Abstract：
BACKGROUND: 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.
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.
摘要：
背景：利伐沙班预防心房颤动（SPAF）卒中的长期有效性和安全性的数据很少，并且无法从随机临床试验中获得。
方法：我们使用了来自前瞻性，非介入性DRESDENNOAC注册评估中风/短暂性脑缺血发作（TIA）/全身性栓塞（SE）和ISTH大出血的发生率，一般来说，事件模式随时间的变化。
结果：在2011年10月1日至2022年12月31日期间，接受利伐沙班的1204例SPAF患者随访6.7±3.4年，平均利伐沙班暴露量为4.9±3.5年。随访期间,卒中/TIA/SE的意向治疗率为3.5/100pt.第一年（95%CI2.5-4.7），降至1.6/100pt。2-5年和2.1/100pt的年份（95%CI1.2-2.0）。5年后的年份（95%CI1.6-2.7）。同样，治疗中事件发生率从2.4/100pt下降.年（95%CI1.5-3.5）至1.1（95%CI0.7-1.5）和1.6（95%CI1.0-2.3），分别。治疗后的大出血率为3.5/100pt。在第2-5年和>5年期间，第一个治疗年（95％CI2.5-4.8）和2.7（95％CI2.2-3.4）和3.5（95％CI2.7-4.6），分别。值得注意的是，在整个随访期间，致命性出血的发生率较低（0.2vs.0.2vs.0.1/100磅。years).
结论：我们的结果证明了利伐沙班治疗在未经选择的SPAF患者的日常护理中的长期有效性和安全性。我们的数据表明，多年来心血管事件的模式保持不变。相比之下,出血模式随着时间的推移而改变，可能是由于人口老龄化合并症的影响。
方法：我们使用了来自前瞻性，非介入性DRESDENNOAC注册评估中风/短暂性脑缺血发作（TIA）/全身性栓塞（SE）和ISTH大出血的发生率，一般来说，事件模式随时间的变化。
结果：在2011年10月1日至2022年12月31日期间，接受利伐沙班的1204例SPAF患者随访6.7±3.4年，平均利伐沙班暴露量为4.9±3.5年。随访期间,卒中/TIA/SE的意向治疗率为3.5/100pt.第一年（95%CI2.5-4.7），降至1.6/100pt。2-5年和2.1/100pt的年份（95%CI1.2-2.0）。5年后的年份（95%CI1.6-2.7）。同样，治疗中事件发生率从2.4/100pt下降.年（95%CI1.5-3.5）至1.1（95%CI0.7-1.5）和1.6（95%CI1.0-2.3），分别。治疗后的大出血率为3.5/100pt。在第2-5年和>5年期间，第一个治疗年（95％CI2.5-4.8）和2.7（95％CI2.2-3.4）和3.5（95％CI2.7-4.6），分别。值得注意的是，在整个随访期间，致命性出血的发生率较低（0.2vs.0.2vs.0.1/100磅。years).
结论：我们的结果证明了利伐沙班治疗在未经选择的SPAF患者的日常护理中的长期有效性和安全性。我们的数据表明，多年来心血管事件的模式保持不变。相比之下,出血模式随着时间的推移而改变，可能是由于人口老龄化合并症的影响。
