Efficacy and Safety of Apixaban (Eliquis) in Stroke/ Systemic Embolism and Bleeding Risk Management: Reliable Evidence that has Transformed Anticoagulation Approaches

With its efficacy and safety well-supported by extensive clinical trial and real- world evidence, physicians were provided a deeper appreciation of apixaban (Eliquis)’s clinical advantages over traditional anticoagulation approaches. The reliable and reassuring body of evidence has driven transformation of therapeutic strategies, not only in the prevention of stroke and systemic embolism but also in mitigating the treatment-associated bleeding risks.

Superior Efficacy in the Prevention of Stroke and Systemic Embolism

Clinical Trial Data

Data from clinical trials have consistently demonstrated the superior efficacy of apixaban over traditional anticoagulation with warfarin in the prevention of stroke and systemic embolism. The landmark ARISTOTLE trial involving 18,201 patients with atrial fibrillation, demonstrated a significant 21% relative risk reduction in stroke or embolism when using apixaban compared to warfarin (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66 to 0.95; p<0.001), across various subgroups and varying baseline characteristics and comorbidities.¹

Real-World Evidence

Aside from its efficacy data, complementary evidence from the ARISTOPHANES study further proved the consistency and versatility of apixaban in reducing risk of stroke and systemic embolism compared to warfarin (hazard ratio [HR], 0.64; 95% CI, 0.58–0.70). Data also showed that its efficacy was not compromised by factors like age, gender or prior stroke history. This should make apixaban a favorable option across patient populations.²

Superior Reduction of Bleeding Risk

Reducing risk of major bleeding can directly impact treatment outcomes and patients’ quality of life. This is why choosing an anticoagulation regimen with the right balance of preventing both embolic events and bleeding complications is a crucial decision point for clinicians.

Clinical Trial Data

Evidence on the safety profile of apixaban from the ARISTOTLE trial was unequivocal, showing a significant 31% reduction in major bleeding compared to warfarin (HR, 0.69; 95% CI, 0.60 to 0.80; p<0.001).¹

Real-World Evidence

The safety of apixaban in real-world settings was also established by data from the ARISTOPHANES study which showed it had significantly lower risk of major bleeding compared to warfarin (HR, 0.60; 95% CI, 0.56–0.63).²

Furthermore, data shows that apixaban does not increase the risk of gastrointestinal bleeding – one of the most encountered clinical adverse effects of anticoagulation. In a study that compared data from randomized controlled trials from different direct oral anticoagulants (DOACs), apixaban had the notable distinction of being the only DOAC that did not increase the risk of gastrointestinal bleeding compared to warfarin.³ (See Table below)

Gastrointestinal Bleeding Risks of Direct Oral Anticoagulants Compared to Warfarin

^{*Only standard licensed doses are shown. Dabigatran 110 mg and 150 mg results are shown as RR (95% CI); all other results are HR (95% CI). There are no available head-to-head trials among DOACs, so direct comparisons cannot be made.}

The Reassurance of Consistent and Complementary RCT and RWE Evidence

Randomized controlled trials remain to be the “gold-standard” in establishing the efficacy and safety profile of medications. The real-world evidence that is consistent and complementary to randomized clinical trial results proves the generalizability of the data to the wider population in real world practice.⁴ When expectations set by the clinical trials are perfectly matched up with the realities from real-world evidence, a deeper appreciation and understanding of the clinical value of drug ensues that often impacts the direction of treatment.

It is no wonder then that apixaban has set out to transform therapeutic approaches to prevention of stroke and systemic embolism.