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Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial
Emmanuelle Duceppe1, Salim Yusuf2, Vikas Tandon3
1McMaster University, Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada; University of Montreal, Department of Medicine, Montreal, Quebec, Canada.
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.
Insights
The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial investigated dabigatran for preventing major vascular complications in patients with myocardial injury after noncardiac surgery (MINS). This is the first trial to assess treatments for MINS.
Area of Science:
- Cardiology
- Vascular Medicine
- Clinical Trials
Background:
- Major surgery affects millions globally, with a significant portion experiencing myocardial injury after noncardiac surgery (MINS).
- Current management strategies for MINS lack robust trial data.
- Antithrombotic agents, like direct oral anticoagulants, are potential interventions for MINS to prevent vascular events.
Purpose of the Study:
- To evaluate the efficacy of dabigatran versus placebo in preventing major vascular complications in patients with MINS.
- To assess the effect of omeprazole versus placebo in reducing upper gastrointestinal bleeding and complications in the same patient cohort.
- To provide the first trial data on the management of MINS.
Main Methods:
- The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial employed a blinded, international, randomized controlled design.
- A partial factorial design was used to simultaneously assess dabigatran and omeprazole treatments.
- Eligible patients received study drugs within 35 days of MINS for up to 2 years, with primary outcomes focused on major vascular and upper gastrointestinal complications.
Main Results:
- The trial randomized 1754 patients between January 2013 and July 2017.
- Participants had a mean age of 69.9 years, with common comorbidities including peripheral artery disease, history of stroke/TIA, previous myocardial infarction, and diabetes.
- Myocardial injury after noncardiac surgery (MINS) was primarily diagnosed via isolated ischemic troponin elevation (80.4%).
Conclusions:
- The MANAGE trial represents the first randomized controlled trial specifically designed to evaluate a treatment for myocardial injury after noncardiac surgery (MINS).
- Findings from this trial will inform future clinical practice regarding the management of MINS.
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