Abstract
Background
Worldwide approximately 200 million adults undergo major surgery annually, of whom
8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS).
There is currently no trial data informing the management of MINS. Antithrombotic
agents such as direct oral anticoagulants might prevent major vascular complications
in patients with MINS.
Methods
The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of
dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design
to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal
bleeding and complications. Both study drugs were initiated in eligible patients within
35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome
is a composite of major vascular complications for the dabigatran trial and a composite
of upper gastrointestinal complications for the omeprazole trial. We present the rationale
and design of the trial and baseline characteristics of enrolled patients.
Results
The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean
age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease,
6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial
infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated
ischemic troponin elevation in 80.4% of participants.
Conclusion
MANAGE is the first randomized controlled trial to evaluate a potential treatment
of patients who suffered MINS.
Résumé
Contexte
Chaque année à l’échelle mondiale, une intervention chirurgicale majeure est pratiquée
chez environ 200 millions d’adultes. De ce nombre, quelque 8 millions subissent une
lésion myocardique après une intervention chirurgicale non cardiaque (LMICNC). À l’heure
actuelle, on ne dispose d’aucune donnée d’essais abordant la prise en charge des LMICNC.
Des antithrombotiques comme les anticoagulants oraux directs pourraient prévenir les
complications vasculaires majeures chez les patients présentant des LMICNC.
Méthodologie
Management of Myocardial Injury After Noncardiac Surgery (MANAGE), un vaste essai international contrôlé, à répartition aléatoire, mené à
l’insu, visait à comparer le dabigatran et un placebo chez des patients ayant subi
des LMICNC. Nous avons utilisé un modèle factoriel partiel afin de déterminer également
l’effet de l’oméprazole, comparativement au placebo, sur la réduction des hémorragies
et des complications gastro-intestinales hautes. L’administration du dabigatran et
du placebo a été instaurée chez les patients admissibles moins de 35 jours après la
survenue des LMICNC; elle s’est poursuivie sur une période qui pouvait aller jusqu’à
2 ans. Le résultat principal regroupe d’une part les complications vasculaires majeures
sous dabigatran et d’autre part les complications gastro-intestinales hautes sous
oméprazole. Nous présentons le fondement et la méthodologie de l’essai, ainsi que
les caractéristiques initiales des patients inscrits.
Résultats
Dans le cadre de l’essai, 1754 patients ont été répartis aléatoirement dans les groupes
de traitement entre janvier 2013 et juillet 2017. Les patients étaient âgés en moyenne
de 69,9 ans; 51,1 % étaient de sexe masculin; 14,3 % avaient des antécédents de maladie
artérielle périphérique, 6,6 %, des antécédents d’accident vasculaire cérébral ou
d'ischémie cérébrale transitoire, et 12,9 %, des antécédents d’infarctus du myocarde;
26,0 % étaient diabétiques. Le diagnostic de LMICNC se fondait sur une élévation isolée
de la concentration de troponine dans un contexte ischémique chez 80,4 % des participants.
Conclusion
MANAGE est le premier essai contrôlé à répartition aléatoire évaluant un traitement
potentiel des LMICNC.
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Article info
Publication history
Published online: February 02, 2018
Accepted:
January 22,
2018
Received:
January 11,
2018
Footnotes
See page 301 for disclosure information.
Identification
Copyright
© 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
