A. Marc Gillinov, MD For the Cardiothoracic Surgical Trials Network (CTSN) ACC April 2016 RATE VERSUS RHYTHM CONTROL FOR ATRIAL FIBRILLATION AFTER CARDIAC.

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Presentation transcript:

A. Marc Gillinov, MD For the Cardiothoracic Surgical Trials Network (CTSN) ACC April 2016 RATE VERSUS RHYTHM CONTROL FOR ATRIAL FIBRILLATION AFTER CARDIAC SURGERY

Disclosures Consultant/Speaker AtriCure Medtronic On-X Edwards Abbott Research Funding St. Jude Medical Tendyne Equity Interest Clear Catheter Cleveland Clinic Right to receive royalties from AtriCure for a left atrial appendage occlusion device

Importance of Post-Op Atrial Fibrillation  Most common complication after cardiac surgery  Incidence 20-50%  No highly effective preventive strategies  Associated with increased rates of death, complications, hospitalizations, and costs

RecommendationCORLOE Rate control with beta-blockers is first- line therapy in hemodynamically stable patients IA J Am Coll Cardiol. 2014;64(21): AHA/ACC/HRS Guidelines Postoperative AF Based on: Preventive studies of POAF Limited clinical data

Purpose  Determine effectiveness and safety of rate control versus rhythm control for new-onset atrial fibrillation or atrial flutter after cardiac surgery  AF criteria: o nset during index hospitalization (within 7 days of surgery) and either:  AF/Aflutter persisting more than 60 minutes  Recurrent episodes of AF/Aflutter

Treatment Interventions  Rhythm control  Amiodarone and/or DC-cardioversion  DCC if AF > 24 hours after initiation of amiodarone  Rate control  Beta blocker, calcium channel blocker, or digoxin  To achieve target heart rate < 100 BPM at rest

Anticoagulation  Indication for warfarin  Persistent AF > 48 hours post-randomization  Recurrent AF  Treatment  Target INR 2-3  Continuous anticoagulation recommended for 60 days  Discontinue at physician’s discretion if NSR maintained > 2 weeks or for complications

Total number of hospital days within 60 days of randomization  ED visits  < 24 hours counts as 1 day  > 24 hours count actual time  Short stays < 24 hours  Rehospitalizations Primary Endpoint

Excluded (n=1586) Enrollment Allocated Rhythm Control (n=261) Allocated to Rate Control (n=262) Allocation Withdrawal or lost to follow-up (n=13) Death (n=2) Discontinued treatment (n=63) Withdrawal or lost to follow-up (n=14) Death (n=3) Received rhythm control (n=70) Follow-Up Primary Endpoint Analysis (n=261) Primary Endpoint Analysis (n=262) Analysis Randomized (n=523) Enrolled Pre-op (n=2109) Study Design

Patient Characteristics Rate Control (N = 262) Rhythm Control (N = 261) Overall (N = 523) Demographics Age, mean (SD)69.2 (9.8)68.4 (8.4)68.8 (9.1) Male197 (75.2)199 (76.2)396 (75.7) White242 (92.4)250 (95.8)492 (94.1) BMI27.6 (25.1, 30.9)28.5 (25.4, 31.9)28.0 (25.2, 31.5) Medical History Diabetes82 (31.3)79 (30.3)161 (30.8) Heart Failure35 (13.4)33 (12.6)68 (13.0) Hypertension193 (73.7)198 (75.9)391 (74.8) History of stroke17 (6.5)15 (5.7)32 (6.1) Prior revascularization46 (17.6)40 (15.3)86 (16.4) Valve disease140 (53.4)148 (56.7)288 (55.1) Continuous variables are expressed as mean (SD) or median (IQR) and categorical variables as count (%).

Patient Characteristics Rate Control (N = 262) Rhythm Control (N = 261) Overall (N = 523) Demographics Age, mean (SD)69.2 (9.8)68.4 (8.4)68.8 (9.1) Male197 (75.2)199 (76.2)396 (75.7) White242 (92.4)250 (95.8)492 (94.1) BMI27.6 (25.1, 30.9)28.5 (25.4, 31.9)28.0 (25.2, 31.5) Medical History Diabetes82 (31.3)79 (30.3)161 (30.8) Heart Failure35 (13.4)33 (12.6)68 (13.0) Hypertension193 (73.7)198 (75.9)391 (74.8) History of stroke17 (6.5)15 (5.7)32 (6.1) Prior revascularization46 (17.6)40 (15.3)86 (16.4) Valve disease140 (53.4)148 (56.7)288 (55.1) Continuous variables are expressed as mean (SD) or median (IQR) and categorical variables as count (%).

Patient Characteristics Rate Control (N = 262) Rhythm Control (N = 261) Overall (N = 523) Demographics Age, mean (SD)69.2 (9.8)68.4 (8.4)68.8 (9.1) Male197 (75.2)199 (76.2)396 (75.7) White242 (92.4)250 (95.8)492 (94.1) BMI27.6 (25.1, 30.9)28.5 (25.4, 31.9)28.0 (25.2, 31.5) Medical History Diabetes82 (31.3)79 (30.3)161 (30.8) Heart Failure35 (13.4)33 (12.6)68 (13.0) Hypertension193 (73.7)198 (75.9)391 (74.8) History of stroke17 (6.5)15 (5.7)32 (6.1) Prior revascularization46 (17.6)40 (15.3)86 (16.4) Valve disease140 (53.4)148 (56.7)288 (55.1) Continuous variables are expressed as mean (SD) or median (IQR) and categorical variables as count (%).

Surgical Characteristics Continuous variables are expressed as mean (SD) or median (IQR) and categorical variables as count (%). a 505 patients underwent bypass. b 500 patients had aorta cross clamped. Rate Control (N = 262) Rhythm Control (N = 261) Overall (N = 523) Isolated CABG112 (42.7)100 (38.3)212 (40.5) Isolated valve99 (37.8)109 (41.8)208 (39.8) Combined CABG and valve 51(19.5)52 (19.9)103 (19.7)

Frequency of Post-Op AF

Days in Hospital (from randomization) Rate Control (N = 262) Rhythm Control (N = 261) P value Total # days in hospital5.1 (3.0, 7.4)5.0 (3.2, 7.5)0.76 Total # days of index hosp.4.3 (2.9,6.6)4.3 (3.0, 7.0)0.88 Total # readmission days2.2 (0.6,5.0)2.1 (1.0, 4.7)0.82 Variables are expressed as median (IQR)

Mortality and Serious Adverse Events Rate Control (N = 262) Rhythm Control (N = 261) P value Bleeding11 ( 2.2)6 ( 1.2) 0.21 Cardiac Arrhythmias21 ( 4.3)23 ( 4.6) 0.80 Conduction abn. requiring PPM5 ( 1.0)7 ( 1.4) 0.58 Conduction abn. without PPM2 ( 0.4)0 ( 0.0) 0.16 Cerebrovascular Thromboembolism4 ( 0.8)2 ( 0.4) 0.40 Stroke4 ( 0.8)1 ( 0.2) 0.18 TIA0 ( 0.0)1 ( 0.2) 0.32 Death3 (0.6)2 (0.4) 0.64 Major Infection28 ( 5.7)22 ( 4.4) 0.37 Non-Cerebral Thromboembolism3 ( 0.6)1 ( 0.2) 0.31 Pleural Effusion10 ( 2.0)23 ( 4.6) 0.03 Variables are expressed as number of events (rate per 100 person-months)

Readmissions Rate Control (N = 262) Rhythm Control (N = 261) P value All readmissions79 (18.5)80 (18.5)0.99 ED visits28 (6.5)24 (5.6)0.55 Short stay (< 24 hours)5 (1.2)4 (0.9)0.73 Rehospitalizations46 (10.8)52 (12.0)0.58 Cardiovascular readmissions29 (6.8)35 (8.1)0.48 AF treatment11 (2.6)17 (3.9)0.27 Non-CV readmissions50 (11.7)45 (10.4)0.57 Variables are expressed as number of events (rate per 100 person-months)

Readmissions Rate Control (N = 262) Rhythm Control (N = 261) P value All readmissions79 (18.5)80 (18.5)0.99 ED visits28 (6.5)24 (5.6)0.55 Short stay (< 24 hours)5 (1.2)4 (0.9)0.73 Rehospitalizations46 (10.8)52 (12.0)0.58 Cardiovascular readmissions29 (6.8)35 (8.1)0.48 AF treatment11 (2.6)17 (3.9)0.27 Non-CV readmissions50 (11.7)45 (10.4)0.57 Variables are expressed as number of events (rate per 100 person-months)

Time to Stable non-AF Rhythm

AF Status by EKG

AF Status from Discharge to 60 Days

Reasons and Timing of Non-Adherence Rate Control (N=70) Rhythm Control (N=62) Reasons for Non-Adherence Pt. & provider preference 14 (20.0%)22 (35.5%) Rate drug intolerance 20 (28.6%)--- Rate drug ineffectiveness 36 (51.4%)--- Rhythm drug intolerance/side effects (64.5%) Timing of Non-Adherence Before index hospital discharge 58 (82.9%)29 (46.8%) Between discharge & 30 days 8 (11.4%)18 (29.0%) After 30 days 4 (5.7%)15 (24.2%)

Anticoagulation Average duration ~45 days in both groups

Limitations  Not powered to detect differences in stroke or serious bleeding  Population limited to new onset AF  AF not continuously monitored post- discharge  Frequent treatment discontinuation  No quality of life assessments

Summary  No clear advantage of rate or rhythm control strategy  Equal numbers of hospital days  Similar complication rates  Low rates of persistent AF 60 days after onset  More rhythm control patients free of AF at day 60

Clinical Inference  Patient and physician preferences should inform treatment choice  An initial strategy of rate control in hemodynamically stable patients with postoperative AF may be reasonable  Avoids toxicity associated with amiodarone  Need to institute rhythm control usually evident during index hospitalization

Post Operative AF Centers  Baylor College of Medicine  Baylor Research Institute  Centre Hospitalier de l'Université de Montréal  Cleveland Clinic Foundation  Columbia University  Duke University  Emory University  Hôpital du Sacré-Coeur de Montréal  Hôpital Laval  Mission Hospital  Montefiore-Einstein Heart Center  Montreal Heart Institute  Mount Sinai Medical Center  NIH Heart Center at Suburban Hospital  Ohio State University Medical Center  University of Alberta Hospital  University of Maryland  University of Michigan Health Services  University of Pennsylvania  University of Southern California  University of Virginia  University of Wisconsin