TY - JOUR
T1 - Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE)
AU - Duceppe, Emmanuelle
AU - Yusuf, Salim
AU - Tandon, Vikas
AU - Rodseth, Reitze
AU - Biccard, Bruce M.
AU - Xavier, Denis
AU - Szczeklik, Wojciech
AU - Meyhoff, Christian S.
AU - Franzosi, Maria Grazia
AU - Vincent, Jessica
AU - Srinathan, Sadeesh K.
AU - Parlow, Joel
AU - Magloire, Patrick
AU - Neary, John
AU - Rao, Mangala
AU - Chaudhry, Navneet K.
AU - Mayosi, Bongani
AU - de Nadal, Miriam
AU - Popova, Ekaterine
AU - Villar, Juan Carlos
AU - Botto, Fernando
AU - Berwanger, Otavio
AU - Guyatt, Gordon
AU - Eikelboom, John W.
AU - Sessler, Daniel I.
AU - Kearon, Clive
AU - Pettit, Shirley
AU - Connolly, Stuart J.
AU - Sharma, Mukul
AU - Bangdiwala, Shrikant I.
AU - Devereaux, P. J.
N1 - Publisher Copyright:
© 2018 Canadian Cardiovascular Society
PY - 2018/3
Y1 - 2018/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85041617414&partnerID=8YFLogxK
U2 - 10.1016/j.cjca.2018.01.020
DO - 10.1016/j.cjca.2018.01.020
M3 - Artículo Científico
C2 - 29398173
AN - SCOPUS:85041617414
SN - 0828-282X
VL - 34
SP - 295
EP - 302
JO - Canadian Journal of Cardiology
JF - Canadian Journal of Cardiology
IS - 3
ER -