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The Lancet Publishes MANAGE Trial Results

Dr. PJ Devereaux, MD

Dr. PJ Devereaux, MD

Leading medical journal, The Lancet, has published the results of the MANAGE trial led by Prof. PJ Devereaux, MD, Scientific Lead – Perioperative Research, at the Population Health Research Institute (PHRI), Professor, Department of Health Research Methods, Evidence, and Impact, and Department, Medicine, McMaster University.

Dr. Devereaux is the first author of the June 2018 article in The Lancet, titled “Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.” He and his research team discovered that dabigatran, which is a blood-thinning drug, significantly reduces the risk of death, heart attack, stroke, and other heart or blood-vessel complications in patients who have a heart injury following major, non-cardiac surgery.

About eight million people globally each year develop MINS, which refers to damage incurred to the tissue of the heart in response to the stress of surgery on the body, such as patients undergoing major procedures like hip or knee replacement, bowel resection, or abdominal aortic aneurysm repair, and can lead to severe complications including heart attack, stroke, blood clots, amputations, and death.

“We now have an option for improving outcomes for a large population of people around the world who have a heart injury after surgery,” says Dr. Devereaux.

The study enrolled 1,754 patients in 19 countries, 51 per cent of whom were male, with an average age of 70 years. After an average follow-up of 16 months, 11 percent of patients treated with dabigatran experienced a MINS-related event, compared with 15 percent of patients who received a placebo. This translates to a 28 per cent reduction in risk for patients receiving dabigatran.

An increased risk of bleeding is an expected complication of treatment with a blood-thinning medication; however, there was no significant difference between the two groups in terms of life-threatening, major, or critical organ bleeding.

The study builds on the discovery made by Dr. Devereaux and his colleagues last year which showed that a simple blood test could identify patients with MINS following surgery and alert clinicians to intervene before complications occurred.

The MANAGE trial results were first released at American College of Cardiology American College of Cardiology’s 67th Annual Scientific Session.