BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) investigated the efficacy and safety of the subcutaneous implantable cardioverter defibrillator (S-ICD) compared with a transvenous ICD (TV-ICD) and showed noninferiority of the S-ICD with regard to the composite end point of device-related complications and inappropriate shocks after 49.1 months. Complications associated with transvenous leads are expected to occur after longer follow-up. The PRAETORIAN-XL trial aims to investigate whether the S-ICD is superior to the TV-ICD with respect to device-related complications at 8-year follow-up. METHODS: The PRAETORIAN trial randomized patients with a class I or IIa indication for ICD therapy without the need for pacing to either S-ICD or TV-ICD among 39 centers in the United States and Europe between March 2011 and January 2017. The follow-up was extended after 49.1 months by an additional 4 years for the PRAETORIAN-XL trial. The primary end point was the composite of all device-related complications. Complications could be related or unrelated to the lead and minor or major, with major complications being those requiring an invasive intervention. End points were analyzed according to the modified intention-to-treat principle using a Fine-Gray subdistribution hazards model to account for competing risks. An as-treated analysis was performed using a Cox proportional hazards model with device type as time-dependent variable. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). Twenty-one percent of the S-ICD group versus 18% of the TV-ICD group were women. The median age at implantation was 63 (interquartile range, 54-69) years for the S-ICD and 64 (interquartile range, 56-69) years for the TV-ICD. After a median follow-up of 87.5 months, all device-related complications (major and minor combined) were not significantly different in the modified intention-to-treat analysis (subdistribution hazard ratio, 0.73 [95% CI, 0.48-1.12]); P=0.15). However, TV-ICD patients more often had a major complication or lead-related complication (P=0.03 and P<0.001, respectively). Moreover, the as-treated analysis showed significantly more complications in patients with a TV-ICD compared with an S-ICD (hazard ratio, 0.64 [95% CI, 0.41-0.99]; P=0.047). CONCLUSIONS: The PRAETORIAN-XL trial demonstrated that there was no significant difference between the S-ICD and TV-ICD in all device-related complications during long-term follow-up. However, the TV-ICD carries a higher risk of major and lead-related complications compared with S-ICD therapy. The S-ICD should therefore be considered for all patients without a pacing indication who are evaluated for ICD therapy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

1st Department of Medicine University Medical Center Mannheim Mannheim Germany

Christian Albrechts University Kiel Kiel Germany

CorVita Science Foundation Chicago IL

Department of Cardiology Amphia Hospital Breda the Netherlands

Department of Cardiology and Amsterdam Cardiovascular Sciences

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Center Maastricht the Netherlands

Department of Cardiology Flevoziekenhuis Almere the Netherlands

Department of Cardiology Homolka Hospital Prague Czech Republic

Department of Cardiology Isala Heart Centre Zwolle the Netherlands

Department of Cardiology OLVG Amsterdam the Netherlands

Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands

Department of Cardiology St Antonius Hospital Nieuwegein the Netherlands

Department of Cardiology Tergooi MC Blaricum the Netherlands

Department of Cardiology The Heart Centre Rigshospitalet University of Copenhagen Copenhagen Denmark

Department of Cardiology University of Amsterdam Amsterdam the Netherlands

Department of Electrophysiology Heart Center at University of Leipzig Leipzig Germany

Department of Medicine 1 Ludwig Maximillians University Hospital München Germany

Department of Medicine Cardiology Columbia University Irving Medical Center New York NY

Department of Medicine Englewood Hospital and Medical Center Englewood NJ

Division of Cardiology Northwestern Memorial Hospital Northwestern University Chicago IL

Division of Cardiology Section of Electrophysiology Emory University Atlanta GA

European Reference Network for Rare Low Prevalence and Complex Diseases of the Heart ERN GUARD Heart

German Center for Cardiovascular Research Munich Heart Alliance Munich Germany

German Center for Cardiovascular Research Partner Site Heidelberg Mannheim Germany

Heart Surgery Heart Center Dresden Carl Gustav Carus Medical Faculty Dresden University of Technology Dresden Germany

Icahn School of Medicine at Mount Sinai Mount Sinai Hospital New York NY

Liverpool Heart and Chest Hospital Liverpool United Kingdom

Medical Spectrum Twente Enschede the Netherlands

Medisch Centrum Leeuwarden Leeuwarden the Netherlands

National Heart and Lung Institute Imperial College London London United Kingdom

Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services University College London and Barts Heart Centre London United Kingdom

Oxford Biomedical Research Centre Oxford University Hospitals NHS Trust Oxford United Kingdom

St George's University Hospitals NHS Foundation Trust London United Kingdom

St George's University of London London United Kingdom

The Valley Health System Ridgewood NJ

University and University Hospital Würzburg Würzburg Germany

Werkgroep Cardiologische Centra Nederland Utrecht the Netherlands

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ClinicalTrials.gov
NCT01296022