Ambassador Blog Series: Devin Mehta from Rush on the ARISTOTLE study

December 24, 2014

Devin Mehta Docphin Ambassador

Name: Devin D. Mehta, MD?
Residency: Internal Medicine at Rush University Medical Center?
Specialty Interest: Cardiology

Devin D. Mehta is a resident physician in the Department of Internal Medicine at Rush University Medical Center in Chicago, Illinois. He has a Bachelors in Finance from the University of Illinois at Urbana-Champaign and a Masters in Medical Sciences from Boston University School of Medicine. Devin attended medical school at Rush University School of Medicine. Enthused by all things innovative, Devin is a co-founder of MedReferrals, a non-profit organization which increases access to healthcare for the underserved and uninsured through a free, online website: medreferrals.org.

Trial: Apixaban versus Warfarin in Patients with Atrial Fibrillation (ARISTOTLE study)

Journal: The New England Journal of Medicine

Date: September 15, 2011

URL: https://www.docphin.com/articledetail.aspx?articleID=103714

Study Relevance: In minimally symptomatic patients, a primary focus of management of atrial fibrillation is the prevention of thromboembolic events. At present, warfarin anticoagulation is the most widely used and accessible pharmacologic therapy for reducing the risk of stroke associated with atrial fibrillation. Patients on warfarin need to have regular INR level checks to ensure they are within the therapeutic range for drug efficacy. The significant financial, psychosocial, and medical burden on patients and providers has created a market need for an alternative anticoagulation therapy without the need for therapeutic level monitoring, thereby easing the burden of anticoagulation and decreasing the risk of complications from those patients who remain non-therapeutic on warfarin.

Drug Background: Apixaban is an oral direct factor Xa inhibitor anticoagulant that does not require monitoring. Apixaban has already been approved in Europe for the prevention of venous thromboembolic events following hip or knee replacement surgeries. The Food and Drug Administration (FDA) has not yet approved apixaban for use in the United States. In June 2012, the FDA delayed the approval of apixaban and based on a press release, the FDA asked for “additional information on data management and verification from the ARISTOTLE trial.” FDA approval remains pending at this time.

Key Takeaway: The ARISTOTLE trial is a randomized, double-blind trial with 18,201 atrial fibrillation patients placed in two arms: apixaban (5 mg orally twice daily) or warfarin (target INR of 2.0 to 3.0). After a median follow-up of 1.8 years, results showed that apixaban was associated with a 21% reduction in the risk of stroke or systemic embolism, a 31% reduction in bleeding, and an 11% reduction in all-cause mortality. In addition, two other relatively new anticoagulants, dabigatran and rivaroxaban, have also shown benefits over warfarin in the RE-LY and ROCKET-AF trials respectively, but apixaban is the first of these three agents to have shown definite reductions in each of the major outcomes of stroke, bleeding, and mortality.

Food For Thought: Bristol-Myers Squibb and Pfizer, the joint venture that developed apixaban, funded the ARISTOTLE study. When a pharmaceutical company funds a well designed study, are any of the study results reliable or does their participation taint all validity?

 

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