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Essence of this Article

Since 2001, several major medical registries and non-interventional studies have been launched to assess real-world outcomes in patients with atrial fibrillation (AF). These include: The Dresden NOAC registry; GARFIELD-AF – Global Anticoagulant Registry in the FIELD; RecordAF – REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation; ORBIT-AF – Outcomes Registry for Better Informed Treatment of Atrial Fibrillation; Paul Coverdell National Acute Stroke Registry; GLORIATM-AF – GLObal RegIstry on long-term oral Anti-thrombotic treatment in patients with Atrial Fibrillation; RealiseAF – ReaL-life global survey evaluating patients with Atrial Fibrillation; PREFER in AF – PREvention oF thromboembolic events – European Registry in Atrial Fibrillation; AFNET – The Central Registry of the German Competence NETwork on Atrial Fibrillation; and XANTUS – Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation.

Atrial Fibrillation (AF)

Since 2001, several major medical registries have been launched to assess real-world outcomes in patients with AF. These registries include:

  • The Dresden NOAC registry
  • GARFIELD-AF – Global Anticoagulant Registry in the FIELD
  • RecordAF – REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation
  • ORBIT-AF – Outcomes Registry for Better Informed Treatment of Atrial Fibrillation
  • Paul Coverdell National Acute Stroke Registry
  • GLORIA-AF – GLObal RegIstry on long-term oral Anti-thrombotic treatment in patients with Atrial Fibrillation
  • RealiseAF – ReaL-life global survey evaluating patients with Atrial Fibrillation
  • PREFER in AF – PREvention oF thromboembolic events – European Registry in Atrial Fibrillation
  • AFNET – The Central Registry of the German Competence NETwork on Atrial Fibrillation
  • XANTUS – Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation

The Dresden NOAC registry

  • Objectives: to evaluate the effectiveness and safety of the novel oral anticoagulants (OACs) in routine clinical practice
  • Aims to enrol approximately 2000 patients who are initiated on a novel OACs in the administrative district of Dresden (Saxony), Germany
  • Launched in October 2011
  • Patients are enrolled by a network of >230 physicians from private practices and hospitals and are followed up by telephone visits at 30 days after enrolment and quarterly thereafter to collect data on the effectiveness, safety and management of novel OAC therapy in daily care
  • As of March 2013, the registry expanded to recruit patients continuing on vitamin K antagonist therapy for sites that had been actively recruiting patients with AF treated with novel OACs in the prior 18 months
  • As of December 2013 the registry included 2346 patients, of whom 1776 (75.7%) were treated with rivaroxaban – results in these patients suggested treatment persistence was high (with a discontinuation rate of ~15% in the first year) and that most major bleeding events were effectively managed by conventional bleeding management protocols without the need for reversal agents

For more information visit:
Dresden NOAC register: http://www.noac-register.de/index.html (site in German)
Clinicaltrials.gov record: https://clinicaltrials.gov/show/NCT01588119

Related key publications:

Beyer-Westendorf J, Gelbricht V, Förster K, et al. Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry. Eur Heart J 2014;35:1888–1896 [PubMed]

Beyer-Westendorf J, Gelbricht V, Förster K, et al. Safety of switching from vitamin K antagonists to dabigatran or rivaroxaban in daily care–results from the Dresden NOAC registry. Br J Clin Pharmacol. 2014;78:908–917 [PubMed]

Beyer-Westendorf J, Förster K, Pannach S, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood 2014; 124:955–962 [PubMed]

Beyer-Westendorf J, Förster K, Ebertz F, et al. Drug persistence with rivaroxaban therapy in atrial fibrillation patients-results from the Dresden non-interventional oral anticoagulation registry. Europace 2015; 17:530–538

Beyer-Westendorf J, Ebertz F, Förster K et al. Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost 2015; 113:1247–1257 [PubMed]

Michalski F, Tittl L, Werth S, et al. Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants. Results from the Dresden NOAC registry. Thromb Haemost 2015; doi:10.1160/TH15-02-0116 [PubMed]

Global Anticoagulant Registry in the FIELD (GARFIELD-AF)

  • Objective: to evaluate the management and outcomes of patients with newly diagnosed non-valvular AF and at least one additional risk factor for stroke. The Registry will prospectively follow patients from 50 countries worldwide for up to 6 years to assess the global burden of AF and describe “real-life” treatment patterns355
  • Aims to enrol 55,000 newly diagnosed patients with AF at over 1000 centres across Europe, Asia, Australia, Africa and the Americas
    • Sites are selected randomly, and the registry includes consecutive newly diagnosed patients receiving oral anticoagulants or other pharmacological therapy for the prevention of thromboembolic stroke, as well as patients receiving no such therapies
  • Launched in December 2009 by the Thrombosis Research Institute, a charitable research foundation based in London, the study has a planned recruitment period of 4 years with a minimum follow-up period of 2 years for each patient
  • GARFIELD-AF will record baseline demographic factors and patient medical history at screening, including type of AF, date and method of diagnosis, related symptoms, and antithrombotic treatment choice
  • Follow-up visits will update patient medical histories, record the occurrence of clinical events since the previous visit, healthcare utilization/hospitalizations, international normalized ratio measurements and values, AF treatment and stroke prophylaxis choices, outcome event type and treatment, and patient treatment satisfaction
  • Results from the first cohort of patients (N=10,614) indicated that anticoagulant prescription in real-world practice often does not follow guideline recommendations:592

    • Despite being recommended to receive anticoagulation, 38% of patients at high risk of stroke (CHADS2 ≥2) did not receive such treatment
    • Despite not being recommended to receive anticoagulation, nearly 43% of patients at low risk (CHADS2 0) received such treatment
  • Further data from 12-month follow-up will be published in the near future

For more information visit:

Thrombosis Research Institute. http://www.tri-london.ac.uk/garfield
ESC 2011 GARFIELD Webcast. http://assets.escardio.org/webcasts/default.aspx?id=ESC2011/1354
ESC 2011 GARFIELD slide presentation: http://spo.escardio.org/eslides/view.aspx?eevtid=48&fp=1354

Clinicaltrials.gov record: http://clinicaltrials.gov/ct2/show/NCT01090362

Related key publications:

Kakkar AK, Mueller I, Bassand JP et al. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One 2013;8:e63479. [PubMed].
Kakkar AK, Mueller I, Bassand JP et al. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J 2012;163:13–19.e1. [PubMed].

REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation (RecordAF)

  • Objective: to investigate how AF is managed in clinical cardiology settings around the world
  • The first international, prospective, observational registry established to assess the burden of AF
  • Launched in 2008, RecordAF was a 12-month survey (now complete) that registered 5604 patients in 532 sites across 21 countries in Europe, North America and Asia
  • Results from RecordAF showed that a rhythm-control strategy (keeping patients in sinus rhythm) was significantly more effective than a rate-control strategy
  • The benefit of rhythm control was manifested in a reduced likelihood of progression to permanent AF356, 593

Related key publications:

De Vos CB, Breithardt G, Camm AJ et al. Progression of atrial fibrillation in the REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation cohort: clinical correlates and the effect of rhythm-control therapy. Am Heart J 2012;163:887–893. [PubMed].
Camm AJ, Breithardt G, Crijns H et al. Real-life observations of clinical outcomes with rhythm- and rate-control therapies for atrial fibrillation RECORDAF (Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation). J Am Coll Cardiol 2011;58:493–501. [PubMed].
Le Heuzey JY, Breithardt G, Camm J et al. The RecordAF study: design, baseline data, and profile of patients according to chosen treatment strategy for atrial fibrillation. Am J Cardiol 2010;105:687–693. [PubMed].

Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT­AF)

  • Objective: to prospectively follow 10,000 patients with AF recruited from 167 outpatient practices in the United States (US) and perform follow-up for approximately 3 years
  • ORBIT-AF is a multicentre, prospective, ambulatory-based registry of incident and prevalent AF launched in 2009357
  • The registry will include information on:
    • The use of both antiplatelet and anticoagulant agents
    • Patient outcomes
    • Costs
    • Quality of life
  • Recently published observations from the registry included the following:

    • Although anticoagulant use was generally high, a significant proportion of outpatients with AF did not receive appropriate anticoagulation594
    • Stroke risk was a significant driver of oral anticoagulant use among those with low risk of bleeding, but use was consistently lower in those at high risk of bleeding, regardless of stroke risk595
    • Prescription of oral anticoagulation was high across all providers and was higher among cardiologists and electrophysiologists than among primary care providers596
    • Uptake of novel oral anticoagulants (dabigatran) was greatest among lower-risk patients, suggesting a cautious approach among prescribers597
    • Patients often received concomitant acetylsalicylic acid (ASA), even in the absence of a cardiovascular indication, and ASA use alongside oral anticoagulation was associated with a significantly increased risk of bleeding.598 In contrast, most eligible patients with cardiovascular comorbidities did not receive recommended medications599
  • A follow-up registry, ORBIT-AF II, has now been launched and will enrol approximately 15,000 patients with newly diagnosed AF as well as those who receive direct oral anticoagulants

For more information visit:

ORBIT-AF. https://www.orbit-af.dcri.duke.edu/

Clinicaltrials.gov record: http://clinicaltrials.gov/ct2/results?term=orbit-af&Search=Search

Related key publications:

Steinberg BA, Holmes DN, Piccini JP et al. Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. J Am Heart Assoc 2013;2:e000535. [PubMed]
Fosbol EL, Holmes DN, Piccini JP et al. Provider specialty and atrial fibrillation treatment strategies in United States community practice: findings from the ORBIT-AF registry. J Am Heart Assoc 2013;2:e000110. [PubMed]
Steinberg BA, Kim S, Piccini JP et al. Use and associated risks of concomitant aspirin therapy with oral anticoagulation in patients with atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Circulation 2013;128:721–728. [PubMed]
Hess PL, Kim S, Piccini JP et al. Use of evidence-based cardiac prevention therapy among outpatients with atrial fibrillation. Am J Med 2013;126:625–632.e1. [PubMed]
Cullen MW, Kim S, Piccini JP Sr et al. Risks and benefits of anticoagulation in atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Circ Cardiovasc Qual Outcomes 2013;6:461–469. [PubMed]
Steinberg BA, Holmes DN, Ezekowitz MD et al. Rate versus rhythm control for management of atrial fibrillation in clinical practice: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J 2013;165:622–629. [PubMed]
Piccini JP, Fraulo ES, Ansell JE et al. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J 2011;162:606–612.e1. [PubMed]

Paul Coverdell National Acute Stroke Registry

  • Objectives:
    • To measure, track and improve the quality of care and access to care in patients hospitalized with acute stroke, from onset of stroke symptoms, through rehabilitation and recovery
    • Promote better future outcomes by supporting secondary prevention
  • Created at the instruction of the US Congress in 2001
  • Funded through to 2012, the registry involves 195 hospitals and over 56,000 patients who have experienced a stroke
  • Registry data have already identified gaps between guideline recommendations and hospital practice for the care of patients presenting with acute stroke
  • However, substantial improvements in dysphagia screening, lipid testing, smoking cessation counselling and antithrombotic therapy being prescribed at discharge have been observed since the registry’s inception358

For more information visit:

Centers for Disease Control and Prevention http://www.cdc.gov/dhdsp/programs/stroke_registry.htm

Related key publications:

Centers for Disease Control and Prevention. 2009. Available at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5807a1.htm. Accessed 18 July 2012.
Centers for Disease Control and Prevention (CDC). Use of a registry to improve acute stroke care–seven states, 2005-2009. MMWR Morb Mortal Wkly Rep 2011;60:206–210. [PubMed].
Reeves MJ, Gargano J, Maier KS et al. Patient-level and hospital-level determinants of the quality of acute stroke care: a multilevel modeling approach. Stroke 2010;41:2924–2931. [PubMed].
George MG, Tong X, McGruder H et al. Paul Coverdell National Acute Stroke Registry Surveillance – four states, 2005–2007. MMWR Surveill Summ 2009;58:1–23. [PubMed].

GLObal RegIstry on long-term oral Anti-thrombotic treatment in patients with Atrial Fibrillation (GLORIATM-AF)

  • Objectives: to collect real-world data in patients with non-valvular AF at risk of stroke on important outcome events, including:
    • The safety and effectiveness of antithrombotic treatments, including the vitamin K antagonist warfarin, ASA and novel oral anticoagulants
    • MI
    • Life-threatening bleeding events
    • Stroke
    • All-cause death
  • Recently established (2011), the GLORIA-AF registry is planned to involve 2200 sites in 50 countries
  • Approximately 56,000 patients will be characterized by:
    • Age
    • Gender
    • Antithrombotic treatment choice at baseline
    • CHADS2, CHA2DS2-VASc and HAS-BLED scores

For more information visit:

Boehringer Ingelheim. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/20_april_2012_dabigatranetexilate.html

The Internet Stroke Center. http://www.strokecenter.org/trials/clinicalstudies/gloria-af-registry-program-second-and-third-phases

Clinicaltrials.gov record. GLORIA-AF phase I. http://clinicaltrials.gov/ct2/show/NCT01428765

Clinicaltrials.gov record. GLORIA-AF phases II and III. http://clinicaltrials.gov/ct2/show/NCT01468701

Real-life global survey evaluating patients with Atrial Fibrillation (RealiseAF)

  • Objective: to determine AF rhythm control strategies
  • Launched in 2009
  • Contains data from >10,000 patients with AF across 26 countries359
  • Assesses:
    • AF management strategies
    • Cardiovascular risk profiles of enrolled patients
  • Will also contains details of:
    • Demographic factors, including risk factors for cardiovascular events
    • Cardiovascular and bleeding event rates
    • Anticoagulant and antithrombotic therapy prescription rates stratified by CHADS2 stroke risk scores
    • AF guidelines compliance
  • Initial data suggests that:
    • Rate, rather than rhythm control, is the most frequently chosen therapeutic strategy (approximately 60% vs 40%); rhythm control was shown to be the most effective,359 but, regardless of method, AF control in the real-world setting is suboptimal600, 601
    • Substantial proportions of patients with controlled AF have symptoms, regardless of rate or rhythm control strategy602
    • Prescriptions of antiarrhythmic drugs for AF and antithrombotic therapy for ischaemic stroke prophylaxis in the real world deviate from guideline recommendations359, 603
    • Patients with AF and heart failure, particularly those with low ejection fraction, have a heavy burden of symptoms and hospitalization, and often have low rates of AF control604

For more information visit:

ESC. http://spo.escardio.org/eslides/view.aspx?eevtid=40&fp=5081

Related key publications:

Murin J, Naditch-Brûlé L, Brette S et al. Clinical characteristics, management, and control of permanent vs. nonpermanent atrial fibrillation: insights from the RealiseAF survey. PLoS One 2014;9:e86443. [PubMed]
Silva-Cardoso J, Zharinov OJ, Ponikowski P et al. Heart failure in patients with atrial fibrillation is associated with a high symptom and hospitalization burden: the RealiseAF survey. Clin Cardiol 2013;36:766–774. [PubMed]
Chiang CE, Goethals M, O'Neill JO et al. Inappropriate use of antiarrhythmic drugs in paroxysmal and persistent atrial fibrillation in a large contemporary international survey: insights from RealiseAF. Europace 2013;15:1733–1740. [PubMed]
Chiang CE, Naditch-Brûlé L, Murin J et al. 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. Circ Arrhythm Electrophysiol 2012;5:632–639. [PubMed]
Steg PG, Alam S, Chiang CE et al. Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry. Heart 2012;98:195–201. [PubMed]
Alam M, Bandeali SJ, Shahzad SA et al. Real-life global survey evaluating patients with atrial fibrillation (REALISE-AF): results of an international observational registry. Expert Rev Cardiovasc Ther 2012;10:283–291. [PubMed]

PREvention oF thromboembolic events – European Registry in Atrial Fibrillation (PREFER in AF)

  • Objectives are to assess:
    • Leading causes of stroke
    • The impact of new anticoagulant therapies for stroke prevention in patients with AF
    • Patient satisfaction with their AF management regimens
    • The impact of AF and its management on patient quality of life
    • The health economic burden of AF in Europe
  • PREFER in AF is a multi-centre, prospective registry with a one-year follow-up
  • Launched in January 2012, it will collect real-life data from 5000 patients with AF across seven countries

For more information visit:

Bloomberg. http://www.bloomberg.com/article/2012-01-16/ah4LusaQPPIc.html

The Central Registry of the German Competence NETwork on Atrial Fibrillation (AFNET) registry

  • Objectives: to establish a nationwide patient registry on diagnostics, therapy, course and complications of AF in Germany
  • AFNET is a national interdisciplinary research network funded by the German Federal Government
  • The registry incorporated 9577 patients who were enrolled between 2004 and 2006 at 191 sites (either at tertiary care centres, district hospitals, by office-based cardiologists or by general practitioners/internists)
  • Key results included:
    • Per guideline recommendations, younger patients and patients with non-permanent AF were more likely to receive rhythm control therapy than older patients and patients with permanent AF360
    • Despite stroke risk being similar across all centre types, enrolment at a tertiary care centre or an office-based cardiologist was associated with a significantly increased chance of receiving adequate thromboprophylaxis compared with other centre types360
  • This difference was consistent irrespective of the stroke risk of the patient, as determined by both CHADS2 and CHA2DS2-VASc scores360
  • Notably, anticoagulant therapy for stroke prevention was given to:361
    • 71.4% of the patients considered eligible by applicable guidelines
    • 48.4% of patients with low risk where guidelines do not recommend anticoagulation

For more information visit:

Kompetenznetz Vorhofflimmern. http://www.kompetenznetz-vorhofflimmern.de/ [Website in German]

Related key publications:

Kirchhof P, Nabauer M, Gerth A et al. Impact of the type of centre on management of AF patients: surprising evidence for differences in antithrombotic therapy decisions. Thromb Haemost 2011;105:1010–1023. [PubMed].
Nabauer M, Gerth A, Limbourg T et al. The registry of the German Competence NETwork on Atrial Fibrillation: patient characteristics and initial management. Europace 2009;11:423–434. [PDF].

Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (XANTUS)

  • Objectives: prospective, international, observational phase IV clinical study to investigate outcomes in patients with non-valvular AF who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism
  • Investigators decide on dose and duration of treatment605
  • 6834 patients were enrolled, and the study completed in March 2015
  • Similar studies are being conducted in Latin America and the Asia-Pacific region

For more information visit:

Clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01606995

Related key publications:
Camm AJ, Amarenco P, Haas S et al. XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag 2014;10:425–434. [PubMed].


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