Contemporary Management of Atrial Fibrillation: What Can Clinical Registries Tell Us About Stroke Prevention and Current Therapeutic Approaches?
2014; Wiley; Volume: 3; Issue: 4 Linguagem: Inglês
10.1161/jaha.114.001179
ISSN2047-9980
AutoresGregory Y.H. Lip, Sana M. Al‐Khatib, Francisco G. Cosío, Amitava Banerjee, Irina Savelieva, Jeremy N. Ruskin, Dan Blendea, Stanley Nattel, Johann S. de Bono, Jennifer Conroy, Paul L. Hess, Eduard Guasch, Jonathan L. Halperin, Paulus Kirchhof, María Dolores García‐Cosío Carmena, A. John Camm,
Tópico(s)Antiplatelet Therapy and Cardiovascular Diseases
ResumoHomeJournal of the American Heart AssociationVol. 3, No. 4Contemporary Management of Atrial Fibrillation: What Can Clinical Registries Tell Us About Stroke Prevention and Current Therapeutic Approaches? Open AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessReview ArticlePDF/EPUBContemporary Management of Atrial Fibrillation: What Can Clinical Registries Tell Us About Stroke Prevention and Current Therapeutic Approaches? Gregory Y. H. Lip, MD, Sana M. Al‐Khatib, MD, MHS, Francisco G. Cosio, MD, Amitava Banerjee, DPhil, Irina Savelieva, MD, Jeremy Ruskin, MD, Dan Blendea, MD, Stanley Nattel, MD, Joseph De Bono, DPhil, Jennifer M. Conroy, MD, Paul L. Hess, MD, Eduard Guasch, MD, Jonathan L. Halperin, MD, Paulus Kirchhof, MD, M. Dolores G. Cosio, MD, PhD and A. John Camm, MD Gregory Y. H. LipGregory Y. H. Lip University of Birmingham Center for Cardiovascular Sciences, City Hospital, Birmingham, UK , Sana M. Al‐KhatibSana M. Al‐Khatib Department of Medicine, Cardiology Division, Duke University Medical Center, Durham, NC , Francisco G. CosioFrancisco G. Cosio Cardiología Department, Hospital Universitario de Getafe, Madrid, Spain , Amitava BanerjeeAmitava Banerjee University of Birmingham Center for Cardiovascular Sciences, City Hospital, Birmingham, UK , Irina SavelievaIrina Savelieva Division of Clinical Sciences, Cardiovascular Science, St George's University of London and Imperial College, London, UK , Jeremy RuskinJeremy Ruskin Department of Medicine, Massachusetts General Hospital, Boston, MA , Dan BlendeaDan Blendea Department of Medicine, Massachusetts General Hospital, Boston, MA , Stanley NattelStanley Nattel Montreal Heart Institute, Montreal, Quebec, Canada , Joseph De BonoJoseph De Bono University Hospitals Birmingham NHS Trust, Birmingham, UK , Jennifer M. ConroyJennifer M. Conroy Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, NY , Paul L. HessPaul L. Hess Department of Medicine, Cardiology Division, Duke University Medical Center, Durham, NC , Eduard GuaschEduard Guasch Montreal Heart Institute, Montreal, Quebec, Canada , Jonathan L. HalperinJonathan L. Halperin Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, NY , Paulus KirchhofPaulus Kirchhof University of Birmingham Center for Cardiovascular Sciences, University of Birmingham and Sandwell and West Birmingham NHS Trust, Birmingham, UK Department of Cardiology and Angiology, Hospital of the University of Münster, Münster, Germany German Atrial Fibrillation Competence NETwork (AFNET), Münster, Germany , M. Dolores G. CosioM. Dolores G. Cosio Heart Failure and Cardiac Transplant Unit, Cardiology Hospital Santa Creu i Sant Pau, Barcelona, Spain and A. John CammA. John Camm Division of Clinical Sciences, Cardiovascular Science, St George's University of London and Imperial College, London, UK Originally published27 Aug 2014https://doi.org/10.1161/JAHA.114.001179Journal of the American Heart Association. 2014;3:e001179IntroductionAtrial fibrillation (AF) is a global health problem. The condition brings an increased risk of stroke, systemic embolism, and heart failure (HF) and is associated with impaired quality of life, frequent hospitalizations, and mortality.1 Observational studies have been the main source of information for many years and have defined the clinical presentation, clinical course, and prognosis of AF. Based on key issues identified by observational studies, management of patients with AF has been informed by randomized, controlled trials (RCTs) that provide the main support for guideline recommendations regarding management of patients with AF and prevention of thromboembolic complications. Nevertheless, important questions regarding the clinical course, risks, and management of AF in clinical practice remain unanswered.1Although RCTs provide high‐level evidence on the efficacy and safety of therapeutic interventions, they generally involve well‐defined study populations that exclude complex patients and have standardized protocols for management with closer monitoring and stricter follow‐up than is typical of routine clinical practice. Thus, their results are not always directly applicable to the general population or routine practice.Traditional observational studies, often limited to small patient populations and performed at a single institution, are giving way to multicenter and national registries, supported by the transfer of information to large databases. Structured data collection can inform the generation of new hypotheses and help to test established ones. Registries are also subject to limitations as well as potential confounding factors related to the population selected, number, and scope of tracked variables and prevailing concepts of the disease under investigation.2 These difficulties have been highlighted by expert groups that elaborated guidelines for reliable reporting of observational studies.3Study designs vary depending on whether the objectives involve disease definition, diagnostic methodology, occurrence, etiology, prevention, prognosis, and treatment. The information obtained from observational and interventional studies provide different approaches that require integration of a wide array of data to derive a complete perspective on a disease or condition.This review provides an overview of available registry data on patients with AF and focuses on 3 areas at the heart of AF management: (1) stroke prevention; (2) pharmacological rhythm and rate control; and (3) catheter‐based ablation. In addition to cataloging the types of registry data available, we consider how these data contribute to understanding and management of patients with AF and speculate on the future directions of observational research.The Search StrategyRegistries or databases reporting on AF management, identified from sources that included CINAHL, Medline, EMBASE, and the Cochrane Database of Systematic Reviews from 2000 to 2012, were selected for closer review, and publications from these registries were tracked. We identified 34 large international or national registries of AF patients, including 17 reporting on thromboprophylaxis and stroke prevention, 8 focused on antiarrhythmic drug (AAD) therapy and cardioversion, 7 studying AF ablation, and 2 detailing left atrial appendage closure (LAAC) registries.Cataloging AF RegistriesTables 1, 2, 3 through 4 provide overviews of the registries identified, which have been grouped into the following broad categories: (1) those focused on thromboprophylaxis and stroke prevention (Table 1); (2) those on cardioversion and AAD therapy (Table 2); (3) those on ablation (Table 3); and LAAC (Table 4). Several registries address multiple aspects of AF diagnosis and management and could be allocated to more than 1 category. To enable some key findings to be visualized more clearly, registries that provide information on medical treatments for AF (including use of agents for rhythm and rate control, warfarin, aspirin, and new oral anticoagulants [NOACs]) are also shown separately in Table 5.Table 1. Registries With a Focus on Thromboprophylaxis and Stroke PreventionRegistry (Sponsor)CountryYearsSettingStudy AimPatient CharacteristicsNo. of AF PatientsFemale (%)Mean Age (±SD)Paroxysmal AF (%)CHADS2 (CHA2DS2VASC)AFNET1 (German Competence Network)Germany2010Inpatients/outpatientsPersonalized managementAF9558———1.6 to 1.9AVAIL4USAJuly 2006–Sept 2009InpatientsLong‐term use of antithrombotic therapiesPatients with ischemic stroke/TIA and AF post discharge29151.676—2 to 6CAPTURE5USA (Illinois)Nov 2002–March 2003InpatientsComparison of quality indicatorsStroke/TIA195353.2/57.166.7/67.5——Euro Heart Survey635 countries EuropeSep 2003–Jul 2004Inpatients/outpatientsManagement against European guidelinesAF confirmed by ECG or Holter recording389043.566.4±12.230.10 to 6GARFIELD (Bayer)750 countries worldwideOngoing (2009–2015)Inpatients/outpatientsEvaluate management and outcomesNewly diagnosed nonvalvular AF with additional risk factor for strokeAiming for 55 000————GLORIA‐AF (Boehringer Ingelheim)8Global (62 centers)May 2011–Jan 2013InpatientsCharacteristics influencing choice of therapyNewly diagnosed nonvalvular AF patients at risk for strokeAiming for 55 000————J‐RHYTHM9JapanJan 2009–July 2009OutpatientsRegional use of anticoagulation therapyAF793731.169.7±9.937.11.7±1.2National Cardiovascular Data Registry's ACTION Registry–Get With the Guidelines10USAJuly 2008–Sept 2009Outcomes of patients with acute myocardial infarction and AFMyocardial infarction with AF494742.4Median 78— 0: 3.7% 1: 12.9% ≥2: 80.9% Nationwide Danish study11DenmarkPatient registry data from 1997–2008Inpatients/outpatientsNet clinical benefit of OACsNon‐valvular AF141 50047.272.6 ±12.9— 0 to 6 (0 to 9) ORBIT‐AF12USAJune 2010–Nov 2014OutpatientsCharacterize treatment and outcomesIncident or prevalent AF10 12643754675% ≥2 (85% ≥2)PINNACLE‐AF (http://www.ncdr.com/webncdr/pinnacle) (National Cardiovascular Data Registry)USAOngoingOutpatientsMonitoring practise pattern changes over timeAF100 000+–———PREFER‐AF (Daiichi‐Sankyo)137 countries Europe2012Inpatients/outpatientsManagement of patients under 2010 guidelinesHistory of AF72434071.5±1130(3.4)REACH1444 countriesOutpatientsImplications of AFPAD patients at risk of AF681435.672.8±9.2—2.8±1.3RE‐LY1547 countriesNov 2005–April 2009Inpatients/outpatientsComparison of warfarin and dabigatranAF with an additional risk factor for stroke13 50745.466.2——REVERSE16 (Sociedad Española de Cardiolgía)SpainFeb–June 2004Inpatients (cardioversion)Comparison of treatment and clinical characteristicsPersistent AF referred for cardioversion15153763±110—Swedish AF Cohort17SwedenJuly 2005–Dec 2008Inpatients/outpatientsInvestigate risk factors in AFAF182 67847%76.2—0 to 6ACTION indicates Acute Coronary Treatment and Intervention Outcomes Network; AF, atrial fibrillation; OAC, oral anticoagulation; PAD, peripheral artery disease; TIA, transient ischemic attack.Table 2. Registries Reporting on Antiarrhythmic Drug Therapy and Cardioversion in AFRegistryCountryYearsSettingStudy AimPatient CharacteristicsNo. of AF PatientsFemale (%)Mean Age (±SD)Paroxysmal AF (%)CHADS2 (CHA2DS2VASC)AFFECTS18, 19USAMar 2005–Dec 2007OutpatientsClinical practice patterns in managementAF with increased risk of stroke146146.366.2±13.379.7—ATRIUM20Germany2009OutpatientsManagement of AF in GermanyAll stages of AF366742.072.0±9.027.12.2±1.3 (3.8±1.7)CARAF I and II21Canada1991–2007OutpatientsUse of AADs in Canada from 1991 to 2007New‐onset paroxysmal AF1400——100—GULF‐SAFE22 (Gulf Heart Association)6 Middle Eastern countriesOct 2009–July 2010Emergency departmentAF management in the GulfAF204348.057.0±16.017.02.1±0.5MADRE23Germany2010–2012OutpatientsEfficacy and tolerance of dronedarone in clinical practiceParoxysmal or persistent AF19144.563±9.962.5—REALISE‐AF2426 countries worldwideNov 2009–June 2010OutpatientsWorld‐wide managementAt least 1 AF episode in the last 12 months10 5234466.6±12.224.8—RECORDAF25, 26, 2721 countries worldwideMay 2007–Apr 2008Inpatients/outpatientsWorld‐wide managementRecent‐onset AF560442.866±11.945.6—RECORDAF‐Asia Pacific288 countries Asia/PacificApr 2009–July 2010OutpatientsManagement across Asia‐PacificRecently diagnosed AF26294064±1349—RHYTHM‐AF29, 3010 countries worldwideMay 2010–Feb 2013Inpatients (cardioversion)Antithrombotic therapy in relation to stroke risk and AF durationAF patients suitable for cardioversion39403866±12—3±2aAADs indicates antiarrhythmic drugs; ACTION, Acute Coronary Treatment and Intervention Outcomes Network; AF, atrial fibrillation.aMean±SD.Table 3. Registries Providing Information on AF AblationRegistryCountryYearsSettingStudy AimPatient CharacteristicsNo. of AF PatientsFemale (%)Mean Age (±SD)Paroxysmal AF (%)CHADS2 (CHA2DS2VASC)AF ablation pilot study of European Heart Rhythm Association3110 countries EuropeOct 2010–May 2011InpatientsClinical epidemiology and therapy of European ablation patientsUndergoing AF ablation1410286062 0 to 5; ≥1 in 57.8% (0 to 7; ≥1 in 78.9%) AF ablation Long‐term Registry of EURObservational Research Programme3254 countries invited (29 participating so far)OngoingInpatientsLong‐term study of the aboveUndergoing AF ablation875 so far41.02%71.16±11.319.04—AF‐Intermountain hospitals33USAOngoingInpatientsLong‐term impact of ablationUndergoing AF ablation21 060 (4212 underwent AF ablation)39.266±13.3——CARAF21Canada1990–1996InpatientsGender‐related differences in AFAF109738Women 65.4±0.7 Men 60.5±0.6100—National Multicenter Registry on Procedural Safety of Catheter Ablation for AF34ItalyJan–Dec 2011InpatientsSafety of catheter ablation for AFPatients who underwent AF catheter ablation23232860541Prospective registry35USAJan 2010–July 2011Ablation in high‐volume centersFeasibility and safety of dabigatran in ablationUndergoing AF ablation29021605730% ≥2 (1.6)SAFARI36USAPlannedInpatientsSafety and efficacy of catheter ablationUndergoing AF ablation5000 (aim)————AF indicates atrial fibrillation.Table 4. Registries Reporting on LAACRegistryCountryYearsSettingStudy AimPatient CharacteristicsNo. of AF PatientsFemale (%)Mean Age (±SD)Paroxysmal AF (%)CHADS2 (CHA2DS2VASC)ACP37EuropeMay 2010–June 2017Patients with AF at a high risk of strokeInitial experience with ACP in European patientsOn warfarin or dabigatran therapy, CHADS2 score ≥2143————ASAP38EuropeJan 2009–Dec 2013Patients contraindicated for long‐term warfarin therapySafety and efficacy of LAAC in patientsAF contraindicated for warfarin150—73 (±7.4)—2.8 (4.4)ACP indicates Amplatzer cardiac plug; AF, atrial fibrillation; ASA, acetylsalicylic acid; LAAC, left atrial appendage closure.Table 5. Registries Providing Information on Medical Treatment of AFRegistryRate‐Control Treatment (%)Rhythm‐Control Treatment (%)Warfarin (%)NOACs (%)Aspirin (%)AVAIL4——49.1—5.5CAPTURE5——4.73——J‐RHYTHM9——87.3—22.3Nationwide Danish study11——17.6——ORBIT‐AF12————35PREFER AF (Daiichi‐Sankyo)13—59.834.16.119.8REACH14——36.2—42.6RE‐LY15——32——Swedish AF Cohort17——40——Euro Heart Survey6——60.9—30.5National Cardiovascular Data Registry's ACTION Registry–Get With the Guidelines10—— 32.5 on admission (41 at discharge) — 51.5 on admission (95 at discharge) AFFECTS18, 193664 58.7 at enrollment (63.7 at follow‐up) — 27.2 at enrollment (31.8 at follow‐up) ATRIUM20751693.0——MADRE23—100——71REALISE‐AF2432.757.542——RECORDAF25, 26, 2745.154.9——43Prospective registry35——5050 (dabigatran)44ACTION indicates Acute Coronary Treatment and Intervention Outcomes Network; AF, atrial fibrillation; NOAC, new oral anticoagulant.Thromboprophylaxis and Stroke Prevention RegistriesA number of registries provide data on management and prevention of thromboembolism in hospitalized and ambulatory patients with AF, offering insights into the effectiveness of oral anticoagulation (OAC) therapy (Table 1). Several large‐scale registries on OAC use have been initiated by the pharmaceutical industry (Table 1) and focus on NOACs. For example, the Global Anticoagulant Registry in the Field (GARFIELD)7 and Global Registry on Long‐term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA‐AF),8 which are observational, global, large‐scale prospective registries, assess patterns and outcomes of thromboprophylaxis.A number of national and regional registries address medication preference by patients. The Adherence eValuation After Ischemic Stroke Longitudinal (AVAIL) registry, for example, expanded on the hospital‐based Get with the Guidelines‐Stroke quality improvement program and Carotid RX ACCULINK/RX ACCUNET Post‐Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE), a prototype registry from the Paul Coverdale National Acute Stroke Registry.4, 5 These evaluate whether patient management accords with practice guidelines and evidence‐based research. The Nationwide Danish study,11 Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT‐AF)12 and Prevention of thromboembolic events–European Registry in Atrial Fibrillation (PREFER‐AF)13 registries address this in European and U.S. patient cohorts. Data have been collected from each of these with the exception of CAPTURE, GARFIELD, and ORBIT‐AF registries, which are ongoing.Registries Reporting on AAD Therapy and CardioversionPharmacological and direct‐current cardioversion of AF has been charted by a number of registries to provide information on global treatment patterns (Table 2). The global Registry on Cardiac rhythm disorders assessing the control of Atrial Fibrillation (RECORD‐AF)25 was one of the first world‐wide observational surveys of the management of patients with newly diagnosed paroxysmal or persistent AF, and the Real Life Global Survey Evaluating Patients with Atrial Fibrillation (REALISE‐AF)24 cross‐sectional study captured data in 26 participating countries on AF management and cardiovascular (CV) risk profiles. RECORD‐AF has also been extended to cover the Asia‐Pacific region (RECORD‐AF Asia Pacific).28 In addition, RHYTHM‐AF is an international prospective study aimed at determining regional variability, outcomes, and cost‐effectiveness among patients with recent‐onset AF considered for cardioversion in 10 countries of antiarrhythmic and antithrombotic treatment.29 As shown in Table 2, other smaller, national registries assessing AAD use and cardioversion include US Atrial Fibrillation Focus on Effective Clinical Treatment Strategies (AFFECTS),18 the German Outpatient Registry Upon Morbidity of Atrial Fibrillation (ATRIUM) registry,20 and the Canadian Registry of Atrial Fibrillation (CARAF).21Registries Reporting on AF Ablation and LAACTable 3 details registries assessing ablation therapy for AF. The Atrial Fibrillation Ablation Pilot Study, a prospective, multinational registry conducted by the European Heart Rhythm Association of the European Society of Cardiology,31 was undertaken preceding a long‐term Atrial Fibrillation Ablation pan‐European Registry by the Euro‐observational Research Programme, which opened in 2012 and invited participation from clinical sites in 54 countries. To date, some 875 patients have been enrolled from 61 or 137 registered centers in 19 or 29 registered nations. Table 3 describes other registries on AF ablation, such as the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI),36organized by the US Cardiac Safety Research Consortium (CSRC),39 and the CARAF program in Canada.21 In addition to AF ablation, LAAC is under investigation as a potential alternative to anticoagulation for patients at high risk of stroke in the Amplatzer cardiac plug (ACP)37 and ASA Plavix Feasibility Study With Watchman LAAC (ASAP)38 registries (Table 4).Insights From RegistriesRegistries on Thromboprophylaxis and Stroke PreventionStroke epidemiology and risk factors.Patients with AF are at risk of stroke and twice as likely to die within 1 year as those without AF.40 The Euro Heart survey, in which patients with AF (new in 18%, paroxysmal in 28%, persistent in 22%, and permanent in 29%) had a mean age of 67 years and 26% older than 75 years, found that 86% were at high risk for stroke.6Data from the Nationwide Danish study highlight that chronic kidney disease (CKD) in patients with AF is associated with even greater risk of stroke or systemic embolism. In this cohort, the risk of stroke or thromboembolism in patients with CKD (hazard ratio, 1.49) was significantly lower in patients treated with warfarin.41 Reports from this registry also note higher risk of bleeding among patients with CKD treated with warfarin, aspirin, or both.42 Bleeding risks associated with OACs are a potential disadvantage of therapy, but data from registries help identify patients most likely to encounter bleeding complications. The concept of "net clinical benefit" aims to balance the risks of ischemic stroke and bleeding on OAC therapy43 and was originally tested using U.S. registry data. This concept, used to compare NOACs and warfarin, have been facilitated by registry data.11, 44 Banerjee et al. used "real‐world" data on net clinical benefit of warfarin from the Danish National Patient Registry and modeled the expected net clinical benefit for NOACs (dabigatran, rivaroxaban, and apixaban) on the basis of recent clinical trial outcomes.11 The findings indicated that when there is a high risk of both ischemic stroke and intracranial hemorrhage, all 3 of the new agents have a greater net clinical benefit, compared to warfarin (Figure).45, 46Download PowerPointFigure 1. Net clinical benefit of warfarin and new oral anticoagulants dabigatran, apixaban, rivaroxaban by CHA2DS2‐VASC and HAS‐BLED scores. A, HAS‐BLED ≤2. B, HAS‐BLED ≤3. For HAS‐BLED ≥3, there were no data with CHA2DS2‐VASC score=0. D110, dabigatran 110 mg (twice‐daily; BID); D150, dabigatran 150 mg BID. Modeling was based on recent clinical trial outcome data for the new oral anticoagulants and "real‐world" data from the Danish National Patient Registry, collected from patients with nonvalvular AF between 1997 and 2008 to predict the net clinical benefit of new oral anticoagulants, compared to warfarin. Reproduced with permission from Banerjee et al.11AF indicates atrial fibrillation.Registry findings, such as those from Denmark and Sweden (Table 1), have helped develop and refine risk‐scoring systems for stroke and bleeding in AF patient cohorts.17, 41 Scoring systems such as CHADS2 and CHA2DS2‐VASc have changed the approach to risk stratification of AF patients and guide judicious use of OAC in patients at greatest risk.47, 48 Registry data have been crucial in deriving risk stratification schemes and validating the utility in clinical practice.48, 49, 50 Both the CHADS2 and CHA2D2‐VASC scores were found, by examination of registry data, to underestimate the risk of thromboembolism associated with previous ischemic events.51 Another scoring system, developed from the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study, identified risk stratification schemes for bleeding and thromboembolism to develop a simple method for quantifying the risk of warfarin‐associated hemorrhage based on 5 clinical variables with performance comparable to the CHADS2 index.52Registry data show that the CHA2DS2VASc score performed better than CHADS2 in identifying patients at high or low risk of thromboembolism. In general, risk stratification systems should be reassessed, given that new data are developed from independent sources. A recent analysis of the ROCKET‐AF clinical trial and ATRIA cohort suggested that renal impairment could be added to the CHADS2 score to improve predictive value for identifying "high‐risk" patients at risk of stroke.53 Because all patients in these cohorts were at high risk of stroke and were treated with OACs, the full range and impact of renal function was not investigated. In another analysis of patients across a wide spectrum of renal impairment who were not anticoagulated, renal impairment added little to the predictive value of the CHADS2 and CHA2DS2‐VASc scores for stratification of thromboembolic risk.54, 55 On the other hand, renal failure patients do have a higher risk of hemorrhagic complications,56, 57 making the net risk‐benefit ratio difficult to establish. This is an area where further clinical trials are needed.OACs and stroke prevention.Multiple clinical trials established the effectiveness of the vitamin K antagonists, compared to placebo, aspirin, other antiplatelet agents, or no antithrombotic therapy in patients with AF.58, 59, 60, 61 Nevertheless, the 2006 Euro Heart Survey noted that AF management can be inadequate, with wide variations in physician adherence to evidence‐based recommendations for anticoagulation.6 In 2013, the EORP‐AF General Registry Pilot program showed improved uptake of OACs by European cardiologists, with OACs prescribed for 80% of patients with AF.32 Registry data have provided information regarding patterns of OACs across various health systems at the primary care,20, 60 hospital,8 network,62 national,63, 64 and international21, 58 hospital,7 network,59 national,60, 61 and international6, 24 levels. Treatment trends over time can be used to project resource utilization and facilitate planning of health services and resources.National prescribing registries suggest systematic underuse of warfarin,65 and data from national registries of AF patients, such as the Japanese J‐RHYTHM registry, indicate warfarin underutilization in patients at high stroke risk, as well as overuse of warfarin in patients at low risk.9 In contrast, the Euro Heart Survey found that OAC prescribing for AF was relatively high throughout all risk categories and noted that this placed a large proportion of patients with low risk of thromboembolism at higher risk of bleeding complications.6 Frequent OAC prescribing may relate to the relatively high proportion of academic and specialized centers participating in this study. Registry data from the National Cardiovascular Data Registry's Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry–Get with the Guidelines program also suggest that the patients at highest risk of ischemic stroke are least likely to take OAC medication,4 again highlighting the need for practice improvement and compliance to ensure the best outcomes among patients with AF. These data on utilization could be gleaned only from registries. Data from a number of registries providing information on the use of warfarin, NOACs, and aspirin are shown in Table 5.The PREFER‐AF Registry found that OACs are now much more widely used than was reported in the German AFNET and the Euro Heart Survey registries on AF, and that NOACs are used by 6.1% of patients with AF.13The increasing number of registries established in recent years to follow trends and outcomes linked to the NOACs—such as GARFIELD, GLORIA‐AF, PREFER‐AF, and Randomized Evaluation of Long‐Term Anticoagulation Therapy (RE‐LY)—will continue to highlight practice variations in diverse healthcare settings and patient populations. For example, in the RE‐LY trial, dabigatran at 150 mg (but not 110 mg) twice‐daily was associated with lower rates of stroke, compared to warfarin.66 These variations may provide targets for improvement of OAC uptake and optimize available treatment options according to patient profiles. In addition to generating pharmacoepidemiological data on OAC use, these registries capture and assess treatment outcomes, specifically the incidence of bleeding and persistence of therapy (including discontinuation, interruption, and changes of therapy regimen).Registries may offer insights into the off‐label use of OAC drugs. The safety and efficacy of periprocedural dabigatran in patients undergoing AF ablation was evaluated in a multicenter registry35 (Table 3), in which dabigatran was associated with a significant increase in the risk of bleeding and thromboembolism compared to uninterrupted warfarin therapy, although different lengths of time on treatment confounds interpretation of these observations. Two other systematic reviews showed no differences in bleeding or thromboembolism with periprocedural dabigatran versus warfarin in patients undergoing ablation.67, 68 Given these contradictory results, more data are needed. Whereas registry data can point to potential new approaches to management, investigation in a controlled trial is the preferred way to compare therapeutic strategies and provide robust, reliable evidence with which to inform practice.Registries on AAD Therapy and CardioversionAmong the registries listed in Table 2, the RECORD‐AF registry involving 21 countries worldwide provides insight into the use of AADs, factors affecting progression from paroxysmal to persistent or permanent AF, and reveals the extent to which clinical practice follows practice guidelines.26, 27, 69 RECORD‐AF reported an overall success rate of 54% for antiarrhythmic therapy, 60% success for maintenance of sinus rhythm, and 47% for maintaining the heart rate at or below 80 beats per minute at 1 year.25 Key clinical outcomes reported for rate control and rhythm control strategies at 1 year are shown in Table 6. The data suggest that clinical outcomes of AF are driven by arrhythmia‐related hospitalization, rather than rate or rhythm management strategy,25 but in patients assigned to rate control, there was relatively rapid progression from paroxysmal to persistent AF. In RECORD‐AF, use of digoxin in patients without HF was uncommon, especially in North America, and amiodarone was used infrequently, except in patients with HF. One‐year findings from the related RECORD‐AF Asia Pacific registry showed that rhythm control strategies were often applied to patients with persistent AF and a history of HF or valvular heart disease (37% of patients), and rate‐control strategies to patients with recently identified, paroxysmal AF (63%).28 Patients in the rhythm‐control group were prescribed class Ic (39%) or III (49%) AADs, with lower use of β‐blockers in this group in the Asia Pacific registry (35%) compared with the global RECORD‐AF registry (51%).Table 6. Key Clinical Outcomes Reported in the RECORD‐AF Registry at 1 Year25Clinical EventsRhythm Control (%)Rate Control (%)P ValueAny clinical event483/2809 (17.2)405/2225 (18.2)0.352Cardiovascular death24/2804 (0.9)61/2213 (2.8)<0.001Myocardial infarction14/2785 (0.5)20/2175 (0.9)0.078Stroke or transient ischemic attack46/2784 (1.7)60/2179 (2.8)0.008Hospitalization for cardiovascular event465/2793 (16.6)366/2195 (16.7)0.891Hospitalization or increased duration of hospital stayDue to arrythmia or proarrhythmia314/2790 (11.3)159/2179 (7.3)<0.001Due to other cardiovascular ev
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