Introduction: Data on long-term effectiveness and safety of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) are scarce and not available from randomized clinical trials.
Methods: We used data from the prospective, non-interventional DRESDEN NOAC REGISTRY to evaluate rates of stroke/transient ischaemic attack (TIA)/systemic embolism (SE) and ISTH major bleeding, in general and changes of event patterns over time.
Results: Between 1st October 2011 and 31st December 2022, 1204 SPAF patients receiving rivaroxaban were followed for 6.7 ± 3.4 years with a mean rivaroxaban exposure of 4.9 ± 3.5 years. During follow up, intention-to treat rates of stroke/TIA/SE were 3.5/100 pt. years (95 % CI 2.5-4.7) in the first year and fell to 1.6/100 pt. years (95 % CI 1.2-2.0) in years 2-5 and 2.1/100 pt. years (95 % CI 1.6-2.7) after 5 years. Similarly, on-treatment event rates fell from 2.4/100 pt. years (95 % CI 1.5-3.5) to 1.1 (95 % CI 0.7-1.5) and 1.6 (95 % CI 1.0-2.3), respectively. Major bleeding rates on treatment were 3.5/100 pt. years in the first treatment year (95 % CI 2.5-4.8) and 2.7 (95 % CI 2.2-3.4) and 3.5 (95 % CI 2.7-4.6) in the periods 2-5 and > 5 years, respectively. Of note, rates of fatal bleeding were low throughout follow-up (0.2 vs. 0.2 vs. 0.1/100 pt. years).
Conclusions: Our results demonstrate the long-term effectiveness and safety of rivaroxaban therapy in unselected SPAF patients in daily care. Our data indicate that patterns of cardiovascular events remain constant over many years. In contrast, bleeding patterns change over time, possibly due to effects of co-morbidities in an ageing population.
Keywords: Anticoagulation; Atrial fibrillation; Bleeding; NOAC; Persistence; Rivaroxaban.
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