Category: Federal Forum Posters
Purpose: The American Heart Association/American College of Cardiology (AHA/ACC) guidelines serve as the standard of care for use of anticoagulation in patients with prosthetic heart valves. Given the lack of primary literature available to evaluate the use of a direct oral anticoagulants (DOAC) with bioprosthetic heart valve (BHV) implantation, the AHA/ACC have yet to make a formal recommendation on the use of DOAC agents with a BHV. The aim of this study is to evaluate whether DOAC use with a BHV is associated with higher risks of significant adverse events compared to observed outcomes from previously conducted trials.
Methods: This study was submitted to the Institutional Review Board. A list of patients receiving DOAC therapy will be generated with a management tool routinely used by our anticoagulation clinic. The list will be further reduced to identify patients on a DOAC with a BHV from January 1, 2013 to September 25, 2018. Inclusion criteria includes a left-sided bioprosthetic mitral or aortic valve replacement, long-term indication for anticoagulation therapy, and an active DOAC prescription. Patients will be excluded if less than 19 years of age, have a history of mechanical heart valve replacement, moderate-to-severe stenosis, or lack of a consistent DOAC fill history. This research study will involve an additional site, Catholic Health Initiatives Creighton University Medical Center - Bergan Mercy. De-identified data from each site will be combined in aggregate form. The primary objectives are the number of stroke or systemic embolic events (SEE), major bleeding events and composite end points of stoke/SEE, major and minor bleeding, and death. The secondary objectives are the incidence of MACE, all-cause mortality, and life-threatening or fatal bleeding, DOAC indication, and start date of DOAC following BHV implantation.
Results: not applicable
Conclusion: not applicable
Thomas Bernier– PGY1 Pharmacy Practice Resident, Veteran Affairs - Nebraska Western Iowa Health Care System: Omaha Division, Omaha, NE