PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease (NCT03168776), a randomized na study. The primary outcome is Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements.

2. Clinical Question

3. Trial Design

PIONEER III was a prospective, global, multicenter, randomized, single-blind, parallel-group trial. The brief summary describes a 2:1 randomization and says the study planned to enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. The registry lists enrollment as 1629. The listed phase is NA.

The comparison was between the BuMA Supreme biodegradable drug-coated coronary stent and Xience or Promus durable-polymer drug-eluting stents. The trial was intended for patients with stable coronary artery disease or non-ST segment elevation acute coronary syndromes, with up to 3 coronary lesions. The registry record identifies the sponsor as Sino Medical Sciences Technology Inc. and lists the study status as completed. The recorded study start was 2017-10-13, and primary completion was 2020-10-01.

The planned clinical follow-up schedule included the in-hospital period, 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years. These are the timepoints described in the trial summary; the registry information does not establish that every participant completed every follow-up. The primary endpoint was assessed at 12 months. The design description identifies a single-blind study, but the registry information does not specify which participants or study personnel were masked. Further details of sequence generation, allocation concealment, site procedures, and the statistical analysis plan are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Baseline Analysis Population excludes 1 subject from the ITT Population who was withdrawn from the study after informed consent but prior to receiving a study device.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements, measured over 12 months.

The primary endpoint is the percentage of participants with target lesion failure (TLF) at 12 months. The registry defines TLF as a composite of cardiac death, target-vessel-related myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). The endpoint therefore counts participants who experience one or more of these specified events within the endpoint’s assessment period; the record does not provide component-specific primary-endpoint results.

In general, a composite endpoint can capture several clinically important outcomes in one measure. It may also make an overall comparison more informative when the components represent related aspects of a clinical problem. But the composite result does not, by itself, show which component contributes most, whether the components have similar importance, or whether every component moves in the same direction. Component-level results and the rules for assigning events are important for interpreting a composite; the record identifies the components but does not report the primary endpoint’s numerical results or detailed event-adjudication procedures.

The percentage describes the proportion of participants meeting the endpoint definition, rather than the number of events alone. The record specifies a 95% confidence interval as the endpoint’s dispersion measure. Neither the group-specific percentages nor their confidence intervals are reported in the registry record, so the primary comparison’s magnitude and precision cannot be assessed from the posted information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group design. In general, random allocation aims to make treatment groups comparable at the start of a trial with respect to both measured and unmeasured characteristics. It does not guarantee that every characteristic will be balanced, and it does not replace clear reporting of outcome results, missing data, and the analysis population. The record describes the trial as single blind, but does not say which individuals were masked or explain how masking was maintained.

What does the primary endpoint estimate?

The primary endpoint is a percentage of participants with TLF at 12 months. For a binary endpoint, each participant is classified as meeting or not meeting the event definition for the stated assessment period. A group percentage expresses the frequency of participants meeting that definition within that group. The registry record specifies the composite components—cardiac death, TV-MI, and clinically driven TLR—but does not report the group percentages. No new estimate can be recovered from the endpoint description alone.

The registry names a 95% confidence interval as the measure of dispersion for the primary endpoint. In general, a confidence interval conveys the statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval’s interpretation also depends on the estimand and analysis method. The record does not give the intervals or explain how they were calculated. It is therefore not possible to assess the primary estimate’s precision or use an interval to evaluate compatibility with possible effects.

Why is a composite endpoint used?

In general, a composite brings multiple event types together into a single endpoint. This can capture a broader range of clinically relevant outcomes, but it can obscure differences among the components. A composite percentage does not reveal how many participants had cardiac death, TV-MI, or clinically driven TLR individually, and the record does not report component-specific primary findings. The clinical interpretation depends on the endpoint definition and on the observed contribution of each component, not merely on the label “TLF.”

How should the safety counts be read?

The registry reports serious adverse event counts alongside the number at risk in each ITT group. In general, a count indicates how many participants were recorded as affected, while the at-risk number gives the group denominator for that summary. Counts alone are not a complete comparison when group sizes differ. A comparative interpretation would normally require clearly defined observation periods and suitable estimates with uncertainty. The record does not report such estimates for these safety figures. It also does not provide enough detail to determine the event-specific observation period or adjudication process.

The ITT label indicates that the reported group summaries are associated with the intention-to-treat population. In general, an ITT approach analyzes participants according to their randomized group, which helps preserve the comparison created by randomization. The registry entry does not provide an analysis description explaining how participants with missing outcome information, protocol deviations, or incomplete follow-up were handled. The label alone cannot establish that every randomized participant had complete data for every outcome.

What can planning calculations tell readers?

Planning calculations are illustrations of the sample size that might be needed under specified assumptions; they are not estimates of the trial’s observed treatment effect and are not observed power. The record’s planning note describes a two-sided significance level of 0.05, equal allocation for the illustration, a normal approximation, and an effect defined as a stated fraction of the observed effect. It also distinguishes event totals for time-to-event calculations from participants per arm for other calculations. Those assumptions describe the planning illustration, not necessarily the trial’s original design. The registry does not report the trial’s sample-size justification or establish that the planning assumptions were part of the original protocol.

Statistical interpretation also depends on whether the endpoint was analyzed as planned, whether outcome ascertainment was consistent, and whether follow-up was sufficiently complete. Those details are not reported in the registry record. Since the primary estimate and its confidence interval are also absent, the posted information does not support a detailed assessment of model assumptions, precision, or the strength of evidence for a difference.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists several secondary outcomes, including cardiac death, MACE, myocardial infarction, stent thrombosis, bleeding complications, lesion success, device success, and procedure success. It does not report a multiplicity strategy for interpreting multiple outcomes. In general, testing many outcomes can increase the chance of at least one apparently unusual result, so an analysis plan may specify how such comparisons will be handled. Whether this trial used an adjustment, a hierarchy, or another approach is not reported in the registry record.

The record lists no analysis entries. It does not provide a statistical analysis plan, identify prespecified subgroup analyses, or describe interim analyses. These details should not be inferred from the randomized design or from the endpoint list. The registry also does not report how missing outcomes, loss to follow-up, withdrawals, or participants with incomplete endpoint information were handled. The planned follow-up schedule is described, but planned visits do not establish completeness of observed follow-up.

The primary endpoint is named and defined, but group estimates and confidence intervals are absent. The registry record therefore does not allow readers to assess the primary comparison, judge the effect of missing data, or determine how multiple outcomes were interpreted. These gaps limit the statistical conclusions that can be drawn from the posted record; they do not demonstrate that the trial team did or did not conduct analyses that are not described there.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: mace (20.8%).

The registry lists serious adverse event summaries for the ITT groups. For BuMA Supreme, 1086 participants were listed at risk and 210 were listed as affected; for durable-polymer EES (XIENCE or Promus DES), 543 were listed at risk and 113 were listed as affected. The record separately lists 79 deaths and 41 deaths, respectively. These figures should be read as counts within the stated groups, not as evidence of a difference between them. The group sizes are unequal, and the registry does not provide comparative estimates, confidence intervals, or statistical tests for these summaries.

MACE is listed as a serious adverse event term at 20.8%. The record does not identify a group-specific denominator for that percentage in the information available. It should therefore not be treated as an arm-to-arm comparison or as the trial’s primary endpoint result. Although the primary TLF definition includes cardiac death, the listed deaths are not identified as cardiac deaths or linked to the TLF timeframe. No cause-specific interpretation is justified by these figures alone.

12. What the Result Does, and Does Not, Mean

The posted record establishes that PIONEER III was a randomized comparison of the BuMA Supreme biodegradable drug-coated coronary stent with Xience or Promus durable-polymer stents, and that its primary endpoint was 12-month TLF. It also provides group-level serious adverse event counts and death counts. These registry entries describe the study design and selected safety summaries, but they do not report the primary endpoint’s group percentages or confidence intervals.

Without the primary estimates, readers cannot determine from the registry record whether TLF was more frequent in one group, how large any difference might have been, or how precisely it was estimated. The absence of a reported comparison is not evidence of equivalence, noninferiority, or a lack of effect. No conclusion about the relative performance of the devices should be drawn from the trial’s title, design, or endpoint definition alone.

The serious adverse event counts are also insufficient on their own to establish a relative safety profile. Raw counts are affected by the number of participants in each group and do not express uncertainty. The listed deaths lack a cause-specific breakdown and are not shown to correspond to the primary endpoint timeframe. The MACE term is not accompanied by a group-specific comparative analysis in the available record.

In general, a complete interpretation of a randomized trial draws on the prespecified estimand, the observed outcome estimates, their uncertainty, the handling of missing data, and the clinical meaning of endpoint components. Much of that information is not reported in the registry record. The reasonable conclusion is therefore limited: the registry documents the intended comparison and some event counts, but the posted information does not permit a statistical conclusion about the primary comparative outcome.

13. Why This Trial Matters Statistically

This trial is statistically notable in the registry because it compares two coronary stent systems using randomized allocation and a defined 12-month composite endpoint. Randomization provides a framework for comparing groups, while the endpoint definition identifies the events counted as target lesion failure: cardiac death, target-vessel-related myocardial infarction, and clinically driven target lesion revascularization. Those design features clarify what the trial intended to assess.

The record also illustrates why outcome definitions and numerical reporting both matter. Naming an endpoint and specifying a confidence interval does not show the estimated result or its precision. Without group-specific TLF percentages, confidence intervals, and a comparative estimate, the primary statistical question remains unanswered in the posted registry information. A reader cannot infer a favorable, unfavorable, or equivalent result from the design description.

The safety summaries make another statistical point: counts need context. The groups have different numbers at risk, so the affected counts should not be compared as though they were standardized measures. The record does not provide comparative estimates or uncertainty for those counts. Nor does it report enough detail to connect the listed deaths to cardiac death or the primary endpoint’s timeframe.

Finally, the registry distinguishes planned follow-up from reported results. A schedule that extends through 5 years describes intended observation timepoints, but does not show how complete follow-up was or what was observed at each visit. The record’s limitations in outcome reporting are consequential for interpretation: the design is informative, yet design alone cannot answer the comparative clinical question.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation in the registry record is that it does not report the numerical primary endpoint results. Although TLF is defined at 12 months and a 95% confidence interval is specified, neither group’s percentage nor the corresponding interval is reported. The record therefore does not show the size, direction, or precision of the primary comparison.

The available serious adverse event summaries are counts, with no comparative estimates or uncertainty. The groups differ in the number listed at risk, and the record does not provide the event-specific observation periods or enough detail about ascertainment to interpret the counts as a complete comparative safety analysis. The death counts are not accompanied by causes, so they cannot be assumed to be cardiac deaths or primary-endpoint events. The MACE percentage is not tied to a group-specific denominator in the available information.

Additional analytic details are also not reported in the registry record. These include how missing follow-up was handled, the statistical analysis plan, any multiplicity strategy, and details of masking and allocation procedures. The planned follow-up schedule does not itself document completeness at each timepoint. The registry lists several secondary outcomes, but does not provide analysis entries in the information available.

These are limitations of the registry information available for interpretation. They do not establish that the trial lacked a prespecified plan or that analyses were not performed; those details are simply not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease — NCT03168776.
• Registry record last updated 2026-01-27; status last verified 2026-01.
• Results first posted 2026-01-27.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes PIONEER III, a completed, randomized, single-blind, parallel-group trial sponsored by Sino Medical Sciences Technology Inc. It compares the BuMA Supreme biodegradable drug-coated coronary stent with Xience or Promus durable-polymer stents in patients with stable coronary artery disease or non-ST segment elevation acute coronary syndromes. The intended population included patients with up to 3 coronary lesions.

The listed enrollment is 1629. The trial summary describes 2:1 randomization and planned follow-up from the in-hospital period through 5 years. The primary endpoint is the percentage of participants with TLF at 12 months, defined as cardiac death, TV-MI, or clinically driven TLR. Numerical results and confidence intervals for this primary endpoint are not reported in the registry record. Serious adverse event and death counts are listed by ITT group, but comparative estimates and cause-specific details are not reported.