Hot Line 6: STEEER-AF, OCEANIC-AF and EPIC-CAD
01 Sep 2024
Ways to optimise the medical management of patients with atrial fibrillation (AF) were discussed in Hot Line 6.
Firstly, Professor Dipak Kotecha (University of Birmingham - Birmingham, UK) presented STEEER-AF, the ESC’s first randomised controlled trial, conducted in collaboration with the European Heart Rhythm Association and the ESC Council on Stroke. STEEER-AF was a cluster randomised trial conducted in France, Germany, Italy, Poland, Spain and the UK, which tested whether a structured educational programme for healthcare professionals could improve guideline-adherent provision of AF care. Treatment centres were randomised to receive a structured education programme over 16 weeks or to their existing educational activities. There was no significant change in guideline adherence for stroke prevention, which improved from 63.4% to 67.5% in the intervention group and from 58.6% to 60.9% in the control group (adjusted risk ratio [RR] 1.10; 95% CI 0.97–1.24; p=0.13). However, a significant 51% improvement was observed in guideline adherence for rhythm control, which increased from 21.4% to 33.9% in the intervention group and from 20.5% to 22.9% in the control group (adjusted RR 1.51; 95% CI 1.04–2.18; p=0.03). “The STEEER-AF trial demonstrates that targeted education for healthcare professionals can improve patient-level guideline adherence where there are substantial gaps in implementation, as clearly demonstrated for rhythm control in AF. Overall, the care of AF was poorly adherent to prior guideline recommendations, requiring a total re-think of how guidelines are constructed, disseminated and implemented. As a result of STEEER-AF, the new 2024 ESC Guidelines for the management of AF1 incorporate numerous approaches to enhance ‘AF-CARE’, with new patient pathways designed to make implementing recommendations easier and more consistent,” concluded Professor Kotecha.
Next, Professor Manesh Patel (Duke University Medical Center - Durham, USA) discussed the double-blind OCEANIC-AF trial, which compared asundexian, an inhibitor of activated factor XI (XIa), with apixaban in 14,830 patients with AF with a high stroke risk. The independent data monitoring committee recommended that the trial was stopped early. After a median follow-up of 160 days, the occurrence of stroke or systemic embolism was higher in those receiving asundexian (1.3%) compared with apixaban (0.4%), and asundexian was considered to be inferior (hazard ratio [HR] 3.79; 95% CI 2.46–5.83). Major bleeding was lower with asundexian vs. apixaban (0.2% vs. 0.7%; HR 0.32; 95% CI 0.18–0.55). Discussing the key learnings from the trial, Prof. Patel said: “Our results show that the dose of asundexian tested was inferior for stroke or systemic embolism compared with apixaban. We could speculate that near-total factor XIa suppression may be needed to prevent thrombus formation. We also noted a lower-than-expected rate of stroke or systemic embolism in the apixaban group, which may reflect prior use of oral anticoagulants and improved medical therapy. Finally, we were able to demonstrate lower bleeding rates with asundexian, which has to be put into context with the stroke findings.”
The session ended with a trial designed to optimise antiplatelet therapy in patients with high-risk AF and stable coronary artery disease (CAD), presented by Doctor Gi-Byoung Nam (Asan Medical Center - Seoul, Republic of Korea). The investigator-initiated, open-label EPIC-CAD trial randomised 1,040 patients with high-risk AF and stable CAD to either monotherapy of standard-dose edoxaban or dual antithrombotic therapy of standard-dose edoxaban plus a single antiplatelet agent. After 1 year, edoxaban monotherapy significantly reduced the primary endpoint (all-cause death, stroke, systemic embolism, myocardial infarction, unplanned revascularisation, and major or clinically relevant non-major bleeding) by 56% compared with dual antithrombotic therapy (6.8% vs. 16.2%; HR 0.44; 95% CI 0.30−0.65; p<0.001). This difference was mainly driven by a 66% reduction in the risk of major bleeding or clinically relevant non-major bleeding with edoxaban monotherapy vs. dual-antithrombotic therapy. There were no differences in major ischaemic events and all-cause mortality between the groups. “Our results are similar to the AFIRE trial in patients with AF and stable CAD, which showed that rivaroxaban monotherapy was non-inferior to dual therapy for efficacy and superior for safety.2 EPIC-CAD used a globally approved dosing regimen. EPIC-CAD provides additional new evidence on the appropriate antithrombotic strategy with standard-dose edoxaban to guide the treatment of patients with AF and stable CAD,” concluded EPIC-CAD’s Principal Investigator, Professor Duk-Woo Park (Asan Medical Center - Seoul, Republic of Korea).
References
- Van Gelder IC, et al. Eur Heart J. 2024. doi:10.1093/eurheartj/ehae176; released on 30 August 2024.
- Yasuda S, et al. N Engl J Med. 2019;381:1103−1113.
