Trial Outcomes & Findings for The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation (NCT NCT00579098)
NCT ID: NCT00579098
Last Updated: 2014-04-23
Results Overview
Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
Baseline through 3 months
Results posted on
2014-04-23
Participant Flow
Patients were enrolled in this trial between January 2008 and December 2009 at Mayo Clinic in Rochester, Minnesota (USA).
847 patients were screened and of those, 567 were excluded, primarily because they were already receiving statin therapy (68%) and/or had known inflammatory disease (16%). 280 met entry criteria but 155 were not willing to participate. 125 were enrolled in the study.
Participant milestones
| Measure |
Atorvastatin
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
|
Overall Study
COMPLETED
|
53
|
55
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Atorvastatin
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
AF returned after ablation
|
3
|
2
|
Baseline Characteristics
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=62 Participants
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 Participants
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 10 • n=99 Participants
|
57 years
STANDARD_DEVIATION 10 • n=107 Participants
|
57 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=99 Participants
|
63 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
Paroxysmal Atrial Fibrillation
|
44 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Duration of Atrial Fibrillation
|
4 Months
n=99 Participants
|
4 Months
n=107 Participants
|
4 Months
n=206 Participants
|
|
Years of Atrial Fibrillation
|
5.7 Years
STANDARD_DEVIATION 4.90 • n=99 Participants
|
4.9 Years
STANDARD_DEVIATION 3.96 • n=107 Participants
|
5.3 Years
STANDARD_DEVIATION 4.45 • n=206 Participants
|
|
Concomitant Conditions
Hypertension
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Concomitant Conditions
Diabetes Mellitus
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Concomitant Conditions
Coronary Artery Disease
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Concomitant Conditions
Congestive Heart Failure
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Concomitant Conditions
Dilated cardiomyopathy
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Concomitant Conditions
Hypertrophic cardiomyopathy
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Concomitant Conditions
Valvular heart disease
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Concomitant Conditions
Old Cardiovascular Accident/Transient Ischemic Att
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Concomitant Conditions
Chronic kidney disease
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Concomitant Conditions
Chronic lung disease
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Concomitant Conditions
Sleep apnea
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Medication on admission
Aspirin
|
28 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Medication on admission
Oral anticoagulation
|
46 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Medication on admission
Beta blocker
|
35 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Medication on admission
ACE inhibitors/Angiotensin Receptor Blockers
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Antiarrhythmic drugs
Total on any antiarrhythmic drug
|
28 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Antiarrhythmic drugs
Sotalol/dofetilide
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Antiarrhythmic drugs
Amiodarone
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Antiarrhythmic drugs
Sodium Channel Blocker Class IC
|
13 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Echocardiographic parameter-LA diameter, long axis
|
58.4 millimeters
STANDARD_DEVIATION 6.7 • n=99 Participants
|
57.5 millimeters
STANDARD_DEVIATION 7.7 • n=107 Participants
|
57.9 millimeters
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Echocardiographic parameter-LA volume index
|
40.4 cc/m^2
STANDARD_DEVIATION 0.7 • n=99 Participants
|
39.4 cc/m^2
STANDARD_DEVIATION 13.1 • n=107 Participants
|
39.9 cc/m^2
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Echocardiographic parameter-LVEF
|
60 Percentage
STANDARD_DEVIATION 10 • n=99 Participants
|
60 Percentage
STANDARD_DEVIATION 9 • n=107 Participants
|
60 Percentage
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Procedural time
|
110 Minutes
STANDARD_DEVIATION 39 • n=99 Participants
|
113 Minutes
STANDARD_DEVIATION 47 • n=107 Participants
|
111 Minutes
STANDARD_DEVIATION 42 • n=206 Participants
|
|
Anatomical area of ablation
Wide-area circumferential ablation
|
44 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Anatomical area of ablation
LA isthmus
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Anatomical area of ablation
Roof line
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Anatomical area of ablation
Cavotricuspid isthmus line
|
49 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Anatomical area of ablation
Nonpulmonary vein foci
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through 3 monthsPopulation: Intent-to-treat analysis population.
Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).
Outcome measures
| Measure |
Atorvastatin
n=62 Participants
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 Participants
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months
|
95 Percentage of subjects
|
93.5 Percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline through 3 monthsPopulation: Intent-to-treat analysis population.
Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.
Outcome measures
| Measure |
Atorvastatin
n=62 Participants
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 Participants
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Percentage of Subjects Without Atrial Arrhythmia at 3 Months
|
85 Percentage of subjects
|
88 Percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent-to-treat analysis population.
Outcome measures
| Measure |
Atorvastatin
n=62 Participants
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 Participants
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Change in Mean C-Reactive Protein Level
|
-0.75 mg/dL
Standard Deviation 3
|
2.1 mg/dL
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent-to-treat analysis population.
A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group.
Outcome measures
| Measure |
Atorvastatin
n=62 Participants
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 Participants
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Change in Mean Quality of Life Score
|
13 units on a scale
Standard Deviation 18
|
11 units on a scale
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Intent-to-treat analysis population.
The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated.
Outcome measures
| Measure |
Atorvastatin
n=62 Participants
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 Participants
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Change in Lipid Levels
Change in total cholesterol
|
-50 mg/dL
Standard Deviation 42
|
15 mg/dL
Standard Deviation 29
|
|
Change in Lipid Levels
Change in LDL (low-density lipoprotein) cholestero
|
-47 mg/dL
Standard Deviation 35
|
9 mg/dL
Standard Deviation 23
|
|
Change in Lipid Levels
Change in HDL (high-density lipoprotein) cholest.
|
3 mg/dL
Standard Deviation 7
|
3 mg/dL
Standard Deviation 9
|
Adverse Events
Atorvastatin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin
n=62 participants at risk
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
|
Placebo
n=63 participants at risk
Placebo (dummy) tablet taken once daily by mouth for 90 days
|
|---|---|---|
|
Surgical and medical procedures
Clot formation in left atrium during ablation procedure
|
0.00%
0/62 • Baseline to 3 months post ablation procedure.
|
1.6%
1/63 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
|
Surgical and medical procedures
Puncture of the subclavian artery during ablation procedure
|
1.6%
1/62 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
0.00%
0/63 • Baseline to 3 months post ablation procedure.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
1.6%
1/62 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
0.00%
0/63 • Baseline to 3 months post ablation procedure.
|
|
Hepatobiliary disorders
Elevated liver function tests
|
1.6%
1/62 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
1.6%
1/63 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/62 • Baseline to 3 months post ablation procedure.
|
1.6%
1/63 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
|
General disorders
Headache
|
1.6%
1/62 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
0.00%
0/63 • Baseline to 3 months post ablation procedure.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/62 • Baseline to 3 months post ablation procedure.
|
1.6%
1/63 • Number of events 1 • Baseline to 3 months post ablation procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place