Arrhythmias & electrophysiologyRandomised controlled trial
Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial
- Randomised controlled trial (long-term follow-up extension of the PRAETORIAN trial)
- multicentre
- superiority
- modified intention-to-treat
- as-treated analysis
Authors' conclusion
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.
Study context
- Population
- Patients with a class I or IIa indication for ICD therapy without need for pacing, 39 centres in the US and Europe, 2011–2017
- Participants
- 426 vs 423
- Comparison
- Subcutaneous implantable cardioverter defibrillator (S-ICD) vs transvenous ICD (TV-ICD)
- S-ICDn = 426
- TV-ICDn = 423reference
- Primary endpoint
- Composite of all device-related complications
- Follow-up
- Median 87.5 months
Primary result
As reported in the abstract
All device-related complications (major and minor combined)
All device-related complications not significantly different
subdistribution HR 0.73 (0.48-1.12); P=0.15 (95% CI)
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| All device-related complications, as-treated analysis · significantly more complications with TV-ICD · as-treated · Cox model, device type time-dependent | 0.64 (0.41–0.99) | P = 0.047 | |
| 0.512Hazard ratio (log scale) |
Major complications; lead-related complications
- Major complications more often with TV-ICD
- P = 0.03
- Lead-related complications more often with TV-ICD
- P < 0.001
Original publication
Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial. Circulation. Published 25 April 2025. doi:10.1161/circulationaha.125.074576
Summarised from the published abstract; every number is checked against it