Title: Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study
1Catheter Ablation vsAntiarrhythmic 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
2Catheter Ablation vsAntiarrhythmic 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, NIHRoyalties
from IP licensed by St. Jude Medical Unpaid
consulting relationships Medtronic, Boston
Scientific,St. Jude, Biosense, Siemens,
Cryocath Other information available from Mayo
Communications
3Disclosures
- The CABANA Pilot study was funded by St. Jude
Medical Foundation. - Dr. D. Packer in the past 12 months has provided
consulting services for Biosense Webster, Inc.,
Boston Scientific, CyberHeart, Medtronic, Inc.,
nContact, Sanofi-Aventis, St. Jude Medical, and
Toray Industries. Dr. Packer received no
personal compensation for these consulting
activities. - Dr. Packer receives research funding from the
NIH, Medtronic, Inc., CryoCath, Siemens AG, EP
Limited, Minnesota Partnership for Biotechnology
and Medical Genomics/ University of Minnesota,
Biosense Webster, Inc. and Boston Scientific. - Mayo Clinic and Drs. D. Packer and R. Robb have a
financial interest in mapping technology that may
have been used at some of the 10 centers
participating in this pilot research. In
accordance with the Bayh-Dole Act, this
technology has been licensed to St. Jude Medical,
and Mayo Clinic and Drs. Packer and Robb have
received annual royalties greater than 10,000,
the federal threshold for significant financial
interest. - Mayo Clinic and Dr. R. Robb have a financial
interest in Analyze-AVW technology that was used
to analyze some of the heart images in this
research. In accordance with the Bayh-Dole Act,
this technology has been licensed to commercial
entities, and both Mayo Clinic and Dr. Robb have
received royalties greater than 10,000, the
federal threshold for significant financial
interest. In addition, Mayo Clinic holds an
equity position in the company to which the AVW
technology has been licensed.
4Purpose of CABANA Pilot Study
- Determine the freedom from AF withablation vs
drug therapy in patients withmore problematic AF
and accompanyingco-morbidities - Test the feasibility of a long-term pivotal trial
for assessing mortality, stroke, hospitalization
and cost outcomes
CABANA Pilot Study ACC 2010
5Design of the CABANA Pilot Study
Inclusion Criteria
- ?2 paroxysmal AF episodes (?1 hour) over 4 mos or
gt1 persistent AF episode (gt1 week) - ?65 yr of age, or lt65 yr with ?1 risk factors
- Hypertension
- Diabetes
- Heart failure
- Prior CVA or TIA
- LA size gt5.0 cm (Vol In ?40 cc/m2)
- EF ?35
- Eligible for ablation and ?2 rhythm control
and/or ?3 rate control drugs
CABANA Pilot Study ACC 2010
6CABANA Pilot StudyBaseline Characteristics in 60
Patients
Age (yrs) 6110 Age lt65 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) 4.41.0 Left atrial
enlargement None () 8 16 Mildmoderate
() 27 54 Severe () 15 30 CHADS2
score ?1 36 61 ?2 23 39
CABANA Pilot Study ACC 2010
7CABANA Pilot StudyArrhythmia History
Type of AF Paroxysmal 19
32 Persistent 22 37
Long standing persistent 19 32 Years
since first AF episode (yrs)
3.34.6 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
8CABANA Pilot StudyTreatment
Drug Therapy n31
Ablation n29
29 (100)
n2589
22 71
n1346
n1138
n6 21
5 16
4 13
n1 4
Rate
Rhythm
Rate rhythm
PVisolation
WACA/antralisolation
LinearAbl
CFAE
GP
CABANA Pilot Study ACC 2010
9CABANA Pilot StudyFirst Post-Blanking AF Event
Over Follow-up
Drug (n31)
Ablation (n29)
n16 52
1st AF episode ()
n7 24
n4 14
n3 10
n3 10
n1 3
3-6
6-9
9-12
Months
CABANA Pilot Study ACC 2010
10Freedom from Recurrence of Symptomatic Atrial
Fibrillation Post Blanking Period
HR 0.42 (0.19-0.95) P0.033
Ablation
65
Freedom from AFrecurrence
Blankingperiod
41
Drug Rx
?24
Time (months)
1 28 27 23 20 7 2 31 30 16 13 7
11Freedom from Recurrence of Any Symptomatic AF,
AFL, or AT
HR 0.46 (0.21-0.99) P0.042
Ablation
61
Freedom from AF/AFL/AT recurrence
Blankingperiod
?23
38
Drug Rx
Months since treatment start
1 28 27 22 19 7 2 31 30 16 12 6
12CABANA Pilot StudyCross-Overs and Redo Therapy
Drug Rx n31
Ablation Rx n29
n8 28
n6 21
n4 13
Pt()
Crossoverto Abl
AA Rx
Re-ablation
CABANA Pilot Study ACC 2010
2 failed Ic 2 failed IIIs
13Maintenance of Sinus Rhythm in CABANA Pilot at
12 Months
AAD Rx n18
Ablation Rx n29
n17
n17
n15
2 pt
0 pt
n13
2 pt
n5
No AFon Rx
No AFNo drug
No AFLate offdrug
No AFon drug
Non AFwith redo
CABANA Pilot Study ACC 2010
14CABANA Pilot StudyRecurrence of Any AF, AFL, or
AT
HR 0.69 (0.37-1.32) P0.264
Drug
(72)
72
(59)
66
Ablation
Blankingperiod
(50)
AF/AFL/AT recurrence ()
(36)
Time (months)
Ablation Rx 29 26 18 14 4 Drug Rx 31 30 12 8 5
CABANA Pilot Study ACC 2010
15CABANA Pilot StudyRecurrence of Any Atrial
Fibrillation
HR 0.56 (0.28-1.11) P0.089
Drug
(66)
69
(55)
? 14
55
Blankingperiod
Probability of recurrence
Ablation
(36)
(25)
Time (months)
Abla Rx 28 26 21 18 5 Drug Rx 31 30 13 10 6
CABANA Pilot Study ACC 2010
16CABANA Pilot StudyPerception of Atrial
Fibrillation
100
Drug (n31)
Ablation (n29)
80
64
61
60
Patients ()
40
29
20
13
8
4
0
Baseline
3 mo
12 mo
CABANA Pilot Study ACC 2010
17Adverse Events in the CABANA Pilot Study
Ablation Drug Rx n29 n31 DVT () 1
(3.4) AV fistula/pseudo aneurysm () 2
(6.8) CVA/TIA () 1 (3.4) PV stenosis Moderate
(50-75) 1 (3.4) Severe (75-95) 0 (0) Atrial
esophageal fistula () 0 (0) Tamponade () 1
(3.4) Congestive heart failure () 3 (10.2)
1 (3.2) Volume overload () 2 (6.8) 0
(0) Myocardial infarction () 1 (3.4) 0
(0) Bradycardia () 1 (3.4) 0 (0) Ventricular
tachycardia () 0 (0) 1 (3.2) Atrial flutter
() 0 (0) 1 (3.2) LFT increase () 0 (0) 1
(3.2) UTI () 1 (3.4) 0 (0) Death, Cardiac
Arrest, CVA 0 (0) 0 (0)
CABANA Pilot Study ACC 2010
18Limitations
- 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
19Conclusion 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
20CABANA Pilot Sites
- 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