Packer Stop Af1

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  • 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
  • 3. Cryoballoon Ablation STOP-AF Trial
    • Trial Design - Multicenter Randomized Clinical
      • Patients
      • Enrollment
      • Enrolling centers
      • Follow-up
    • Organization
      • Principal Investigator
      • Steering Committee Chair
      • Clinical Events Committee
      • Image Core Laboratory
      • ECG Core Laboratory
      • CRO
      • Study Sponsor
      • 245 (82 DRUG, 163 CRYO)
      • Oct 10, 2006-June 30, 2008
      • 26 (U.S. and Canada)
      • 12 months
      • Douglas Packer, MD
      • Jeremy Ruskin, MD
      • Denis Roy, MD, Andrew Epstein, MD, and Alfred Buxton, MD
      • eImage
      • Agility Research
      • Cato Research
      • Medtronic Cryocath LP
  • 4. STOP-AF Study Hypotheses
        • Primary Effectiveness Hypothesis:
      • Cryoballoon ablation would have significantly greater Treatment Success at 12 months than Drug therapy
    • Co-Primary Safety Hypotheses
      • Cryoablation Major AF Event (MAFE) rate would be non-inferior to DRUG, and
      • Cryoablation Procedure Event (CPE) rate would be < 14.8%
  • 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
  • 6. 1 Study Outcome Measures
    • Effectiveness: freedom from CTF =
      • No detectable AF (non-blanked period)
      • No use of nonstudy drugs
      • No AF interventions
    • Safety
      • MAFE: composite of disease / treatment SAEs
      • CPE (Cryo) only: composite of device/procedure- related SAEs
  • 7. Arctic Front Cryocatheter and Ablation Methods
    • Cryoballoon design
      • Cryoballoon sizes 23 and 28 mm
      • Structure Double balloon
      • Cooling (in balloon) Liquid gas transition
    • Balloon delivery
      • Catheter Steerable
      • Sheath 14 French deflectable
      • Ablation PVI w / no lines
    Focal Catheter 9 Fr, 8mm tip
  • 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
  • 9. Baseline Subject-Reported Arrhythmia Symptom Prevalence in STOP-AF Prior AF hosp Dizziness % Palpitations Rapid heart beat Dyspnea Fatigue Syncope 36 112 34 14 22 78 213 73 140 164 56 108 141 53 88 189 66 123 12 6 6 P=0.451 P=0.415 P=0.552 P=0.775 P=0.132 P=0.423 P=0.224 Subject-reported arrhythmia symptoms Subjects All (n = 245) DRUG (n = 82) CRYO (n = 163)
  • 10. Cryoballoon Procedural Data
    • Acute Procedural Success (APS) 3 PVs isolated at end of first procedure 98.2%
    • Balloon-only per-vein APS of all attempted PVs 90.8%
    • Mean durations:
      • Procedure = 371.0 min (200 650)
      • Cryoablation = 65.7 min (17 180)
      • Fluoro = 62.8 min (8 229)
    • Deliveries / PV 2.9 3.4
    • Cryoballoon temperatures - 49C to - 54C
    • Mean duration / delivery 196 230 secs
    • Repeat cryoablation in 31 Ablation patients
    • all with ERAF within the 90 day follow-up 19%
  • 11. Primary Effectiveness Analysis Treatment Success Treatment success (%) Days P