1. Cryoballoon Ablation of Pulmonary Veins for Paroxysmal Atrial Fibrillation First Results of the North American Arctic Front STOP-AF Pivotal Trial Douglas L. Packer, James M. Irwin, Jean Champagne, Peter G. Guerra, Marc Dubuc, Kevin R. Wheelan, Robert C. Kowal, Vivek Reddy, John W. Lehmann, Richard G. Holcomb, Jeremy N. Ruskin for the STOP-AF Cryoablation Investigators ACC Atlanta March 15, 2010
2. Disclosure Information Dr. D. Packer in the past 12 months has provided consulting services for Biosense Webster, Inc., Biotronik, Inc., Boston Scientific, CyberHeart, InnerPulse, 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., Siemens AG, EP Limited, Minnesota Partnership for Biotechnology and Medical Genomics/ University of Minnesota, Biosense Webster, Inc. and Boston Scientific. Additional information available from Mayo Communications
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5. Study Design of the STOP-AF Trial Follow- up 1,3,6,9, &12 mo Holters Weekly TTMs Inclusions: Patients >2 AF episodes in 2 months w ECG doc. of 1 Rx Failure of > 1 AA Rx Blanking period (90 day) Redo ablation n=31 Drug optimization 90 days AA Rx failure n=304 Randomized 2:1 to ablation vs. Drug Rx Screening Exclusion n=46 Consent withdrawal n=7 Screening failure n=6 Cryoballoon ablation n=163 Drug Rx n=82 Cross-over n=65
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8. Baseline Characteristics * p value for comparison between DRUG and CRYO subjects Baseline/demographic ALL DRUG CRYO p value* Age (years) 56.6 56.4 56.7 0.80 Male (%) 77% 78% 76% 0.87 Left atrial AP diameter (mm) 40.5 40.9 40.3 0.35 LV ejection fraction (%) 60% 61% 60% 0.41 NYHA None / Class I (%) 94% 94% 93% 1.00 Class II (%) 6.5% 6.1% 6.7% 1.00 AF episodes within 2 mo (no.) 23.2 21.2 24.3 0.54 Previous cardioversion (%) 22% 21% 23% 0.87 History of atrial flutter (%) 45% 44% 46% 0.79 Efficacy-failed AF drugs Flecainide (%) 36% 35% 37% 0.87 Propafenone (%) 47% 44% 49% 0.50 Sotalol (%) 29% 31% 29% 0.88 CHADS2 0.6 0.6 0.6 0.92 Overall SF-36 (v2) score 70.6 70.4 70.8 0.87
11. Primary Effectiveness Analysis Treatment Success Treatment success (%) Days P<0.001 vs 7.3% (SE 2.9%) CRYO 69.9% 114/163 Blanked DRUG Rx 7.3% 6/82 30 days KM estimate 68.6% (SE 3.9%)
12. Treatment Success By Analysis Method On Rx DRUG n = 82 % CRYO n = 163 (19% redo) p < 0.001 Absolute 62.6% n = 6 7.3% n = 114 69.9% n = 94 (57.7%) No Drug n = 20 12.3% n = 98 60.1 % Absolute 56.8% p < 0.001 9% 65.8% On-Treatment Analysis CRYO on / off drug n = 163 CRYO single proc n = 163 DRUG n = 67 CRYO n = 114 Intention to Treat On / Off Drug Single Ablation
13. Ongoing Drug Rx in CRYO Subjects Treatment in STOP-AF at 12 Months Pt (%) Anti-arrhythmic Drugs Warfarin 100 80 60 40 20 0 100% 26% 95% 24%
17. Pulmonary Vein Area Change Pulmonary veins (no.) Cryoablated pulmonary veins, change in cross sectional area from baseline -100% -75% -50% -25% -0% +25% >+100% 10, 1.1% 23, 2.5% 180, 19.4% 433, 46.7% 219, 23.6% 35, 3.8% n = 927 cryoablated PVs 10 stenotic PVs in 7 pts >75% area change 1 cryo abl only in 4 pts 2 cryo abls in 2 pts 1 RF redo in 1 pt
18. Phrenic Nerve Paralysis in the STOP-AF Trial in 228 Patients Immediate post-procedure Resolved at 12 mo Persisting at 12 mo 11.2% n=29 86.2% n=25 13.8% n=4 28 patients 1 with Sx
