Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study

Daniela Poli; Emilia Antonucci; Walter Ageno; Lorenza Bertù; Ludovica Migliaccio; Lucia Martinese; Giuseppe Pilato; Sophie Testa; Gualtiero Palareti

doi:10.1371/journal.pone.0216831

Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study

PLoS One. 2019 May 23;14(5):e0216831. doi: 10.1371/journal.pone.0216831. eCollection 2019.

Authors

Daniela Poli¹, Emilia Antonucci², Walter Ageno³, Lorenza Bertù³, Ludovica Migliaccio², Lucia Martinese⁴, Giuseppe Pilato⁴, Sophie Testa⁵, Gualtiero Palareti²

Affiliations

¹ Center for Atherothrombotic Diseases, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
² Arianna Anticoagulazione Foundation, Bologna, Italy.
³ Department of Medicine and Surgery, University of Insubria, Varese, Italy.
⁴ Department of Experimental and Clinical Medicine, University of Florence, Firenze, Italy.
⁵ Haemostasis and Thrombosis Centre, Hospital of Cremona, Cremona, Italy.

Abstract

Direct oral anticoagulants (DOACs) have shown similar efficacy and safety with respect to warfarin in patients with atrial fibrillation (AF). However, the proportion of patients aged ≥85 years enrolled in clinical trials was low and the applicability of their results to very elderly patients is still uncertain. We have carried out a prospective cohort study on AF patients aged ≥85 years enrolled in the Survey on anticoagulaTed pAtients RegisTer (START2-Register) and treated with either VKAs or DOACs, with the aim to evaluate mortality, bleeding and thrombotic rates during a long-term follow-up. We enrolled 1124 patients who started anticoagulation at ≥85 years with VKA (58.7%) or DOACs (41.3%), Clinical characteristics of patients were similar, except for a higher prevalence of coronary artery disease and renal failure in VKAs patients and of a history of previous bleeding and previous stroke/TIA in patients on DOACs. Median CHA2DS2VASc and HAS-BLED scores were similar between the two groups. During follow-up, 47 major bleedings (rate 2.3 x100 pt-yrs) and 19 stroke/TIA (0.9 x100 pt-yrs) were recorded. The incidence of bleeding was similar between patients on VKAs and DOACs. Patients on DOACs showed a higher rate of thrombotic events during treatment (rate 1.84 and 0.50,respectively). Mortality rate was higher in patients on VKAs than in patients on DOACs (HR 0.64 (95% CI 0.46-0.91). In conclusion, we confirm the overall safety and effectiveness of anticoagulant treatment in very elderly AF patients, with lower mortality rates in DOACs patients, similar bleeding risk, and a higher risk for cerebral thrombotic events in DOACs patients.

Publication types

Clinical Trial
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Oral
Aged, 80 and over
Anticoagulants / administration & dosage
Anticoagulants / adverse effects
Atrial Fibrillation* / drug therapy
Atrial Fibrillation* / epidemiology
Female
Follow-Up Studies*
Hemorrhage* / chemically induced
Hemorrhage* / epidemiology
Humans
Incidence
Male
Prospective Studies
Registries*
Risk Factors
Stroke* / chemically induced
Stroke* / epidemiology
Warfarin* / administration & dosage
Warfarin* / adverse effects

Substances

Anticoagulants
Warfarin

Grants and funding

The Arianna Anticoagulation Foundation supported the START2 Register and the study. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.