title: Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study).
abstract: BACKGROUND
  The implantable cardioverter-defibrillator (ICD) is the standard therapy to prevent sudden cardiac death in patients with coronary artery disease and unstable ventricular tachyarrhythmias. The prospective multinational SMS (Substrate Modification Study) was designed to assess whether prophylactic ablation of the arrhythmogenic substrate reduces or prevents the recurrence of ventricular tachycardia/ventricular fibrillation in such patients.
  
  
  RESULTS
  Of 111 patients included in an intention-to-treat analysis, 54 were randomly assigned catheter ablation plus ICD implantation (ablation group: 68±8 years; 47 men), whereas 57 were assigned ICD implantation without catheter ablation (ICD-only group: 66±8 years; 46 men). Primary study end point was the time to first recurrence of ventricular tachycardia/ventricular fibrillation. ICD episodes were assessed and verified by an independent board. Patients were followed up for 2.3±1.1 years. The primary end point was reached by 25 ablation patients and 26 ICD-only patients. Two-year event-free survival was estimated at 49.0% (95% confidence interval, 33.3%-62.9%) in the former and 52.4% (36.7%-65.9%) in the latter groups. Comparison of episode incidence revealed no significant difference in the primary end point (P=0.84). In an Andersen-Gill regression model with multiple end point recurrences, the difference between the study arms significantly favored catheter ablation for both the primary end point and all but one of the predefined subgroups of detected arrhythmia events.
  
  
  CONCLUSIONS
  SMS failed to meet the primary end point of time to first ventricular tachycardia/ventricular fibrillation recurrence. However, catheter ablation did reduce the total number of ICD interventions during the duration of follow-up.
  
  
  BACKGROUND
  https://clinicaltrials.gov. Unique identifier: NCT00170287.
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.). k.kuck@asklepios.com.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Roland Richard
authors.initials: RR
authors.lastname: Tilz
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Deneke
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Boris A
authors.initials: BA
authors.lastname: Hoffmann
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Ventura
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Peter Steen
authors.initials: PS
authors.lastname: Hansen
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Markus
authors.initials: M
authors.lastname: Zarse
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Josef
authors.initials: J
authors.lastname: Kautzner
authors.affiliation: From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
authors.forename: Stephan
authors.initials: S
authors.lastname: Willems
mesh_terms: D000328:Adult; D000368:Aged; D018780:Body Surface Potential Mapping; D017115:Catheter Ablation / Q000379:methods* / Q000401:mortality; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016016:Proportional Hazards Models; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D017180:Tachycardia, Ventricular / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*
keywords: catheter ablation; coronary artery disease; defibrillators, implantable; prognosis; quality of life