The RealiseAF registry:

Transcription

1 The RealiseAF registry: An International, observational, cross-sectional survey evaluating atrial fibrillation management and the cardiovascular risk profile of AF patients initial results PG.Steg on behalf of the RealiseAF registry investigators INSERM U-698, Université Paris 7 Hôpital Bichat, Paris, France

2 Presenter Disclosures Research grant: Servier Speaking or consulting: Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi-Sankyo-Lilly, GSK, Merck, Medtronic, Otsuka, Pfizer, Roche, sanofiaventis, Servier,The Medicines Company Stockholding: Aterovax The RealiseAF registry is sponsored by sanofi-aventis 22

3 Rationale The information on patient characteristics, management and outcomes of AF often has limitations Drawn from RCTs which are highly selected Stems from North America or Western Europe Information gathered from hospital sources or on the occasion of an event (stroke, cardioversion), therefore not reflective of the status of stable outpatients with AF Not contemporary, as practice and epidemiology are rapidly changing Pertains to certain types of AF There is a need for Contemporary International Representative information on patients characteristics and management of outpatients with the whole spectrum of AF 33

4 Methods An international (26 countries) large scale (more than 1 Pts) contemporary (21) cross-sectional survey Patients Inclusion criteria History of AF (treated or not and whatever the rhythm at inclusion) with at least one AF episode documented by standard ECG or by ECG-Holter monitoring in the last 12 months, or documented current AF Signed written informed consent Exclusion criteria Inability to provide consent (mentally disabled, language issues, etc..) Post operative AF (< 3 months after surgery) Participation in an AF or antithrombotic clinical trial in the previous month 44

5 Representativeness and Quality control Unbiased recruitment Random selection of participating physicians (cardiologists and internists) Ratio of Cardiologist to Internist pre-determined on a national basis from existing data Short enrollment period (< 6 weeks) to maximize consecutive recruitment Enrollment target per site: min of 1, max of 3 pts per site Data quality Random data quality control of sites (1%) Field-tested CRF 55

6 Pre-specified Aims Primary: Assess "control" of AF (either SR or AF with HR 8 bpm) at the time of the visit Investigate the CV risk profile of AF pts Secondary: Describe AF characteristics Describe AF management strategies Rate vs rhythm control Rhythm and/or rate control agents Assess whether practice is consistent with evidence based guidelines Use of antithrombotics as a function of CHADS2 score Appropriate therapies consistent with ACC/AHA/ESC 26 guidelines The frequency of patients with pre-specified symptoms and the scoring of symptoms according to EHRA AF cardiac symptoms classification Assess Health-related QOL associated with AF 66

7 Patient flow 11,198 pts screened at 831 active sites 1,548 enrolled pts 1,523 eligible pts 6.1% exclusions 3.% declined consent 4.2% other No history of AF 6 (<.1%) Mentally disabled 1 (<.1%) Post-cardiac surgery AF 1 (<.1%) Clinical trial in AF or antithrombotic in the previous month 3 (<.1%) Other 14 (.1%) 768 / 831 active sites completed the screening log 77

8 RealiseAF: participating countries Enrollment from October 3th, 29 to May 3rd, 21 88

9 Patients and AF characteristics Total N=1,523 Age 6 years (%) 73.9 Age mean (SD) 66.6 (12.2) Males (%) 56.4 Ethnicity(%) Caucasian 84.2 Black.1 Asian 1.1 Hispanic 3.5 Other 2.1 BMI (kg/m 2 ) mean (SD) 28.3 (5.2) SBP (mm Hg) mean (SD) (19.4) DBP (mm Hg) mean (SD) 79.8 (11.4) Total (%) Lone AF* 5.1 Time since AF diagnosis < 3 months to 6 months to 12 months 1.2 > 12 months 62.9 Type of AF Paroxysmal 24.8 Persistent 22.3 Permanent 46.4 Unable to assign (first episode) 6.4 Paroxysmal+Persistent <.1 * Patients aged under 6 years with no Coronary Artery Disease, no Heart Failure, no Valvular heart disease, no Chronic pulmonary disease, no VTE and no Arterial Hypertension 99

10 High prevalence of concomitant CV risk factors in AF patients %

11 Primary outcome: control of AF Sinus rhythm or AF with HR 8 bpm, on the ECG the day of the visit Patients evaluable for primary criterion (n=9,665) AF not controlled 41.% [4.% ; 42.%] 59.% [58.% ; 6.%] AF controlled (SR or AF with HR 8bpm) 11 11

12 Primary outcome: control of AF Sinus rhythm or AF with HR 8 bpm, on the ECG the day of the visit Patients evaluable for primary criterion (n=9,665) AF not controlled 41.% [4.% ; 42.%] Not controlled 41.% Sinus Rhythm 26.5% AF with HR 8bpm 32.5% AF controlled (SR or AF with HR 8bpm) 59.% [58.% ; 6.%] 12 12

13 Age in classes: 75 years vs < 75 years Predictors of AF control Logistic regression adjusted for country n = 8585 Obesity ( BMI 3 kg/m²): Yes vs No At least one symptom last week including the day of the visit: Yes vs No Type of AF: Unable to assign because first episode vs Paroxysmal Type of AF: Persistent vs Paroxysmal Type of AF: Permanent vs Paroxysmal Time since first AF diagnosis in classes: [3-6]months vs <3 months Time since first AF diagnosis in classes: ]6-12]months vs <3 months Time since first AF diagnosis in classes: >12 months vs <3 months Heart Failure: NYHA class II vs No HF or NYHA class I Heart Failure: NYHA class III or IV vs No HF or NYHA class I Coronary artery disease: Yes vs No Valvular heart disease: Yes vs No Arterial hypertension: Yes vs No Therapeutic strategy chosen for AF before this visit: None vs Rate-control Therapeutic strategy chosen for AF before this visit: Rhythm-control vs Rate-control ACEi or ARB or anti-aldosterone in the 7 previous days: Yes vs No Left ventricular hypertrophy: Yes vs No C-statistic=.732 / Hosmer-Lemeshow test, p= Odds ratio (95% confidence interval) 13 13

14 History of CV disease according to AF control 4 % 77% of pts had at least one comorbidity AF control AF not controlled CAD PAD CVD Valvular heart disease Carotid stenosis >= 5% VTE 14 14

15 Frequent and severe CV events leading to unplanned hospitalisation in AF patients In the last 12 months % % 8 2 AF control 6 AF not controlled At least one cardiovascular event Acute Acute coronary decompensation syndrome of heart failure Stroke Transient Non CNS ischemic attack peripheral embolic events Pulmonary embolism 15 15

16 CV interventions in AF patients In the last 12 months % %

17 AF control was not indicative of symptom control At least one symptom* Symptom* 1 % 1 % AF control AF not controlled AF control AF not controlled Palpitation Dyspnea Fatigue Lightheadedness/ dizziness Chest pain Syncope *Symptoms last week including the day of the visit according to AF control 17 17

18 Preliminary Results - Sub-analysis on-going Management of AF in a real life setting deviates from guidelines* At least one AAD class Ic % % 2 Sotalol prescribed 1 % Amiodarone prescribed In 1rst Line In 2nd Line % If yes, disease % Lone AF or hypertension w ithout LV hypertrophy *ACC/AHA/ESC guidelines 2. Other If yes, disease 82.6 Lone AF or hypertension w ithout hypertrophy or CAD 16. Other 1 % If first line, disease 49.3 Heart failure or hypertension with significant LV hypertrophy Other If second line, disease Lone AF or hypertension without hypertrophy or CAD 17.5 Other 18 18

19 Preliminary Results - Sub-analysis on-going Management of AF in a real life setting deviates from guidelines* * vitamin K antagonist *ACC/AHA/ESC guidelines 19 19

20 Rate control was the strategy most frequently chosen Therapeutic strategy chosen at the end of the visit % % Therapeutic strategy chosen at the end of the visit - according to AF control AF control AF not controlled 2 1 Rhythm control Rate control 5.1 None.2 Both Rhythm control Rate control None Both 2 2

21 Conclusions In this large international registry of real-life practice, AF was frequently not controlled and frequently symptomatic AF was frequently associated with comorbidities and multiple CV risk factors. AF patients were at high risk of CV events & hospitalization Guidelines for both AADs use and antithrombotics were not optimally implemented suggesting a continuous need for medical education and information Rate control was the most commonly used strategy (even if the least successful) The RealiseAF results highlight the need for newer therapies (antiarrhythmic and antithrombotic agents) to manage AF with a view to improve CV outcomes as well as a need for greater education to promote better adherence to guidelines

22 Upcoming data: HRC, Birmingham, Oct 4, 21 Use of medications Compliance with guidelines Detailed symptoms description according to strategy Health-related QoL data Scientific committee PG.Steg, France (Chair) M.Goethals, Belgium J.Murin, Slovakia T.Lewalter, Germany M.Rosenqvist, Sweden J.O Neill, Ireland C-E.Chiang, Taiwan S.Alam, Lebanon H.Gamra, Tunisia P.Ponikowski, Poland O.Zharinov, Ukraine J.Silva Cardoso, Portugal H.Inoue, Japan More information can be found online at 22