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Clinical Trial
. 2022 Dec;122(12):2030-2041.
doi: 10.1055/s-0042-1756355. Epub 2022 Aug 29.

Clinical Complexity Domains, Anticoagulation, and Outcomes in Patients with Atrial Fibrillation: A Report from the GLORIA-AF Registry Phase II and III

Giulio Francesco Romiti  1   2 , Marco Proietti  2   3   4 , Niccolò Bonini  2   5 , Wern Yew Ding  1 , Giuseppe Boriani  5 , Menno V Huisman  6 , Gregory Y H Lip  1   7 ; GLORIA-AF Investigators
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Free article
Clinical Trial

Clinical Complexity Domains, Anticoagulation, and Outcomes in Patients with Atrial Fibrillation: A Report from the GLORIA-AF Registry Phase II and III

Giulio Francesco Romiti et al. Thromb Haemost. 2022 Dec.
Free article

Abstract

Background: Clinical complexity is common in atrial fibrillation (AF) patients. We assessed the impact of clinical complexity on oral anticoagulant (OAC) treatment patterns and major adverse outcomes in a contemporary cohort of AF patients.

Methods: The GLORIA-AF Phase II and III Registry enrolled newly diagnosed AF patients with at least one stroke risk factor. Among patients with CHA2DS2-VASc score ≥2, we defined four domains of perceived clinical complexity: frail elderly (age ≥75 years and body mass index <23 kg/m2), chronic kidney disease (CKD, creatinine clearance <60 mL/min), history of bleeding, and those with ≥2 of the above conditions. We evaluated the associations between clinical complexity domains and antithrombotic treatment prescription, risk of OAC discontinuation, and major adverse outcomes.

Results: Among the 29,625 patients included (mean age 69.6 ± 10.7 years, 44.2% females), 9,504 (32.1%) presented with at least one complexity criterion. Clinical complexity was associated with lower OAC prescription, with stronger associations in frail elderly (odds ratio [OR]: 0.47, 95% confidence interval [CI]: 0.36-0.62) and those with ≥2 complexity domains (OR: 0.50, 95% CI: 0.44-0.57). Risk of OAC discontinuation was higher among frail elderly (hazard ratio [HR]: 1.30, 95% CI: 1.00-1.69), CKD (HR: 1.10, 95% CI: 1.02-1.20), and those with ≥2 complexity domains (HR: 1.39, 95% CI: 1.23-1.57). Clinical complexity was associated with higher risk of the primary outcome of all-cause death, thromboembolism, and major bleeding, with the highest magnitude in those with ≥2 criteria (HR: 1.63, 95% CI: 1.43-1.86).

Conclusion: In AF patients, clinical complexity influences OAC treatment management, and increases the risk of poor clinical outcomes. These patients require additional efforts, such as integrated care approach, to improve their management and prognosis.

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Conflict of interest statement

G.Y.H.L.: consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are received personally. G.Y.H.L. is co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 899871. M.V.H. has been receiving research grants from the Dutch Healthcare Fund, Dutch Heart Foundation, BMS-Pfizer, Bayer Healthcare, and Boehringer Ingelheim, and consulting fees from BMS-Pfizer, Bayer Healthcare, and Boehringer Ingelheim. G.F.R. has been part-funded by an educational grant from Anthos. All other authors have nothing to declare.

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