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ARISTOTLE: Apixaban bests warfarin for stroke prevention in AF
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European Society of Cardiology Congress 2011
The oral factor Xa inhibitor apixaban was superior to warfarin for the prevention of both stroke and systemic embolism in patients with atrial fibrillation, new study results indicated.
The ARISTOTLE trial included 18,201 patients with AF who were randomly assigned to either 5 mg apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) twice daily or warfarin (Coumadin, Bristol-Myers Squibb). Results of the trial were presented at the European Society of Cardiology Congress 2011 in Paris.
The primary results of the study were of import, according to the presenter, because they indicated that apixaban provided an alternative to warfarin.
“There is an enormous unmet need in terms of treatment of patients at risk for stroke associated with AF,” Christopher B. Granger, MD, a professor of medicine at Duke University in Durham, N.C., said in a press release. “Only about half of patients who should be treated are being treated. The disparity exists because warfarin has several limitations.”
Patients receiving apixaban demonstrated a 21% real rate of reduction in the primary outcome of ischemic or hemorrhagic or systemic embolism vs. warfarin (1.27% vs. 1.6% per year, P=.011). In addition, there was also a reduction in major bleeding in the apixaban group vs. warfarin (2.13% vs. 3.09% per year, P<.001). According to Granger, apixaban prevented six strokes, 15 major bleeds and eight deaths per 1,000 patients treated during a 1.8-year period.
“In patients with AF, apixaban is superior to warfarin at preventing stroke or systemic embolism, causes less bleeding and results in lower mortality,” he said.
In the discussant portion of the presentation, Michael Ezekowitz, MD, of Thomas Jefferson Medical School in Philadelphia, said the ARISTOTLE results, together with the demonstrated superiority of dabigatran, may signal a “new dawn” in stroke reduction in the AF patient population.
“Millions of patients worldwide with AF will benefit from significant stroke reduction,” he said. “The challenge will be translating clinical trials into practice.”
For more information:
- Ezekowitz M. Hotline I. Presented at: European Society of Cardiology Congress 2011; Aug. 27-31; Paris.
- Granger C. Hotline I. Presented at: European Society of Cardiology Congress 2011; Aug. 27-31; Paris.
Disclosures: Dr. Ezekowitz has consulted for Pfizer. Dr. Granger has received research support from, and has consulted for, Bristol-Myers Squibb and Pfizer.
For me, the results of ARISTOTLE were the highlight of this year’s ESC Congress in Paris. In patients with AF, the oral direct factor Xa inhibitor apixaban was superior to warfarin for preventing stroke and systemic embolism (21% RR reduction) with less bleeding (31% RR reduction) and lower mortality (11% relative risk reduction). Hemorrhagic stroke was reduced by about half. That these results were consistent regardless of “time in therapeutic range” with warfarin are very convincing as the best results to date for a new anticoagulant. Furthermore, no coagulation monitoring and minimal interactions with other medications or food make this agent a very attractive addition to our management. This agent even makes anticoagulation options attractive for our lower-risk AF patients.
– Carl J. Pepine, MD
Cardiology Today Chief Medical Editor
Disclosure: Dr. Pepine reports receiving research grants from Pfizer.
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