PMID- 34792111 OWN - NLM STAT- MEDLINE DCOM- 20220718 LR - 20221029 IS - 1532-2092 (Electronic) IS - 1099-5129 (Print) IS - 1099-5129 (Linking) VI - 24 IP - 6 DP - 2022 Jul 15 TI - International cohort study on the effectiveness of dronedarone and other antiarrhythmic drugs for atrial fibrillation in real-world practice (EFFECT-AF). PG - 899-909 LID - 10.1093/europace/euab262 [doi] AB - AIMS: To evaluate the effectiveness and safety of dronedarone compared with other commonly used antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrences. METHODS AND RESULTS: An international observational cohort study in Germany, Spain, Italy, and the USA enrolling patients with AF receiving AAD therapy. Patients with New York Heart Association (NYHA) Class IV heart failure were excluded. Participants were followed for up to 18 months, regardless of discontinuation or subsequent AAD switches. Atrial fibrillation recurrence was captured by hospitalization, emergency room visit, or electrocardiogram-based documentation of AF. Confounding bias was controlled for in the analysis of AF recurrence using multivariate models of 19 variables for adjustment. A total of 1009 participants [mean age 67.2 (10.8) years, male to female ratio 1.3] were recruited from 170 centres, 693 (69%) of which were from across Europe and the remaining 316 (31%) from the USA. At the time of enrolment, participants were taking dronedarone (51%) or other AADs (49%) [flecainide or propafenone (42%), sotalol (11%), and amiodarone (47%)]. No significant differences in the risk of first confirmed AF recurrence with dronedarone vs. other AADs [crude hazard ratio (HR) 1.10 (95% confidence interval 0.85-1.42); adjusted HR 1.16 (0.87-1.55)] were found, irrespective of whether univariate or multivariate models were used. Reported safety events were in accordance with the known safety profile of dronedarone. CONCLUSION: In this population of patients from either Europe or the USA receiving dronedarone or another AAD, the effectiveness of dronedarone was comparable to that observed for other AADs in preventing first AF recurrence. CI - (c) The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology. FAU - Khachatryan, Artak AU - Khachatryan A AUID- ORCID: 0000-0003-3888-2347 AD - (Pharmaco)*Epidemiologist with Laser Group at Time of the Study, London, UK. FAU - Merino, Jose L AU - Merino JL AUID- ORCID: 0000-0002-1737-1903 AD - University Hospital La Paz, Autonoma University, Arrhythmia & Robotic EP Unit, IdiPaz, Madrid, Spain. FAU - de Abajo, Francisco Jose AU - de Abajo FJ AUID- ORCID: 0000-0001-9119-8646 AD - Department of Biomedical Sciences, University Hospital Principe de Asturias, Clinical Pharmacology Unit, University of Alcala (IRYCIS), Alcala de Henares, Madrid, Spain. FAU - Botto, Giovanni L AU - Botto GL AUID- ORCID: 0000-0002-8049-7517 AD - ASST Rhodense, Rho & Garbagnate Hospitals, Head of Electrophysiology and Clinical Arrhythmology, Milan, Italy. FAU - Kirchhof, Paulus AU - Kirchhof P AUID- ORCID: 0000-0002-1881-0197 AD - Department of Cardiology, University Heart and Vascular Centre UKE, Hamburg, Germany. AD - German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lubeck, Hamburg, Germany. AD - University of Birmingham, Institute of Cardiovascular Sciences, Birmingham, UK. FAU - Breithardt, Guenter AU - Breithardt G AD - Department of Cardiovascular Medicine, University Hospital of Munster, Munster, Germany. FAU - Stambler, Bruce AU - Stambler B AUID- ORCID: 0000-0001-5692-2619 AD - Piedmont Heart Institute, Atlanta, GA, USA. FAU - Abenhaim, Lucien AU - Abenhaim L AUID- ORCID: 0000-0001-6106-9923 AD - Center for Risk Research CRRx Inc, Montreal, Canada. AD - London School of Hygiene & Tropical Medicine, London, UK. FAU - Grimaldi-Bensouda, Lamiae AU - Grimaldi-Bensouda L AUID- ORCID: 0000-0003-1952-5467 AD - Hospital Group Paris-Saclay, Assistance Publique- Hopitaux de Paris, Paris, France. AD - Paris-Saclay University, INSERM, CESP Anti-Infective Evasion and Pharmacoepidemiology Team, Paris, France. LA - eng PT - Journal Article PT - Observational Study PL - England TA - Europace JT - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology JID - 100883649 RN - 0 (Anti-Arrhythmia Agents) RN - JQZ1L091Y2 (Dronedarone) RN - N3RQ532IUT (Amiodarone) SB - IM MH - Aged MH - *Amiodarone/adverse effects MH - Anti-Arrhythmia Agents/adverse effects MH - *Atrial Fibrillation/chemically induced/diagnosis/drug therapy MH - Cohort Studies MH - Dronedarone/adverse effects MH - Female MH - Humans MH - Male PMC - PMC9282916 OTO - NOTNLM OT - Atrial fibrillation OT - Cardiovascular OT - Cohort OT - Dronedarone OT - Effectiveness OT - Safety EDAT- 2021/11/19 06:00 MHDA- 2022/07/19 06:00 PMCR- 2021/11/18 CRDT- 2021/11/18 08:50 PHST- 2021/08/06 00:00 [received] PHST- 2021/10/26 00:00 [accepted] PHST- 2021/11/19 06:00 [pubmed] PHST- 2022/07/19 06:00 [medline] PHST- 2021/11/18 08:50 [entrez] PHST- 2021/11/18 00:00 [pmc-release] AID - 6430919 [pii] AID - euab262 [pii] AID - 10.1093/europace/euab262 [doi] PST - ppublish SO - Europace. 2022 Jul 15;24(6):899-909. doi: 10.1093/europace/euab262.