Physicians' Academy for Cardiovascular Education

Prospective data of large real-world registry confirm safety profile of NOAC for stroke prevention in AF

News - Mar. 20, 2018

New data from the prospective ongoing Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) Registry showed low rates of major bleeding (0.97%) and stroke (0.65%). These data of GLORIA-AF were presented at the EHRA 2018, the annual congress of the European Heart Rhythm Association (EHRA). The registry examined two-year safety and effectiveness outcomes of nearly 5,000 AF patients treated with dabigatran. These findings confirm the sustained safety and effectiveness of dabigatran and are highly consistent with the long-term safety profile observed in other real-world evidence, as well as in randomized clinical trials.

In an additional analysis from GLORIA-AF, the safety of uninterrupted dabigatran for patients undergoing cardiovascular (CV) interventions was evaluated. The rates of major bleeding and stroke/ systemic embolism were very low, i.e. one major bleed and one systemic embolic event occurred in 412 CV interventions that were performed with uninterrupted dabigatran.

The GLORIA-AF Registry also examines physicians’ prescribing behaviors in treating AF, as well as the factors behind their prescribing decisions. In addition, GLORIA-AF Phase II, which has recently completed, provides safety and effectiveness data from dabigatran during 2 years of follow-up. Phase III, which is currently ongoing, follows patients independent of antithrombotic therapy for three years to evaluate the safety and effectiveness of oral anticoagulants (OACs). GLORIA-AF is currently the only study with the objective to provide long-term prospective comparative real-world outcomes of OACs for AF during its third Phase. The Registry will enroll up to 56,000 patients newly diagnosed with AF at risk of stroke from up to 2,200 sites in nearly 50 countries. So far more than 38,000 patients have been included.

Source: press release Boehringer Ingelheim, March 20, 2018