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Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo).
Circulation 2017; 136(22):2119-2131Circ

Abstract

BACKGROUND

Out-of-hospital cardiac arrest (OHCA) commonly presents with nonshockable rhythms (asystole and pulseless electric activity). It is unknown whether antiarrhythmic drugs are safe and effective when nonshockable rhythms evolve to shockable rhythms (ventricular fibrillation/pulseless ventricular tachycardia [VF/VT]) during resuscitation.

METHODS

Adults with nontraumatic OHCA, vascular access, and VF/VT anytime after ≥1 shock(s) were prospectively randomized, double-blind, to receive amiodarone, lidocaine, or placebo by paramedics. Patients presenting with initial shock-refractory VF/VT were previously reported. The current study was a prespecified analysis in a separate cohort that initially presented with nonshockable OHCA and was randomized on subsequently developing shock-refractory VF/VT. The primary outcome was survival to hospital discharge. Secondary outcomes included discharge functional status and adverse drug-related effects.

RESULTS

Of 37 889 patients with OHCA, 3026 with initial VF/VT and 1063 with initial nonshockable-turned-shockable rhythms were treatment-eligible, were randomized, and received their assigned drug. Baseline characteristics among patients with nonshockable-turned-shockable rhythms were balanced across treatment arms, except that recipients of a placebo included fewer men and were less likely to receive bystander cardiopulmonary resuscitation. Active-drug recipients in this cohort required fewer shocks, supplemental doses of their assigned drug, and ancillary antiarrhythmic drugs than recipients of a placebo (P<0.05). In all, 16 (4.1%) amiodarone, 11 (3.1%) lidocaine, and 6 (1.9%) placebo-treated patients survived to hospital discharge (P=0.24). No significant interaction between treatment assignment and discharge survival occurred with the initiating OHCA rhythm (asystole, pulseless electric activity, or VF/VT). Survival in each of these categories was consistently higher with active drugs, although the trends were not statistically significant. Adjusted absolute differences (95% confidence interval) in survival from nonshockable-turned-shockable arrhythmias with amiodarone versus placebo were 2.3% (-0.3, 4.8), P=0.08, and for lidocaine versus placebo 1.2% (-1.1, 3.6), P=0.30. More than 50% of these survivors were functionally independent or required minimal assistance. Drug-related adverse effects were infrequent.

CONCLUSIONS

Outcome from nonshockable-turned-shockable OHCA is poor but not invariably fatal. Although not statistically significant, point estimates for survival were greater after amiodarone or lidocaine than placebo, without increased risk of adverse effects or disability and consistent with previously observed favorable trends from treatment of initial shock-refractory VF/VT with these drugs. Together the findings may signal a clinical benefit that invites further investigation.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01401647.

Authors+Show Affiliations

Department of Medicine, Division of Cardiology, University of Washington and King County Emergency Medical Services, Public Health-Seattle & King County, WA (P.J.K., T.R.). kudenchu@u.washington.edu.Department of Biostatistics, University of Washington Clinical Trial Center, Seattle, WA (B.G.L.).Department of Emergency Medicine, Oregon Health & Science University, Portland (M.D.).Department of Medicine, Division of Cardiology, University of Washington and King County Emergency Medical Services, Public Health-Seattle & King County, WA (P.J.K., T.R.).Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Canada (C.V., I.G.S.).Rescu, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Ontario, Canada (L.J.M., P.D.).University of Pittsburgh, PA (C.W.C.).Department of Emergency Medicine, University of British Columbia Faculty of Medicine, Vancouver, Canada (J.C.).Department of Emergency Medicine, Virginia Commonwealth University Health System, Richmond, VA (J.P.O.).Department of Emergency Medicine, University of California San Diego, San Diego Fire-Rescue Department (J.V.D., G.M.V.).Clark County Emergency Medical Services, Vancouver, WA (L.W.).Johns Hopkins University, Baltimore, MD (M.L.W.).Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee (T.P.A.).Department of Emergency Medicine, University of California San Diego, San Diego Fire-Rescue Department (J.V.D., G.M.V.).Departments of Emergency Medicine and Internal Medicine, University of Texas Southwestern Medical Center, Dallas (A.H.I.).Department of Emergency Medicine, Ottawa Hospital Research Institute, University of Ottawa, Canada (C.V., I.G.S.).Department of Emergency Medicine and Pediatrics, Medical College of Wisconsin, Milwaukee (M.R.C.).Dallas Fire-Rescue Department, TX (T.K.).National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (D.E., P.D.-N.).National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (D.E., P.D.-N.).University of Alabama, Birmingham (P.G., R.G.).University of Alabama, Birmingham (P.G., R.G.).Providence Health and British Columbia Emergency Health Services, Vancouver, Canada (R.S.).Rescu, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Ontario, Canada (L.J.M., P.D.).No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28904070

Citation

Kudenchuk, Peter J., et al. "Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: the ALPS Study (Amiodarone, Lidocaine, or Placebo)." Circulation, vol. 136, no. 22, 2017, pp. 2119-2131.
Kudenchuk PJ, Leroux BG, Daya M, et al. Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo). Circulation. 2017;136(22):2119-2131.
Kudenchuk, P. J., Leroux, B. G., Daya, M., Rea, T., Vaillancourt, C., Morrison, L. J., ... Dorian, P. (2017). Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo). Circulation, 136(22), pp. 2119-2131. doi:10.1161/CIRCULATIONAHA.117.028624.
Kudenchuk PJ, et al. Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: the ALPS Study (Amiodarone, Lidocaine, or Placebo). Circulation. 2017 Nov 28;136(22):2119-2131. PubMed PMID: 28904070.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo). AU - Kudenchuk,Peter J, AU - Leroux,Brian G, AU - Daya,Mohamud, AU - Rea,Thomas, AU - Vaillancourt,Christian, AU - Morrison,Laurie J, AU - Callaway,Clifton W, AU - Christenson,James, AU - Ornato,Joseph P, AU - Dunford,James V, AU - Wittwer,Lynn, AU - Weisfeldt,Myron L, AU - Aufderheide,Tom P, AU - Vilke,Gary M, AU - Idris,Ahamed H, AU - Stiell,Ian G, AU - Colella,M Riccardo, AU - Kayea,Tami, AU - Egan,Debra, AU - Desvigne-Nickens,Patrice, AU - Gray,Pamela, AU - Gray,Randal, AU - Straight,Ron, AU - Dorian,Paul, AU - ,, Y1 - 2017/09/13/ PY - 2017/03/27/received PY - 2017/08/31/accepted PY - 2017/9/15/pubmed PY - 2017/12/5/medline PY - 2017/9/15/entrez KW - amiodarone KW - cardiac arrest KW - lidocaine KW - placebo KW - resuscitation SP - 2119 EP - 2131 JF - Circulation JO - Circulation VL - 136 IS - 22 N2 - BACKGROUND: Out-of-hospital cardiac arrest (OHCA) commonly presents with nonshockable rhythms (asystole and pulseless electric activity). It is unknown whether antiarrhythmic drugs are safe and effective when nonshockable rhythms evolve to shockable rhythms (ventricular fibrillation/pulseless ventricular tachycardia [VF/VT]) during resuscitation. METHODS: Adults with nontraumatic OHCA, vascular access, and VF/VT anytime after ≥1 shock(s) were prospectively randomized, double-blind, to receive amiodarone, lidocaine, or placebo by paramedics. Patients presenting with initial shock-refractory VF/VT were previously reported. The current study was a prespecified analysis in a separate cohort that initially presented with nonshockable OHCA and was randomized on subsequently developing shock-refractory VF/VT. The primary outcome was survival to hospital discharge. Secondary outcomes included discharge functional status and adverse drug-related effects. RESULTS: Of 37 889 patients with OHCA, 3026 with initial VF/VT and 1063 with initial nonshockable-turned-shockable rhythms were treatment-eligible, were randomized, and received their assigned drug. Baseline characteristics among patients with nonshockable-turned-shockable rhythms were balanced across treatment arms, except that recipients of a placebo included fewer men and were less likely to receive bystander cardiopulmonary resuscitation. Active-drug recipients in this cohort required fewer shocks, supplemental doses of their assigned drug, and ancillary antiarrhythmic drugs than recipients of a placebo (P<0.05). In all, 16 (4.1%) amiodarone, 11 (3.1%) lidocaine, and 6 (1.9%) placebo-treated patients survived to hospital discharge (P=0.24). No significant interaction between treatment assignment and discharge survival occurred with the initiating OHCA rhythm (asystole, pulseless electric activity, or VF/VT). Survival in each of these categories was consistently higher with active drugs, although the trends were not statistically significant. Adjusted absolute differences (95% confidence interval) in survival from nonshockable-turned-shockable arrhythmias with amiodarone versus placebo were 2.3% (-0.3, 4.8), P=0.08, and for lidocaine versus placebo 1.2% (-1.1, 3.6), P=0.30. More than 50% of these survivors were functionally independent or required minimal assistance. Drug-related adverse effects were infrequent. CONCLUSIONS: Outcome from nonshockable-turned-shockable OHCA is poor but not invariably fatal. Although not statistically significant, point estimates for survival were greater after amiodarone or lidocaine than placebo, without increased risk of adverse effects or disability and consistent with previously observed favorable trends from treatment of initial shock-refractory VF/VT with these drugs. Together the findings may signal a clinical benefit that invites further investigation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01401647. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/28904070/Antiarrhythmic_Drugs_for_Nonshockable_Turned_Shockable_Out_of_Hospital_Cardiac_Arrest:_The_ALPS_Study__Amiodarone_Lidocaine_or_Placebo__ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.117.028624?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -