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Cabana
1. 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
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2. 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
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3. 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 30335
4. Design of the CABANA Pilot Study
Atrial fibrillation
Atrial fibrillation
Inclusion Criteria
Warranting Therapy
Warranting Therapy ∀≥ 2 paroxysmal AF episodes (≥ 1
hour) over 4 mos or >1 persistent
AF episode (>1 week)
>65 yr of age or
>65 yr of age or
<65 yr with ≥ 1 CVA risk factor
<65 yr with ≥ 1 CVA risk factor ∀≥ 65 yr of age, or <65 yr with ≥ 1
Eligible for ablation and/ or drug therapy
Eligible for ablation and/ or drug therapy risk factors
Hypertension
R Diabetes
Heart failure
Prior CVA or TIA
Drug Rx and AC
Drug Rx and AC 1° ablation & AC
1° ablation & AC
• Rate control
Rate control • PV isolation
PV isolation LA size >5.0 cm (Vol In ≥ 40
• Rhythm Rx
Rhythm Rx • Adjunctive
Adjunctive cc/m2)
EF ≤ 35 %
• Eligible for ablation and ≥ 2
Follow-up
Follow-up rhythm control and/or ≥ 3 rate
12 months
12 months control drugs
CABANA Pilot Study; ACC 2010
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5. CABANA Pilot Study
Baseline Characteristics in 60 Patients Qui ckTi m e™ a n a
d eco mp re ss o r
d
a re ne ed ed to s e e th is pictu re .
Age (yrs) 61±10
Age <65 yrs old with ≥ 2 risk factors 25 66%
Gender Male / Female (%) 77% 23%
Hypertension (%) 48 80%
Diabetes (%) 11 18%
CAD (%) 21 35%
Prior MI (%) 6 10%
Prior CABG/PTCA (%) 13 22%
Dilated cardiomyopathy (%) 10 17%
Congestive heart failure 13 22%
Ejection fraction (%) 55 ± 10
LA size (mm) 4.4±1.0
Left atrial enlargement
None (%) 8 16%
Mild–moderate (%) 27 54%
Severe (%) 15 30%
CHADS2 score
≤1 36 61%
≥2 23 39%
CABANA Pilot Study; ACC 2010 30335
6. CABANA Pilot Study
Arrhythmia History
QuickTime™ and a
decompressor
are nee ded to see this picture .
Type of AF
Paroxysmal 19 32%
Persistent 22 37%
Long standing persistent 19 32%
Years since first AF episode (yrs) 3.3±4.6
CCS AF severity
Class 1-2 18 32%
Class 3-4 35 61%
Prior anti-arrhythmic drugs (no.)
0 42 70%
1 15 25%
2 3 5%
Hospitalized for AF 28 47%
Direct current cardio-version 32 53%
History of atrial flutter 14 23%
CABANA Pilot Study; ACC 2010 30335
7. CABANA Pilot Study Qui ckTi me™ a nd a
d e co mp re sso r
a re n eed e d to s ee th i s p ic tu re.
Treatment
Drug Therapy Ablation
n=31 29 (100) n=29
100 100 n=25
89%
22
80 71%
80
60 60
n=13
% % 46%
n=11
40 40 38%
5 n=6
16% 21%
20 4
20
13% n=1
4%
0 0
Rate Rhythm Rate & PV WACA/ Linear CFAE GP
rhythm isolation antral Abl
isolation
CABANA Pilot Study; ACC 2010
30335
8. CABANA Pilot Study
Qu ickTim e™ a nd a
de com pres so r
are ne ed ed to see t hi s pi ctu re.
First Post-Blanking AF Event Over Follow-up
Drug (n=31)
Ablation (n=29)
1 st AF episode (%)
n=16
52%
n=7
24% n=4
n=3 n=3
n=1 14%
10% 10%
3%
3-6 6-9 9-12
Months
CABANA Pilot Study; ACC 2010
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9. Freedom from Recurrence of Symptomatic
Atrial Fibrillation Post Blanking Period
100
HR 0.42 (0.19-0.95) P=0.033
80
Freedom from AF
Ablation
recurrence
60
Blanking
65%
period*
40
Drug Rx 41%
20 ∆ 24%
0
0 3 6 9 12
Time (months)
1 28 27 23 20 7
2 31 30 16 13 7
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10. Freedom from Recurrence of
Any Symptomatic AF, AFL, or AT
100
HR 0.46 (0.21-0.99) P=0.042
Freedom from AF/AFL/
80
AT recurrence
Ablation
60 61%
Blanking
period*
∆ 23%
40 38%
Drug Rx
20
0
0 3 6 9 12
Months since treatment start
1 28 27 22 19 7
2 31 30 16 12 6
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11. CABANA Pilot Study
Cross-Overs and Redo Therapy
QuickTime™ and a
decompressor
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Drug Rx Ablation Rx
30 n=31 n=29
n=8 28%
n=6
21%
20
n=4
Pt
13%*
(%)
10
0
Crossover AA Rx Re-ablation
to Abl
CABANA Pilot Study; ACC 2010
*2 failed Ic; 2 failed IIIs 303354
12. Maintenance of Sinus Rhythm Qu ckTi me ™ a nd a
i
d eco mp res so r
a re n e e ded to s ee th i s pictu re.
in CABANA Pilot at 12 Months
AAD Rx Ablation Rx
n=18 n=29
n=17 n=17
n=15
+2 pt +0 pt
n=13
+2 pt
n=5
No AF No AF No AF No AF Non AF
on Rx No drug Late off on drug with redo
drug
CABANA Pilot Study; ACC 2010
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13. CABANA Pilot Study
Recurrence of Any AF, AFL, or AT QuickTime™ and a
decompressor
are nee ded to see this picture .
1.0
HR 0.69 (0.37-1.32) P=0.264
AF/AFL/AT recurrence (%)
(72) Drug
72%
0.8
(59)
66%
0.6
Blanking Ablation
(50)
period
0.4
(36)
0.2
0.0
0 3 6 9 12
Time (months)
Ablation Rx 29 26 18 14 4
Drug Rx 31 30 12 8 5
CABANA Pilot Study; ACC 2010 303354
14. CABANA Pilot Study QuickTime™ and a
decompressor
are nee ded to see this picture .
Perception of Atrial Fibrillation
100
Drug (n=31)
80 Ablation (n=29)
64
Patients (%)
61
60
40
29
20 13
8
4
0
Baseline 3 mo 12 mo
CABANA Pilot Study; ACC 2010
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16. 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
303354
17. 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
303354
18. CABANA Pilot Sites QuickTime™ and a
decompressor
are nee ded to see this picture .
• Mayo Clinic Doug Packer
• Loyola University Dave Wilber
• Mercy Med/Des Moines Steve Bailin
• Ohio State John Hummel
• Intermountain Med Center Crandall/Day
• Good Samaritan Anil Bhandari
• University of Alabama Neal Kay
• Mass General Boston Reddy/Ruskin
• Johns Hopkins Hugh Calkins
• Brigham and Womens Bill Stevenson
• University of Pennsylvania Callans/Marchlinski
Enrolled: 60 of 60 patients
CABANA Pilot Study; ACC 2010
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19. CABANA Pilot Study
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decompressor
are nee ded to see this picture .
Time to Treatment Initiation
Randomization
5 (1,15)
Drug
n=31 To Rx Blanking 90 days
23 (17,42)
Ablation
n=28 To ablation Blanking 90 days
Time
CABANA Pilot Study; ACC 2010
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20. CABANA Pilot Study
Change in LA Size in Ablated Patients
Volume Volume index
Baseline 3 mo Change Baseline 3 mo Change
CABANA Pilot Study; ACC 2010
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