Quality of oral anticoagulation with vitamin K antagonists in ‘real-world’ patients with atrial fibrillation: a report from the prospective multicentre FANTASIIA registry

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26.0% vs 16.6%, P = .02) and previous major bleeding (8.1% vs 3.6%, P = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( P = .15), 3.45 vs 4.41 ( P = .48), and 8.2 vs 11.0 ( P = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, P = .19; HR: 0.88, 95% CI: 0.44-1.76, P = .72 and HR: 0.84, 95% CI: 0.53-1.33, P = .46, respectively). Conclusion: In this “real-world” registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.

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4037Nurse counseling of patients with atrial fibrillation to improve compliance to oral anticoagulation

European Heart Journal ◽

10.1093/eurheartj/ehz745.0092 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

R Chilian-Hof ◽

S Schnupp ◽

C Mahnkopf ◽

J Brachmann ◽

C Kleinecke

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Oral Anticoagulation ◽

Vitamin K Antagonists ◽

Randomised Trial ◽

Female Gender ◽

Bleeding Risk ◽

Telephone Counseling ◽

Bleeding Events

Abstract Background Atrial fibrillation (AF) is the most frequent arrhythmia with a prevalence of 1%–2% in the general population. Oral anticoagulation (OAC) is state-of-the art for preventions of thromboembolic events, in particular ischemic stroke, in patients with atrial fibrillation. Despite its proven benefit, numerous studies have documented under use of OAC for a variety of reasons. Purpose To establish a program of nurse counseling in patient with atrial fibrillation and treatment with oral anticoagulation. The program is designed to improve patients satisfaction, compliance to OAC, prevention of medication errors, ischemic and bleeding events. Methods Patients with atrial fibrillation and treatment with oral anticoagulation were prospectively identified at the department of cardiology of our clinic. They received a 30 minutes nurse counseling about oral anticoagulation during the hospital stay and another 30 minutes telephone counseling 3 months after inclusion. Furthermore, they received a brochure to inform about atrial fibrillation, oral anticoagulation and methods to improve medication compliance. Demographic characteristics with stroke and bleeding risk (CHA2DS2-VASc and HAS-BLED scores), as well as procedural data were systematically assessed in a predefined standardized way and captured in a dedicated database. Results Between June 2017 and January 2018, a total of 617 patients (female gender: 43.1%) with atrial fibrillation and oral anticoagulation received nurse counseling. Demographic and follow-up data of 204 patients (female gender: 85/204 (41.7%); mean age 69.7±17.3, CHA2DS2-VASc score 4.2±1.7, HAS-BLED score 2.8±0.37) were assessed in a dedicated database. Indication for OAC was paroxysmal and persistent/permanent AF in 110/204 (53.9%), 93/204 (45.6%) and others 17 (8.3%), respectively. 33/2014 (16.2%) were treated with vitamin K antagonists, and 172/204 (84.3%) with non-vitamin K antagonists. After a follow-up of 0.46±2.9 years and 187 patients-years the rates of cardiovascular death, major bleeding events and all-cause stroke and TIA were 1.07%, 2.14% and 1.61% per 100 patient-years. Conclusion Nurse counseling in patients with atrial fibrillation and treatment with oral anticoagulation has been established at the REGIOMED clinics, Germany. Its effectiveness in terms of quality of live, medication complications and cardiovascular events has to be proven in a randomised trial. Acknowledgement/Funding Daichi-Sankyo

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Long-term quality of VKA treatment and clinical outcome after extreme overanticoagulation in 14,777 AF and VTE patients

Thrombosis and Haemostasis ◽

10.1160/th14-06-0537 ◽

2015 ◽

Vol 113 (04) ◽

pp. 881-890 ◽

Cited By ~ 9

Author(s):

Nic J. G. M. Veeger ◽

Nakisa Khorsand ◽

Hanneke C. Kluin-Nelemans ◽

Hilde A. M. Kooistra ◽

Karina Meijer ◽

...

Keyword(s):

Atrial Fibrillation ◽

Venous Thromboembolism ◽

Clinical Outcome ◽

Vitamin K ◽

Vitamin K Antagonists ◽

P Value ◽

Risk Of Bleeding ◽

Increased Risk

SummaryVitamin K antagonists (VKA) are widely used in atrial fibrillation and venous thromboembolism (VTE). Their efficacy and safety depend on individual time in the therapeutic range (iTTR). Due to the variable dose-response relationship within patients, also patients with initially stable VKA treatment may develop extreme overanticoagulation (EO). EO is associated with an immediate bleeding risk, but it is unknown whether VKA treatment will subsequently restabilise. We evaluated long-term quality of VKA treatment and clinical outcome after EO. EO was defined as international normalized ratio (INR) ≥ 8.0 and/or unscheduled vitamin K supplementation. We included a consecutive cohort of initially stable atrial fibrillation and venous thromboembolism patients. In EO patients, the 90 days pre- and post-period were compared. In addition, patients with EO were compared with patients without EO using a matched 1:2 cohort. Of 14,777 initially stable patients, 800 patients developed EO. The pre-period was characterised by frequent overanticoagulation, and half of EO patients had an inadequate iTTR (< 65 %). After EO, underanticoagulation became more prevalent. Although the mean time between INR-measurements decreased from 18.6 to 13.2 days, after EO inadequate iTTR became more frequent (62 %), p-value < 0.001. A 2.3 times (95 % confidence interval [CI] 2.0–2.5) higher risk for iTTR< 65 % after EO, was accompanied by increased risk of bleeding (hazard ratio [HR] 2.1;CI 1.4–3.2), VKA-related death 17.0 (HR 17.0;CI 2.1–138) and thrombosis (HR 5.7;CI 1.5–22.2), compared to the 1600 controls. In conclusion, patients continuing VKA after EO have long-lasting inferior quality of VKA treatment despite intensified INR-monitoring, and an increased risk of bleeding, thrombosis and VKA-related death.Note: There have been no previous presentations, reports or publications of the complete data that appear in the article. Parts of the data in this article have been presented as a poster at the American Society of Hematology (ASH) congress 2013, New Orleans, United States.

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Real-world clinical evidence on rivaroxaban, dabigatran, and apixaban compared with -vitamin K antagonists in patients with non-valvular atrial fibrillation: a systematic literature review

Expert Review of Pharmacoeconomics & Outcomes Research ◽

10.1080/14737167.2019.1592834 ◽

2019 ◽

Vol 19 (3) ◽

pp. 243-244 ◽

Cited By ~ 2

Author(s):

Steve Deitelzweig ◽

Gregory Y. H. Lip

Keyword(s):

Atrial Fibrillation ◽

Literature Review ◽

Vitamin K ◽

Systematic Literature Review ◽

Real World ◽

Clinical Evidence ◽

Vitamin K Antagonists

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Antikoagulation bei Vorhofflimmern

Hämostaseologie ◽

10.5482/ha-1186 ◽

2012 ◽

Vol 32 (01) ◽

pp. 37-39 ◽

Cited By ~ 5

Author(s):

C. Bode ◽

M. Moser

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Vitamin K Antagonists ◽

Bleeding Risk ◽

Coagulation Factors ◽

Additional Risk ◽

New Anticoagulants ◽

Therapeutic Anticoagulation ◽

Impaired Quality

SummaryAtrial fibrillation is one of the most frequent reasons for therapeutic anticoagulation in everyday practice. Oral vitamin K antagonists such as Marcumar have been state of the art anticoagulants to prevent thrombembolic events in patients with atrial fibrillation and additional risk factors. But these drugs are accompanied by disadvantages such as increased bleeding risk and impaired quality of life caused by interactions with food or other medications as well as frequent controls of INRs.The new anticoagulants apixaban, rivaroxaban and dabigatran are direct antagonists of coagulation factors (FXa or FIIa) and demonstrate a promising risk/benefit profile in large clinical trials compared with vitamin K antagonists.Their approval for clinical use will open up new therapeutic perspectives for patients with atrial fibrillation and indication for anticoagulation.

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