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The year 2009 was a turning point for thromboprophylaxis for the patients with non-valvular atrial fibrillation (NVAF). The first randomised control trial (RCT) for a currently licensed non-vitamin K antagonist oral anticoagulant (NOAC), the RE-LY trial comparing the oral direct throkbin inhibitor dabigatran with warfarin, was published.1 This trial led to the global approval of dabigatran as an alternative to vitamin K antagonists (VKAs; eg, warfarin) for the prevention of stroke and thromboembolic events in patients with NVAF.
Since the RE-LY trial, three more NOACs (ie, rivaroxaban, apixaban and edoxaban) supported by their respective RCTs against VKAs, have gained approval and the NOACs are now recommended by international guidelines as the treatment of choice for stroke prevention in NVAF. Due to the availability of additional treatment options and the minor but significant differences in some outcomes between the NOACs, guidelines recommend a more individualised patient approach regarding the selection and dosing of the available drugs.2
In this issue, Lauw et al 3 report a substudy of the RE-LY trial investigating the influence of age on the efficacy and safety outcomes of the original RCTs for the two different doses of dabigatran, that is, 150 mg twice daily and 110 mg twice daily. A reasonable question is what a substudy of an RCT published almost 8 years ago can offer …
Competing interests GYHL: Consultant for Bayer/Janssen, BMS/Pfizer, Biotronik, Medtronic, Boehringer Ingelheim, Microlife and Daiichi-Sankyo. Speaker for Bayer, BMS/Pfizer, Medtronic, Boehringer Ingelheim, Microlife, Roche and Daiichi-Sankyo No fees are received personally. Consultancy and speaker honoraria are received into a group private practice company.
Provenance and peer review Commissioned; internally peer reviewed.