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Cardioversion in patients with newly diagnosed non-valvular atrial fibrillation: observational study using prospectively collected registry data
The BMJ ( IF 105.7 ) Pub Date : 2021-10-27 , DOI: 10.1136/bmj-2021-066450
Marita Knudsen Pope 1, 2 , Trygve S Hall 3 , Valentina Schirripa 4 , Petra Radic 5 , Saverio Virdone 6 , Karen S Pieper 6 , Jean-Yves Le Heuzey 7 , Petr Jansky 8 , David A Fitzmaurice 9 , Riccardo Cappato 10 , Dan Atar 1, 3 , A John Camm 11 , Ajay K Kakkar 6 ,
Affiliation  

Objective To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation. Design Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF—GARFIELD-AF). Setting 1317 participating sites in 35 countries. Participants 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks’ duration) and at least one investigator determined stroke risk factor. Main outcome measures Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection. Results 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up. Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively. Conclusion In this large dataset of patients with recent onset non-valvular atrial fibrillation, a small proportion were treated with cardioversion. Direct current cardioversion was performed twice as often as pharmacological cardioversion, and there appeared to be no major difference in outcome events for these two cardioversion modalities. For the overall cardioversion group, after adjustments for confounders, a significantly lower risk of mortality was found in patients who received early cardioversion compared with those who did not receive early cardioversion. Study registration ClinicalTrials.gov [NCT01090362][1]. Requests for patient level data can be made to the head of statistics at the Thrombosis Research Institute (kpieper@tri-london.ac.uk). These requests should include a protocol summary and a summary of the statistical analysis plan. The request will be reviewed by the data sharing committee for approval and next steps will be discussed with the requestor. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01090362&atom=%2Fbmj%2F375%2Fbmj-2021-066450.atom

中文翻译:

新诊断的非瓣膜性房颤患者的心脏复律:使用前瞻性收集的注册数据的观察性研究

目的 在近期发生的非瓣膜性房颤患者的大型数据集中,调查接受心脏复律的患者与未接受心脏复律的患者的临床结局。使用前瞻性收集的注册数据(FIELD-AF-GARFIELD-AF 中的全球抗凝剂注册)设计观察性研究。在 35 个国家/地区设置 1317 个参与站点。参与者 52 057 名 18 岁及以上的新诊断房颤患者(持续时间长达 6 周)和至少一名研究人员确定了中风危险因素。主要结局指标 在基线时接受心脏复律的患者和未接受心脏复律的患者之间,以及接受直流电复律的患者和接受药物复律的患者之间进行了比较。使用 Cox 比例风险模型的重叠倾向加权来评估复律对临床终点(全因死亡率、非出血性中风或全身性栓塞和大出血)的影响,并根据基线风险和患者选择进行调整。结果 44 201 名患者被纳入比较心脏复律和未复律的分析,其中 6595 人(14.9%)在基线时接受了心脏复律。心脏复律组全因死亡率的倾向评分加权风险比从基线到一年随访为 0.74(95% 置信区间 0.63 至 0.86),从一年至两年随访为 0.77(0.64 至 0.93)。在基线时进行复律的 6595 名患者中,299 例在入组后 48 天以上进行了后续复律。在比较心脏复律类型的分析中评估了 7175 名患者:2427 名(33.8%)接受了药物复律,4748 名(66.2%)接受了直流电复律。在一年随访期间,接受直流电复律和药物复律的患者全因死亡率的事件率(每 100 患者年)分别为 1.36(1.13 至 1.64)和 1.70(1.35 至 2.14)。结论 在这个近期出现非瓣膜性房颤患者的大型数据集中,一小部分患者接受了心脏复律治疗。直流电复律的执行频率是药物复律的两倍,这两种复律方式的结果事件似乎没有重大差异。对于整个心脏复律组,在调整混杂因素后,与未接受早期心脏复律的患者相比,接受早期心脏复律的患者的死亡风险显着降低。研究注册 ClinicalTrials.gov [NCT01090362][1]。可以向血栓形成研究所的统计主管 (kpieper@tri-london.ac.uk) 索取患者水平数据。这些请求应包括协议摘要和统计分析计划摘要。该请求将由数据共享委员会审查以供批准,并将与请求者讨论后续步骤。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01090362&atom=%2Fbmj%2F375%2Fbmj-2021-066450.atom 政府 [NCT01090362][1]。可以向血栓形成研究所的统计主管 (kpieper@tri-london.ac.uk) 索取患者水平数据。这些请求应包括协议摘要和统计分析计划摘要。该请求将由数据共享委员会审核批准,并将与请求者讨论后续步骤。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01090362&atom=%2Fbmj%2F375%2Fbmj-2021-066450.atom 政府 [NCT01090362][1]。可以向血栓形成研究所的统计主管 (kpieper@tri-london.ac.uk) 索取患者水平数据。这些请求应包括协议摘要和统计分析计划摘要。该请求将由数据共享委员会审核批准,并将与请求者讨论后续步骤。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01090362&atom=%2Fbmj%2F375%2Fbmj-2021-066450.atom
更新日期:2021-10-27
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