Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial.

Humans Amiodarone / therapeutic use Anti-Arrhythmia Agents / therapeutic use Atrial Fibrillation / therapy Propafenone / therapeutic use Prospective Studies Shock, Septic / complications Stroke Volume Ventricular Function, Left

Amiodarone Atrial fibrillation Atrial flutter Cardioversion Propafenone Septic shock Supraventricular arrhythmia

Journal

Intensive care medicine

ISSN: 1432-1238

Titre abrégé: Intensive Care Med

Pays: United States

ID NLM: 7704851

Informations de publication

Date de publication:
11 2023

Historique:

received: 19 05 2023

accepted: 21 08 2023

medline: 3 11 2023

pubmed: 12 9 2023

entrez: 12 9 2023

Statut: ppublish

Résumé

Acute onset supraventricular arrhythmias can contribute to haemodynamic compromise in septic shock. Both amiodarone and propafenone are available interventions, but their clinical effects have not yet been directly compared. In this two-centre, prospective controlled parallel group double blind trial we recruited 209 septic shock patients with new-onset arrhythmia and a left ventricular ejection fraction above 35%. The patients were randomised in a 1:1 ratio to receive either intravenous propafenone (70 mg bolus followed by 400-840 mg/24 h) or amiodarone (300 mg bolus followed by 600-1800 mg/24 h). The primary outcomes were the proportion of patients who had sinus rhythm 24 h after the start of the infusion, time to restoration of the first sinus rhythm and the proportion of patients with arrhythmia recurrence. Out of 209 randomized patients, 200 (96%) received the study drug. After 24 h, 77 (72.8%) and 71 (67.3%) were in sinus rhythm (p = 0.4), restored after a median of 3.7 h (95% CI 2.3-6.8) and 7.3 h (95% CI 5-11), p = 0.02, with propafenone and amiodarone, respectively. The arrhythmia recurred in 54 (52%) patients treated with propafenone and in 80 (76%) with amiodarone, p < 0.001. Patients with a dilated left atrium had better rhythm control with amiodarone (6.4 h (95% CI 3.5; 14.1) until cardioversion vs 18 h (95% CI 2.8; 24.7) in propafenone, p = 0.05). Propafenone does not provide better rhythm control at 24 h yet offers faster cardioversion with fewer arrhythmia recurrences than with amiodarone, especially in patients with a non-dilated left atrium. No differences between propafenone and amiodarone on the prespecified short- and long-term outcomes were observed.

Identifiants

DOI: 10.1007/s00134-023-07208-3 PMID: 37698594

pubmed: 37698594

doi: 10.1007/s00134-023-07208-3

pii: 10.1007/s00134-023-07208-3

doi:

Substances chimiques

Amiodarone N3RQ532IUT

Anti-Arrhythmia Agents 0

Propafenone 68IQX3T69U

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

1283-1292

Subventions

Organisme : Agentura Pro Zdravotnický Výzkum České Republiky

ID : NV18-06-00417

Informations de copyright

Références

Arrigo M, Bettex D, Rudiger A (2014) Management of atrial fibrillation in critically ill patients. Crit Care Res Prac 2014:840615

Klein Klouwenberg PM FJ, Kuipers S, Ong DS, Peelen LM, van Vught LA, Schultz MJ, van der Poll T, Bonten MJ, Cremer OL, MARS Consortium (2016) Incidence, predictors and outcomes of new-onset atrial fibrillation in critically ill patients with sepsis: a cohort study. Am J Respir Crit Care Med

Kuipers S, Klein Klouwenberg P, Cremer OL (2014) Incidence, risk factors and outcomes of new-onset atrial fibrillation in patients with sepsis: a systematic review. Crit Care 18:688

doi: 10.1186/s13054-014-0688-5 pubmed: 25498795 pmcid: 4296551

Arrigo M, Jaeger N, Seifert B, Spahn DR, Bettex D, Rudiger A (2015) Disappointing success of electrical cardioversion for new-onset atrial fibrillation in cardiosurgical ICU patients. Crit Care Med 43:2354–2359

doi: 10.1097/CCM.0000000000001257 pubmed: 26468695

Balik M, Kolnikova I, Maly M, Waldauf P, Tavazzi G, Kristof J (2017) Propafenone for supraventricular arrhythmias in septic shock-Comparison to amiodarone and metoprolol. J Crit Care 41:16–23

doi: 10.1016/j.jcrc.2017.04.027 pubmed: 28463737

O’Bryan LJ, Redfern OC, Bedford J, Petrinic T, Young JD, Watkinson PJ (2020) Managing new-onset atrial fibrillation in critically ill patients: a systematic narrative review. BMJ Open 10:e034774

doi: 10.1136/bmjopen-2019-034774 pubmed: 32209631 pmcid: 7202704

Allen LaPointe NM, Dai D, Thomas L, Piccini JP, Peterson ED, Al-Khatib SM (2015) Antiarrhythmic drug use in patients <65 years with atrial fibrillation and without structural heart disease. Am J Cardiol 115:316–322

doi: 10.1016/j.amjcard.2014.11.005 pubmed: 25491240

Balik M, Matousek V, Maly M, Brozek T (2017) Management of arrhythmia in sepsis and septic shock. Anaesthesiol Intensive Ther 49:419–429

doi: 10.5603/AIT.a2017.0061 pubmed: 29151002

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL (2021) 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 42:373–498

doi: 10.1093/eurheartj/ehaa612 pubmed: 32860505

Wetterslev M, Møller MH, Granholm A, Hassager C, Haase N, Aslam TN, Shen J, Young PJ, Aneman A, Hästbacka J, Siegemund M, Cronhjort M, Lindqvist E, Myatra SN, Kalvit K, Arabi YM, Szczeklik W, Sigurdsson MI, Balik M, Keus F, Perner A (2022) Management of acute atrial fibrillation in the intensive care unit: an international survey. Acta Anaesthesiol Scand 66:375–385

doi: 10.1111/aas.14007 pubmed: 34870855

Gwag HB, Chun KJ, Hwang JK, Park SJ, Kim JS, Park KM, On YK (2018) Which antiarrhythmic drug to choose after electrical cardioversion: a study on non-valvular atrial fibrillation patients. PLoS ONE 13:e0197352

doi: 10.1371/journal.pone.0197352 pubmed: 29787592 pmcid: 5963785

Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P (2016) 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 37:2893–2962

doi: 10.1093/eurheartj/ehw210 pubmed: 27567408

Echt DSLP, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL et al (1991) Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. NEJM 324:781–788

doi: 10.1056/NEJM199103213241201 pubmed: 1900101

Chevalier PD-DA, Burri H, Cucherat M, Kirkorian G, Touboul P (2003) Amiodarone versus placebo and class Ic drugs for cardioversion of recent-onset atrial fibrillation: a meta-analysis. J Am Coll Cardiol 41:255–262

doi: 10.1016/S0735-1097(02)02705-5 pubmed: 12535819

Courand PYSF, Ranc S, Mullier A, Kirkorian G, Bonnefoy E (2013) Arrhythmogenic effect of flecainide toxicity. Cardiol J 20:203–205

doi: 10.5603/CJ.2013.0035 pubmed: 23558880

Varon J, Marik PE (2008) Irwin and Rippe’s intensive care medicine. In: Rippe JM (ed) Irwin RS. Wolters Kluwer Health/Lippincott Williams & Wilkins, Philadelphia, pp 1855–1869

Ganetsky M (2008) Antiarythmic agents. In: Irwin RS (ed) Intensive care medicine. Wolters Kluwer/Lippincott, Williams & Wilkins, Philadelphia, pp 1486–1498

Stoschitzky K, Stoschitzky G, Lercher P, Brussee H, Lamprecht G, Lindner W (2016) Propafenone shows class Ic and class II antiarrhythmic effects. Europace 18:568–571

doi: 10.1093/europace/euv195 pubmed: 26056191

Lafuente-Lafuente C, Valembois L, Bergmann JF, Belmin J (2015) Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev Cd005049

Valembois L, Audureau E, Takeda A, Jarzebowski W, Belmin J, Lafuente-Lafuente C (2019) Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database Syst Rev 9:Cd005049

pubmed: 31483500

Balik M, Waldauf P, Maly M, Matousek V, Brozek T, Rulisek J, Porizka M, Sachl R, Otahal M, Brestovansky P, Svobodova E, Flaksa M, Stach Z, Pazout J, Duska F, Smid O, Stritesky M (2019) Efficacy and safety of 1C class antiarrhythmic agent (propafenone) for supraventricular arrhythmias in septic shock compared to amiodarone: protocol of a prospective randomised double-blind study. BMJ Open 9:e031678

doi: 10.1136/bmjopen-2019-031678 pubmed: 31481571 pmcid: 6731952

Singer MDC, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC (2016) The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 315:801–810

doi: 10.1001/jama.2016.0287 pubmed: 26903338 pmcid: 4968574

Team RC (2022) A language and environment for statistical computing

Team P (2022) RStudio: integrated development environment for R. Posit Software

Bonora A, Turcato G, Franchi E, Taioli G, Dilda A, Zerman G, Maccagnani A, Pistorelli C, Olivieri O (2017) Efficacy and safety in pharmacological cardioversion of recent-onset atrial fibrillation: a propensity score matching to compare amiodarone vs class IC antiarrhythmic drugs. Intern Emerg Med 12:853–859

doi: 10.1007/s11739-016-1497-4 pubmed: 27384766

Manning WJ, Silverman DI, Katz SE, Riley MF, Come PC, Doherty RM, Munson JT, Douglas PS (1994) Impaired left atrial mechanical function after cardioversion: relation to the duration of atrial fibrillation. J Am Coll Cardiol 23:1535–1540

doi: 10.1016/0735-1097(94)90652-1 pubmed: 8195510

Grundvold I, Tveit A, Smith P, Seljeflot I, Abdelnoor M, Arnesen H (2008) The predictive value of transthoracic echocardiographic variables for sinus rhythm maintenance after electrical cardioversion of atrial fibrillation. Results from the CAPRAF study, a prospective, randomized, placebo-controlled study. Cardiology 111:30–35

doi: 10.1159/000113424 pubmed: 18239389

Otto C (2012) The role of echocardiography in atrial fibrillation and flutter. In: Otto C (ed) The practice of clinical echocardiography. Elsevier Health Sciences, Philadelphia, pp 821–827

Balik M, Rulisek J, Leden P, Zakharchenko M, Otahal M, Bartakova H, Korinek J (2012) Concomitant use of beta-1 adrenoreceptor blocker and norepinephrine in patients with septic shock. Wien Klin Wochenschr 124:552–556

doi: 10.1007/s00508-012-0209-y pubmed: 22815003

Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D’Egidio A, D’Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M (2013) Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA 310:1683–1691

doi: 10.1001/jama.2013.278477 pubmed: 24108526

Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD (2002) A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 347:1825–1833

doi: 10.1056/NEJMoa021328 pubmed: 12466506

Gillinov AM, Bagiella E, Moskowitz AJ, Raiten JM, Groh MA, Bowdish ME, Ailawadi G, Kirkwood KA, Perrault LP, Parides MK, Smith RL 2nd, Kern JA, Dussault G, Hackmann AE, Jeffries NO, Miller MA, Taddei-Peters WC, Rose EA, Weisel RD, Williams DL, Mangusan RF, Argenziano M, Moquete EG, O’Sullivan KL, Pellerin M, Shah KJ, Gammie JS, Mayer ML, Voisine P, Gelijns AC, O’Gara PT, Mack MJ (2016) Rate control versus rhythm control for atrial fibrillation after cardiac surgery. N Engl J Med 374:1911–1921

doi: 10.1056/NEJMoa1602002 pubmed: 27043047 pmcid: 4908812

Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, Said SA, Darmanata JI, Timmermans AJ, Tijssen JG, Crijns HJ (2002) A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med 347:1834–1840

doi: 10.1056/NEJMoa021375 pubmed: 12466507

McLean AS, Taccone FS, Vieillard-Baron A (2016) Beta-blockers in septic shock to optimize hemodynamics? No. Intensive Care Med 42:1610–1612

doi: 10.1007/s00134-016-4407-3 pubmed: 27349242

McIntyre WF, Um KJ, Alhazzani W, Lengyel AP, Hajjar L, Gordon AC, Lamontagne F, Healey JS, Whitlock RP, Belley-Côté EP (2018) Association of vasopressin plus catecholamine vasopressors vs catecholamines alone with atrial fibrillation in patients with distributive shock: a systematic review and meta-analysis. JAMA 319:1889–1900

doi: 10.1001/jama.2018.4528 pubmed: 29801010 pmcid: 6583502

Balik M (2018) New-onset atrial fibrillation in critically ill patients—implications for rhythm rather than rate control therapy? Int J Cardiol 266:147–148

doi: 10.1016/j.ijcard.2018.04.078 pubmed: 29887432

Sterling SA, Puskarich MA, Glass AF, Guirgis F, Jones AE (2017) The impact of the sepsis-3 septic shock definition on previously defined septic shock patients. Crit Care Med 45:1436–1442

doi: 10.1097/CCM.0000000000002512 pubmed: 28542029 pmcid: 5693309

Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G (2003) 2001 SCCM/ESICM/ACCP/ATS/SIS international sepsis definitions conference. Crit Care Med 31:1250–1256

doi: 10.1097/01.CCM.0000050454.01978.3B pubmed: 12682500