Extracorporeal life support in cardiac arrest: a post hoc Bayesian re-analysis of the INCEPTION trial

Author:

Heuts Samuel12ORCID,van de Koolwijk Anina F3,Gabrio Andrea4,Ubben Johannes F H35,van der Horst Iwan C C23,Delnoij Thijs S R3,Suverein Martje M3,Maessen Jos G12,Lorusso Roberto12ORCID,van de Poll Marcel C G36

Affiliation:

1. Department of Cardiothoracic Surgery, Maastricht University Medical Center , P. Debyelaan 25 , Maastricht 6229HX, The Netherlands

2. Cardiovascular Research Institute Maastricht (CARIM), Maastricht University , Universiteitssingel 50, Maastricht 6229ER , The Netherlands

3. Department of Intensive Care Medicine, Maastricht University Medical Center , P. Debyelaan 25, Maastricht 6229HX , The Netherlands

4. Department of Methodology and Statistics, Maastricht University , P. Debyeplein 1, Maastricht 6229HA , The Netherlands

5. Department of Anesthesiology and Pain Medicine, Maastricht University Medical Center , P. Debyelaan 25, Maastricht 6229HX , The Netherlands

6. School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University , Universiteitssingel 40, Maastricht 6229ER , The Netherlands

Abstract

Abstract Aims Previously, we performed the multicentre INCEPTION trial, randomizing patients with refractory out-of-hospital cardiac arrest (OHCA) to extracorporeal cardiopulmonary resuscitation (ECPR) or conventional cardiopulmonary resuscitation (CCPR). Frequentist analysis showed no statistically significant treatment effect for the primary outcome; 30-day survival with a favourable neurologic outcome (cerebral performance category score of 1–2). To facilitate a probabilistic interpretation of the results, we present a Bayesian re-analysis of the INCEPTION trial. Methods and results We analysed survival with a favourable neurologic outcome at 30 days and 6 months under a minimally informative prior in the intention-to-treat population. Effect sizes are presented as absolute risk differences (ARDs) and relative risks (RRs), with 95% credible intervals (CrIs). We estimated posterior probabilities at various thresholds, including the minimal clinically important difference (MCID) (5% ARD), based on expert consensus, and performed sensitivity analyses under sceptical and literature-based priors. The mean ARD for 30-day survival with a favourable neurologic outcome was 3.6% (95% CrI −9.5–16.7%), favouring ECPR, with a median RR of 1.22 (95% CrI 0.59–2.51). The posterior probability of an MCID was 42% at 30 days and 42% at 6 months, in favour of ECPR. Conclusion Bayesian re-analysis of the INCEPTION trial estimated a 42% probability of an MCID between ECPR and CCPR in refractory OHCA in terms of 30-day survival with a favourable neurologic outcome. Trial registration Clinicaltrials.gov (NCT03101787, registered 5 April 2017).

Funder

ZonMw

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Critical Care and Intensive Care Medicine,General Medicine

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