CYP2D6 Genotype-guided Metoprolol Therapy in Cardiac Surgery Patients: Rationale and Design of the Pharmacogenetic-guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery (PREEMPTIVE) Pilot Study.
CYP2D6 polymorphisms
atrial fibrillation
cardiac surgery
clinical decision support tool
metoprolol
outcomes
Journal
Journal of cardiothoracic and vascular anesthesia
ISSN: 1532-8422
Titre abrégé: J Cardiothorac Vasc Anesth
Pays: United States
ID NLM: 9110208
Informations de publication
Date de publication:
Jan 2020
Jan 2020
Historique:
received:
29
07
2019
revised:
29
08
2019
accepted:
04
09
2019
pubmed:
14
10
2019
medline:
28
4
2021
entrez:
14
10
2019
Statut:
ppublish
Résumé
The Preemptive Pharmacogenetic-guided Metoprolol Management for Atrial Fibrillation in Cardiac Surgery (PREEMPTIVE) pilot trial aims to use existing institutional resources to develop a process for integrating CYP2D6 pharmacogenetic test results into the patient electronic health record, to develop an evidence-based clinical decision support tool to facilitate CYP2D6 genotype-guided metoprolol administration in the cardiac surgery setting, and to determine the impact of implementing this CYP2D6 genotype-guided integrated approach on the incidence of postoperative atrial fibrillation (AF), provider, and cost outcomes. One-arm Bayesian adaptive design clinical trial. Single center, university hospital. The authors will screen (including CYP2D6 genotype) up to 600 (264 ± 144 expected under the adaptive design) cardiac surgery patients, and enroll up to 200 (88 ± 48 expected) poor, intermediate, and ultrarapid CYP2D6 metabolizers over a period of 2 years at a tertiary academic center. All consented and enrolled patients will receive the intervention of CYP2D6 genotype-guided metoprolol management based on CYP2D6 phenotype classified as a poor, intermediate, extensive (normal), or ultrarapid metabolizer. The primary outcome will be the incidence of postoperative AF. Secondary outcomes relating to rates of CYP2D6 genotype-guided prescription changes, costs, lengths of stay, and implementation metrics also will be investigated. The PREEMPTIVE pilot study is the first perioperative pilot trial to provide essential information for the design of a future, large-scale trial comparing CYP2D6 genotype-guided metoprolol management with a nontailored strategy in terms of managing AF. In addition, secondary outcomes regarding implementation, clinical benefit, safety, and cost-effectiveness in patients undergoing cardiac surgery will be examined.
Identifiants
pubmed: 31606278
pii: S1053-0770(19)30962-0
doi: 10.1053/j.jvca.2019.09.003
pmc: PMC6911825
mid: NIHMS1056007
pii:
doi:
Substances chimiques
Cytochrome P-450 CYP2D6
EC 1.14.14.1
Metoprolol
GEB06NHM23
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
20-28Subventions
Organisme : NCATS NIH HHS
ID : KL2 TR002245
Pays : United States
Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.
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