A Phase III clinical trial, known as ARISTOTLE, found Eliquis (apixaban) to be better than Warfarin in reducing stroke or systemic embolism risk in patients with atrial fibrillation – there was also considerably less bleeding among the Eliquis patients. ARISTOTLE showed that Eliquis is the number one oral blood thinner to considerably lower all-cause-death.

ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), a Phase III clinical trial, involving 18,201 individuals with atrial fibrillation (AF) and at least one risk factor for stroke, compared Eliquis to Warfarin for the prevention of systemic embolism or stroke.

The trial demonstrated that Eliquis:

  • Reduced stroke or systemic embolism risk by 21%
  • Reduced major bleeding risk by 31%
  • Reduced mortality by 11%

Adverse events were shown to be similar for those taking Eliquis (81.5%) and Warfarin (83.1%) – they were also similar for serious adverse events (35% and 36.5% respectively). Discontinuation of the drug during the study was lower among those taking Eliquis (25.3%, and 3.6% due to death) compared to Warfarin (27.5%, and 3.8% due to death).

ARISTOTLE was carried out in 39 nations, in 1,034 centers, and was coordinated by the Uppsala Clinical Research Institute, Sweden, and Duke Clinical Research Institute, Durham, North Carolina, USA.

Researchers presented their findings at the Hot Line session at the ESC (European Society of Cardiology) Congress, Paris, France. The results also appear in the NEJM (New England Journal of English).

Lead investigator, Dr. Christopher B. Granger, Duke University Medical Center, said:

“The risk for stroke in patients with atrial fibrillation is a major public health concern in an aging population. We are therefore encouraged by the outcome of the ARISTOTLE trial, which showed that apixaban, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism, major bleeding, and mortality.”

Eliquis, part of a class of agents under investigation for blood clot prevention potential, is a new oral direct Factor XA inhibitor.

  • Approximately 11 million people are thought to suffer from atrial fibrillation in the USA and the European Union (EU) – 5 million in the US, and 6 million in the EU.
  • AT is the most common sustained irregular heartbeat (cardiac arrhythmia) condition.
  • About 1 in every 4 people over 40 years of age is expected to develop AT in the USA and EU.
  • Individuals with AT have a 5 times greater risk of stroke than people without AT.
  • 15% of all strokes are thought to be caused by AT in the USA.
  • 50% of AT patients who develop a stroke die within a year of having a stroke – a much higher figure than for other patients who have a stroke.
  • 24% of AT patients die within 30 days of having a stroke – also a much higher figure when compared to other patients who have a stroke.

In an Abstract in the NEJM, the authors concluded:

“In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.”

Eliquis is the result of a collaboration between BristolMyersSquibb and Pfizer.

Written by Christian Nordqvist