A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) (NCT03647475), a na na study. The primary outcome is Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction.

2. Clinical Question

The central interpretive issue is the distinction between the overall trial enrollment and the primary endpoint population. Enrollment is listed as 752, while the endpoint population is defined by eligibility, stent receipt, and the one-month-clear criterion across two named trials. Those are not stated to be the same group. The trial’s single-group structure also means that any assessment against a performance goal would depend on the goal and its prespecified statistical approach; those details are not reported in the registry record.

3. Trial Design

Onyx ONE Clear is registered as a completed, single-group trial of the Resolute Onyx zotarolimus-eluting coronary stent followed by one-month DAPT. The registry lists enrollment of 752 and gives the condition as coronary artery disease. The start date is 2018-10-01, and the primary completion date is 2020-03-10. The trial is not randomized, and masking is listed as none. Its phase is listed as NA.

The intervention description frames the study around patients considered at high risk for bleeding and/or medically unsuitable for more than one month of DAPT. The primary endpoint description, however, identifies an analysis population that combines eligible subjects enrolled in the Onyx ONE US & Japan Trial and Onyx ONE Global RCT. It includes those who received the Resolute Onyx stent only and met the definition for one-month clear. The registry record does not report the size of this defined population or explain how it relates numerically to the enrollment of 752.

The arm description says that eligible participants were treated with the stent followed by one-month DAPT and that safety was evaluated against a performance goal. The value and rationale for that goal, and the details of the comparison, are not reported in the registry record. No concurrent control arm is listed. A single-group design can describe outcomes among treated participants, but by itself it does not provide a randomized estimate of how outcomes would differ under another treatment strategy. The record lists 13 outcome measures, including the primary composite and secondary outcomes such as target lesion failure, procedure success, death, myocardial infarction, target vessel failure, revascularization, and stent thrombosis. It lists no analyses.

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.

Before assignment: Per protocol, the 752 subjects enrolled in the US \& Japan were pooled with A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients" (NCT03344653). Subjects enrolled under NCT03344653 were in regions outside of the US and Japan.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The analysis population combines eligible subjects enrolled in the Onyx ONE US \& Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear.

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: The analysis population combines eligible subjects enrolled in the Onyx ONE US \& Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, were adherent to DAPT for the one-month period, were event-free on or prior to the DAPT stop date, and transitioned from DAPT to SAPT one month after procedure.

6. Primary Endpoint

The registry lists the primary outcome as Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction, measured over One Month to one year.

The primary endpoint is the number of participants with the composite of cardiac death and myocardial infarction. The description places the endpoint at one year for a one-month-clear population and gives a timeframe of one month to one year. A composite endpoint combines multiple clinical events into one outcome, so a participant meeting either component may contribute to the composite. This can provide a broader summary of clinically important events than either component alone, but interpretation depends on knowing the component definitions, event counts, and how events were ascertained. Those details are not reported in the registry record.

The endpoint is used to assess clinical safety in the population defined as one-month clear after receiving the Resolute Onyx stent. The arm description states that safety was evaluated against a performance goal. In a single-group study, that kind of assessment relies on a specified benchmark rather than a randomized concurrent control. The performance goal and the statistical procedure used to compare the observed endpoint with it are not reported in the registry record.

The registry record gives no primary endpoint count, rate, confidence interval, or test result. Therefore, the endpoint definition and intended role can be described, but the magnitude and precision of the observed outcome cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group study, not a randomized comparison. In a randomized trial, allocation is used to create groups whose outcomes can be compared under a defined analysis. Here, allocation is listed as NA and masking as none. The record says that safety was evaluated against a performance goal, but the goal and the comparison method are not reported in the registry record. Without those details, the planned statistical test, its assumptions, and the decision rule cannot be reconstructed.

What does a participant count represent?

The primary outcome is stated as a count of participants with a cardiac-death-and-myocardial-infarction composite. A count records how many people experienced an event, but it needs a denominator and a defined observation period to support interpretation as a proportion or rate. The registry gives the endpoint timeframe as one month to one year, but does not report the endpoint count or the number of participants in the primary endpoint population. No event proportion or rate can therefore be stated from this record.

General statistical explanation: an estimate is a summary of the observed data, while a confidence interval describes uncertainty around that estimate under a specified statistical model and procedure. Wider intervals indicate greater uncertainty than narrower intervals, all else equal. The registry record does not report a primary endpoint estimate or confidence interval, so its precision cannot be evaluated. A confidence interval would not by itself address possible bias from eligibility, follow-up, outcome ascertainment, or the lack of a randomized control.

Why does a performance goal matter?

In general, a performance goal is a prespecified reference value used to judge an outcome in a single-group study. The choice of reference, the population to which it applies, and the statistical method for comparison are important to interpretation. The record states that a performance goal was used but does not report its value, justification, or analysis. It is therefore not possible to assess whether the goal was clinically and statistically appropriate or whether the study met it.

A single-group outcome can describe what happened among participants who received the intervention. It cannot, without further assumptions or a suitable external benchmark, isolate the effect of the intervention from other explanations for the observed outcomes. The registry record does not report a randomized comparator. The absence of masking is also relevant in general because knowledge of treatment assignment can influence some aspects of care, event assessment, or reporting; whether and how that was addressed is not reported in the registry record.

What do the planning assumptions mean?

The record includes planning assumptions for a sample-size illustration: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect is described as a stated fraction of the observed effect. For time-to-event calculations, the illustration is described as giving the total number of events; for other calculations, it gives participants per arm. These are general planning conventions described for an illustration, not evidence that the trial itself had two randomized arms. The trial is listed as single-group, and no sample-size justification or statistical design plan is reported in the registry record.

Such planning calculations are not observed power. General statistical explanation: a sample-size calculation asks how much information a hypothetical design might need to detect an assumed effect under stated assumptions. It does not show the probability that a completed trial has demonstrated an effect, and it cannot replace the reported estimate and its uncertainty. The record does not provide the illustration’s calculated sample-size values in the registry record for this analysis, so no such values are stated.

The registry lists 13 outcome measures and no analyses. It does not report the statistical model, confidence level for interval estimates, handling of censoring, rules for repeated events, or a method for the primary comparison. It also does not report whether subgroup or sensitivity analyses were planned. Those omissions mean the analysis cannot be independently reproduced from the registry information. General statistical methods may explain how such analyses are often conducted, but they cannot establish which methods this trial used.

How should composites and multiple outcomes be understood?

General statistical explanation: a composite endpoint combines multiple events into one outcome. The overall result can be influenced by how often each component occurs and by differences in clinical importance across components. Component-specific results help readers understand what contributes to a composite. The registry names cardiac death and myocardial infarction as the primary components but does not report their separate counts or the composite count.

When a study evaluates multiple outcomes or multiple statistical hypotheses, the chance of at least one false-positive finding can increase if each is tested without an adjustment or a prespecified hierarchy. Whether such an adjustment is appropriate depends on the intended claims and analysis plan. The record does not report a multiplicity strategy or any inferential analyses, so it is not possible to determine how multiple outcomes were handled.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Medtronic Resolute Onyx Zotarolimus-Eluting Corona")
n      <- c(1506)
events <- c(104)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Medtronic Resolute Onyx Zotarolimus-Eluting Corona  1506  104  6.9  5.7  8.3  5.7  8.3  5.7  8.3

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and eight named secondary outcomes, but reports no analyses. It does not state whether the primary endpoint was tested against a performance goal, whether secondary outcomes were descriptive or inferential, or whether any multiplicity adjustment or hierarchy was prespecified. Without those details, the risk of selectively emphasizing among multiple outcomes cannot be assessed. The outcome list alone does not show which results were analyzed or how conclusions were reached.

The primary endpoint population is described as eligible participants from two named trials who received the Resolute Onyx stent only and met the one-month-clear definition. The record does not report the size of that population, the number included in the primary analysis, or the handling of participants who did not meet the definition. It also does not report missing endpoint data, loss to follow-up, censoring rules, or how incomplete records were handled. These details matter because the analyzed participants and their follow-up determine the denominator and the interpretation of an event count.

In general, missing-data methods describe how an analysis accounts for measurements or outcomes that are unavailable. Different approaches can lead to different estimates when missingness is related to participants’ health or outcomes. The appropriate approach depends on the pattern and reasons for missingness; neither is reported in the registry record. No imputation method, sensitivity analysis, or missing-data assumption is reported.

The enrollment of 752 should not be assumed to equal the primary endpoint population. The endpoint definition draws on participants from Onyx ONE US & Japan Trial and Onyx ONE Global RCT and applies eligibility, treatment-receipt, and one-month-clear criteria. The registry record does not report how these criteria affect the analysis denominator. The absence of reported analysis details limits assessment of both completeness and potential selection effects.

12. 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

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: atrial fibrillation (3.2%), pneumonia (2.9%), cardiac failure congestive (2.7%), acute myocardial infarction (2.5%), anaemia (2.3%).

The registry lists a safety group titled Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent. For serious adverse events, it reports 1506 participants at risk and 591 affected. For other adverse events, it reports 1506 at risk and 755 affected. It also reports 89 deaths. The serious-event terms with their listed percentages are atrial fibrillation, 3.2%; pneumonia, 2.9%; cardiac failure congestive, 2.7%; acute myocardial infarction, 2.5%; anaemia, 2.3%; and acute kidney injury, 2.0%.

These figures describe the safety information listed in the registry record. They are not the primary endpoint result: the primary endpoint is a composite of cardiac death and myocardial infarction in the one-month-clear population, while the safety figures are presented for the stent group. The record does not report how the safety population relates to the primary endpoint population or whether the safety counts refer to participants with at least one event or to event episodes. The labels should therefore be read as reported rather than reinterpreted.

No concurrent control group is listed, so these figures do not quantify a comparative increase or decrease in risk. Serious-event percentages and counts also do not establish that the stent caused a particular event. The registry record does not report event-level timing, adjudication details, or comparative safety analyses.

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

The registry record identifies the clinical question and some features of the study: a single-group evaluation of the Resolute Onyx stent followed by one-month DAPT, with a primary composite of cardiac death and myocardial infarction in a one-month-clear population. It also lists enrollment, study dates, outcome titles, and safety counts. These details describe the registered study and its reported safety information, but they do not provide the numerical primary endpoint result.

Because the primary count, denominator, estimate, and confidence interval are not reported in the registry record, the frequency and precision of the primary outcome cannot be assessed. The record also does not report the performance goal or the method used to compare outcomes with it. As a result, it cannot establish whether the stated safety objective was met. The listed 89 deaths are not a substitute for the primary composite result, because the endpoint population and definitions are not shown to be the same.

The design also limits the kind of conclusion that can be drawn. A single-group study can describe events among participants who received the intervention. Without a randomized comparator, it does not directly estimate how outcomes would differ under another stent or DAPT strategy. A performance-goal comparison can provide a benchmark-based assessment only when the goal and analysis are specified and appropriate; those details are not reported in the registry record.

The meaning of the outcome list is likewise limited. The registry names multiple secondary outcomes, but supplies no analyses or outcome estimates for them in the information described. Their presence does not establish that the outcomes occurred, that they were analyzed, or that any difference was statistically meaningful. The record supports a description of the trial’s purpose, design, and listed safety data, not a conclusion about comparative benefit, treatment effect, or the success of the primary endpoint.

14. Why This Trial Matters Statistically

This trial raises several important statistical interpretation issues. First, its single-group design makes the benchmark central to understanding the primary safety assessment. The registry states that outcomes were evaluated against a performance goal, but does not report the goal, its justification, or the statistical comparison. A benchmark-based conclusion cannot be evaluated without knowing what value was used and how uncertainty around the observed outcome was handled.

Second, the primary endpoint population is defined by eligibility, receipt of the Resolute Onyx stent, and meeting the one-month-clear criterion, drawing on two named trials. This definition is more specific than the overall enrollment figure. Without the analysis denominator and endpoint count, readers cannot assess the observed event frequency or the precision of its estimate. Clear reporting of population flow and follow-up would be needed to understand who contributed to the endpoint.

Third, the primary outcome is a composite. Composite endpoints can summarize more than one event type, but the overall result is most informative when the component counts and definitions are also available. The registry names cardiac death and myocardial infarction but does not report the primary result or the separate component outcomes. This prevents assessment of which component, if either, contributed most to the composite.

Finally, the registry lists multiple outcomes while reporting no analyses. Prespecification and transparent reporting of the analysis plan help readers distinguish planned inference from exploratory findings and assess how multiplicity was handled. The listed safety counts add descriptive context, but they do not replace a primary endpoint analysis or a comparison group. Taken together, the missing analysis details make the registry record useful for understanding the study question and design, but insufficient for evaluating the statistical evidence for its stated primary objective.

15. 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.

Several limitations follow from the information reported in the registry record. The primary endpoint result is not reported, including the number of participants with the composite, its denominator, an effect estimate, a confidence interval, or a test result. The stated performance goal is also not reported, so the intended benchmark comparison cannot be evaluated. These omissions prevent assessment of the endpoint’s observed frequency, precision, and relationship to the trial’s stated objective.

The primary population is described as eligible participants from Onyx ONE US & Japan Trial and Onyx ONE Global RCT who received the stent only and met the one-month-clear definition. The number meeting those conditions is not reported. The relationship between that group and the listed enrollment of 752 is also not stated. The record does not report how missing outcomes, incomplete follow-up, or participants outside the primary population were handled.

The study is single-group and unmasked, with allocation listed as NA. It has no concurrent randomized control arm described. Accordingly, the record cannot support a direct randomized comparison with another intervention. The performance-goal value and its rationale are not reported, and the record does not describe the statistical method used for that assessment.

Although 13 outcome measures are listed, the record reports no analyses. It does not describe the statistical analysis plan, multiplicity approach, endpoint adjudication, or sensitivity analyses. Safety counts are listed, but their relation to the primary endpoint population and the participant-versus-event counting details are not reported. These limitations are specific to interpreting this registry record; they do not establish what may be available in other sources.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) — NCT03647475.
• Registry record last updated 2021-11-01; status last verified 2021-10.
• Results first posted 2021-05-06.
• 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.

19. Record Summary

Onyx ONE Clear (NCT03647475) is listed as a completed, single-group trial of the Medtronic Resolute Onyx zotarolimus-eluting coronary stent followed by one-month DAPT. The registry lists enrollment of 752, coronary artery disease as the condition, no masking, and phase NA. The recorded start date is 2018-10-01, and the primary completion date is 2020-03-10.

The primary endpoint is the number of participants with cardiac death and myocardial infarction in a one-month-clear population, with a stated timeframe of one month to one year. That population combines eligible participants from Onyx ONE US & Japan Trial and Onyx ONE Global RCT who received the Resolute Onyx stent only and met the one-month-clear definition. The endpoint result and analysis are not reported in the registry record. The record lists 13 outcome measures and no analyses.

Safety information lists 1506 participants at risk for serious adverse events, 591 affected, 1506 at risk for other adverse events, 755 affected, and 89 deaths. These descriptive counts do not provide a randomized comparison or the primary endpoint result.