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3033548-1
Catheter Ablation vsCatheter Ablation vsAntiarrhythmic Drug Therapy for Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the Atrial Fibrillation: Results of the
CABANA Pilot StudyCABANA Pilot Study
Douglas L. Packer, Kerry L. Lee, Daniel B. Mark, Kristi H. Monahan,Douglas L. Packer, Kerry L. Lee, Daniel B. Mark, Kristi H. Monahan,Kathleen L. Hoffmann, Gail E. Hafley, Jeanne E. Poole,Kathleen L. Hoffmann, Gail E. Hafley, Jeanne E. Poole,Tristram D. Bahnson, David J. Bradley, Richard Robb,Tristram D. Bahnson, David J. Bradley, Richard Robb,
Maryam Rettmann, David R. Holmes III, William Stevenson,Maryam Rettmann, David R. Holmes III, William Stevenson,John D. Hummel, Steven J. Bailin, John D. Day, Anil K. Bhandari,John D. Hummel, Steven J. Bailin, John D. Day, Anil K. Bhandari,
Francis Marchlinski, Neil Kay, Hugh Calkins, David J. WilberFrancis Marchlinski, Neil Kay, Hugh Calkins, David J. Wilber
ACC AtlantaACC AtlantaMarch 15, 2010March 15, 2010
3033548-2
Catheter Ablation vsCatheter Ablation vsAntiarrhythmic Drug Therapy for Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the Atrial Fibrillation: Results of the
CABANA Pilot StudyCABANA Pilot Study
Research Relationships (DLP) with Biosense, Acuson, Siemens, Research Relationships (DLP) with Biosense, Acuson, Siemens, Cryocath, EPT, St. Jude, Cardiofocus, Symphony, Prorhythm, NIHCryocath, EPT, St. Jude, Cardiofocus, Symphony, Prorhythm, NIHRoyalties from IP licensed by St. Jude MedicalRoyalties from IP licensed by St. Jude MedicalUnpaid consulting relationships: Medtronic, Boston Scientific,Unpaid consulting relationships: Medtronic, Boston Scientific,St. Jude, Biosense, Siemens, CryocathSt. Jude, Biosense, Siemens, Cryocath
Other information available from Mayo CommunicationsOther information available from Mayo Communications
Funded by St. Jude Medical Foundation,Funded by St. Jude Medical Foundation,St. Paul, MinnesotaSt. Paul, Minnesota
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Purpose of CABANA Pilot StudyPurpose of CABANA Pilot Study
• Determine the freedom from AF withDetermine the freedom from AF withablation vs drug therapy in patients withablation vs drug therapy in patients withmore problematic AF and accompanyingmore problematic AF and accompanyingco-morbiditiesco-morbidities
• Test the feasibility of a long-term pivotal trial Test the feasibility of a long-term pivotal trial for assessing mortality, stroke, hospitalization for assessing mortality, stroke, hospitalization and cost outcomesand cost outcomes
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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Design of the CABANA Pilot StudyDesign of the CABANA Pilot Study
2 paroxysmal AF episodes (2 paroxysmal AF episodes (1 1 hour) over 4 mos or hour) over 4 mos or >>1 persistent 1 persistent AF episode (>1 week)AF episode (>1 week)
65 yr of age, or <65 yr with 65 yr of age, or <65 yr with 1 1 risk factorsrisk factors
HypertensionHypertension
DiabetesDiabetes
Heart failureHeart failure
Prior CVA or TIAPrior CVA or TIA
LA size >5.0 cm (Vol In LA size >5.0 cm (Vol In 40 40 cc/mcc/m22))
EF EF 35 %35 %
• Eligible for ablation and Eligible for ablation and 2 2 rhythm control and/or rhythm control and/or 3 rate 3 rate control drugscontrol drugs
Atrial fibrillationAtrial fibrillationWarranting TherapyWarranting Therapy
Atrial fibrillationAtrial fibrillationWarranting TherapyWarranting Therapy
>>65 yr of age or65 yr of age or<65 yr with <65 yr with 1 CVA risk factor1 CVA risk factor
Eligible for ablation and/ or drug therapyEligible for ablation and/ or drug therapy
>>65 yr of age or65 yr of age or<65 yr with <65 yr with 1 CVA risk factor1 CVA risk factor
Eligible for ablation and/ or drug therapyEligible for ablation and/ or drug therapy
Drug Rx and ACDrug Rx and AC• Rate controlRate control• Rhythm RxRhythm Rx
Drug Rx and ACDrug Rx and AC• Rate controlRate control• Rhythm RxRhythm Rx
1° ablation & AC1° ablation & AC• PV isolationPV isolation• AdjunctiveAdjunctive
1° ablation & AC1° ablation & AC• PV isolationPV isolation• AdjunctiveAdjunctive
Follow-upFollow-up12 months12 monthsFollow-upFollow-up12 months12 months
RRRR
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
Inclusion Criteria
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CABANA Pilot StudyCABANA Pilot StudyBaseline Characteristics in 60 PatientsBaseline Characteristics in 60 Patients
Age (yrs)Age (yrs) 61±1061±10Age <65 yrs old with Age <65 yrs old with 2 risk factors2 risk factors 2525 66%66%Gender Male / Female (%) Gender Male / Female (%) 77%77% 23%23%
Hypertension (%)Hypertension (%) 4848 80%80%Diabetes (%)Diabetes (%) 1111 18%18%CAD (%)CAD (%) 2121 35%35%Prior MI (%)Prior MI (%) 6 6 10%10%Prior CABG/PTCA (%) Prior CABG/PTCA (%) 1313 22%22%Dilated cardiomyopathy (%)Dilated cardiomyopathy (%) 1010 17%17%Congestive heart failureCongestive heart failure 1313 22%22%
Ejection fraction (%)Ejection fraction (%) 55 ± 1055 ± 10LA size (mm)LA size (mm) 4.4±1.04.4±1.0Left atrial enlargementLeft atrial enlargement
None (%)None (%) 8 8 16%16%Mild–moderate (%)Mild–moderate (%) 27 27 54%54%Severe (%)Severe (%) 15 15 30%30%
CHADS2 scoreCHADS2 score11 36 36 61%61%2 2 23 23 39%39%
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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CABANA Pilot StudyCABANA Pilot StudyArrhythmia HistoryArrhythmia History
Type of AFType of AF ParoxysmalParoxysmal 19 32%19 32% Persistent Persistent 22 37%22 37% Long standing persistentLong standing persistent 19 32%19 32%
Years since first AF episode (yrs)Years since first AF episode (yrs) 3.3±4.6 3.3±4.6
CCS AF severityCCS AF severity Class 1-2 Class 1-2 18 32%18 32% Class 3-4 Class 3-4 35 61%35 61%Prior anti-arrhythmic drugs (no.)Prior anti-arrhythmic drugs (no.) 0 0 42 70%42 70% 1 1 15 25%15 25% 2 2 3 5% 3 5%Hospitalized for AFHospitalized for AF 28 47%28 47%Direct current cardio-versionDirect current cardio-version 32 53%32 53%
History of atrial flutterHistory of atrial flutter 14 23%14 23%
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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CABANA Pilot StudyCABANA Pilot StudyTreatmentTreatment
%%
Drug TherapyDrug Therapyn=31n=31
RateRate
100
80
60
40
20
0RhythmRhythm Rate &Rate &
rhythmrhythm
AblationAblationn=29n=29
PVPVisolationisolation
WACA/WACA/antralantral
isolationisolation
LinearLinearAblAbl
CFAECFAE GPGP
%%
100
80
60
40
20
0
n=1346%
n=2589%
n=1138%
n=621%
n=14%
4 13%
5 16%
2271%
29 (100)
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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CABANA Pilot StudyCABANA Pilot StudyFirst Post-Blanking AF Event Over Follow-upFirst Post-Blanking AF Event Over Follow-up
11sts
t AF
ep
iso
de
(%)
AF
ep
iso
de
(%)
MonthsMonths3-63-6 6-96-9 9-129-12
n=16 n=16 52%52%
n=7 n=7 24%24%
n=3 n=3 10%10%
n=3 n=3 10%10% n=1 n=1
3%3%
n=4 n=4 14%14%
Drug (n=31)Drug (n=31)
Ablation (n=29)Ablation (n=29)
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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0
20
40
60
80
100
0 3 6 9 12
Freedom from Recurrence of Freedom from Recurrence of SymptomaticSymptomatic Atrial Fibrillation Post Blanking PeriodAtrial Fibrillation Post Blanking Period
Fre
edo
m f
rom
AF
Fre
edo
m f
rom
AF
recu
rren
cere
curr
ence
Time (months)Time (months)
AblationAblation
Drug RxDrug Rx
HR 0.42 (0.19-0.95) P=0.033HR 0.42 (0.19-0.95) P=0.033
BlankingBlankingperiod*period*
24%24%
11 2828 2727 2323 2020 7722 3131 3030 1616 1313 77
65%65%
41%41%
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0
20
40
60
80
100
0 3 6 9 12
Freedom from Recurrence of Freedom from Recurrence of Any Any SymptomaticSymptomatic AF, AFL, or AT AF, AFL, or AT
11 2828 2727 2222 1919 7722 3131 3030 1616 1212 66
Fre
edo
m f
rom
AF
/AF
L/
Fre
edo
m f
rom
AF
/AF
L/
AT
rec
urr
ence
AT
rec
urr
ence
Months since treatment startMonths since treatment start
AblationAblation
Drug RxDrug Rx
HR 0.46 (0.21-0.99) P=0.042HR 0.46 (0.21-0.99) P=0.042
BlankingBlankingperiod*period*
61%61%
38%38%
23%23%
3033548-12CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
CABANA Pilot StudyCABANA Pilot StudyCross-Overs and Redo TherapyCross-Overs and Redo Therapy
*2 failed Ic; 2 failed IIIs*2 failed Ic; 2 failed IIIs
0
10
20
30
CrossoverCrossoverto Ablto Abl
AA RxAA Rx
n=6 n=6 21%21%
Drug RxDrug Rxn=31n=31
n=4 n=4 13%*13%*
n=8 28%n=8 28%
Ablation RxAblation Rxn=29n=29
PtPt(%)(%)
Re-ablationRe-ablation
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Maintenance of Sinus Rhythm Maintenance of Sinus Rhythm in CABANA Pilot at 12 Monthsin CABANA Pilot at 12 Months
No AFNo AFon Rxon Rx
AAD RxAAD Rxn=18n=18
No AFNo AFNo drugNo drug
No AFNo AFLate offLate off
drugdrug
No AFNo AFon drugon drug
Non AFNon AFwith redowith redo
n=5n=5
Ablation RxAblation Rxn=29n=29
n=13n=13n=15n=15
n=17n=17 n=17n=17
+2 pt+2 pt +0 pt
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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0.0
0.2
0.4
0.6
0.8
1.0
0 3 6 9 12
CABANA Pilot StudyCABANA Pilot StudyRecurrence of Recurrence of AnyAny AF, AFL, or AT AF, AFL, or AT
AF
/AF
L/A
T r
ecu
rren
ce (
%)
AF
/AF
L/A
T r
ecu
rren
ce (
%)
Time (months)Time (months)Ablation RxAblation Rx 2929 2626 1818 1414 44Drug RxDrug Rx 3131 3030 1212 8 8 55
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
DrugDrug
AblationAblation
HR 0.69 (0.37-1.32) P=0.264HR 0.69 (0.37-1.32) P=0.264
(36)(36)
(72)(72)
(50)(50)
72%72%
66%66%(59)(59)
BlankingBlankingperiodperiod
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CABANA Pilot StudyCABANA Pilot StudyPerception of Atrial FibrillationPerception of Atrial Fibrillation
61
8
29
64
4
13
0
20
40
60
80
100
BaselineBaseline 3 mo3 mo 12 mo12 mo
Pat
ien
ts (
%)
Pat
ien
ts (
%)
Drug (n=31)Drug (n=31)
Ablation (n=29)Ablation (n=29)
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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Adverse Events in the CABANA Pilot StudyAdverse Events in the CABANA Pilot StudyAblationAblation Drug RxDrug Rx
n=29n=29 n=31n=31DVT (%)DVT (%) 1 (3.4) 1 (3.4)AV fistula/pseudo aneurysm (%)AV fistula/pseudo aneurysm (%) 2 (6.8) 2 (6.8)CVA/TIA (%)CVA/TIA (%) 1 (3.4) 1 (3.4)PV stenosisPV stenosis
Moderate (50-75%)Moderate (50-75%) 1 (3.4) 1 (3.4)Severe (75-95%)Severe (75-95%) 0 (0)0 (0)
Atrial esophageal fistula (%)Atrial esophageal fistula (%) 0 (0)0 (0)Tamponade (%)Tamponade (%) 1 (3.4) 1 (3.4)Congestive heart failure (%)Congestive heart failure (%) 3 (10.2) 3 (10.2) 1 (3.2) 1 (3.2)Volume overload (%)Volume overload (%) 2 (6.8) 2 (6.8) 0 (0)0 (0)Myocardial infarction (%)Myocardial infarction (%) 1 (3.4) 1 (3.4) 0 (0)0 (0)Bradycardia (%)Bradycardia (%) 1 (3.4) 1 (3.4) 0 (0)0 (0)Ventricular tachycardia (%)Ventricular tachycardia (%) 0 (0)0 (0) 1 (3.2) 1 (3.2)Atrial flutter (%)Atrial flutter (%) 0 (0)0 (0) 1 (3.2) 1 (3.2)LFT increase (%)LFT increase (%) 0 (0)0 (0) 1 (3.2) 1 (3.2)UTI (%)UTI (%) 1 (3.4) 1 (3.4) 0 (0)0 (0)Death, Cardiac Arrest, CVADeath, Cardiac Arrest, CVA 0 (0)0 (0) 0 (0)0 (0)
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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LimitationsLimitations
• Limited number of subjects in this Limited number of subjects in this pilotpilot study study
• Follow-up was limited to 12 monthsFollow-up was limited to 12 months
• As expected a small number of patients crossed As expected a small number of patients crossed over from drug to ablative therapyover from drug to ablative therapy
• Small numbers of at risk patients at 12 months Small numbers of at risk patients at 12 months limiting “late” conclusion that can be drawnlimiting “late” conclusion that can be drawn
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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Conclusion of the CABANA Pilot StudyConclusion of the CABANA Pilot Study
• Ablative intervention was more effective than drug Ablative intervention was more effective than drug therapy for preventing recurrent therapy for preventing recurrent symptomaticsymptomatic atrial atrial fibrillationfibrillation
• Treatment success rates in this population, which Treatment success rates in this population, which include a significant percentage with persistent and include a significant percentage with persistent and long-standing persistent AF, were lower than long-standing persistent AF, were lower than observed in other randomized clinical trialsobserved in other randomized clinical trials
• Late recurrence of AF may reduce long-term Late recurrence of AF may reduce long-term effectiveness of ablationeffectiveness of ablation
• This pilot study establishes the feasibility and This pilot study establishes the feasibility and importance of conducting a pivotal trial for importance of conducting a pivotal trial for establishing long-term outcome, mortality, quality of establishing long-term outcome, mortality, quality of life, and cost of therapy for AFlife, and cost of therapy for AF
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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CABANA Pilot SitesCABANA Pilot Sites
• Mayo ClinicMayo Clinic Doug PackerDoug Packer
• Loyola UniversityLoyola University Dave WilberDave Wilber
• Mercy Med/Des MoinesMercy Med/Des Moines Steve BailinSteve Bailin
• Ohio StateOhio State John HummelJohn Hummel
• Intermountain Med CenterIntermountain Med Center Crandall/DayCrandall/Day
• Good SamaritanGood Samaritan Anil BhandariAnil Bhandari
• University of AlabamaUniversity of Alabama Neal KayNeal Kay
• Mass General BostonMass General Boston Reddy/RuskinReddy/Ruskin
• Johns HopkinsJohns Hopkins Hugh CalkinsHugh Calkins
• Brigham and WomensBrigham and Womens Bill StevensonBill Stevenson
• University of PennsylvaniaUniversity of PennsylvaniaCallans/MarchlinskiCallans/MarchlinskiEnrolled: 60 of 60 patientsEnrolled: 60 of 60 patients
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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CABANA Pilot StudyCABANA Pilot StudyTime to Treatment InitiationTime to Treatment Initiation
Drugn=31
Ablationn=28
Randomization
To ablation
To Rx
5 (1,15)
Blanking 90 daysBlanking 90 days
Blanking 90 daysBlanking 90 days
23 (17,42)
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
Time
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CABANA Pilot StudyCABANA Pilot StudyChange in LA Size in Ablated PatientsChange in LA Size in Ablated Patients
BaselineBaseline 3 mo3 mo ChangeChange
VolumeVolume
BaselineBaseline 3 mo3 mo ChangeChange
Volume indexVolume index
CABANA Pilot Study; ACC 2010CABANA Pilot Study; ACC 2010
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