Professor Choi Eue Keun (left) and Professer Lee So-ryoung

Korean researchers have published the first-ever real-world study on a novel oral anticoagulant (NOAC) in the Journal of the American College of Cardiology on Aug. 21.

The study focused on Lixiana (edoxaban), a NOAC developed by Daiichi Sankyo, and real-world data (RWD) refers to data obtained from the clinical field, not through large-scale clinical trials.

The study is the world’s first real-world study on Lixiana that examines the safety and efficacy of the non-vitamin K antagonist oral anticoagulant. It marks the first time researchers published RWD related to Asians rather than Westerners in NOAC.

The team, led by SNUH Professors Choi Eue Keun and Lee So-ryoung, evaluated the safety and efficacy of Lixiana compared to warfarin in Korean patients with nonvalvular atrial fibrillation.

The researchers matched 4,061 patients taking Lixiana and 12,183 patients taking Warfarin for stroke prevention from atrial fibrillation between 2014 and 2016 and compared six clinical indicators -- ischemic stroke, intracranial hemorrhage, significant hemorrhage admission due to gastrointestinal bleeding, all-cause mortality and combined assessment of all five.

As a result, the Lixiana showed lower risk in all six indications when compared with Warfarin.

The results of the specific indicators showed that patients taking Lixiana had a 30 percent lower risk of ischemic stroke and a 60 percent lower risk of intracranial hemorrhage than those taking warfarin.

Also, compared to warfarin, patients taking Lixiana had reduced the risk of hospitalization due to gastrointestinal bleeding by 40 percent and the risk of hospitalization due to other major bleeding factors by 47 percent.,

In total, Lixiana lowered the risk of all-cause mortality by 28 percent and showed better results in the combined assessment.

In the analysis of adjusting dosing duration and the risk of death of the entire study group, the trend of all indications was consistent.

“The study confirmed that Edoxaban had superior efficacy and safety in ischemic stroke and all-cause mortality in Korean patients with atrial fibrillation when compared to Warfarin,” Professor Lee said.

Professor Choi also said, “The hospital is very proud as this is one of the first data that confirmed the real world data on Asians. Until now, RWD on Asians came after research teams released data on Westerners.”

As this is the most extensive study of atrial fibrillation patients in the Asia-Pacific region that has received Edoxaban, he went on to say, this research team has provided essential grounds for the treatment of anticoagulants in Asians who were not considered in large-scale clinical trials.

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