Symptoms based on EHRA score

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Symptoms based on EHRA score Comparing Incidence of Stroke and non-CNS Embolism in Patients with Symptomatic and Asymptomatic Atrial Fibrillation: Insights from the ORBIT-AF Registry Munveer Thind1, DaJuanicia Holmes2, Marwan Badri3, Karen Pieper2, Amitoj Singh4, Rosalia Blanco2, Gregg C. Fonarow5, Bernard J. Gersh6, Kenneth W. Mahaffey7, Eric D. Peterson2, Jonathan P. Piccini2, Peter R. Kowey3 on behalf of the ORBIT-AF patients and investigators. 1Lankenau Medical Center, Wynnewood, PA, Department of Internal Medicine; 2Duke Clinical Research Institute, Durham, NC; 3Lankenau Medical Center, Wynnewood, PA, Division of Cardiology; 4Brigham and Women’s Hospital, Boston, MA, Department of Noninvasive Cardiac Imaging; 5University of California, Los Angeles, LA, CA, Division of Cardiology; 6Mayo Clinic College of Medicine, Rochester, MN, Division of Cardiology; 7Stanford Center for Clinical Research (SCCR), Stanford University, Stanford, CA, Department of Medicine BACKGROUND RESULTS Baseline Characteristics in Asymptomatic and Symptomatic Patients with Atrial Fibrillation: Outcomes in Asymptomatic and Symptomatic Patients with Atrial Fibrillation: Symptoms based on EHRA score Overall N=9319 EHRA = 1 N=3582 (38%) EHRA ≥2 N=5737 (62%) P value Demographics/Vitals Age 75.0 (67.0,82.0) 76.0 (68.0,82.0) 74.0 (66.0,81.0) <0.0001 Female 3944 (42.3) 1269 (35.4) 2675 (46.6) Race/ethnicity White Black Hispanic Other 0.0002 8344 (89.5) 3203 (89.4) 5141 (89.6) 450 (4.8) 147 (4.1) 303 (5.3) 377 (4.0) 179 (5.0) 198 (3.5) 133 (1.4) 48 (1.3) 85 (1.5) Payor/Insurance Medicare/Medicaid Private 0.02 6536 (70.1) 2572 (71.8) 3964 (69.1) 2351 (25.2) 854 (23.8) 1497 (26.1) 431 (4.6) 156 (4.4) 275 (4.8) BMI 29.2 (25.4,34.1) 29.1 (25.7,33.6) 29.3 (25.2,34.5) 0.43 Heart rate 70.0 (63.0,80.0) 70.0 (62.0,79.0) Systolic BP 126.0 (116.0,138.0) 126.0 (118.0,138.0) 124.0 (115.0,138.0) 0.005 Diastolic BP 72.0 (66.0,80.0) 72.0 (67.0,80.0) 0.11 Medical history Hypertension 7765 (83.3) 3003 (83.8) 4762 (83.0) 0.30 Hyperlipidemia 6717 (72.1) 2668 (74.5) 4049 (70.6) Diabetes 2747 (29.5) 1061 (29.6) 1686 (29.4) 0.81 Chronic kidney disease (CKD) 3180 (34.1) 1186 (33.1) 1994 (34.8) 0.17 CKD on dialysis 117 (1.3) 44 (1.2) 73 (1.3) 0.85 Anemia 1671 (17.9) 631 (17.6) 1040 (18.1) 0.53 Smoking status Non-smoker Recent/former smoker Current smoker 0.16 4812 (51.6) 1832 (51.1) 2980 (51.9) 3971 (42.6) 1560 (43.6) 2411 (42.0) 535 (5.7) 189 (5.3) 346 (6.0) Congestive heart failure (CHF) 2969 (31.9) 1011 (28.2) 1958 (34.1) Implanted device 2509 (26.9) 899 (25.1) 1610 (28.1) 0.002 Coronary artery disease 3333 (35.8) 1292 (36.1) 2041 (35.6) 0.63 Stroke/TIA 1383 (14.8) 519 (14.5) 864 (15.1) 0.45 Type of AF New onset Paroxysmal Persistent/Permanent 426 (4.6) 120 (3.4) 306 (5.3) 4777 (51.3) 1643 (45.9) 3134 (54.6) 4116 (44.2) 1819 (50.8) 2297 (40.0) Management strategy Rate control Rhythm control 6309 (67.7) 2640 (73.7) 3669 (64.0) 2985 (32.0) 931 (26.0) 2054 (35.8) Medications Oral anticoagulants 7054 (75.7) 2762 (77.1) 4292 (74.8) 0.01 Anti-platelets 4429 (47.5) 1662 (46.4) 2767 (48.2) 0.08 Anti-arrhythmics 2702 (29.0) 802 (22.4) 1900 (33.1) Stroke risk scores CHADS2 score CHA2DS2VASc score 2.0 (1.0,3.0) 0.9 4.0 (3.0,5.0) 0.18 Bleeding risk scores Atria score ORBIT score 3.0 (1.0,4.0) 0.05 2.0 (1.0,4.0) 0.54 1. At baseline, symptomatic AF patients were more likely to be female, have CHF, have paroxysmal AF, and be prescribed anti-arrhythmics Atrial fibrillation (AF) can be symptomatic or asymptomatic Asymptomatic AF is being increasingly diagnosed via interrogation of implanted devices1 and screening with insertable cardiac monitors2-4 Management of asymptomatic AF remains controversial as the associated adverse events have not been well described This study was thus designed to examine the incidence of major adverse outcomes in patients with asymptomatic versus symptomatic AF METHODS Data Source: ORBIT-AF is an observational, prospective registry of patients with incident or prevalent AF from a variety of outpatient practices across 176 sites throughout the United States Population: After exclusions (no documented symptoms score, mechanical heart valve, moderate/severe mitral stenosis, missing follow-up data) the study population included 9,319 patients across 174 sites Definitions and Outcomes: Asymptomatic patients were defined by having an EHRA symptom score of 1, or by the absence of symptoms based on the itemized symptom checklist filled in by patients Patients were followed at 6 month intervals for a minimum of 2 years and up to a maximum of 3 years Outcomes First stroke or non-CNS embolism First major bleeding event MACNE (composite MI, SSE, TIA, CV death) All-cause death Statistical Analysis: For baseline characteristics; Chi-square test was used to compare categorical variables and Wilcoxon rank-sum to compare continuous variables Cox frailty model was used for multivariate adjustment 2. In this population of 9,319 patients with AF, 38% were asymptomatic at baseline and both symptom classifications identified asymptomatic patients in similar fashion 3. There were no major differences in risk of stroke/non-CNS embolism, major bleeding, MACNE, and all cause death between asymptomatic and symptomatic patients with AF LIMITATIONS This is an observational analysis and is subject to the risk of confounding despite adjustment for a large number of covariates Patients included in this study were selected from outpatient practices, so these results may not be generalizable to an inpatient population or untreated populations who do not attend outpatient clinics The AF patients enrolled in this registry had clinically identified AF and therefore may have had symptoms at the time of initial diagnosis, prior to enrolment Hypotheses generated by this analysis of patients with known asymptomatic or symptomatic AF with regard to the association of symptoms with outcomes may not be applicable to a population of patients with untreated, undiagnosed subclinical AF CONCLUSIONS A similar risk of thromboembolic events, bleeding, and death was observed in patients with asymptomatic versus symptomatic AF Prospective, randomized studies are needed to further define associated adverse events and delineate optimal prophylactic therapies in patients with asymptomatic AF ACKNOWLEDGEMENTS 2. Reiffel JA, Verma A, Kowey PR, et al. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. August 2017. doi:10.1001/jamacardio.2017.3180. REFERENCES: 3. Nasir JM, Pomeroy W, Marler A, et al. Predicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF) Study. Heart Rhythm. 2017;14(7):955-961. doi:10.1016/j.hrthm.2017.04.026. 1. 1. Healey JS, Connolly SJ, Gold MR, et al. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012;366(2):120-129. doi:10.1056/NEJMoa1105575. 4. Healey JS, Alings M, Ha AC, et al. Subclinical Atrial Fibrillation in Older Patients. Circulation. August 2017. doi:10.1161/CIRCULATIONAHA.117.028845. Conflict of Interest Disclosures: The ORBIT-AF registry was sponsored by Janssen Scientific Affairs, LLC. Dr. Fonarow has received consultancy fees from Janssen and Medtronic. Dr. Gersh has received personal fees from Mount Sinai–St Luke’s, Boston Scientific Corp, Janssen Scientific Affairs, St Jude Medical, Baxter Healthcare Corp, Cardiovascular Research Foundation, Medtronic, Xenon Pharmaceuticals, Cipla Ltd, Thrombosis Research Institute, and Armetheon Inc. Dr. Kenneth W. Mahaffey’s financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. Dr. Peterson has received personal fees from Boehringer Ingelheim, Sanofi, AstraZeneca, Valeant, and Bayer; grants and personal fees from Janssen; and research support from Eli Lilly & Co and Janssen Scientific Affairs. Dr. Piccini received a grant from Janssen Pharmaceuticals; consulting fees from Bristol-Myers Squibb/Pfizer and Johnson & Johnson; research support from ARCA Biopharma, Boston Scientific, GE Healthcare, and Johnson & Johnson/Janssen Scientific Affairs; and consultancy fees from Forest Laboratories, Janssen Scientific Affairs, Pfizer/Bristol-Myers Squibb, Spectranetics, and Medtronic. Dr. Kowey is a consultant for and advisory board member with Boehringer Ingelheim, Bristol-Myers Squibb, Johnson & Johnson, Portola, Merck, Sanofi, Daiichi-Sankyo, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.