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Study of Pradaxa in Mechanical Heart-Valve Patients Halted

Study of Pradaxa in Mechanical Heart-Valve Patients Halted

September 9, 2013 — The New England Journal of Medicine has published the results of the RE-ALIGN clinical trial, which compared the blood-thinners Pradaxa (dabigatran) with Coumadin (warfarin) in patients with mechanical heart-valves.

The study had to be halted prematurely when Pradaxa patients were significantly more likely to suffer from blood clots, heart attacks, strokes, and bleeding.

The researchers recruited 252 people for the study, of whom 168 were assigned to Pradaxa and 84 to warfarin. The researchers found alarming results:

  • Thromboembolic events (heart attack, stroke, death, etc.) occurred in 15 Pradaxa patients (9%) versus four warfarin patients (5%).
  • Strokes occurred in 9 (5%) of Pradaxa patients, and zero patients on warfarin.
  • Major bleeding occurred in 7 (4%) of Pradaxa patients, and 2 (2%) on warfarin.
  • Pericardial bleeding (blood around the heart) occurred in all patients who had serious bleeding.

The researcher warned:

“Dabigatran is not appropriate as an alternative to warfarin for the prevention of thromboembolic complications in patients who require anticoagulation after the implantation of a prosthetic heart valve.”

The study raises significant concerns about the link between Pradaxa and heart attacks. Other studies have found that Pradaxa may increase the risk of heart attack, including a study published in the American College of Cardiology linking Pradaxa to a 48% increased risk of heart attack.

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