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CARDIOSTIM 2016 LATE BREAKING CLINICAL TRIAL

FIRE AND ICE℠ AF Ablation Clinical Trial

Secondary Analyses: Reintervention, Rehospitalization, and Quality-of-Life Outcomes

INTRODUCTION

FIRE AND ICE is the largest randomized trial demonstrating non-inferiority of cryoballoon vs. radiofrequency ablation1

Current analysis examines secondary parameters important in a comprehensive clinically meaningful evaluation

Published studies have reported:

Nearly 40% hospitalization rates <1 year post-AF ablation2,3

AF-related readmission rates as high as 22%2,3

Approximately 10% of patients have a repeat ablation <1 year2,3,4

1. Kuck, et al. N Engl J Med 2016 [Epub ahead of print]. 2. Shah, et al. J AM Coll Cardiol. 2012; 59: 143-149. 3. Opolski, et al. Cardiol J. 2015: 22(6): 630-636. 4. Calkins, et al. Europace. 2012; 14:528-606.

FIREANDICE AF Ablation Clinical Trial

OBJECTIVES Evaluate clinical patient management after PVI by either:

Cryoablation (Arctic Front™ / Arctic Front Advance™ catheters) guided by fluoroscopy (or)

RFC ablation (THERMOCOOL® / THERMOCOOL® SF / THERMOCOOL

SMARTTOUCH® catheters) guided by fluoroscopy and CARTO® 3D mapping system

Secondary analyses:

Cardiovascular hospitalization* (including AF hospitalization†)

Repeat ablation*

Quality-of-life*

All-cause hospitalization

Direct current cardioversion (DCCV)

* Predefined secondary analyses † Not predefined but included in analyses


METHODS

Key Inclusion Criteria

Symptomatic PAF

Prior AAD failure

≥ 18 & ≤ 75 years of age

Key Exclusion Criteria

Previous LA ablation or surgery

PCI, MI within 3M of enrollment

Stroke/TIA within 6M of enrollment

LVEF < 35%

LA diameter > 55 mm


METHODS

Investigators must have documented experience

≥ 50 cases with either technology

PVI-only approach

Sites reported all hospitalizations / reinterventions

Cardiovascular-related, repeat ablations, and DCCVs

Defined as prolonged stay ≥2 nights post-index procedure or in-patient stay not concurrent with index procedure ≥1 calendar day

Quality-of-life assessed every 6 months using SF-12 and EQ-5D-3L


COMMITTEES

Steering Committee Prof. Dr. Karl-Heinz Kuck – PI Hamburg, DE

Prof. Dr. Josep Brugada Barcelona, ES

Dr. Alexander Fürnkranz Frankfurt, DE

Dr. Jean-Paul Albenque Toulouse, FR

Prof. Dr. Claudio Tondo Milan, IT

Prof. Dr. Stuart Pocock London, UK

PD Dr. Kurt Bestehorn Munich, DE

Independent Endpoint Review Committee

Prof. Dr. Thorsten Lewalter – Chairman Munich, DE

Dr. Malte Kuniss Bad Nauheim, DE

Prof. Dr. Lars Lickfett Moenchengladbach, DE

Independent Data & Safety Monitoring Board

Prof. Dr. Hein J. J. Wellens – Chairman Maastricht, NL

Dr. Ricardo Cappato Milano, IT

Dr. David Wyn Davies London, UK

Dr. Jan Tijssen – Statistician Amsterdam, NL


RESULTS

SUBJECT FLOW CHART


DEMOGRAPHICS

Demographics RFC (N=376) Cryoballoon (N=374) P-Value*

Gender (male,%) 236 (63%) 221 (59%) 0.30

Age (years) 60.1 ± 9.2 59.9 ± 9.8 0.83

BMI (kg/m2) 27.8 ± 4.5 28.0 ± 4.7 0.66

CHA2DS2-VASc score (N, %) 0.19**

0 58 (15.5%) 67 (17.8%)

1 108 (28.9%) 109 (29.0%)

2 95 (25.4%) 97 (25.8%)

3 60 (16.0%) 62 (16.5%)

4 40 (10.7%) 33 (8.8%)

5 10 (2.7%) 7 (1.9%)

6 3 (0.8%) 1 (0.3%)

First PAF diagnosis (years) 4.7 ± 5.3 4.6 ± 5.1 0.97

Left atrial dimension (mm) 40.6 ± 5.8 40.8 ± 6.5 0.58

Previous DC cardioversion (N,%) 88 (23.4%) 86 (23.0%) 0.89

Systolic blood pressure (mm Hg) 134.8 ± 18.9 133.6 ± 18.0 0.40

Diastolic blood pressure (mm Hg) 78.9 ± 10.6 78.8 ± 11.5 0.83

* t-test for continuous variables, Fisher ’s exact test for dichotomous ** Cochran-Mantel-Haenszel statistics


FREEDOM FROM ALL-CAUSE HOSPITALIZATION

Modified ITT Analysis

Cryo: 210 events in 122 subjects (122/374; 32.6%)

RFC: 267 events in 156 subjects (156/376; 41.5%)

Event Free Survival Total Events


FREEDOM FROM CARDIOVASCULAR HOSPITALIZATION


Cryo:139 events in 89 subjects (89/374; 23.8%)

RFC:203 events in 135 subjects (135/376; 35.9%)



FREEDOM FROM CARDIOVASCULAR HOSPITALIZATION SUBGROUP ANALYSIS OF BASELINE CHARACTERISTICS


FREEDOM FROM CARDIOVASCULAR HOSPITALIZATION SUBGROUP ANALYSIS OF SUBJECTS WITH BASELINE DCCV

Subjects with a CV Hospitalization (n, %)

P-Value*

Cryoballoon No Prior DCCV

71/288 (24.7%)

<0.01 RFC No Prior DCCV

92/288 (31.9%)

Cryoballoon Prior DCCV

18/86 (20.9%)

=0.05 RFC Prior DCCV

43/88 (48.9%)

Cardiovascular Hospitalization

* P-value from interaction term in Cox regression model


FREEDOM FROM DIRECT CURRENT CARDIOVERSION






FREEDOM FROM REPEAT ABLATION






SUBJECT QUALITY-OF-LIFE

Summary of SF-12 Data at Baseline and 6 Months

Quality-of-life improved during follow-up in both groups and was maintained throughout 30 months

Baseline 6 Months ∆ P-Value*

Cryoballoon

N=258

Mental 47.1±10.3 51.1±8.9 4.0±9.8 <0.01

Physical 43.7±9.1 47.0±9.1 3.2±8.2 <0.01

RFC

N=267

Mental 48.9±9.8 50.8±8.8 1.9±9.9 <0.01

Physical 44.5±9.5 47.6±8.6 3.1±8.6 <0.01 35

40

45

50

55

60

65

Baseline 6 12 18 24 30

Follow-up Visit (Months)

Cryo - Mental

Cryo - Physical

RFC - Mental

RFC - Physical

Me

an

SF

-12

Sco

re

* t-test



CONCLUSIONS

Subjects treated with cryoballoon compared to RFC had significantly fewer:

Cardiovascular hospitalizations*

Includes AF hospitalizations† (218/342, 63.7%)

Repeat ablations*

All-cause hospitalizations

Direct current cardioversions

Both patient groups demonstrated improved quality-of-life scores after an AF ablation*

The secondary analyses favor cryoballoon over RFC, with important implications on daily clinical practice

* Predefined secondary analyses † Not predefined but included in analyses

BACK UP

PARTICIPATING SITES Investigator Center Country

Prof. Dr. Karl-Heinz Kuck Asklepios Klinik St. Georg, Hamburg Germany

Dr. Julian Chun Cardioangiologisches Centrum Bethanien CCB, Frankfurt Germany

Dr. Arif Elvan Isala Klinieken, Zwolle The Netherlands

Prof. Dr. Thomas Arentz Krozingen University Heart Center Freiburg, Bad Krozingen Germany

PD Dr. Michael Kühne Universitätsspital, Basel Switzerland

Dr. Laszlo Gellér Semmelweis Egyetem, Budapest Hungary

Dr. Matthias Busch Universitaetsmedizin, Greifswald Germany

Dr. Lluis Mont Hospital Clinic de Barcelona, Barcelona Spain

Dr. Alberto Barrera Hospital Clínico Universitario “Virgen de la Victoria”, Malaga Spain

PD Dr. Thomas Deneke Herz-und Gefaess-Klinik, Bad Neustadt Germany

Dr. Jean-Paul Albenque Clinique Pasteur, Toulouse France

Prof. Dr. Volker Kühlkamp Herz-Zentrum Bodensee, Konstanz Germany

Prof. Dr. Claudio Tondo Centro Cardiologico Monzino University of Milan, Milan Italy

Dr. Ricardo Ruiz-Granell Hospital Clinico Universitario, Valencia Spain

Prof. Petr Neuzil Na Homolce Hospital, Prague Czech Republic

Dr. Nicasio Pérez-Castellano Hospital Clinico San Carlos, Madrid Spain


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