower with dabigatran, compared to warfarin. We found no evidence of an excess of bleeding events or myocardial infarction amongst dabigatran treated patients in this propensity-matched comparison against warfarin, even in the subgroup with ≥1 year’s followup.