A randomized clinical trial of catheter ablation and antiarrhythmic drug therapy for suppression of ventricular tachycardia in ischemic cardiomyopathy: The VANISH2 trial

Am Heart J. 2024 Aug:274:1-10. doi: 10.1016/j.ahj.2024.04.009. Epub 2024 Apr 21.

Abstract

Background: Recurrent ventricular tachycardia (VT) in patients with prior myocardial infarction is associated with adverse quality of life and clinical outcomes, despite the presence of implanted defibrillators (ICDs). Suppression of recurrent VT can be accomplished with antiarrhythmic drug therapy or catheter ablation. The Ventricular Tachycardia Antiarrhythmics or Ablation In Structural Heart Disease 2 (VANISH2) trial is designed to determine whether ablation is superior to antiarrhythmic drug therapy as first line therapy for patients with ischemic cardiomyopathy and VT.

Methods: The VANISH2 trial enrolls patients with prior myocardial infarction and VT (with one of: ≥1 ICD shock; ≥3 episodes treated with antitachycardia pacing (ATP) and symptoms; ≥5 episodes treated with ATP regardless of symptoms; ≥3 episodes within 24 hours; or sustained VT treated with electrical cardioversion or pharmacologic conversion). Enrolled patients are classified as either sotalol-eligible, or amiodarone-eligible, and then are randomized to either catheter ablation or to that antiarrhythmic drug therapy, with randomization stratified by drug-eligibility group. Drug therapy, catheter ablation procedures and ICD programming are standardized. All patients will be followed until two years after randomization. The primary endpoint is a composite of mortality at any time, appropriate ICD shock after 14 days, VT storm after 14 days, and treated sustained VT below detection of the ICD after 14 days. The outcomes will be analyzed according to the intention-to-treat principle using survival analysis techniques RESULTS: The results of the VANISH2 trial are intended to provide data to support clinical decisions on how to suppress VT for patients with prior myocardial infarction.

Clinicaltrials: gov registration NCT02830360.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amiodarone / therapeutic use
  • Anti-Arrhythmia Agents* / therapeutic use
  • Cardiomyopathies* / complications
  • Cardiomyopathies* / therapy
  • Catheter Ablation* / methods
  • Combined Modality Therapy
  • Defibrillators, Implantable
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Ischemia* / complications
  • Sotalol / therapeutic use
  • Tachycardia, Ventricular* / therapy
  • Treatment Outcome

Substances

  • Anti-Arrhythmia Agents
  • Amiodarone
  • Sotalol

Associated data

  • ClinicalTrials.gov/NCT02830360