Valvular & structural heart diseaseRandomised controlled trial
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial
- Randomised controlled trial
- investigator-initiated
- prospective
- open-label
- non-inferiority
- 2 Austrian heart centres
Authors' conclusion
CMR-guided TAVR was noninferior to CT-guided TAVR in terms of device implantation success.
Study context
- Population
- Transcatheter aortic valve replacement (TAVR) candidates with severe symptomatic AS, excluding CKD level 4 or 5267 underwent TAVR (mITT)
- Participants
- 380 candidates
- Comparison
- CMR-guided vs computed tomography (CT)-guided TAVR planning
- CMRn = 191
- CTn = 189reference
- Primary endpoint
- VARC-2 implantation success (absence of procedural mortality, correct positioning of a single prosthetic valve, proper prosthetic valve performance)
- Follow-up
- Discharge
Primary result
Implantation success (modified ITT cohort)
Between-group difference
2.8%
90% CI −2.7% to 8.2%
P < 0.01 for non-inferiority
Events by treatment group
CMR vs CT
between-group difference 2.8% (90% CI −2.7% to 8.2%); P for non-inferiority < 0.01
As reported in the abstract
Further findings
Implantation success, per-protocol cohort · discharge
- Between-group difference, per-protocol cohort (n=248)
- 2.0% (90% CI, −3.8% to 7.8%; P<0.01 for noninferiority)
- per-protocol cohort of 248 patients (121 CMR-guided, 127 CT-guided)
- non-inferiority margin 9% (absolute risk difference)
Original publication
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial. Circulation. Published 27 August 2023. doi:10.1161/circulationaha.123.066498
Summarised from the published abstract; every number is checked against it