Abstract T P335: Eligibility and Preference of New Oral Anticoagulants in Patients With Atrial Fibrillation: Comparison Between Patients With Versus Without Stroke or TIA
BACKGROUNDS: Recent randomized clinical trials of new oral anticoagulants (NOACs) forms the basis for international guidelines for the management of patients with atrial fibrillation. However, strict enrollment criteria may limit the applicability of results of trials to clinical practice. We estimated the eligibility for participation in landmark trials of NOACs of an unselected group of atrial fibrillation patients with or without stroke/TIA. In addition, we compared the preference for NOACs use between patients with versus without stroke/TIA.
METHODS: Four hundred patients were prospectively and consecutively enrolled in a database from a university medical center. We applied three large NOAC trials' enrollment criteria (RE-LY, ROCKET-AF, and ARISTOTLE). In addition, INR lability (time in therapeutic window for patients taking warfarin) and bleeding risk schemes (ATRIA) were measured.
RESULTS: The proportions of patients fulfilling the trial enrollment criteria ranged from 20% to 75%, depending on the differences in the indications/contraindications of studies (lower in ROCKET-AF than others) and presence or absence of stroke/TIA (20-60% vs. 75%). The main reasons for ineligible for NOACs are lower CHADS2 score and planned cardioversion for patients without stroke/TIA, whereas low creatinine clearance and bleeding-related complications for those with stroke/TIA. TTR is lower in the former, especially in patients with severe disability. In addition, bleeding tendency as measured by ATRIA is much higher in patients with stroke/TIA, mainly due to concomitant use of antithrombotics.
CONCLUSIONS: Our data confirm that patients enrolled in randomized clinical trials are representative of most stroke patients with atrial fibrillation, but partly of nonstroke patients, in clinical practice. When INR lability and bleeding tendency with warfarin use were considered, the use of NOACs was preferred in patients with stroke/TIA than in patients without
Author Disclosures: C. Yoon: None. Y. Park: None. S. Kim: None. M. Lee: None. S. Ryoo: None. G. Kim: None. C. Chung: None. K. Lee: None. O. Bang: None.
- © 2014 by American Heart Association, Inc.