Net Clinical Benefit of Non-Vitamin K Antagonist vs Vitamin K Antagonist Anticoagulants in Elderly Patients with Atrial Fibrillation

Abstract

BACKGROUND: The risks of thromboembolic and hemorrhagic events in patients with atrial fibrillation both increase with age; therefore, net clinical benefit analyses of anticoagulant treatments in the elderly population are crucial to guide treatment. We evaluated the 1-year clinical outcomes with non-vitamin-K antagonist and vitamin K antagonist oral anticoagulants (NOACs vs VKAs) in elderly (≥75 years) patients with atrial fibrillation in a prospective registry setting. METHODS: Data on 3825 elderly patients were pooled from the PREFER in AF and PREFER in AF PRO-LONGATION registries. The primary outcome was the incidence of the net composite endpoint, including major bleeding and ischemic cardiovascular events on NOACs (n = 1556) compared with VKAs (n = 2269). RESULTS: The rates of the net composite endpoint were 6.6%/year with NOACs vs 9.1%/year with VKAs (odds ratio [OR] 0.71; 95% confidence interval [CI], 0.51-0.99; P = .042). NOAC therapy was associated with a lower rate of major bleeding compared with VKA use (OR 0.58; 95% CI, 0.38-0.90; P = .013). Ischemic events were nominally reduced too (OR 0.71; 95% CI, 0.51-1.00; P = .050). Major bleeding with NOACs was numerically lower in higher-risk patients with low body mass index (BMI; OR 0.50; 95% CI, 0.22-1.12; P = .07) or with age ≥85 years (OR 0.44; 95% CI, 0.13-1.49; P = .17). CONCLUSIONS: Our real-world data indicate that, compared with VKAs, NOAC use is associated with a better net clinical benefit in elderly patients with atrial fibrillation, primarily due to lower rates of major bleeding. Major bleeding with NOACs was numerically lower also in higher-risk patients with low BMI or age ≥85 years.

Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

“…Leaving aside the registration trials, which often include patient populations that are greatly different from those observed in daily clinical practice, we can confirm that the ADR data analyzed in this paper corroborate results of important international observational studies such as XANTUS and PREFER [23,36,37]. These studies represent patient cohorts that are more representative to those of the real world versus patients enrolled in phase 3 trials.…”

Practical use of Direct Oral Anti Coagulants (DOACs) in the older persons with atrial fibrillation.

“…A propensity-matched analysis of patients ≥ 90 years of age from the National Health Insurance Research Database in Taiwan showed similar efficacy and reduced incidence of intracranial hemorrhage with DOACs over warfarin [23]. In 3285 elderly patients from the PREFER in AF registries, the primary net composite end-point (ischemic cardiovascular events and major bleeding) was lower with DOACs than with VKAs (6.6% vs 9.1%, respectively, OR 0.71, 95% CI 0.51-0.99), with a net clinical benefit of DOACs primarily due to lower rates of major bleedings [24]. In a propensity score adjusted analysis of a retrospective US Medicare cohort of new-user AF patients who initiated warfarin or full doses of dabigatran, rivaroxaban and apixaban, compared to warfarin each DOAC was associated with reduced risks of thromboembolic stroke (20-29%), intracranial hemorrhage (35-62%) and mortality (19-34%) [25].…”

Non-Vitamin K Oral Anticoagulants (NOAC) versus Vitamin K Antagonists (VKA) for Atrial Fibrillation with Elective or Urgent Percutaneous Coronary Intervention: A Meta-Analysis with a Particular Focus on Combination Type

“…In order to reduce the risk of both stroke and coronary ischemic events in this vulnerable population of patients with AF who concomitantly received coronary stents, triple antithrombotic therapies (TAT i.e., a combination of oral anticoagulants (OAC) and DAPT) have been used for the last decade [5]. As a consequence, increased bleeding risks were reported in the literature for such a combination [6,7], with however unknown risk to benefit ratio, especially with the use of NOACs instead of warfarin [8].…”