Comparison · NCT01314313-deaths
PIIA: SAPIEN XT - 2 Year vs Control: SAVR - 2 Year: deaths from any cause
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. PIIA: SAPIEN XT - 2 Year vs Control: SAVR - 2 Year: deaths from any cause. Trial comparisons, record NCT01314313-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01314313-deaths
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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 | 0.164 | 0.143 | 0.188 | wilson | |
| Risk in group 2 | 0.167 | 0.145 | 0.191 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00231 | -0.0346 | 0.03 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.986 | 0.811 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.983 | 0.778 | 1.24 | log | |
| Number needed to treat, for one fewer death from any cause on PIIA: SAPIEN XT - 2 Year than on Control: SAVR - 2 Year | 433 | from the risk difference interval | the interval includes no difference |
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 | PIIA: SAPIEN XT - 2 Year | Edwards SAPIEN XT Transcatheter Heart Valve (THV) | 166 | 1,011 | EG000 |
| Group 2 | Control: SAVR - 2 Year | Surgical Aortic Valve Replacement (SAVR)~NOTE: SAVR with surgical bioprosthetic heart valve is the control arm. | 170 | 1,021 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock.
Source ClinicalTrials.gov
Trial
- Title
- PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
- NCT number
- NCT01314313
- Phases
- NA
- Conditions
- Symptomatic Severe Aortic Stenosis
- Interventions
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Lead sponsor
- Edwards Lifesciences
- Results first posted
- 2018-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01314313?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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