Valvular & structural heart disease
Representativeness of surgical controls in aortic valve replacement trials: comparison with routine surgical cohorts
Authors' conclusion
Compared with typical SAVR patients treated in routine practice, RCT SAVR patients experienced higher complication rates and worse long-term survival, despite similar or lower surgical risk scores. These findings question the external validity of SAVR versus TAVI trials.
Study context
- Population
- Low-risk or intermediate-risk patients undergoing surgical aortic valve replacement (SAVR) in randomised controlled trials (RCTs) comparing transcatheter aortic valve implantation (TAVI) and SAVR, and in routine clinical practiceSAVR patients in 19 studies (9 RCTs and 10 studies describing routine clinical practice) · RCTs 9 · studies describing routine clinical practice 10
- Participants
- 74,797 participants
- Comparison
- Patient characteristics, early outcomes and 5-year survival compared between RCT SAVR cohorts and those treated in routine clinical practice settings
- Outcome
- Early mortality
Methodological detailsRCTs and large prospective studies (n≥500 SAVR patients), low-risk or intermediate-risk patients since 2010, stratification by risk category
- RCTs and large prospective studies (n≥500 SAVR patients)
- Low-risk or intermediate-risk patients since 2010
- Stratification by risk category
Pooled result
As reported in the abstract
- Comparable early mortality in routine clinical practice vs RCT SAVR patients
Further pooled results
| Outcome | HR (95% CI) | |
|---|---|---|
| Overall survival · 5 years | 0.64 (0.55–0.75) | |
| 0.512Hazard ratio (log scale) |
- Overall survival: low-risk patients; survival higher in routine clinical practice
Periprocedural complications (stroke, pacemaker implantation, myocardial infarction)
- Fewer periprocedural complications in routine clinical practice, including lower rates of stroke, pacemaker implantation and myocardial infarction
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Representativeness of surgical controls in aortic valve replacement trials: comparison with routine surgical cohorts. Heart. Published 8 July 2025. doi:10.
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