Catheter Ablation vs
Antiarrhythmic Drug Therapy for
Atrial Fibrillation: Results of the
CABANA Pilot Study
Douglas L. Packer, Kerry L. Lee, Daniel B. Mark, Kristi H. Monahan,
Kathleen L. Hoffmann, Gail E. Hafley, Jeanne E. Poole,
Tristram D. Bahnson, David J. Bradley, Richard Robb,
Maryam Rettmann, David R. Holmes III, William Stevenson,
John D. Hummel, Steven J. Bailin, John D. Day, Anil K. Bhandari,
Francis Marchlinski, Neil Kay, Hugh Calkins, David J. Wilber
ACC Atlanta
March 15, 2010
3033548
Catheter Ablation vs
Antiarrhythmic Drug Therapy for
Atrial Fibrillation: Results of the
CABANA Pilot Study
Funded by St. Jude Medical Foundation,
St. Paul, Minnesota
Research Relationships (DLP) with Biosense, Acuson, Siemens,
Cryocath, EPT, St. Jude, Cardiofocus, Symphony, Prorhythm, NIH
Royalties from IP licensed by St. Jude Medical
Unpaid consulting relationships: Medtronic, Boston Scientific,
St. Jude, Biosense, Siemens, Cryocath
Other information available from Mayo Communications
3033548
Purpose of CABANA Pilot Study
• Determine the freedom from AF with
ablation vs drug therapy in patients with
more problematic AF and accompanying
co-morbidities
• Test the feasibility of a long-term pivotal trial
for assessing mortality, stroke, hospitalization
and cost outcomes
CABANA Pilot Study; ACC 2010
3033548
Design of the CABANA Pilot Study
Atrial fibrillation
Warranting Therapy
>65 yr of age or
<65 yr with 1 CVA risk factor
Eligible for ablation and/ or drug therapy
Inclusion Criteria
• 2 paroxysmal AF episodes (1
hour) over 4 mos or >1 persistent
AF episode (>1 week)
• 65 yr of age, or <65 yr with 1
risk factors
Hypertension
Diabetes
R
Heart failure
Drug Rx and AC
• Rate control
• Rhythm Rx
1° ablation & AC
• PV isolation
• Adjunctive
Prior CVA or TIA
LA size >5.0 cm (Vol In 40
cc/m2)
EF 35 %
Follow-up
12 months
• Eligible for ablation and 2 rhythm
control and/or 3 rate control
drugs
CABANA Pilot Study; ACC 2010
3033548
CABANA Pilot Study
Baseline Characteristics in 60 Patients
Age (yrs)
Age <65 yrs old with 2 risk factors
Gender Male / Female (%)
61±10
25
77%
66%
23%
Hypertension (%)
Diabetes (%)
CAD (%)
Prior MI (%)
Prior CABG/PTCA (%)
Dilated cardiomyopathy (%)
Congestive heart failure
48
11
21
6
13
10
13
80%
18%
35%
10%
22%
17%
22%
Ejection fraction (%)
LA size (mm)
Left atrial enlargement
None (%)
Mild–moderate (%)
Severe (%)
55 ± 10
4.4±1.0
CHADS2 score
1
2
CABANA Pilot Study; ACC 2010
8
27
15
16%
54%
30%
36
23
61%
39%
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CABANA Pilot Study
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Arrhythmia History
Type of AF
Paroxysmal
Persistent
Long standing persistent
Years since first AF episode (yrs)
CCS AF severity
Class 1-2
Class 3-4
Prior anti-arrhythmic drugs (no.)
0
1
2
Hospitalized for AF
Direct current cardio-version
History of atrial flutter
CABANA Pilot Study; ACC 2010
19
22
19
32%
37%
32%
3.3±4.6
18
35
32%
61%
42
15
3
28
32
14
70%
25%
5%
47%
53%
23%
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CABANA Pilot Study
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Treatment
Drug Therapy
Ablation
n=31
29 (100)
100
100
22
71%
80
n=25
89%
80
60
60
%
n=13
46%
%
40
20
n=29
40
4
13%
5
16%
n=11
38%
n=6
21%
20
n=1
4%
0
0
Rate
Rhythm
Rate &
rhythm
PV
WACA/ Linear
isolation antral
Abl
isolation
CFAE
GP
CABANA Pilot Study; ACC 2010
3033548
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CABANA Pilot Study
First Post-Blanking AF Event Over Follow-up
1st AF episode (%)
100
Drug (n=31)
Ablation (n=29)
80
60
n=16
52%
40
n=7
24%
n=3
10%
20
n=3
10%
n=1
3%
n=4
14%
0
3-6
6-9
9-12
Months
CABANA Pilot Study; ACC 2010
3033548
Freedom from Recurrence of Symptomatic
Atrial Fibrillation Post Blanking Period
100
Freedom from AF
recurrence
HR 0.42 (0.19-0.95) P=0.033
80
Ablation
60
65%
Blanking
period*
40
41%
Drug Rx
24%
20
0
0
3
6
9
12
Time (months)
1 28
2 31
27
30
23
16
20
13
7
7
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Freedom from Recurrence of
Any Symptomatic AF, AFL, or AT
Freedom from AF/AFL/
AT recurrence
100
HR 0.46 (0.21-0.99) P=0.042
80
Ablation
60
61%
Blanking
period*
23%
38%
40
Drug Rx
20
0
0
1
2
28
31
3
6
9
12
27
30
22
16
19
12
7
6
Months since treatment start
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CABANA Pilot Study
Cross-Overs and Redo Therapy
30
Drug Rx
n=31
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Ablation Rx
n=29
n=8 28%
n=6
21%
20
n=4
13%*
Pt
(%)
10
0
CABANA Pilot Study; ACC 2010
Crossover
to Abl
AA Rx
Re-ablation
*2 failed Ic; 2 failed IIIs
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Maintenance of Sinus Rhythm
in CABANA Pilot at 12 Months
100
AAD Rx
n=18
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Ablation Rx
n=29
80
60
n=15
n=13
40
n=17
n=17
+2 pt
+0 pt
No AF
on drug
Non AF
with redo
+2 pt
n=5
20
0
No AF
on Rx
No AF
No drug
No AF
Late off
drug
CABANA Pilot Study; ACC 2010
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CABANA Pilot Study
Recurrence of Any AF, AFL, or AT
AF/AFL/AT recurrence (%)
1.0
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HR 0.69 (0.37-1.32) P=0.264
(72)
0.8
Drug
(59)
0.6
Blanking
period
66%
(50)
0.4
72%
Ablation
(36)
0.2
0.0
0
3
6
9
12
14
8
4
5
Time (months)
Ablation Rx
Drug Rx
29
31
CABANA Pilot Study; ACC 2010
26
30
18
12
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CABANA Pilot Study
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Perception of Atrial Fibrillation
100
Drug (n=31)
Ablation (n=29)
Patients (%)
80
60
61
64
40
29
20
8
13
4
0
Baseline
3 mo
12 mo
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Adverse Events in the CABANA Pilot Study
DVT (%)
AV fistula/pseudo aneurysm (%)
CVA/TIA (%)
PV stenosis
Moderate (50-75%)
Severe (75-95%)
Atrial esophageal fistula (%)
Tamponade (%)
Congestive heart failure (%)
Volume overload (%)
Myocardial infarction (%)
Bradycardia (%)
Ventricular tachycardia (%)
Atrial flutter (%)
LFT increase (%)
UTI (%)
Death, Cardiac Arrest, CVA
CABANA Pilot Study; ACC 2010
Ablation
n=29
1 (3.4)
2 (6.8)
1 (3.4)
1 (3.4)
0 (0)
0 (0)
1 (3.4)
3 (10.2)
2 (6.8)
1 (3.4)
1 (3.4)
0 (0)
0 (0)
0 (0)
1 (3.4)
0 (0)
Drug Rx
n=31
1 (3.2)
0 (0)
0 (0)
0 (0)
1 (3.2)
1 (3.2)
1 (3.2)
0 (0)
0 (0)
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Limitations
• Limited number of subjects in this pilot study
• Follow-up was limited to 12 months
• As expected a small number of patients crossed
over from drug to ablative therapy
• Small numbers of at risk patients at 12 months
limiting “late” conclusion that can be drawn
CABANA Pilot Study; ACC 2010
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Conclusion of the CABANA Pilot Study
• Ablative intervention was more effective than drug
therapy for preventing recurrent symptomatic atrial
fibrillation
• Treatment success rates in this population, which
include a significant percentage with persistent and
long-standing persistent AF, were lower than
observed in other randomized clinical trials
• Late recurrence of AF may reduce long-term
effectiveness of ablation
• This pilot study establishes the feasibility and
importance of conducting a pivotal trial for
establishing long-term outcome, mortality, quality of
life, and cost of therapy for AF
CABANA Pilot Study; ACC 2010
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CABANA Pilot Sites
• Mayo Clinic
• Loyola University
• Mercy Med/Des Moines
• Ohio State
• Intermountain Med Center
• Good Samaritan
• University of Alabama
• Mass General Boston
• Johns Hopkins
• Brigham and Womens
• University of Pennsylvania
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Doug Packer
Dave Wilber
Steve Bailin
John Hummel
Crandall/Day
Anil Bhandari
Neal Kay
Reddy/Ruskin
Hugh Calkins
Bill Stevenson
Callans/Marchlinski
Enrolled: 60 of 60 patients
CABANA Pilot Study; ACC 2010
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