Comparison · NCT01586910-sae
Medtronic CoreValve® System TAVI vs SAVR: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Medtronic CoreValve® System TAVI vs SAVR: serious adverse events. Trial comparisons, record NCT01586910-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01586910-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.831 | 0.805 | 0.855 | wilson | |
| Risk in group 2 | 0.872 | 0.847 | 0.893 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0408 | -0.0749 | -0.00651 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.953 | 0.916 | 0.992 | log | |
| Odds ratio, group 1 over group 2 | 0.723 | 0.55 | 0.95 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Medtronic CoreValve® System TAVI than on SAVR | 24.5 | 13.4 | 154 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Medtronic CoreValve® System TAVI | Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)~Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) | 718 | 864 | EG000 |
| Group 2 | SAVR | Surgical Aortic Valve Replacement (SAVR) | 694 | 796 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
- NCT number
- NCT01586910
- Phases
- NA
- Conditions
- Severe Aortic Stenosis
- Interventions
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Lead sponsor
- Medtronic Cardiovascular
- Results first posted
- 2019-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01586910?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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