RT Journal Article
SR Electronic
T1 Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e001892
DO 10.1136/openhrt-2021-001892
VO 9
IS 1
A1 Robert C. Welsh
A1 Payam Dehghani
A1 Renato Lopes
A1 Daniel M Wojdyla
A1 Ronald Aronson
A1 Christopher B Granger
A1 Stephan Windecker
A1 Amit N Vora
A1 Dragos Vinereanu
A1 Sigrun Halvorsen
A1 Alexander Parkhomenko
A1 Roxana Mehran
A1 John H Alexander
A1 Shaun Goodman
YR 2022
UL http://openheart.bmj.com/content/9/1/e001892.abstract
AB Objective Managing antithrombotic therapy in patients with atrial fibrillation (AF) and an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) is challenging and can be affected by prior oral anticoagulant (OAC) treatment. We examined the relationship between prior OAC use and outcomes in the AUGUSTUS trial.Methods This prespecified secondary analysis is from AUGUSTUS, an open-label, 2-by-2 factorial, RCT to evaluate the safety of apixaban versus vitamin K antagonist (VKA) and aspirin versus placebo in patients with AF and ACS and/or PCI. The primary endpoint, major or clinically relevant non-major bleeding and clinical outcomes were compared in patients receiving (n=2262) or not receiving (n=2352) an OAC prior to enrolment.Results Patients with prior OAC use had more comorbidities, higher CHA2DS2-VASC and HAS-BLED scores, and were more likely enrolled following elective PCI. There was no difference in major or clinically relevant non-major bleeding with or without prior OAC (30 days: 5.1% vs 5.9% (adjusted HR (aHR) 0.82, 95% CI 0.63 to 1.06); 180 days: 13.5% vs 13.5% (aHR 0.98, 95% CI 0.83 to 1.16)). Patients with prior OAC use had a lower risk of death or ischaemic events (30 days: 1.7% vs 2.8% (aHR 0.61, 95% CI 0.41 to 0.92); 180 days: 5.4% vs 7.6% (aHR 0.70, 95% CI 0.55 to 0.88)). No interactions between randomised treatment (apixaban vs VKA, aspirin vs placebo) and prior OAC status were observed for outcomes, apart from apixaban (vs VKA) being associated with a lower risk of myocardial infarction with prior OAC use (180 days: 2.0% vs 3.7% (aHR 0.56, 95% CI 0.33 to 0.91().Conclusions In AUGUSTUS, prior OAC use was associated with fewer ischaemic events but not more bleeding. In patients with AF and ACS and/or undergoing PCI, clinicians can be assured that the trial results can be applied to patients regardless of their prior OAC status.Trial registration number NCT02415400.Data are available on reasonable request. Duke Clinical Research Institute manages the AUGUSTUS trial data base.