Randomized Pilot Clinical Trial of Early Coronary Angiography Versus No Early Coronary Angiography After Cardiac Arrest Without ST-Segment Elevation: The PEARL Study.


Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
24 11 2020
Historique:
pubmed: 29 9 2020
medline: 12 10 2021
entrez: 28 9 2020
Statut: ppublish

Résumé

The benefit of emergency coronary angiography after resuscitation from out-of-hospital cardiac arrest is uncertain for patients without ST-segment elevation. The aim of this randomized trial was to evaluate the efficacy and safety of early coronary angiography and to determine the prevalence of acute coronary occlusion in resuscitated patients with out-of-hospital cardiac arrest without ST-segment elevation. Adult (>18 years) comatose survivors without ST-segment elevation after resuscitation from out-of-hospital cardiac arrest were prospectively randomized in a 1:1 fashion under exception to informed consent regulations to early coronary angiography versus no early coronary angiography in this multicenter study. Early angiography was defined as ≤120 minutes from arrival at the percutaneous coronary intervention-capable facility. The primary end point was a composite of efficacy and safety measures, including efficacy measures of survival to discharge, favorable neurologic status at discharge (Cerebral Performance Category score ≤2), echocardiographic measures of left ventricular ejection fraction >50%, and a normal regional wall motion score of 16 within 24 hours of admission. Adverse events included rearrest, pulmonary edema on chest x-ray, acute renal dysfunction, bleeding requiring transfusion or intervention, hypotension (systolic arterial pressure ≤90 mm Hg), and pneumonia. Secondary end points included the incidence of culprit vessels with acute occlusion. The study was terminated prematurely before enrolling the target number of patients. A total of 99 patients were enrolled from 2015 to 2018, including 75 with initially shockable rhythms. Forty-nine patients were randomized to early coronary angiography. The primary end point of efficacy and safety was not different between the 2 groups (55.1% versus 46.0%; This underpowered study, when considered together with previous clinical trials, does not support early coronary angiography for comatose survivors of cardiac arrest without ST elevation. Whether early detection of occluded potential culprit arteries leads to interventions that improve outcomes requires additional study. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02387398.

Sections du résumé

BACKGROUND
The benefit of emergency coronary angiography after resuscitation from out-of-hospital cardiac arrest is uncertain for patients without ST-segment elevation. The aim of this randomized trial was to evaluate the efficacy and safety of early coronary angiography and to determine the prevalence of acute coronary occlusion in resuscitated patients with out-of-hospital cardiac arrest without ST-segment elevation.
METHODS
Adult (>18 years) comatose survivors without ST-segment elevation after resuscitation from out-of-hospital cardiac arrest were prospectively randomized in a 1:1 fashion under exception to informed consent regulations to early coronary angiography versus no early coronary angiography in this multicenter study. Early angiography was defined as ≤120 minutes from arrival at the percutaneous coronary intervention-capable facility. The primary end point was a composite of efficacy and safety measures, including efficacy measures of survival to discharge, favorable neurologic status at discharge (Cerebral Performance Category score ≤2), echocardiographic measures of left ventricular ejection fraction >50%, and a normal regional wall motion score of 16 within 24 hours of admission. Adverse events included rearrest, pulmonary edema on chest x-ray, acute renal dysfunction, bleeding requiring transfusion or intervention, hypotension (systolic arterial pressure ≤90 mm Hg), and pneumonia. Secondary end points included the incidence of culprit vessels with acute occlusion.
RESULTS
The study was terminated prematurely before enrolling the target number of patients. A total of 99 patients were enrolled from 2015 to 2018, including 75 with initially shockable rhythms. Forty-nine patients were randomized to early coronary angiography. The primary end point of efficacy and safety was not different between the 2 groups (55.1% versus 46.0%;
CONCLUSIONS
This underpowered study, when considered together with previous clinical trials, does not support early coronary angiography for comatose survivors of cardiac arrest without ST elevation. Whether early detection of occluded potential culprit arteries leads to interventions that improve outcomes requires additional study.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02387398.

Identifiants

pubmed: 32985249
doi: 10.1161/CIRCULATIONAHA.120.049569
doi:

Banques de données

ClinicalTrials.gov
['NCT02387398']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2002-2012

Commentaires et corrections

Type : CommentIn
Type : ErratumIn

Auteurs

Karl B Kern (KB)

Department of Medicine, Sarver Heart Center (K.B.K., K.S.L., K.L., R.J.), University of Arizona, Tucson.

Peter Radsel (P)

Center for Intensive Internal Medicine, University Medical Center Ljubljana, Faculty of Medicine, University of Ljubljana, Slovenia (P.R., M.N.).

Jacob C Jentzer (JC)

Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (J.C.J.).

David B Seder (DB)

Department of Critical Care Services, Maine Medical Center, Portland (D.B.S.).

Kwan S Lee (KS)

Department of Medicine, Sarver Heart Center (K.B.K., K.S.L., K.L., R.J.), University of Arizona, Tucson.

Kapildeo Lotun (K)

Department of Medicine, Sarver Heart Center (K.B.K., K.S.L., K.L., R.J.), University of Arizona, Tucson.

Rajesh Janardhanan (R)

Department of Medicine, Sarver Heart Center (K.B.K., K.S.L., K.L., R.J.), University of Arizona, Tucson.

Dion Stub (D)

Alfred Hospital & Monash University, Melbourne, Australia (D.S.).

Chiu-Hsieh Hsu (CH)

College of Public Health (C.-H.H.), University of Arizona, Tucson.

Marko Noc (M)

Center for Intensive Internal Medicine, University Medical Center Ljubljana, Faculty of Medicine, University of Ljubljana, Slovenia (P.R., M.N.).

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