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Registry Hot Line: Atrial fibrillation and myocardial infarction

ESC Congress 2014 - Hot Line report

Resources are published as they become available during the congress

Atrial Fibrillation


Global registry on long-term oral antithrombotic treatment in patients with atrial fibrillation: baseline characteristics of the first 10,000 patients in GLORIA-AF Phase II

Professor Menno HuismanBy Menno Huisman, (Leiden, Netherlands)
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Authors:
MV. Huisman 1, H-C. Diener 2, SJ. Dubner 3, JL. Halperin 4, CS. Ma 5, KJ. Rothman 6, K. Zint 7, E. Kleine 7, C. Teutsch 7, GYH. Lip 8
(1) Leiden University Medical Center, Department of Thrombosis and Haemostasis , Leiden, Netherlands (2) University Hospital of Essen (Ruhr), Clinique for Neurology, Essen, Germany (3) Clinica y Maternidad Suizo, Arrhythmias and Electrophysiology Service , Buenos Aires, Argentina (4) Mount Sinai School of Medicine, Clinical Cardiology Services, New York, United States of America (5) Capital Medical University, Department of Cardiology, Beijing, China, People's Republic of (6) Boston University, School of Public Health, Boston, United States of America (7) Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany (8) Birmingham City Hospital, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, United Kingdom

Abstract

Purpose/Background:
GLORIA-AF is a prospective, global, observational study program of patients with newly diagnosed non-valvular AF and one or more risk factor for stroke, enrolling up to 56,000 patients in nearly 50 countries. Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide and is a major risk factor for cardioembolic stroke. Until recently, the only treatment choices for stroke prevention in patients with AF were vitamin K antagonists (VKAs, e.g., warfarin) or antiplatelet agents such as aspirin (ASA). In clinical trials novel oral anticoagulants (NOACs) have been shown to be comparable or better than VKAs in reducing the occurrence of stroke and systemic emboli with a lower risk of intracranial hemorrhage. After the introduction of NOACs, treatment patterns for stroke prevention in AF are changing worldwide. To assess these changes the GLORIA-AF Program collects data from routine clinical care using an inception cohort design. The main goals are to characterize patients newly diagnosed with non-valvular AF at risk for stroke on a global level and per region and to study patterns, predictors and outcomes (Phase III of GLORIA-AF) of different antithrombotic treatment regimens.
Methods:
The specific phase design of GLORIA-AF accounted for the first availability of NOACs in the respective countries. Phase II was started early after approval of dabigatran etexilate (dabigatran), the first NOAC available for stroke prevention in AF. This cross sectional analysis assesses the treatment pattern globally and per region Patients ≥18 years newly diagnosed with non-valvular AF (≤3 months) were eligible. Clinical sites from all over the world were selected to reflect a wide variety of site types (e.g. hospitals, anticoagulation clinics and private offices). To reduce selection bias, patients were recruited in consecutive fashion, irrespective of antithrombotic therapy received.
Results:
Overall 10,675 AF patients from 39 countries were included in Phase II between Nov 2011 and Feb 2014. Median age was 71 years and 45.5% were female; 74.9% of patients had hypertension, 23.0% diabetes mellitus, 23.7% heart failure and 20.6% presented with coronary artery disease. A high stroke risk (CHA2DS2-VASc ≥ 2) was seen in 85.5 % of the patients.
Overall, patients were most frequently treated with dabigatran and VKA (32.2%, N=3439, and 32.3%, N=3449 respectively), followed by rivaroxaban and ASA (12.0%, N=1282 and 11.5%, N=1225 respectively). 7.6% of patients (N=814) received no antithrombotic therapy. Antithrombotic treatment patterns differed across the 5 regions.


Conclusion:
The first global results of Phase II of GLORIA-AF show regional differences in treatment patterns within the first years of NOAC availability. In patients with newly diagnosed AF VKAs are still widely used despite increasing penetration of NOACs in clinical practice; in some regions (e.g. North America and Europe), there is evidence of increasing uptake of NOACs and preference over VKA. Despite high stroke risk, high proportions of patients specifically in Asia but also to some extent in North America remain untreated or are treated with ASA only.

Intracranial haemorrhage and subsequent ischemic stroke in patients with atrial fibrillation: what does 'real world' registry data tell us

By Peter Bronnum Nielsen, (Aalborg, Denmark)
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Authors:
P B. Nielsen 1, T B. Larsen 1, A. Gorst-Rasmussen 1, F. Skjoeth 1, L H. Rasmussen 1, G Y H. Lip 2
(1) Aalborg University, Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg, Denmark (2) Birmingham City Hospital, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, United Kingdom

Abstract

Purpose
The risk of ischemic stroke/thromboembolic events after an intracranial haemorrhage (ICH) in atrial fibrillation (AF) patients on warfarin treatment is not well characterised.  In clinical practice, an ICH event necessitates temporary cessation of antithrombotic treatment, requiring the physician to balance the risk of an additional bleeding event with the risk of a thromboembolic event in the absence of antithrombotic treatment. The aim of this study was to assess the association between the risk of ischaemic stroke/thromboembolic events and ICH.
Methods
:
Linkage of three Danish nationwide administrative registries in the period between 1999-2012 identified AF patients on warfarin treatment. Event rate ratios of stroke/thromboembolic events, major bleeding and all-cause mortality stratified by ICH were calculated, and Cox proportional hazard models were used to compare event rates among ICH survivors. A matched odds ratio (OR) was calculated for ICH occurrences within 0-3 months relative to 3-6 months prior to a stroke/thromboembolic event. A rate ratio of claimed warfarin prescriptions in a 3-month period pre- and post-ICH was also calculated.
Results
:
The study comprises 58,815 AF patients. The rate ratio of stroke/SE/TIA comparing the ICH group to the non-ICH group was 3.67 (95% confidence interval [CI], 3.12 to 4.31), while the rate ratio of major bleeding was 1.06 (95% CI, 0.81 to 1.39), see Table 1. The matched OR of ICH occurrences prior to a stroke/SE/TIA was 4.33 (95% CI, 2.44 to 8.15). The rate ratio of claimed warfarin prescriptions post and pre-ICH event was 0.28 (95% CI, 0.24 to 0.33).
Conclusion
:
In this large-scale study of AF patients treated with warfarin, first-time ICH was associated with an increased rate of ischaemic stroke/SE/TIA compared to the non-ICH group, and a decrease in the warfarin prescription purchase rate post-ICH period compared to pre-ICH.

Risk of Ischemic Stroke for Male Patients with Atrial Fibrillation with a CHA2DS2-VASc Score of 1

Tze Fan ChaoBy Tze-Fan Chao, (Taipei, Taiwan)
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Authors:
Tze-Fan Chao, M.D.1,2, Chia-Jen Liu, M.D.3,4, Gregory Y. H. Lip, M.D.5, Shih-Ann Chen, M.D.1,21-Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 2-Institute of Clinical Medicine, and Cardiovascular Research Center, National Yang-Ming University, Taipei, Taiwan.
3-Division of Hematology and Oncology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
4-Institute of Public Health and School of Medicine, National Yang-Ming University, Taipei, Taiwan.
5-University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom

Abstract

Aim:
Although the CHA2DS2-VASc score is recommended by both American and European guidelines for stroke risk stratification in atrial fibrillation (AF), the treatment recommendations for a CHA2DS2-VASc score of 1 are less clear.  We investigated the risk of ischemic stroke in patients with a single additional stroke risk factor (ie. CHA2DS2-VASc score=1 (males) or 2 (females)) and the impact of different component risk factors.
Methods and Results:
We used the “National Health Insurance Research Database” in Taiwan. Among 186,570 AF patients who were not receiving anti-platelet or anticoagulant drugs, there were 12,935 males with a CHA2DS2-VASc score of 1 and 7,900 females with a CHA2DS2-VASc score of 2. The clinical endpoint was the occurrence of ischemic stroke. Among 12,935 male AF patients with a CHA2DS2-VASc score of 1, 1,858 patients (14.4%) experienced ischemic stroke during the follow-up of 5.2 ± 4.3 years, with an annual stroke rate of 2.75%. The risk of ischemic stroke ranged from 1.96%/year for AF patients with vascular disease to 3.50%/year for those aged 65-74 years. For AF females with a CHA2DS2-VASc score of 2, 14.9% of them experienced ischemic stroke with an annual stroke rate of 2.55%. The risk of ischemic stroke increased from 1.91%/year for patients with hypertension to 3.34%/year for those aged 65-74 years.
Conclusions:
Not all risk factors in CHA2DS2-VASc score carried an equal risk, and age 65-74 was associated with the highest stroke rate. Oral anticoagulants should be considered for AF patients with 1 additional stroke risk factor (ie. CHA2DS2-VASc score of 1 (males) or 2 (females)) given their high risk of ischemic stroke.

One-Year Follow-Up of the EURObservational Research Programme - Atrial Fibrillation General Registry Pilot Phase

Professor Gregory Y H Lip, FESCBy Gregory Y H Lip, FESC (Birmingham, United Kingdom)
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Authors:
GYH. Lip 1, HJGM. Crijns 2, C. Laroche 3, P. Kirchhof 1, P. Vardas 4, L. Tavazzi 5, AP. Maggioni 6
(1) University of Birmingham, Centre for Cardiovascular Sciences, Birmingham, United Kingdom (2) Maastricht University, Department of Cardiology, Maastricht, Netherlands (3) European Society of Cardiology, EURObservational Research Programme, Sophia Antipolis, France (4) University Hospital of Heraklion, Department of Cardiology, Heraklion, Greece (5) Maria Cecilia Hospital, Cotignola, Italy (6) ANMCO Research Center, Florence, Italy

Abstract

Background
The EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot) provides systematic collection of contemporary data regarding the management and treatment of 3119 subjects with AF from 9 member European Society of Cardiology (ESC) countries. In this analysis, we report the development of symptoms, use of antithrombotic therapy and rate vs. rhythm strategies, as well as determinants of mortality and/or stroke/transient ischaemic attack (TIA)/peripheral embolism during 1-year follow-up in this contemporary European registry of AF patients.
Methods
The registry population comprised consecutive in- and out-patients with AF presenting to cardiologists in participating ESC countries. Consecutive patients with AF documented by ECG were enrolled. Follow-up was performed by the local investigator, initially at 1 year, as part of a long-term cohort study.
Results
At the follow-up, patients were frequently asymptomatic (76.8%), but symptoms are nevertheless common among paroxysmal and persistent AFpatients, especially palpitations, fatigue, and shortness of breath. Oral anticoagulant (OAC) use remains high, 78% overall at follow-up, and of those on vitamin K antagonist (VKA), 84% remained on VKA during the follow-up, while of those on non-VKA oral anticoagulant (NOAC) at baseline, 86% remained on NOAC, and 11.8% had changed to a VKA and 1.1% to antiplatelet therapy. Digitalis was commonly used in paroxysmal AF patients. Of rhythm control interventions, electrical cardioversion was performed in 9.7%, pharmacological cardioversion in 5.1%, and catheter ablation in 4.4%. Despite good adherence to anticoagulation, 1-year mortality was high (5.7%), with most deaths were cardiovascular (70%). Hospital readmissions were common, especially for atrial tachyarrhythmias and heart failure. On multivariate analysis, independent baseline predictors for mortality and/or stroke/TIA/peripheral embolism were age, AF as primary presentation, previous TIA, chronic kidney disease, chronic heart failure, malignancy, and minor bleeding. Independent predictors of mortality were age, chronic kidney disease, AF as primary presentation, prior TIA, chronic obstructive pulmonary disease, malignancy, minor bleeding, and diuretic use. Statin use was predictive of lower mortality.
Conclusion
In this 1-year follow-up analysis of the EORP-AF pilot general registry,we provide data on the first contemporary registry focused on management practices among European cardiologists, conducted since the publication of the new ESC guidelines.
Overall OAC use remains high, although persistence with therapy may be problematic. Nonetheless, continued OAC use was more common than in prior reports. Despite the high prescription of OAC, 1-year mortality and morbidity remain high in AF patients, particularly from heart failure and hospitalizations.

Can beta-blockers be stopped in patients with preserved left ventricular function after acute myocardial infarction? Five-year follow-up of FAST-MI 2005

By Etienne Puymirat, (Paris, France)
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Assessing the Impact of Medication Adherence on Long-term Outcomes Post Myocardial Infarction

Sameer BansilalBy Sameer Bansilal, (New York, United States of America)
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Authors:
S. Bansilal 1, JM. Castellano 2, HG. Wei 3, EG. Vinado 4, A. Freeman 5, CM. Spettell 5, FG. Alonso 4, G. Steinberg 3, G. Sanz 2, V. Fuster 1
(1) Mount Sinai School of Medicine, The Zena and Michael A. Wiener Cardiovascular Institute, New York, United States of America (2) National Centre for Cardiovascular Research (CNIC), Madrid, Spain (3) Aetna Inc., Clinical Innovation, New York, United States of America (4) Grupo Ferrer, Barcelona, Spain (5) Aetna Inc., Evaluation & Predictive Analytics, Blue Bell, United States of America

Abstract

Background:
Guideline recommended therapies reduce major cardiovascular (CV) events (MACE) in patients post myocardial infarction (MI). However, adherence to such therapies has been shown to be poor. We attempted to study the association between levels of medication adherence and long term MACE in patients post MI.
Methods:
We queried the claims data for a large U.S.-based health insurer for adult patients with a hospitalization for MI between 1/1/2010 and 2/28/2013 and minimum 6 months of continuous medical and pharmacy benefits eligibility pre and post- event. The primary outcome measure was a composite of all-cause death, MI, Stroke or coronary revascularisation, obtained through insurer claims data. Using proportion of days covered (PDC) for statins and ACE-inhibitors in the six months immediately post-MI, patients were stratified by PDC as fully adherent (≥80%), partially adherent (≥40 % to ≤79%) or non-adherent (<40%). Pearson Chi-square statistics were used to compare the unadjusted MACE incidence rates. Multivariable adjustment was performed utilising >15 covariates related to comorbid conditions, comorbidity indices, demographics, pharmacy information and medical behavior. Time to MACE for the 3 groups was compared using Cox Proportional Hazards regression models.
Results:
Of the 14,119 patients who met the MI and time period inclusion criteria, 4015 were included in our analysis set (others were excluded due to lack of pre- and post event continuous benefits eligibility). 1031 (26%) patients were classified as non-adherent, 1263 (31%) as partially adherent and 1721 (43%) as fully adherent. At 2 years follow up, the fully adherent group had significantly lower rate of MACE than the non- adherent (18.9% vs. 26.3%; HR-0.73 CI-0.61-0.86, p<0.0004) and the partially-adherent groups (18.9% vs. 24.7%; HR-0.81 CI-0.69-0.96, p<0.016). No statistical difference was observed between the non-adherent and partially-adherent cohorts (p=0.22). All-cause ER visits were lower in the fully adherent (RR=0.71, p= 0.000001) and the partially adherent groups (RR=0.8, p=0.00237) compared to the non-adherent group. Nominal differences were noted for hospitalisations related to cardiac and cerebrovascular symptoms, outpatient cardiac visits or CV testing; but these did not meet statistical significance in adjusted analyses.
Figure 1

International comparison of outcomes among 140,880 patients stable after acute MI; real world evidence from electronic health and administrative records

Harry HemingwayBy Harry Hemingway, (London, United Kingdom)
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Authors:
E. Rapsomaniki 1, M. Janzon 2, DJ. Cohen 3, T. Jernberg 4, N. Moore 5, M. Thuresson 6, E. Yang 7, P. Blin 5, S. Johansson 8, H. Hemingway 1
(1) University College London, Farr Institute for Health Informatics Research, London, United Kingdom (2) Linkoping University Hospital, Linkoping, Sweden (3) St. Luke's Mid America Heart Institute, Kansas City, United States of America (4) Karolinska Institute, Stockholm, Sweden (5) University of Bordeaux, Pharmacology, Bordeaux, France (6) Statisticon AB, Uppsala, Sweden (7) Evidera, Lexington, United States of America (8) AstraZeneca R&D, Observational Research Center, Mölndal, Sweden

Abstract

Background:
International comparisons have shown differences in short-term outcomes in myocardial infarction (MI) patients, but many remain at elevated risk beyond this period. Multiple registries derived from electronic health and administrative records offer an innovative approach to understanding which factors have greatest impact on the prognosis of high risk
patients and how this varies across different healthcare systems, with the potential to inform quality improvement initiatives.
Objective:
To compare the atherothrombotic and bleeding risks in 1-year post-MI survivors across the USA, Sweden, England, and France.
Patients and methods:
We analyzed linked electronic health records and disease registries (England, Sweden) and administrative data (US, France) according to common disease definitions based on admission ICD-10 codes and common analysis protocol. Eligible patients were those who had survived without further MI for 1 year following hospitalization for MI in 2002-2011 [N=77,976 (Sweden), 53,909 (US; sample restricted to ≥65 years old patients), 7,238 (England), and 1,757 (France)]. Outcome predictors were identified and used in multivariate CoxPH models to estimate adjusted risks.
Outcomes:
MI, stroke, CVD death, all-cause mortality, and hospitalized bleeding.
Results:
Compared to Swedish and English patients (mean age ~70), French patients were younger (mean age 66) and healthier, and US patients older (minimum age 65; mean age 79) with more comorbidities. Outcome predictors (prevalence range over countries) were age (54-100% aged ≥65), male gender (51-68%), diabetes (21-35%), history of >1 MI (12-19%),stroke (7-10%), heart failure (21-45%), peripheral arterial disease (1-10%), renal disease (3-7%), prior hospitalization for bleeding (4-17%), atrial fibrillation (14-28%), COPD (8-28%), and cancer (7-12%), all of which had similar strong positive associations with the outcomes in each country. Use of PCI (42-62%) or CABG (6-17%) in the year post-MI was associated with lower risk across all studies and outcomes. There were large differences in the observed 3-year cumulative risk for the composite of MI, stroke, or death across the different countries, ranging from 17.3 % (France) to 36.2% (US), and in the 3-year cumulative risk of hospitalized bleeding, ranging from 2.2% (France) to 7.1% (US). After multiple adjustments risk differences for MI, stroke, or death were small, but differences in risk of bleeding remained substantial (Table 1).
Conclusion:
Risk of CV events remained high across the 3 years and across the 4 countries studied. The predictors for identifying increased risk of cardiovascular or bleeding events in post-MI survivors are similar across different countries and partially explain differences in observed risks. This study highlights the importance of comorbidity management in this high risk population and exemplifies the power and generaliseability of prognosis research that utilizes the clinical records of different countries.
Funding: AstraZeneca

References


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SessionTitle:

Registry Hot Line: Atrial fibrillation and myocardial infarction

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.