Trial Outcomes & Findings for Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation (NCT NCT02132767)
NCT ID: NCT02132767
Last Updated: 2019-03-15
Results Overview
The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
523 participants
Primary outcome timeframe
Within 60 days of randomization
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
Rate Control
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Overall Study
STARTED
|
262
|
261
|
|
Overall Study
COMPLETED
|
245
|
246
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Rate Control
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Rate Control
n=262 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
Total
n=523 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
252 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
242 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
492 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
230 participants
n=5 Participants
|
232 participants
n=7 Participants
|
462 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 60 days of randomizationPopulation: All randomized patients (intent to treat)
The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
Outcome measures
| Measure |
Rate Control
n=262 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Total Number of Days in Hospital
|
5.1 days
Interval 3.0 to 7.4
|
5.0 days
Interval 3.2 to 7.5
|
SECONDARY outcome
Timeframe: Up to index hospital discharge or 7 days post surgery, whichever came firstPopulation: All randomized patients (intent to treat)
Outcome measures
| Measure |
Rate Control
n=262 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Time to Conversion to Sustained, Stable Non-AF Rhythm
|
1.85 days
Interval 0.46 to 4.81
|
0.95 days
Interval 0.27 to 3.21
|
SECONDARY outcome
Timeframe: Hospital dischargeCompare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge
Outcome measures
| Measure |
Rate Control
n=257 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Heart Rhythm Comparison
|
231 participants
|
244 participants
|
SECONDARY outcome
Timeframe: 30 days after randomizationCompare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization
Outcome measures
| Measure |
Rate Control
n=242 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=248 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Heart Rhythm Comparison
|
220 participants
|
223 participants
|
SECONDARY outcome
Timeframe: 60 days after randomizationCompare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization
Outcome measures
| Measure |
Rate Control
n=234 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=236 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Heart Rhythm Comparison
|
220 participants
|
231 participants
|
SECONDARY outcome
Timeframe: Within 60 days post surgeryOverall length of stay for the index hospitalization
Outcome measures
| Measure |
Rate Control
n=262 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Length of Stay (Index Hospitalization)
|
4.3 days
Interval 2.9 to 6.6
|
4.3 days
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Within 60 days of randomizationCompare length of stay between groups for any cause and AF-related hospitalizations, including ED visits
Outcome measures
| Measure |
Rate Control
n=262 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Length of Stay (Rehospitalization, Including ED Visits)
|
2.2 days
Interval 0.6 to 5.0
|
2.1 days
Interval 1.0 to 4.7
|
SECONDARY outcome
Timeframe: Within 60 days of randomizationCompare frequency of outpatient visits between groups for any cause and AF-related causes
Outcome measures
| Measure |
Rate Control
n=262 Participants
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 Participants
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
Outpatient Interventions
|
5 hospital stays < 24 hours
|
4 hospital stays < 24 hours
|
SECONDARY outcome
Timeframe: Within 60 days of randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 60 days of randomizationCompare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups
Outcome measures
Outcome data not reported
Adverse Events
Rate Control
Serious events: 71 serious events
Other events: 29 other events
Deaths: 0 deaths
Rhythm Control
Serious events: 73 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rate Control
n=262 participants at risk
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 participants at risk
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
General disorders
Bleeding
|
3.8%
10/262 • Number of events 11
|
2.3%
6/261 • Number of events 6
|
|
Cardiac disorders
Cardiac Arrhythmias
|
7.6%
20/262 • Number of events 21
|
7.3%
19/261 • Number of events 23
|
|
Nervous system disorders
Cerebrovascular Thromboembolism
|
1.5%
4/262 • Number of events 4
|
0.77%
2/261 • Number of events 2
|
|
Cardiac disorders
Heart Failure
|
3.1%
8/262 • Number of events 9
|
2.7%
7/261 • Number of events 9
|
|
Infections and infestations
Major Infection
|
8.8%
23/262 • Number of events 28
|
6.1%
16/261 • Number of events 22
|
|
Vascular disorders
Non-Cerebral Thromboembolism
|
0.76%
2/262 • Number of events 2
|
0.00%
0/261
|
|
Cardiac disorders
Pericardial Fluid Collection
|
0.76%
2/262 • Number of events 2
|
0.00%
0/261
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.8%
10/262 • Number of events 10
|
7.3%
19/261 • Number of events 23
|
|
Renal and urinary disorders
Renal Events
|
1.9%
5/262 • Number of events 5
|
1.9%
5/261 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.9%
5/262 • Number of events 5
|
2.3%
6/261 • Number of events 8
|
|
General disorders
Anemia
|
0.00%
0/262
|
1.1%
3/261 • Number of events 3
|
|
Injury, poisoning and procedural complications
Coumadin Toxicity
|
0.38%
1/262 • Number of events 1
|
0.38%
1/261 • Number of events 1
|
|
Cardiac disorders
Hypotension/Syncope
|
1.9%
5/262 • Number of events 6
|
1.1%
3/261 • Number of events 4
|
|
Injury, poisoning and procedural complications
Amiodarone Toxicity
|
0.00%
0/262
|
0.77%
2/261 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Distress
|
0.76%
2/262 • Number of events 2
|
0.00%
0/261
|
|
Cardiac disorders
Chest Pain
|
0.76%
2/262 • Number of events 2
|
1.9%
5/261 • Number of events 5
|
|
General disorders
Dysphagia
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall Not Related to Syncope
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
Injury, poisoning and procedural complications
Heparin-Induced Thrombocytopenia
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
General disorders
Hyperkalemia
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
General disorders
Hypoglycemia
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
Gastrointestinal disorders
Ischemic Colitis
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
General disorders
Nosocomial Fever
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
Vascular disorders
Peripheral Arterial Thrombus
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.38%
1/262 • Number of events 1
|
1.1%
3/261 • Number of events 3
|
|
Psychiatric disorders
Psychosis
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
Injury, poisoning and procedural complications
Right Groin Hematoma
|
0.00%
0/262
|
0.38%
1/261 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sternal Wound Dehiscence
|
0.38%
1/262 • Number of events 1
|
0.77%
2/261 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/262
|
0.77%
2/261 • Number of events 2
|
|
General disorders
Encephalopathy
|
0.38%
1/262 • Number of events 1
|
0.38%
1/261 • Number of events 1
|
|
Cardiac disorders
Post-Pericardiotomy Syndrome
|
0.38%
1/262 • Number of events 1
|
0.38%
1/261 • Number of events 1
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
Respiratory, thoracic and mediastinal disorders
Non-Cerebral Thromboembolism
|
0.38%
1/262 • Number of events 1
|
0.38%
1/261 • Number of events 1
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.76%
2/262 • Number of events 2
|
0.38%
1/261 • Number of events 1
|
Other adverse events
| Measure |
Rate Control
n=262 participants at risk
Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.
Rate Control Agents:
Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin
|
Rhythm Control
n=261 participants at risk
Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.
If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.
|
|---|---|---|
|
General disorders
Bleeding
|
0.76%
2/262 • Number of events 2
|
0.38%
1/261 • Number of events 2
|
|
Cardiac disorders
Cardiac Arrhythmias
|
0.76%
2/262 • Number of events 2
|
2.7%
7/261 • Number of events 8
|
|
Infections and infestations
Major infection
|
6.5%
17/262 • Number of events 18
|
4.2%
11/261 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
5/262 • Number of events 5
|
0.38%
1/261 • Number of events 1
|
|
Renal and urinary disorders
Renal events
|
1.1%
3/262 • Number of events 4
|
2.3%
6/261 • Number of events 6
|
|
Vascular disorders
Superficial venous thrombosis
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
|
Vascular disorders
Thrombophlebitis left limb
|
0.38%
1/262 • Number of events 1
|
0.00%
0/261
|
Additional Information
Annetine C. Gelijns, PhD
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place