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AF Real-World Studies

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Real World Evidence and Claims Databases – a Guide for Healthcare Professionals
Prof. Craig I. Coleman gives an appreciation of the methodology used to perform Real World Evidence studies, particularly those investigating the effectiveness and safety, of non-vitamin K antagonist oral anticoagulants (or NOACs) in non-valvular atrial fibrillation patients. He also provides some key insights on what real world evidence and specifically claims databases can - and cannot - tell us.
Approval Number PP-XAR-ALL-0036-2

  • Objectives: to evaluate the effectiveness and safety of the NOACs in routine clinical practice
  • Enrolment: patients who are initiated on NOAC therapy in the administrative district of Dresden (Saxony), Germany
  • Launched in October 2011
  • Ongoing registry currently includes more than 2700 patients on NOAC therapy in daily care
  • Patients are followed up by telephone visits at 30 days after enrolment and quarterly thereafter to collect data on the effectiveness, safety and management of NOAC therapy in daily care
  • In March 2013, the registry expanded to recruit patients continuing with VKA therapy for sites that had been actively recruiting patients with AF treated with NOACs in the prior 18 months
  • Key findings
    • The effectiveness and relative safety of rivaroxaban was confirmed in daily-care patients, with considerably lower discontinuation rates than VKA users1,2
    • The effectiveness and relative safety of dabigatran was confirmed in daily-care patients, although discontinuation rates were not lower than those reported with VKAs3
    • The effectiveness and relative safety of apixaban was confirmed in daily-care patients, with considerably lower discontinuation rates than VKA users4
    • The risk of major bleeding with VKAs was 4.15 per 100 patient-years (95% confidence interval 2.60–6.29) with a case–fatality rate of 16.3%5

 

For more information visit:

Dresden NOAC Registry (site in German): (Accessed 9 November 2020)

Clinicaltrials.gov (Accessed 9 November 2020)

 

Related key publications:
Helmert S, Marten S, Mizera H et al. Effectiveness and safety of apixaban therapy in dailycare patients with atrial fibrillation: results from the Dresden NOAC Registry. J Thromb Thrombolysis 2017;44:169–178.

Hecker J, Marten S, Keller L et al. Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost 2016;115:939–949.

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.

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.

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;114:1076–1084.

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.

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.

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.

 

  • Objective: to evaluate the management and outcomes of patients with newly diagnosed non-valvular AF and at least one additional risk factor for stroke
  • GARFIELD-AF prospectively followed patients from 35 countries worldwide for up to 6 years to assess the global burden of AF and describe “real-life” treatment patterns6,7
  • Enrolled over 55,000 newly diagnosed patients with AF at over 1000 centres across Europe, Asia, Australia, Africa and the Americas (sites were selected at random)
  • GARFIELD-AF included consecutive newly diagnosed patients receiving an oral anticoagulant (OAC) 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, GARFIELD-AF completed patient enrolment in August 2016. The study had a minimum follow-up period of 2 years for each patient
  • GARFIELD-AF recorded 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 aimed to update patient medical histories, record the occurrence of clinical events since the previous visit, healthcare utilization/hospitalizations, INR 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:8
    • Despite being recommended to receive anticoagulation, 38% of patients at high risk of stroke (CHADS2 score ≥2) did not receive such treatment
    • Despite not being recommended to receive anticoagulation, nearly 43% of patients at low risk (CHADS2 score 0) received such treatment
  • Outcomes at 2-year follow-up in 17,162 patients showed that event rates of all-cause mortality, stroke/systemic embolism (SE) and major bleeding were highest in the 4 months after diagnosis9
    • Death was the most frequent of the three outcomes, and because its most common causes are not influenced by anticoagulation, this suggested a need for AF management approaches that include the targeting of modifiable, cause-specific factors for mortality
  • Two-year follow-up data from the first three cohorts (N=28,628) indicated that a range of variables, including age, vascular disease, chronic kidney disease and congestive heart failure, are associated with increased risk of one or more of death, stroke/SE or major bleeding10
    • In addition to anticoagulation, improved implementation of guideline-recommended therapies for co-morbidities (particularly vascular disease, chronic kidney disease and congestive heart failure) that are strongly associated with outcomes should form part of a comprehensive management strategy in patients with AF
  • Analyses of changes in antithrombotic treatment patterns across four sequential cohorts (N=39,670) showed an increase in newly diagnosed patients with AF at risk of stroke receiving guideline-recommended therapy, mainly because of an increased use of NOACs and a reduction in the use of VKAs (with or without antiplatelets) or antiplatelets alone11

For more information visit:

Thrombosis Research Institute (Accessed 9 November 2020)

Clinicaltrials.gov (Accessed 9 November 2020)

 

Related key publications:
Bassand JP, Accetta G, Al Mahmeed W et al. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PLoS One 2018;13:e0191592.

Fox KAA, Accetta G, Pieper KS et al. Why are outcomes different for registry patients enrolled prospectively and retrospectively? Insights from the global anticoagulant registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). Eur Heart J Qual Care Clin Outcomes 2018;4:27–35.

Verheugt FWA, Gao H, Al Mahmeed W et al. Characteristics of patients with atrial fibrillation prescribed antiplatelet monotherapy compared with those on anticoagulants: insights from the GARFIELD-AF registry. Eur Heart J 2018;39:464–473.

Camm AJ, Accetta G, Al Mahmeed W et al. Impact of gender on event rates at 1 year in patients with newly diagnosed non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF registry. BMJ Open 2017;7:e014579.

Fox KAA, Gersh BJ, Traore S et al. Evolving quality standards for large-scale registries: the GARFIELD-AF experience. Eur Heart J Qual Care Clin Outcomes 2017;3:114–122.

Fitzmaurice DA, Accetta G, Haas S et al. Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists. Br J Haematol 2016;174:610–623.

Haas S, Ten Cate H, Accetta G et al. Quality of vitamin K antagonist control and 1-year outcomes in patients with atrial fibrillation: a global perspective from the GARFIELD-AF registry. PLoS One 2016;11:e0164076.

Stępińska J, Kremis E, Konopka A et al. Stroke prevention in atrial fibrillation patients in Poland and other European countries: insights from the GARFIELD-AF registry. Kardiol Pol 2016;74:362–371.

Lip GYH, Rushton-Smith SK, Goldhaber SZ et al. Does sex affect anticoagulant use for stroke prevention in nonvalvular atrial fibrillation? The prospective global anticoagulant registry in the FIELD-Atrial Fibrillation. Circ Cardiovasc Qual Outcomes 2015;8:S12–S20.

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.

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.

 

  • Objective: to investigate how AF is managed in clinical cardiology settings around the world
  • RecordAF (launched in 2008) was the first international, prospective, observational registry established to assess the burden of AF
  • A total of 5814 patients with AF were registered, and 5604 were eligible for evaluation 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 in reducing the likelihood of progression to permanent AF12-14
    • However, there are regional inconsistencies in AF management, with the rhythmcontrol approach being more prevalent in Europe compared with North America, and a significant discrepancy in OAC use in Eastern Europe versus Western Europe and North America15

 

Related key publications:
Darrat YH, Shah J, Elayi CS et al. Regional lack of consistency in the management of atrial fibrillation (from the RECORD-AF trial). Am J Cardiol 2017;119:47–51.

Ha AC, Breithardt G, Camm AJ et al. Health-related quality of life in patients with atrial fibrillation treated with rhythm control versus rate control: insights from a prospective international registry (Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation: RECORD-AF). Circ Cardiovasc Qual Outcomes 2014;7:896–904.

Opolski G, Kosior DA, Kurzelewski M et al. One-year follow-up of the Polish subset of the RecordAF registry of patients with newly diagnosed atrial fibrillation. Pol Arch Med Wewn 2013;123:238–245.

Zhang YY, Qiu C, Davis PJ et al. Predictors of progression of recently diagnosed atrial fibrillation in REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation (RecordAF)-United States cohort. Am J Cardiol 2013;112:79–84.

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.

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.

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.

 

  • Objective: to prospectively follow 10,000 patients with AF recruited from 167 outpatient practices in the US and perform follow-up for approximately 3 years
  • ORBIT-AF (launched in 2010) is a multicentre, prospective, ambulatory-based registry of the incidence and prevalence of AF16
  • The registry includes information on:
    • Use of antiplatelet and anticoagulant agents
    • Patient outcomes
    • Costs
    • Quality of life
  • Published observations from the registry:
    • Although anticoagulant use was generally high, a significant proportion of outpatients with AF did not receive appropriate anticoagulation17-19
    • Stroke risk was a significant driver of OAC use among those with a low risk of bleeding, but use was consistently lower in patients at high risk of bleeding, regardless of stroke risk20
    • Prescription of OACs was high across all providers, particularly among cardiologists and electrophysiologists21
    • Uptake of NOACs was greatest among lower-risk patients, suggesting a cautious approach among prescribers22
    • Patients often received concomitant ASA, even in the absence of a cardiovascular indication, and ASA use alongside an OAC was associated with a significantly increased risk of bleeding23
      • In contrast, most eligible patients with cardiovascular co-morbidities did not receive recommended medications24
      • Contraindications to OAC therapy among patients with AF were common but many patients with reported contraindications were receiving OAC, suggesting that the perceived benefit outweighed the potential harm posed by the relative contraindication25
      • Many patients with reported contraindications were receiving OACs, suggesting that the perceived benefit outweighed the potential harm posed by the relative contraindication
    • Patients with a family history of AF developed AF at a younger age, had fewer co-morbidities and were more symptomatic26
    • Relative to white and Hispanic patients, black patients with AF had more symptoms, were less likely to receive rhythm-control interventions and had lower quality of warfarin management27
    • Nuisance bleeding is common in OAC-treated patients with AF but does not increase the risks of major bleeding or stroke/SE, which suggests that changing the OAC treatment strategy is not necessary for nuisance bleeding events29
      • Nearly one-third of patients (31.6%) discontinued OAC therapy after a major bleeding event, 12.7% after a clinically relevant non-major bleeding event and 4.5% after a nuisance bleeding event29
    • In patients with AF in community practice, significant valvular heart disease (VHD) is common; those with moderate-to-severe biological VHD have more co-morbidities and elevated mortality risk versus patients without VHD. Stroke and major bleeding rates are similar regardless of the presence of VHD30
    • Patients with AF and diabetes had more severe AF symptoms, reduced quality of life, and increased mortality and hospitalizations, but not thromboembolic or bleeding events, versus those without diabetes31
    • Up to one-quarter of patients with AF have cancer. Antithrombotic treatment, rates of cerebrovascular accident, other thrombotic events and cardiac death were similar between patients with or without a history of cancer; those with cancer had a higher risk of major bleeding and non-cardiovascular (CV) death than those without32
    • Anticoagulation management strategies vary in patients with AF undergoing cardiac implantable electronic device implantation. OAC therapy is interrupted in >50% of warfarin- and NOAC-treated patients. Bleeding and stroke rates were low with both treatments33
    • Incident heart failure (HF) is common in patients with AF, is more likely to be HF with preserved ejection fraction and is associated with poor long-term outcomes. Traditional HF risk factors, AF type and baseline heart rate are independent clinical predictors of incident HF34
      • HF increased the risk of death and hospitalization and reduced quality of life, but it did not increase rates of thromboembolism regardless of left ventricular ejection fraction in those with AF35
    • Patients with AF who underwent cardioversion did not experience improvement in AFrelated quality of life or less progression. Adjunctive rhythm control therapies are not prescribed in many patients who undergo cardioversion36
    • Quality of life in patients with AF shows wide variation. Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnoea, symptomatic HF, chronic obstructive pulmonary disease and coronary artery disease were all independently associated with reductions in quality of life in patients with AF37
    • Physician risk assessments had a graded relationship with outcomes; discrimination was moderate with both physician-based and empirical risk scores. Empirical scores yielded valuable risk stratification information (with or without physician judgment), but physician assessment added little to existing scores38
  • Compared with men with AF, women with AF have more symptoms and worse quality of life. Despite increased risk levels, women have lower risk-adjusted all-cause and CV death, but higher stroke rates, than male patients39
  • A follow-up registry, ORBIT-AF II enrolled approximately 13,785 patients with newly diagnosed AF, including those who received NOACs40
    • Patients were followed for up to 2 years, including clinical status, outcomes (major adverse cardiovascular events, bleeding) and management of anticoagulation surrounding bleeding events
    • Warfarin and NOAC-treated patients had similar major bleeding rates, but NOACrelated bleeding eventss required less blood product administration and rarely required factor replacement
    • Approximately 13% of those treated with NOACs received doses inconsistent with the product label (9.4% were under-dosed and 3.4% were over-dosed), which was associated with increased risks of adverse events41
    • In patients who received NOACs, most dose reductions were not concordant with US Food and Drug Administration guidelines42
    • A combined analysis of the ORBIT-AF, ORBIT-AF II and GARFIELD-AF studies demonstrated that use of NOACs has increased over time with a corresponding decrease in antiplatelet monotherapy in patients with new-onset AF43
      • Low-risk patients frequently received anticoagulation, but its use was inconsistent in those at high risk of stroke
      • Additionally, there was considerable geographic variation in anticoagulation treatment

 

For more information visit:

ORBIT-AF I Clinicaltrials.gov record (Accessed 9 November 2020)

ORBIT-AF II Clinicaltrials.gov record (Accessed 9 November 2020)

 

Related key publications:
O'Brien EC, Holmes DN, Thomas LE et al. Prognostic significance of nuisance bleeding in anticoagulated patients with atrial fibrillation. Circulation 2018: doi:10.1161/CIRCULATIONAHA.117.031354.

O'Brien EC, Holmes DN, Thomas L et al. Therapeutic strategies following major, clinically relevant nonmajor, and nuisance bleeding in atrial fibrillation: findings from ORBIT-AF. J Am Heart Assoc 2018;7:e006391.

Steinberg BA, Shrader P, Pieper K et al. Frequency and outcomes of reduced dose nonvitamin k antagonist anticoagulants: results from ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II). J Am Heart Assoc 2018;7:e007633.

Barnett AS, Kim S, Fonarow GC et al. Treatment of atrial fibrillation and concordance with the American Heart Association/American College of Cardiology/Heart Rhythm Society Guidelines: findings from ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation). Circ Arrhythm Electrophysiol 2017;10:e005051.

Black-Maier, Kim S, Steinberg BA et al. Oral anticoagulation management in patients with atrial fibrillation undergoing cardiac implantable electronic device implantation. Clin Cardiol 2017;40:746–751.

Cherian TS, Shrader P, Fonarow GC et al. Effect of atrial fibrillation on mortality, stroke risk, and quality-of-life scores in patients with heart failure (from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF]). Am J Cardiol 2017;119:1763–1769.

Echouffo-Tcheugui JB, Shrader P, Thomas L et al. Care patterns and outcomes in atrial fibrillation patients with and without diabetes: ORBIT-AF registry. J Am Coll Cardiol 2017;70:1325–1335.

Hess PL, Kim S, Fonarow GC et al. Absence of oral anticoagulation and subsequent outcomes among outpatients with atrial fibrillation. Am J Med 2017;130:449–456.

Melloni C, Shrader P, Carver J et al. Management and outcomes of patients with atrial fibrillation and a history of cancer: the ORBIT-AF registry. Eur Heart J Qual Care Clin Outcomes 2017;3:192–197.

Pandey A, Kim S, Moore C et al. Predictors and prognostic implications of incident heart failure in patients with prevalent atrial fibrillation. JACC Heart Fail 2017;5:44–52.

Pokorney SD, Kim S, Thomas L et al. Cardioversion and subsequent quality of life and natural history of atrial fibrillation. Am Heart J 2017;185:59–66.

Steinberg BA, Gao H, Shrader P et al. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J 2017;194:132–140.

Steinberg BA, Shrader P, Thomas L et al. Factors associated with non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). Am Heart J 2017;189:40–47.

Steinberg BA, Simon DN, Thomas L et al. Management of major bleeding in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants compared with warfarin in clinical practice (from phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]). Am J Cardiol 2017;119:1590–1595.

Thomas KL, Jackson LR 2nd, Shrader P et al. Prevalence, characteristics, and outcomes of valvular heart disease in patients with atrial fibrillation: insights from the ORBIT-AF (Outcomes Registry for Better Informed Treatment for Atrial Fibrillation). J Am Heart Assoc 2017;6:e006475.

Golwala H, Jackson LR 2nd, Simon DN et al. Racial/ethnic differences in atrial fibrillation symptoms, treatment patterns, and outcomes: insights from Outcomes Registry for Better Informed Treatment for Atrial Fibrillation registry. Am Heart J 2016;174:29–36.

Gundlund A, Fosbøl EL, Kim S et al. Family history of atrial fibrillation is associated with earlier-onset and more symptomatic atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J 2016;175:28–35.

Piccini JP, Simon DN, Steinberg BA et al. Differences in clinical and functional outcomes of atrial fibrillation in women and men: two-year results from the ORBIT-AF registry. JAMA Cardiol 2016;1:282–291.

Randolph TC, Simon DN, Thomas L et al. Patient factors associated with quality of life in atrial fibrillation. Am Heart J 2016;182:135–143.

Steinberg BA, Shrader P, Kim S et al. How well does physician risk assessment predict stroke and bleeding in atrial fibrillation? Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J 2016;181:145–152.

Steinberg BA, Shrader P, Thomas L et al. Off-Label dosing of non-vitamin K antagonist oral anticoagulants and adverse outcomes: the ORBIT-AF II registry. J Am Coll Cardiol 2016;68:2597–2604.

O'Brien EC, Holmes DN, Ansell JE et al. Physician practices regarding contraindications to oral anticoagulation in atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Am Heart J 2014;167:601–609.

Steinberg BA, Blanco RG, Ollis D et al. Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II: rationale and design of the ORBIT-AF II registry. Am Heart J 2014;168:160–167.

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.

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.

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.

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.

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.

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.

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.

 

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 involved 195 hospitals and over 56,000 patients who had experienced a stroke
  • Registry data have already identified gaps between guideline recommendations and hospital practice for the care of patients presenting with acute stroke44
    • 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 inception45

 

For more information visit:

Centers for Disease Control and Prevention (Accessed 9 November 2020)

 

Related key publications:

Tong X, George MG, Yang Q et al. Predictors of in-hospital death and symptomatic intracranial hemorrhage in patients with acute ischemic stroke treated with thrombolytic therapy: Paul Coverdell Acute Stroke Registry 2008-2012. Int J Stroke 2014;9:728–734.


Nickles A, Fiedler J, Roberts S et al. Compliance with the stroke education performance measure in the Michigan Paul Coverdell National Acute Stroke Registry. Stroke 2013;44:1459–1462.


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.


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.


Centers for Disease Control and Prevention. 2009. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5807a1.htm [Accessed 19 November 2020].


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.

 

 

  • Objectives: to collect real-world data in patients with non-valvular AF at risk of stroke on important outcome events, including:
    • Safety and effectiveness of antithrombotic treatments, including warfarin, ASA and NOACs
    • MI
    • Life-threatening bleeding events
    • Stroke
    • All-cause death
  • GLORIA-AF registry (launched 2011) planned to involve 2200 sites in nearly 50 countries46-49
  • The registry planned to enrol approximately 56,000 patients and characterize them by:
    • Age
    • Gender
    • Antithrombotic treatment choice at baseline
    • CHADS2, CHA2DS2-VASc and HAS-BLED scores
  • Baseline characteristics and initial antithrombotic management of the first 10,000 patients in phase II of the GLORIA-AF registry50
    • OAC use was high in Europe and North America, with overall NOAC use higher than VKA use
    • A considerable proportion of high-risk patients in North America still received antiplatelet treatment or were untreated, whereas Asian patients had a high proportion of ASA use and non-treatment
  • In total during phase II, 15,641 patients were enrolled and their baseline data showed higher rates of NOAC use versus VKA use in Europe and North America; globally, however, a sizeable proportion of patients remains undertreated51
    • Two-year follow-up results for 2937 patients who received dabigatran confirmed the sustained safety and effectiveness of dabigatran, consistent with clinical trial and real-world data52

 

For more information visit:

GLORIA-AF phase I Clinicaltrials.gov (Accessed 9 November 2020)

GLORIA-AF phases II and III Clinicaltrials.gov (Accessed 9 November 2020)

 

Related key publications:
Huisman MV, Rothman KJ, Paquette M et al. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J 2018;198:55–63.

Mazurek M, Huisman MV, Rothman KJ et al. Gender differences in antithrombotic treatment for newly diagnosed atrial fibrillation: the GLORIA-AF registry program. Am J Med 2018;131:945–955.

Mazurek M, Huisman MV, Rothman KJ et al. Regional differences in antithrombotic treatment for atrial fibrillation: insights from the GLORIA-AF phase II registry. Thromb Haemost 2017;117:2376–2388.

McIntyre WF, Conen D, Olshansky B et al. Stroke-prevention strategies in North American patients with atrial fibrillation: the GLORIA-AF registry program. Clin Cardiol 2018;41:744–751.

Huisman MV, Rothman KJ, Paquette M et al. The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2. J Am Coll Cardiol 2017;69:777–785.

Huisman MV, Ma CS, Diener HC et al. Antithrombotic therapy use in patients with atrial fibrillation before the era of non-vitamin K antagonist oral anticoagulants: the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) phase I cohort. Europace 2016;18:1308–1318.

Huisman MV, Rothman KJ, Paquette M et al. Antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation: the GLORIA-AF registry, phase II. Am J Med 2015;128:1306–1313.

Huisman MV, Lip GYH, Diener HC et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J 2014;167:329–334.

 

  • Objective: to determine AF rhythm-control strategies
  • RealiseAF (launched in 2009) includes data from >10,000 patients with AF across 26 countries53
  • Assesses:
    • AF management strategies
    • Cardiovascular risk profiles of enrolled patients
    • 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
  • Available data suggest 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,53 but, regardless of method, AF control in the real-world setting is suboptimal54
    • Substantial proportions of patients with controlled AF have symptoms, regardless of rate or rhythm control strategy55
    • A change in strategy was uncommon, even in symptomatic patients56
    • Prescriptions of antiarrhythmic drugs for AF and antithrombotic therapy for ischaemic stroke prophylaxis in the real world deviate from guideline recommendations53,57,58
    • 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 control59

 

Related key publications:
Chiang CE, Naditch-Brûlé L, Brette S et al. Atrial fibrillation management strategies in routine clinical practice: insights from the international RealiseAF survey. PLoS One 2016;11:e0147536.

Narasimhan C, Verma JS, Ravi Kishore AG et al. Cardiovascular risk profile and management of atrial fibrillation in India: Real world data from RealiseAF survey. Indian Heart J 2016;68:663–670.

Gamra H, Murin J, Chiang CE et al. Use of antithrombotics in atrial fibrillation in Africa, Europe, Asia and South America: insights from the International RealiseAF Survey. Arch Cardiovasc Dis 2014;107:77–87.

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.

Wang KL, Wu CH, Huang CC et al. Complexity of atrial fibrillation patients and management in Chinese ethnicity in routine daily practice: insights from the RealiseAF Taiwanese cohort. J Cardiol 2014;64:211–217.

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.

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.

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.

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.

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.

 

  • PREFER in AF (launched in 2012) is a multicentre, prospective registry with a 1-year follow-up
  • Between January 2013–January 2014, real-life data were collected from 7728 patients with AF across seven countries to assess:60
    • Leading causes of stroke
    • Impact of NOACs for stroke prevention in patients with AF
    • Patient satisfaction with their AF management regimens
    • Impact of AF and its management on patient quality of life
    • Health economic burden of AF in Europe
  • Available data suggest:
    • Management of AF patients has slowly adapted to the 2010 European Society of Cardiology guidelines, with VKAs or NOACs given to >80% eligible patients, including those at risk for bleeding60,61
    • Rhythm control therapy was widely used
    • Patient characteristics were generally homogeneous across countries. However, anticoagulation management showed important differences,62 with the proportion of patients taking VKAs varying between 86.0% (France) and 71.4% (Italy), with warfarin predominantly used in the UK and Italy (74.9% and 62.0%, respectively)
    • The combined, but largely inappropriate, use of antiplatelet and NOAC therapy was common in patients with AF, which might be explained by the coexistence of coronary artery disease or peripheral arterial disease, but was not influenced by considerations on bleeding risk63
    • AF pattern (paroxysmal, persistent or permanent) is important because there is an association between incident HF and permanent AF at baseline. Many well-managed patients with AF showed AF progression over 1 year, although there was not a strong association of AF progression itself and outcome. Current classification of AF types may, therefore, need refinement to enhance clinical utility64
    • When NOACs first became available in Europe, physicians tended to switch low-risk patients from VKAs to NOACs. The choice to switch appeared to be related to, and may have influenced, complaints about bruising or bleeding, dissatisfaction with treatment, mobility problems and anxiety/depression traits65

 

Related key publications:
De Caterina R, Brüggenjürgen B, Darius H et al. Quality of life and patient satisfaction in patients with atrial fibrillation on stable vitamin K antagonist treatment or switched to a non-vitamin K antagonist oral anticoagulant during a 1-year follow-up: a PREFER in AF registry substudy. Arch Cardiovasc Dis 2018;111:74–84.

Schnabel RB, Pecen L, Engler D et al. Atrial fibrillation patterns are associated with arrhythmia progression and clinical outcomes. Heart 2018;104:1608–1614.

Siller-Matula JM, Pecen L, Patti G et al. Heart failure subtypes and thromboembolic risk in patients with atrial fibrillation: The PREFER in AF - HF substudy. Int J Cardiol 2018;265:141–147.

Hanon O, Vidal JS, Le Heuzey JY et al. Oral anticoagulant use in octogenarian European patients with atrial fibrillation: A subanalysis of PREFER in AF. Int J Cardiol 2017;232:98–104.

Patti G, Lucerna M, Cavallari I et al. Insulin-requiring versus noninsulin-requiring diabetes and thromboembolic risk in patients with atrial fibrillation: PREFER in AF. J Am Coll Cardiol 2017;69:409–419.

Patti G, Lucerna M, Pecen L et al. Thromboembolic risk, bleeding outcomes and effect of different antithrombotic strategies in very elderly patients with atrial fibrillation: a sub-analysis from the PREFER in AF (PREvention oF Thromboembolic Events-European Registry in Atrial Fibrillation). J Am Heart Assoc 2017;6:e005657.

Schnabel RB, Pecen L, Ojeda FM et al. Gender differences in clinical presentation and 1-year outcomes in atrial fibrillation. Heart 2017;103:1024–1030.

Bakhai A, Darius H, De Caterina R et al. Characteristics and outcomes of atrial fibrillation patients with or without specific symptoms: results from the PREFER in AF registry. Eur Heart J Qual Care Clin Outcomes 2016;2:299–305.

Renda M, Schilling R, Le Heuzey JY et al. Antithrombotic management of atrial fibrillation: follow-up data from the PREFER in AF registry. Eur Heart J 2016;37:494–5: Abstract P2548.

Brüggenjürgen B, Schliephacke T, Darius H et al. Discontinuation and hospitalisation rates in patients with atrial fibrillation: follow-up results of the PREFER in AF registry. Value Health 2014;17:A473. Abstract PCV2.

Brüggenjürgen B, Schliephacke T, Darius H et al. Health state in patients with atrial fibrillation on new oral anticoagulants as assessed with the new EQ-5D-5L questionnaire at baseline and 12-month follow-up: PREFER in AF registry. Value Health 2014;17:A493. Abstract PCV120.

Brüggenjürgen B, Schliephacke T, Darius H et al. Treatment satisfaction in patients with atrial fibrillation on new oral anticoagulants as assessed with PACT-Q2 at baseline and 12-month follow-up: PREFER in AF registry. Value Health 2014;17:A497. Abstract PCV140.

De Caterina R, Ammentorp B, Darius H et al. Frequent and possibly inappropriate use of combination therapy with an oral anticoagulant and antiplatelet agents in patients with atrial fibrillation in Europe. Heart 2014;100:1625–1635.

Kirchhof P, Ammentorp B, Darius H et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboembolic events–European Registry in Atrial Fibrillation (PREFER in AF). Europace 2014;16:6–14.

Le Heuzey JY, Ammentorp B, Darius H et al. Differences among Western European countries in anticoagulation management of atrial fibrillation. Data from the PREFER IN AF registry. Thromb Haemost 2014;111:833–841.

 

  • 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 AF66
    • 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 types66
  • This difference was consistent irrespective of the stroke risk of the patient, as determined by both CHADS2 and CHA2DS2-VASc scores66
  • Notably, anticoagulant therapy for stroke prevention was given to:67
    • 71.4% of the patients considered eligible by applicable guidelines
    • 48.4% of patients at low risk where guidelines do not recommend anticoagulation
  • Two factors associated with withholding oral anticoagulation in stroke survivors were identified as high age and treatment by a general practitioner/internist or physicians working at regional hospitals68

 

For more information visit:

Kompetenznetz Vorhofflimmern (Site in German) (Accessed 9 November 2020)

 

Related key publications:
Haeusler KG, Gerth A, Limbourg T et al. Use of vitamin K antagonists for secondary stroke prevention depends on the treating healthcare provider in Germany – results from the German AFNET registry. BMC Neurol 2015;15:129.

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.

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.

 

 

Video title

YYMMDD Author/Uploaded by

XANTUS pooled: global rivaroxaban use in real-world patients with non-valvular atrial fibrillation
The XANTUS programme evaluated the safety and efficacy of rivaroxaban in real-world patients with NVAF across the globe
© Bayer AG, 2017 | Approval Number PP-XAR-ALL-0639-1

  • Objectives: prospective, international, observational/non-interventional 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 treatment69
  • 6834 patients were enrolled, and the study completed in March 2015
  • Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice70
  • Similar studies have been completed in Latin America (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region [XANTUS-EL]) and the Asia-Pacific region (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia [XANAP])71,72
    • XANAP enrolled 2273 patients from 10 countries, and demonstrated low rates of stroke and bleeding, consistent with the XANTUS and phase III ROCKET- AF studies
    • In a global analysis of 11,121 patients from 47 countries in all three studies in the global XANTUS programme, rivaroxaban was associated with low bleeding and stroke rates and low discontinuation rates, with broadly consistent results across regions

 

For more information visit:

Clinicaltrials.gov (Accessed 9 November 2020)

 

Related key publications:
Camm AJ, Turpie AGG, Hess S et al. Outcomes after catheter ablation and cardioversion in patients with non-valvular atrial fibrillation: results from the prospective, observational XANTUS study. Europace 2018;20:e87–e95.

Camm AJ, Amarenco P, Haas S et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 2016;37:1145–1153.

Coleman CI, Haas S, Turpie AGG et al. Impact of switching from a vitamin k antagonist to rivaroxaban on satisfaction with anticoagulation therapy: the XANTUS-ACTS substudy. Clin Cardiol 2016;39:565–569.

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.

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  • 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. Return to content
  • 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. Return to content
  • Chiang CE, Naditch-Brûlé L, Brette S et al. Atrial fibrillation management strategies in routine clinical practice: insights from the international RealiseAF survey. PLoS One 2016;11:e0147536. Return to content
  • 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. Return to content
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  • Kirchhof P, Ammentorp B, Darius H et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboemolic events--European Registry in Atrial Fibrillation (PREFER in AF). Europace 2014;16:6–14. Return to content
  • Le Heuzey JY, Ammentorp B, Darius H et al. Differences among western European countries in anticoagulation management of atrial fibrillation. Data from the PREFER in AF registry. Thromb Haemost 2014;111:833–841. Return to content
  • De Caterina R, Ammentorp B, Darius H et al. Frequent and possibly inappropriate use of combination therapy with an oral anticoagulant and antiplatelet agents in patients with atrial fibrillation in Europe. Heart 2014;100:1625–1635. Return to content
  • Schnabel RB, Pecen L, Engler D et al. Atrial fibrillation patterns are associated with arrhythmia progression and clinical outcomes. Heart 2018;104:1608–1614. Return to content
  • De Caterina R, Bruggenjurgen B, Darius H et al. Quality of life and patient satisfaction in patients with atrial fibrillation on stable vitamin K antagonist treatment or switched to a non-vitamin K antagonist oral anticoagulant during a 1-year follow-up: A PREFER in AF Registry substudy. Arch Cardiovasc Dis 2018;111:74–84. Return to content
  • 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. Return to content
  • 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. Return to content
  • Haeusler KG, Gerth A, Limbourg T et al. Use of vitamin K antagonists for secondary stroke prevention depends on the treating healthcare provider in Germany - results from the German AFNET registry. BMC Neurol 2015;15:129. Return to content
  • 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. Return to content
  • Camm AJ, Amarenco P, Haas S et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 2016;37:1145–1153. Return to content
  • Kim YH, Shim J, Tsai CT et al. XANAP: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation in Asia. J Arrhythm 2018;34:418–427. Return to content
  • Kirchhof P, Radaideh G, Kim YH et al. Global prospective safety analysis of rivaroxaban. J Am Coll Cardiol 2018;72:141–153. Return to content

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