Stroke and systemic embolism prevention in patients with atrial fibrillation in Belgium: comparative cost effectiveness of new oral anticoagulants and warfarin.

BACKGROUND AND OBJECTIVE: Management of non-valvular atrial fibrillation (NVAF) focuses on the use of anticoagulation to mitigate the risk of stroke. Until recently, vitamin K antagonist (VKA) treatment was considered the standard of care, with the emergence of non-VKA oral anticoagulants (NOACs) shifting treatment practice. The objective of this study was therefore to assess the use of warfarin and the NOACs for stroke prevention in patients with NVAF from the perspective of a Belgian healthcare payer using a cost-effectiveness analysis and the efficiency frontier approach. METHODS: A previously published Markov model was adapted to the Belgian healthcare setting. Clinical events modelled include ischaemic and haemorrhagic stroke, systemic embolism, intracranial haemorrhage, other major bleeding, clinically relevant non-major bleeding, myocardial infarction, cardiovascular hospitalisation and treatment discontinuations. Efficacy and bleeding data for warfarin and apixaban 5 mg twice daily were obtained from the ARISTOTLE trial, whilst those for other NOACs (rivaroxaban 20 mg once daily, dabigatran 110 mg twice daily, dabigatran 150 mg twice daily) were from published indirect comparisons. Acute medical costs were obtained from reimbursement payments made to Belgian hospitals, whilst long-term medical costs and utility data were derived from the literature. The efficiency frontier was calculated using total costs and quality-adjusted life-years (QALYs) as outcomes. Univariate and probabilistic sensitivity analyses were performed. RESULTS: Warfarin and apixaban were the two optimal treatment choices, as the other three treatment alternatives including dabigatran 110 mg, dabigatran 150 mg switching to dabigatran 110 mg at the age of 80 years and rivaroxaban were extendedly or strictly dominated on the efficiency frontier. Apixaban was a cost-effective alternative vs warfarin at an incremental cost-effectiveness ratio of 7,212/QALY gained. CONCLUSIONS: Amongst NOACs, apixaban may be the most economically efficient alternative to warfarin in NVAF patients who are suitable for VKA treatment and eligible for stroke prevention in Belgium.

Cost-effectiveness of rivaroxaban versus warfarin for stroke prevention in atrial fibrillation in the Belgian healthcare setting.

BACKGROUND: Warfarin, an inexpensive drug that has been available for over half a century, has been the mainstay of anticoagulant therapy for stroke prevention in patients with atrial fibrillation (AF). Recently, rivaroxaban, a novel oral anticoagulant (NOAC) which offers some distinct advantages over warfarin, the standard of care in a world without NOACs, has been introduced and is now recommended by international guidelines. OBJECTIVE: The aim of this study was to evaluate, from a Belgian healthcare payer perspective, the cost-effectiveness of rivaroxaban versus use of warfarin for the treatment of patients with non-valvular AF at moderate to high risk. METHODS: A Markov model was designed and populated with local cost estimates, safety-on-treatment clinical results from the pivotal phase III ROCKET AF trial and utility values obtained from the literature. RESULTS: Rivaroxaban treatment was associated with fewer ischemic strokes and systemic embolisms (0.308 vs. 0.321 events), intracranial bleeds (0.048 vs. 0.063), and myocardial infarctions (0.082 vs. 0.095) per patient compared with warfarin. Over a lifetime time horizon, rivaroxaban led to a reduction of 0.042 life-threatening events per patient, and increases of 0.111 life-years and 0.094 quality-adjusted life-years (QALYs) versus warfarin treatment. This resulted in an incremental cost-effectiveness ratio of €8,809 per QALY or €7,493 per life-year gained. These results are based on valuated data from 2010. Sensitivity analysis indicated that these results were robust and that rivaroxaban is cost-effective compared with warfarin in 87 % of cases should a willingness-to-pay threshold of €35,000/QALY gained be considered. CONCLUSIONS: The present analysis suggests that rivaroxaban is a cost-effective alternative to warfarin therapy for the prevention of stroke in patients with AF in the Belgian healthcare setting.

Inappropriate use of antiarrhythmic drugs in paroxysmal and persistent atrial fibrillation in a large contemporary international survey: insights from RealiseAF.

AIMS: International atrial fibrillation (AF) guidelines have defined optimal drugs for patients with various underlying diseases, but the extent to which real-life practice complies with these guidelines is unknown. This study aimed to evaluate the appropriate use of antiarrhythmic drugs (AADs) in patients with paroxysmal and persistent AF from the RealiseAF survey, according to the 2006 American College of Cardiology/American Heart Association/European Society of Cardiology AF guidelines. METHODS AND RESULTS: RealiseAF was an international cross-sectional, observational survey of 10 523 eligible patients from 26 countries on 4 continents, with ≥1 AF episode documented by standard electrocardiogram or by Holter monitoring in the last 12 months. Participating physicians were randomly selected during 2009-10 from lists of office-based or hospital-based cardiologists and internists. Overall, 4947 patients with paroxysmal (n = 2606) or persistent AF (n = 2341) were included; mean (standard deviation) age was 64.7 (12.4) and 66.0 (11.8) years, respectively. Class Ic drugs were prescribed in 589 patients (11.9%); however, in 20.0% of these patients, the indication was not consistent with published guidelines. Similarly, for the 219 patients prescribed sotalol (4.4%), 16.0% received treatment for an indication that deviated from the published guidelines. Amiodarone was prescribed as first-line therapy in 1268 patients (25.6%), but 49.9% of these did not have heart failure or hypertension with significant left ventricular hypertrophy. CONCLUSION: The use of AADs for persistent or paroxysmal AF in this large contemporary international survey showed some deviations from international guidelines. The highest discordance came with the use of amiodarone in first line. Clearly, there is a large discrepancy between published guidelines and current practice.

Prevalence of atrial fibrillation in adults participating in a large-scale voluntary screening programme in Belgium.

OBJECTIVE: Atrial fibrillation (AF) is a common arrhythmia in clinical practice. AF fulfils many of the criteria for a screening programme. No data about the prevalence of AF in non-hospitalized patients are available in Belgium. The aim of the study was to assess feasibility and effectiveness of a nationwide-organized voluntary screening programme in the general population in Belgium. METHODS: A total of 13.564 participants were screened, of whom 10,758 were older than 40 years (GSP group). Participants filled in stroke risk stratification questionnaires (CHADS2 and CHA2DS2-VASc). A one-lead electrocardiogram was performed. RESULTS: 228 participants had AF at the time of screening (AF group), with 125 women and 103 men (i.e., 1.9% and 2.6% of total women and men), representing a prevalence of 2.2% (95% CI 1.3% and 3.0%) of the screened population. Age of the AF group was 67 +/- 12 y (range 40-87 y). Using the CHADS2-score, 58% of participants with a positive AF screening had a high risk score, and 21% had an intermediate risk score. Using the CHA2DS2-VASc-score, 72% of the participants had a high risk score, and 21% had an intermediate risk score. CONCLUSION: AF was present in 2.2% of the respondents. At least 60% of AF group had an increased risk for thrombo-embolism. Although substantial methodological issues limit the exact interpretation of these results, the present study shows that a volunatry screening programme with a simple screening protocol is able to detect an important number of patients with previously undetected AF.

Distribution and risk profile of paroxysmal, persistent, and permanent atrial fibrillation in routine clinical practice: insight from the real-life global survey evaluating patients with atrial fibrillation international registry.

BACKGROUND: There is a paucity of international data on the various types of atrial fibrillation (AF) outside the highly selected populations from randomized trials. This study aimed to describe patient characteristics, risk factors, comorbidities, symptoms, management strategy, and control of different types of AF in real-life practice. METHODS AND RESULTS: Real-life global survey evaluating patients with atrial fibrillation (RealiseAF) was a contemporary, large-scale, cross-sectional international survey of patients with AF who had ≥1 episode in the past 12 months. Investigators were randomly selected to avoid bias. Among 9816 eligible patients from 831 sites in 26 countries, 2606 (26.5%) had paroxysmal, 2341 (23.8%) had persistent, and 4869 (49.6%) had permanent AF. As AF progressed from paroxysmal to persistent and permanent forms, the prevalence of comorbidities, such as heart failure (32.9%, 44.3%, and 55.6%), coronary artery disease (30.0%, 32.9%, and 34.3%), cerebrovascular disease (11.7%, 10.8%, and 17.6%), and valvular disease (16.7%, 21.2%, and 35.8%), increased, and the prevalence of lone AF decreased. Similarly, there was an increase in mean CHADS(2) [cardiac failure, hypertension, age, diabetes, stroke (doubled)] score (1.7, 1.8, and 2.2), and more than half of patients (51.0%, 56.7%, and 67.3%) qualified for oral anticoagulants. Almost 90% of patients received ≥1 antiarrhythmic drug, but >60% had European Heart Rhythm Association symptom scores from II to IV. Furthermore, 40.7% of persistent and 49.8% of permanent AF patients were still in AF with a heart rate >80 beats per minute. CONCLUSIONS: This survey disclosed high cardiovascular risks and an unmet need in daily practice for patients with any type of AF, especially those with the permanent form.

Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry.

BACKGROUND: Rate control and rhythm control are accepted management strategies for atrial fibrillation (AF). OBJECTIVE: RealiseAF aimed to describe the success of either strategy and the impact of control on symptomatic status of patients with AF. METHODS: This international, observational, cross-sectional survey of patients with any history of AF in the previous year, recorded AF characteristics, management and frequency of control (defined as sinus rhythm or AF with resting heart rate ≤80 bpm). RESULTS: Overall, 9665 patients were evaluable for AF control, with 59.0% controlled (sinus rhythm 26.5%, AF ≤80 bpm 32.5%) and 41.0% uncontrolled. Symptom prevalence in the previous week was lower in controlled than uncontrolled AF (55.7% vs 68.4%; p<0.001) and similar for patients in sinus rhythm versus AF ≤80 bpm (54.8% vs 56.4%; p=0.23). At the visit, AF-related functional impairment (EHRA class >I) was seen in 67.4% of patients with controlled AF and 82.1% of patients with uncontrolled AF (p<0.001). Quality-of-life (QoL, measured using EQ-5D) was better for patients with controlled versus uncontrolled AF using the Visual Analogue Scale (mean (SD) score 67.1 (18.4) vs 63.2 (18.9); p<0.001), single index utility score (median 0.78 vs 0.73; p<0.001), or five dimensions of well-being (all p<0.001). Irrespective of AF control, cardiovascular events had led to hospitalisation in the past year in 28.1%. CONCLUSION: AF control is not optimal. Control appears to be associated with fewer symptoms and better QoL, but even patients with controlled AF have frequent symptoms, functional impairment, altered QoL and cardiovascular events. New treatments are needed to improve control and minimise the functional and QoL burden of AF.

Amiodarone and polymorphic ventricular tachycardia: to slow down or to accelerate the underlying rhythm?

Polymorphic ventricular tachycardia (VT) comprises a variety of different subforms. Two patients were admitted to our hospital and developed polymorphic VT under treatment with amiodarone. However, each of them turned out to have a very different form of the arrhythmia and therefore required a different therapeutic approach. The clinical decision-making required a distinction between the two forms, and the following therapeutic approach included terminating the administration of amiodarone in the first case and continuing administration in the other case. As the most common forms of polymorphic VT are described, it becomes clear that each different form should be identified because of the important therapeutic implications. In particular, the role of amiodarone can be quite different in the management of these different forms of polymorphic VT.

Internal cardioversion: a worthwhile alternative after failed external cardioversion in obese patients.

Transthoracic external cardioversion is, if carried out properly, a highly effective cardioversion modality for most patients with atrial fibrillation. Failure to return to sinus rhythm (even for one or two beats) can be related to high transthoracic impedance. Internal cardioversion may offer a safe and worthwhile alternative for these patients, in need of sinus rhythm. This technique, mostly requiring only mild sedation, is actually performed in many electrophysiology centers. Because recurrence rates of atrial fibrillation seem to be the same for both methods, this invasive technique should be considered in patients with a rather low chance of atrial fibrillation recurrences. We present a case report of an extremely obese woman, resistant to external cardioversion. She successfully underwent internal low-energy cardioversion.