What a difference a day makes: Pradaxa v. Warfarin
  • Fri, 06/22/2012 - 11:25am

Recent findings reveal that patients with atrial fibrillation facing surgery could forgo their blood thinner therapy for a shorter time while on Pradaxa, resulting in less time unprotected against strokes.
Blood thinners are often prescribed for patients with a type of irregular heart beat called atrial fibrillation, which can cause blood clotting and stroke. According to MedicineNet, a stroke occurs when part of the brain cannot receive oxygen and glucose due to an interruption of blood flow, resulting in partial brain death.
The RE-LY trial showed that patients could stop using Pradaxa about two days (49 hours) before surgery, compared to over four days (114 hours) for patients taking warfarin. Patients on Pradaxa were less vulnerable to potential strokes because the drug left their system quickly, allowing surgery to be performed as soon as possible.
Published online in Circulation, the trial contained 4,591 patients, all of whom had at least one surgical procedure performed and were taking either Pradaxa or warfarin.
The results of the trial also indicated that there was little difference in the rates of major pre-procedural bleeding for patients on either drug.
“This analysis provides reassurance that dabigatran (Pradaxa) is as safe as warfarin with regards to peri-operative bleeding and thromboembolic events in patients undergoing surgery or invasive procedures, irrespective of whether interventions were minor or major,” said Dr. Jeff Healey of McMaster University in Hamilton, Canada, “In addition, nearly half of all patients using dabigatran were able to have their procedures performed within 48 hours of the discontinuation of treatment with the anticoagulant, ensuring a shorter interruption of protection from thromboembolic complications than with warfarin.”
Serious bleeding is often a side effect of blood thinner use, but unlike warfarin, Pradaxa has no reversal agent to stop that bleeding in the case of an emergency. With warfarin, vitamin K can be used to stop that bleeding.
Despite the lack of a reversal agent for bleeding events on Pradaxa, the RE-LY trial suggests that patients undergoing surgery or other invasive procedures are more protected while taking Pradaxa because of the shorter time necessary to forgo drug use before surgery.
"Emergency surgery is a frightening proposition for any patient taking an anticoagulant given the increased risk of bleeding encountered," said Co-Founder and Chief Executive of AntiCoagulation Europe (ACE) Eve Knight. "This data is encouraging for patients as it demonstrates that with Pradaxa shorter therapy interruptions with no increase in bleeding risk are possible."


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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