Comparison · NCT03168776-sae
BuMA Supreme Coronary Stent System (ITT) vs Durable Polymer EES (XIENCE or Promus DES) (ITT): 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. BuMA Supreme Coronary Stent System (ITT) vs Durable Polymer EES (XIENCE or Promus DES) (ITT): serious adverse events. Trial comparisons, record NCT03168776-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03168776-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 | 0.193 | 0.171 | 0.218 | wilson | |
| Risk in group 2 | 0.208 | 0.176 | 0.244 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0147 | -0.0572 | 0.0256 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.929 | 0.758 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.912 | 0.706 | 1.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on BuMA Supreme Coronary Stent System (ITT) than on Durable Polymer EES (XIENCE or Promus DES) (ITT) | 67.9 | 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 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | 210 | 1,086 | EG000 |
| Group 2 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. | 113 | 543 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 5 Years
Source ClinicalTrials.gov
Trial
- Title
- PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
- NCT number
- NCT03168776
- Phases
- NA
- Conditions
- Coronary Artery Disease
- Interventions
- BuMA Supreme DES, Xience or Promus DES
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Results first posted
- 2026-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03168776?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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