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• W3035310930 abstract "HomeCirculation: Arrhythmia and ElectrophysiologyVol. 13, No. 7Canakinumab After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplementary MaterialsFree AccessReview ArticlePDF/EPUBCanakinumab After Electrical Cardioversion in Patients With Persistent Atrial FibrillationA Pilot Randomized Trial Philipp Krisai, MD, Steffen Blum, MD, PhD, Renate B. Schnabel, MD, Christian Sticherling, MD, Michael Kühne, MD, Stefanie von Felten, PhD, Peter Ammann, MD, Etienne Pruvot, MD, Christine M. Albert, MD, MPH and David Conen, MD, MPH Philipp KrisaiPhilipp Krisai https://orcid.org/0000-0002-4367-2363 Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland. Cardiovascular Research Institute Basel (P.K., S.B., C.S., M.K., D.C.), University Hospital Basel, Switzerland. Search for more papers by this author , Steffen BlumSteffen Blum https://orcid.org/0000-0002-0325-8993 Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland. Cardiovascular Research Institute Basel (P.K., S.B., C.S., M.K., D.C.), University Hospital Basel, Switzerland. Search for more papers by this author , Renate B. SchnabelRenate B. Schnabel https://orcid.org/0000-0001-7170-9509 Department of General and Interventional Cardiology, University Heart and Vascular Center Hamburg, Germany (R.B.S.). Search for more papers by this author , Christian SticherlingChristian Sticherling https://orcid.org/0000-0001-8428-7050 Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland. Cardiovascular Research Institute Basel (P.K., S.B., C.S., M.K., D.C.), University Hospital Basel, Switzerland. Search for more papers by this author , Michael KühneMichael Kühne https://orcid.org/0000-0002-2937-3711 Department of Cardiology (P.K., S.B., C.S., M.K.), University Hospital Basel, Switzerland. Cardiovascular Research Institute Basel (P.K., S.B., C.S., M.K., D.C.), University Hospital Basel, Switzerland. Search for more papers by this author , Stefanie von FeltenStefanie von Felten https://orcid.org/0000-0002-5264-6394 German Center for Cardiovascular Research, Partner Site Hamburg/Kiel/Luebeck (R.B.S.). Clinical Trial Unit, Department of Clinical Research, University of Basel, Switzerland (S.v.F.). Department of Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland (S.v.F.). Search for more papers by this author , Peter AmmannPeter Ammann Department of Cardiology, Kantonsspital St. Gallen, Switzerland (P.A.). Search for more papers by this author , Etienne PruvotEtienne Pruvot https://orcid.org/0000-0003-1386-9285 Department of Cardiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (E.P.). Search for more papers by this author , Christine M. AlbertChristine M. Albert Department of Cardiology, Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, CA (C.M.A.). Search for more papers by this author and David ConenDavid Conen Correspondence to: David Conen, MD, MPH, Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton St E, Hamilton, ON L8L 2X2, Canada. Email E-mail Address: [email protected] https://orcid.org/0000-0002-2459-5251 Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada (D.C.). Search for more papers by this author Originally published14 Jun 2020https://doi.org/10.1161/CIRCEP.119.008197Circulation: Arrhythmia and Electrophysiology. 2020;13:e008197Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: June 15, 2020: Ahead of Print Nearly half of all patients with atrial fibrillation (AF) undergoing electrical cardioversion (ECV) experience AF recurrences within 6 months, even with antiarrhythmic drug treatment.1 As inflammatory biomarkers are associated with AF recurrences, anti-inflammatory treatment may improve long-term success rates after ECV.2 In this pilot study, we investigated the effects of canakinumab, a specific interleukin-1β antibody, on AF recurrence after ECV in patients with persistent AF and elevated hsCRP (high-sensitivity C-reactive protein) levels.CONVERT-AF (Canakinumab for the Prevention of Recurrences After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation) was a randomized, double-blind, placebo-controlled trial enrolling patients with persistent AF undergoing ECV. All patients scheduled for ECV were prospectively screened 2 to 10 days before ECV at 5 study centers. Inclusion criteria were ECG-documented AF before ECV, hsCRP levels ≥2 mg/L, age ≥50 years (women needed to be postmenopausal), and the ability to give informed consent. Main exclusion criteria were AF persistence after ECV or AF recurrence before randomization and use of amiodarone within the last 6 months. After inclusion of 11 patients, hsCRP for inclusion was decreased to ≥1.25 mg/L (corresponding to the median hsCRP level of all previous screen) to facilitate recruitment. The study was approved by local ethics committees, and patients provided informed written consent.After sinus rhythm restoration, patients were randomly assigned within 60 minutes to a single subcutaneous injection of 150 mg of canakinumab or matching placebo. The 150-mg dose was chosen based on anticipated efficacy, safety, and hsCRP lowering from a prior phase-2 study in diabetes mellitus.3 Patients, healthcare providers, data collectors, and outcome adjudicators were blinded to treatment allocation. Patients were followed at 1, 3, and 6 months after randomization by trained study personnel. AF recurrence was ascertained at each study visit by 12-lead ECG and through medical record review. Patients were advised to obtain ECG documentation in case of arrhythmia symptoms.The primary outcome was AF recurrence within 6 months. Secondary outcomes were time to first redo-ECV, hospitalization-free survival, antiarrhythmic drug use at 6 months, and change in hsCRP from randomization to 6 months. The main safety outcomes were infections and infection-related hospitalizations. Cox proportional hazards models were used to compare the incidence of the primary and secondary end points across treatment groups. Antiarrhythmic drug use after 6 months was analyzed using a generalized linear model with binomial distribution and logit-link function. All hsCRP levels were log transformed and analyzed using a linear model with baseline hsCRP levels as covariate. Statistical analyses were performed using R 3.2.2.Eleven and 13 patients were randomized to canakinumab and placebo, respectively. Mean overall age was 66 years; 24% were women (Table I in the Data Supplement). AF recurrence at 6 months occurred in 10 (77%) and 4 (36%) patients in the placebo and canakinumab groups, respectively (Figure), the hazard ratio being 0.36 ([95% CI, 0.11–1.15]; P=0.09). At 1 month, AF recurred in 6 (46%) and 4 (36%) patients, at 3 months in 8 (62%) and 4 (36%) patients, respectively. The hazard ratios for time to first redo-ECV and hospitalization-free survival were 0.29 ([95% CI, 0.03–2.57]; P=0.27) and 0.74 ([95% CI, 0.12–4.46]; P=0.75), respectively. At 6 months, antiarrhythmic drugs were used in 7 (54%) and 9 (82%) patients in the placebo and canakinumab groups, respectively (odds ratio, 3.86 [95% CI, 0.65–32.36]; P=0.16; Figure). Log-transformed hsCRP was 31% lower in the canakinumab group ([95% CI, −67 to 40]; P=0.27) at 6 months. Adverse events occurred in 3 (23%) and 3 (27%) patients in the placebo and canakinumab groups, respectively (Table II in the Data Supplement). Infections occurred in 2 (15%) and 2 (18%) patients in the placebo and canakinumab groups, respectively. There was 1 infection-related hospital admission in the canakinumab group (Data Supplement) and none in the placebo group.Download figureDownload PowerPointFigure. Primary and secondary outcomes.A, Cumulative incidence of atrial fibrillation (AF) recurrence up to 6 mo of follow-up. y axis indicates proportion of patients with documented AF recurrence. B, Estimates for the primary and secondary outcomes. AAD indicates antiarrhythmic drug; ECV, electrical cardioversion; HR, hazard ratio; and OR, odds ratio. *Truncated upper CI.Prior studies found a strong relationship of inflammatory biomarkers with incident AF. Patients with persistent AF had higher inflammatory biomarker levels than patients with paroxysmal AF, suggesting that anti-inflammatory treatment may be particularly effective in these patients.2,4 Accordingly, a previous study using glucocorticoids showed a reduction in AF recurrence after cardioversion.5 Recently, specific inflammatory pathways including the NLRP3 (NOD, LRR, and pyrin domain-containing protein-3) inflammasome activation with release of interleukin-1β were involved in AF pathogenesis (see Appendix in the Data Supplement for detailed description).2 Although we found a numerically lower incidence of AF recurrence at 6 months with a nonsignificant trend, no significant reductions were found. We believe that these data support further studies targeting this pathway and show the clinical feasibility of canakinumab use after ECV. Larger trials are needed to definitely assess the efficacy and safety of canakinumab to reduce AF recurrences after ECV, which remains an unmet clinical need. Potential limitations of our study include the small number of patients enrolled and the lack of long-term ECG monitoring during follow-up.In conclusion, anti-inflammatory treatment with canakinumab did not reduce AF recurrences after ECV in patients with persistent AF, although we observed a promising trend in this pilot trial.The data that support the findings of this study are available from the corresponding author upon reasonable request.Nonstandard Abbreviations and AcronymsAFatrial fibrillationCONVERT-AFCanakinumab for the Prevention of Recurrences After Electrical Cardioversion in Patients With Persistent Atrial FibrillationECVelectrical cardioversionhsCRPhigh-sensitivity C-reactive proteinNLRP3NOD, LRR, and pyrin domain-containing protein-3Sources of FundingNovartis Pharma Ag provided study medications free of charge. Dr Krisai is supported by the University of Basel, the Mach-Gaensslen Foundation, and the Bangerter-Rhyner Foundation.DisclosuresDr Schnabel has received lecture fees and advisory board fees from Bristol-Myers Squibb (BMS)/Pfizer outside this work. Dr Kühne reports personal fees from Bayer, Boehringer Ingelheim, BMS/Pfizer, Daiichi Sankyo, Medtronic, Biotronik, Boston Scientific, and Johnson & Johnson and grants from Bayer, BMS/Pfizer, Boston Scientific, Swiss National Science Foundation, and Swiss Heart Foundation, outside the submitted work. The other authors report no conflicts.FootnotesFor Sources of Funding and Disclosures, see page 714.The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCEP.120.008577.Correspondence to: David Conen, MD, MPH, Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton St E, Hamilton, ON L8L 2X2, Canada. Email [email protected]caReferences1. Kirchhof P, Andresen D, Bosch R, Borggrefe M, Meinertz T, Parade U, Ravens U, Samol A, Steinbeck G, Treszl A, et al. Short-term versus long-term antiarrhythmic drug treatment after cardioversion of atrial fibrillation (Flec-SL): a prospective, randomised, open-label, blinded endpoint assessment trial.Lancet. 2012; 380:238–246. doi: 10.1016/S0140-6736(12)60570-4CrossrefMedlineGoogle Scholar2. Yao C, Veleva T, Scott L, Cao S, Li L, Chen G, Jeyabal P, Pan X, Alsina KM, Abu-Taha I, et al. Enhanced cardiomyocyte nlrp3 inflammasome signaling promotes atrial fibrillation.Circulation. 2018; 138:2227–2242. doi: 10.1161/CIRCULATIONAHA.118.035202LinkGoogle Scholar3. Ridker PM, Howard CP, Walter V, Everett B, Libby P, Hensen J, Thuren T; CANTOS Pilot Investigative Group. Effects of interleukin-1β inhibition with canakinumab on hemoglobin A1c, lipids, C-reactive protein, interleukin-6, and fibrinogen: a phase IIb randomized, placebo-controlled trial.Circulation. 2012; 126:2739–2748. doi: 10.1161/CIRCULATIONAHA.112.122556LinkGoogle Scholar4. Chung MK, Martin DO, Sprecher D, Wazni O, Kanderian A, Carnes CA, Bauer JA, Tchou PJ, Niebauer MJ, Natale A, et al. C-reactive protein elevation in patients with atrial arrhythmias: inflammatory mechanisms and persistence of atrial fibrillation.Circulation. 2001; 104:2886–2891. doi: 10.1161/hc4901.101760LinkGoogle Scholar5. Dernellis J, Panaretou M. Relationship between C-reactive protein concentrations during glucocorticoid therapy and recurrent atrial fibrillation.Eur Heart J. 2004; 25:1100–1107. doi: 10.1016/j.ehj.2004.04.025CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Armbruster A, Campbell K, Kahanda M and Cuculich P (2022) The role of inflammation in the pathogenesis and treatment of arrhythmias, Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 10.1002/phar.2663, 42:3, (250-262), Online publication date: 1-Mar-2022. Varghese B, Feldman D, Chew C, Valilis E, Blumenthal R, Sharma G and Calkins H (2021) Inflammation, atrial fibrillation, and the potential role for colchicine therapy, Heart Rhythm O2, 10.1016/j.hroo.2021.03.011, 2:3, (298-303), Online publication date: 1-Jun-2021. Papathanasiou K, Giotaki S, Vrachatis D, Siasos G, Lambadiari V, Iliodromitis K, Kossyvakis C, Kaoukis A, Raisakis K, Deftereos G, Papaioannou T, Giannopoulos G, Avramides D and Deftereos S (2021) Molecular Insights in Atrial Fibrillation Pathogenesis and Therapeutics: A Narrative Review, Diagnostics, 10.3390/diagnostics11091584, 11:9, (1584) Saljic A, Heijman J and Dobrev D (2022) Emerging Antiarrhythmic Drugs for Atrial Fibrillation, International Journal of Molecular Sciences, 10.3390/ijms23084096, 23:8, (4096) Wang Q, Richardson T, Sanderson E, Tudball M, Ala-Korpela M, Davey Smith G and Holmes M (2022) A phenome-wide bidirectional Mendelian randomization analysis of atrial fibrillation, International Journal of Epidemiology, 10.1093/ije/dyac041 July 2020Vol 13, Issue 7 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.119.008197PMID: 32536195 Originally publishedJune 14, 2020 Keywordsinterleukin-1inflammationatrial fibrillationC-reactive proteinhumansPDF download Advertisement SubjectsArrhythmiasAtrial FibrillationInflammationPharmacologyTreatment" @default.
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