Results of the pooled analysis of the global XANTUS real-world study programme were announced recently at the European Society of Cardiology (ESC) Congress in Barcelona, Spain. The study investigated the use of the non-vitamin K antagonist oral anticoagulant (NOAC) rivaroxaban for stroke prevention in patients with non-valvular atrial fibrillation (AF) (irregular heart beat). The study showed low rates of both stroke and major bleeding, including fatal intracranial (skull) bleeds in AF patients on Xarelto® for stroke prevention. The majority (96.1%) of the pooled XANTUS population did not experience stroke/ systemic embolism, major bleeding and all-cause death. This is generally consistent with the Phase III ROCKET AF trial and reaffirms the safety and efficacy of rivaroxaban in AF management.
The global XANTUS programme is the largest prospective observational study on a single NOAC for stroke prevention in AF. This pooled analysis combined real-world data from three prospective, single-arm, multi-centre studies across multiple regions, which together followed more than 11,000 patients from 47 countries:
- XANTUS, the largest of the studies, which followed 6,784 patients from Canada, Israel and 10 countries across Europe.
- XANAP, the first Pan-Asian real-world study of rivaroxaban in AF stroke prevention, which followed 2,273 patients from 10 countries/territories in Asia (Hong Kong, S.A.R., China SAR, Indonesia, South Korea, Malaysia, Philippines, Singapore, Taiwan, China, Thailand, Vietnam and Pakistan).
- XANTUS-EL which involved 2,101 patients from 17 countries in Eastern Europe, Middle East, Africa, and Latin America.
Unmet Needs in Atrial Fibrillation
AF is a heart condition characterised by irregular heartbeats which increases the risk of stroke caused by blood clots by five-fold. Strokes due to AF are also more severe, causing disability in over 50% of patients and generally worse outcomes than strokes due to other causes. The incidence of AF increases with age.
The prevalence of AF is a global issue with the number of AF patients growing rapidly and expected to have doubled by 2050. AF is especially of concern in Asia due the regions rapidly ageing populations. It is estimated that by 2050, Asia will have 72 million AF patients, and 2.9 million among them will suffer from an AF-associated stroke.
The good news is AF-related stroke can be prevented. However, there are still a significant number of AF patients in Asia not receiving optimal anticoagulant therapy for stroke prevention. Older anticoagulant therapy with Vitamin K Antagonist (VKAs) such as warfarin makes effective anticoagulation harder for patients and physicians due to its manifold food and drug interactions, regular blood monitoring requirements and risk of intracranial (skull) bleeding. These serious disadvantages cause VKAs to be under-used or under-dosed in AF stroke prevention, leaving patients unprotected.
"NOACs like rivaroxaban can potentially address this medical challenge as they are at least as effective as traditional warfarin therapy in preventing strokes in AF patients, but are easier to administer and carry a significantly lower risk of the life-threatening intracranial bleeding," said Professor John Camm, the Professor of Clinical Cardiology at St George’s University of London who presented the results at ESC. "While this has been well proven in clinical trials and real-world studies, the consistency of the combined data from the worldwide XANTUS programme adds significantly to our understanding on the safety of NOACs in AF patients, and gives physicians the confidence to prescribe rivaroxaban in daily clinical practice."
In the XANTUS pooled analysis, a total of 11,121 patients were enrolled into the three real-world studies and included in the analysis. Patients were from 47 countries in Western Europe/ Canada/Israel (47.5%), Eastern Europe (23.2%), East Asia (20.1%), the Middle East/Africa (6.2%) and Latin America (3.0%). The majority of patients (73.1%) initially received rivaroxaban 20mg once daily, while 25.1%, 1.6% and 0.2% of patients received rivaroxaban 15mg once daily, 10mg once daily and other doses, respectively. There were differences in patient demographics, clinical characteristics as well ...
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