Medtronic Resolute Onyx 2.0 mm Clinical Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Medtronic Resolute Onyx 2.0 mm Clinical Study (NCT02412501), a na na study. The primary outcome is Number of Participants With Target Lesion Failure at 12 Months Post-Procedure.

2. Clinical Question

This question combines events that differ in clinical nature but relate to the target lesion or its consequences. A composite endpoint can summarize whether any component occurred, but a total count alone does not show which component contributed most. Component-specific primary endpoint results are not reported in the registry record. The registry entries therefore describe the question the study set out to assess, not the observed frequency of target lesion failure or the precision of an estimated frequency.

3. Trial Design

The Medtronic Resolute Onyx 2.0 mm Clinical Study is listed as completed, with a single-group model and enrollment of 101. The registry lists the intervention as the 2.0 mm Resolute Onyx zotarolimus-eluting coronary stent. Allocation is marked NA, and masking is listed as none. There is no separate comparison group described in the record, so the design does not support a direct between-group comparison of outcomes.

The study started on 2015-04-06, and the primary completion date is 2017-02-13. The phase is listed as NA. The purpose statement concerns safety and efficacy of the stent for de novo lesions in native coronary arteries where a 2.0 mm diameter stent can be used. The primary outcome is a count of participants with target lesion failure at 12 months post-procedure. The registry also lists secondary outcomes at 12 and 24 months, including cardiac death, target vessel myocardial infarction, major adverse cardiac events, target lesion failure, target vessel failure, and stent thrombosis.

A single-group study can report the outcomes observed among its participants, but without a concurrent control group it cannot separate outcomes associated with the device from background risk, patient characteristics, or other aspects of care. Whether the protocol specified a historical benchmark or another inferential comparison is not reported in the registry record. The record lists 18 outcome measures and zero analyses. It does not report the primary endpoint result, an inferential analysis, or further details of the statistical design.

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Target Lesion Failure at 12 Months Post-Procedure, measured over 12 Months.

The primary endpoint is the number of participants with target lesion failure at 12 months after the procedure. The registry defines an event as cardiac death, target vessel myocardial infarction, or target lesion revascularization by percutaneous or surgical methods. Thus, the endpoint is a composite: a participant meeting any of the listed criteria is counted as having target lesion failure, while the count does not by itself distinguish the type of event.

In general, composite endpoints can capture several clinically important outcomes in one measure and can provide a broad summary of events related to a treatment or procedure. They also require careful interpretation. Components may differ in severity, frequency, or practical meaning; if one component is more common, it may account for much of the composite result. Component-level results are needed to understand that pattern. The registry record does not report component counts for the primary endpoint.

The endpoint is expressed as a count of participants, not as a time-to-event estimate or a continuous measurement. A count alone is difficult to interpret without its denominator, the completeness of follow-up, and an estimate of uncertainty. Although enrollment was 101, the primary endpoint analysis population and its denominator are not reported in the registry record. Nor is the observed 12-month count reported. The endpoint definition is available, but the result and its precision cannot be assessed from the registry information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary outcome is a count of participants who experienced a defined event by 12 months. In general, a count is a direct summary of the number of people meeting an endpoint definition. To interpret it as a frequency, readers also need to know how many participants were included in the analysis and how many had outcome status established. A count without that context cannot establish a participant-level risk or the precision of an estimate. For this study, the 12-month target lesion failure count and its analysis denominator are not reported in the registry record.

Why does the endpoint definition matter?

Target lesion failure is defined as a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization by percutaneous or surgical methods. In general, a composite can consolidate several event types into one endpoint, but the total may obscure variation among its components. A component breakdown helps readers determine whether the overall result reflects one event type or several. The registry does not report component-specific primary endpoint results.

What can a confidence interval tell readers?

In general, a confidence interval describes the statistical uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while neither interval alone establishes causation or clinical importance. The interpretation depends on the endpoint, study design, and analysis population. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be assessed.

What does a single-group design allow?

The study is listed as single-group, with allocation marked NA and masking marked none. In general, a single-group study can describe outcomes in the participants observed, but it does not provide a concurrent control group for estimating a between-group effect. Differences between observed outcomes and an external expectation can be difficult to interpret because patient selection, background risk, and other care may differ. Whether a protocol-defined benchmark was used is not reported in the registry record. There is no basis in the record for treating the study as a randomized comparison.

How should sample-size planning be understood?

The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect; time-to-event illustrations use a total event count, while other illustrations use participants per arm. These assumptions describe a planning framework, not the actual single-group design listed for this study. The planning illustration is not observed power, and it does not establish that the study was designed around a particular justification. The protocol’s sample-size justification and any resulting planning values are not reported in the registry record.

What analysis procedures were used?

In general, analysis of a binary participant endpoint may involve estimating the event count and the proportion of participants with known outcome status, with an uncertainty interval chosen for the design and assumptions. A comparative analysis would require a comparison group and a method suited to the endpoint and study design. These are general statistical concepts, not a description of methods used in this study. The registry lists zero analyses, and specific estimation methods, hypothesis tests, adjustment procedures, and analysis populations are not reported in the registry record.

The study lists outcomes with follow-up at 12 and 24 months. In general, results at different time points answer distinct questions and should be interpreted with attention to who remained under observation and how missing follow-up was handled. The registry record does not report those details or the primary endpoint result. The methods available for interpretation are therefore limited to the design labels, endpoint definition, and stated planning assumptions.

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("Device")
n      <- c(101)
events <- c(5)
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  Device  101  5  5.0  1.6  11.2  2.1  11.1  2.2  11.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures, including a primary endpoint and secondary outcomes at 12 and 24 months. When several outcomes or time points are examined, the chance of at least one apparently unusual result can increase if many statistical tests are performed. Statistical approaches can address multiplicity in different ways, depending on the study aims and analysis plan. Whether any adjustment, hierarchy, or other multiplicity strategy was specified or used is not reported in the registry record. Zero analyses are listed, and no outcome-level inferential results are reported.

Missing data can affect both the denominator and the interpretation of an endpoint count. For a 12-month outcome, readers need to know how many participants had outcome status assessed, how participants without known status were treated, and whether any imputation or sensitivity analysis was used. These details are not reported in the registry record. The enrolled total of 101 does not establish that all participants contributed known endpoint status.

The record does not describe the primary endpoint analysis population, such as whether analysis followed enrollment, treatment received, or another defined set. The protocol-defined analysis populations and their use are not reported in the registry record. It is also not reported whether follow-up differed across outcomes or whether reasons for missing outcome information were documented.

Without the analysis plan, missing-data procedures, and results, readers cannot determine whether multiplicity or incomplete follow-up influenced reported estimates. Since the primary endpoint result itself is not reported in the registry record, these issues cannot be evaluated from an observed analysis.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: coronary artery disease (10.9%), vascular stent stenosis (5.9%), coronary artery stenosis (5.0%), chest pain (5.0%), pneumonia (4.0%).

The adverse-event listing describes one group, titled Onyx 2.0mm, with 101 participants at risk for serious adverse events and 101 at risk for other adverse events. It records 63 participants affected by serious adverse events, 43 affected by other adverse events, and 3 deaths. These figures should be read as separate registry summaries; they should not be added together, since the record does not explain whether participants could appear in more than one category. The timing of events and the relationship of events to the device or procedure are not reported in the registry record.

The listed serious adverse event terms include Coronary Artery Disease at 10.9%, Vascular Stent Stenosis at 5.9%, Coronary Artery Stenosis at 5.0%, Chest Pain at 5.0%, Pneumonia at 4.0%, and Chronic Obstructive Pulmonary Disease at 4.0%. These are registry-listed percentages for the terms, not proof that the device caused those events. Definitions, event-level detail, and attribution procedures are not reported in the registry record.

Counts and listed terms describe reported safety events; they do not by themselves establish comparative safety. With no separate control group described, the record does not provide a like-for-like safety comparison. The cause of the 3 deaths is not reported in the registry record.

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

The available record describes a completed, single-group evaluation of the Resolute Onyx 2.0 mm stent, the intended clinical setting, and a primary composite endpoint assessed at 12 months. It also lists safety-event summaries and secondary outcome definitions. These details help identify what the study was intended to assess and what kinds of events were tracked.

They do not reveal the observed primary endpoint result. The number of participants with target lesion failure, the component-specific results, and any uncertainty estimate are not reported in the registry record. It is therefore not possible to determine from this information how frequent target lesion failure was among participants with known follow-up, or how precise an estimate might be.

The single-group design also limits interpretation. Without a concurrent control group, a result would describe outcomes in the study group rather than provide a direct estimate of how outcomes differed under another treatment or device. The registry does not describe a randomized comparison. It would be unwarranted to infer a causal effect from the design details or safety counts alone.

In general, a study result should be interpreted in light of the enrolled population, endpoint definition, analysis population, follow-up completeness, and statistical uncertainty. Several of these details are not reported in the registry record. The safety listing is descriptive and does not, on its own, establish whether an event was caused by the device. The appropriate conclusion is limited: the record identifies the study design and planned outcomes, while the primary outcome findings needed to assess the observed result are not reported in the registry record.

14. Why This Trial Matters Statistically

This study illustrates an important distinction between a clearly defined endpoint and a reportable endpoint result. The primary outcome definition specifies the events included in target lesion failure and the 12-month time point. But without the observed count, denominator, and uncertainty estimate, readers cannot judge the frequency or precision of the outcome. Registration information can describe what was planned without supplying the evidence needed to interpret what occurred.

The study is also a useful example of the interpretive limits of single-group designs. An observed event count may describe participants in the study, but it cannot by itself establish how outcomes would compare with a different device or control condition. That distinction remains important even when enrollment, follow-up times, and outcome definitions are stated.

Finally, a composite endpoint requires attention to its components. Combining cardiac death, target vessel myocardial infarction, and target lesion revascularization produces a single summary measure, but an overall count would not reveal the contribution of each component. Component-level results and transparent reporting of analysis methods are important for understanding what a composite result means. Here, the registry record defines the composite but does not report its results. The statistical lesson is that endpoint planning, outcome reporting, and design-based interpretation are separate parts of evidence assessment.

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.

The most important trial-specific limitation for interpretation is that the primary endpoint result is not reported in the registry record. The record also does not report a confidence interval, a statistical test, or component-specific results for target lesion failure. As a result, neither the observed outcome frequency nor its precision can be assessed.

The study is listed as single-group, with allocation marked NA and masking marked none. No concurrent comparison group is described, so the design does not provide a direct comparison with another intervention. Enrollment was 101, but the primary endpoint analysis denominator and the number with known 12-month outcome status are not reported in the registry record.

Further limitations include absent information about missing-data handling, analysis populations, outcome adjudication, and the statistical methods used. The registry lists 18 outcome measures and zero analyses, while multiplicity procedures are not reported in the registry record. The record also does not provide a detailed description of participant characteristics or subgroup results. The adverse-event summary gives counts and selected terms, but event timing, attribution, and detailed definitions are not reported in the registry record. These gaps restrict interpretation of both the primary outcome and the safety information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Medtronic Resolute Onyx 2.0 mm Clinical Study — NCT02412501.
• Registry record last updated 2019-07-02; status last verified 2019-06.
• Results first posted 2018-04-10.
• 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

NCT02412501 is a completed, single-group clinical evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm coronary stent. Enrollment was 101; allocation is listed as NA and masking as none. The primary endpoint is the number of participants with target lesion failure at 12 months, defined by cardiac death, target vessel myocardial infarction, or target lesion revascularization. The registry lists 18 outcome measures and zero analyses.

The record includes adverse-event summaries for a group of 101 participants at risk, including 63 affected by serious adverse events, 43 by other adverse events, and 3 deaths. However, the primary endpoint result, its analysis denominator, and its statistical uncertainty are not reported in the registry record. The single-group design does not provide a concurrent control comparison.