Comparison · NCT02389946-sae
Orsiro Sirolimus Coronary Stent System vs Xience Everolimus Coronary Stent System: 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. Orsiro Sirolimus Coronary Stent System vs Xience Everolimus Coronary Stent System: serious adverse events. Trial comparisons, record NCT02389946-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02389946-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 | 0.62 | 0.587 | 0.651 | wilson | |
| Risk in group 2 | 0.651 | 0.606 | 0.694 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0312 | -0.0847 | 0.0238 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.952 | 0.874 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.874 | 0.69 | 1.11 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Orsiro Sirolimus Coronary Stent System than on Xience Everolimus Coronary Stent System | 32 | 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 | Orsiro Sirolimus Coronary Stent System | Intervention with a Orsiro DES.~Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating. | 548 | 884 | EG000 |
| Group 2 | Xience Everolimus Coronary Stent System | Intervention with a Xience DES.~Xience DES | 293 | 450 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 5 year
Source ClinicalTrials.gov
Trial
- Title
- Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
- NCT number
- NCT02389946
- Phases
- NA
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndrome, Angina Pectoris
- Interventions
- Orsiro DES, Xience DES
- Lead sponsor
- Biotronik, Inc.
- Results first posted
- 2019-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02389946?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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