Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent (NCT00968019), a registered phase not stated study. The primary outcome is Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)).

2. Clinical Question

3. Trial Design

This was a multicenter postmarket surveillance registry evaluating the performance and long-term safety of the Presillion stent. The registry record lists Johnson and Johnson, S.A. as sponsor and describes a single group treated with the device. The study status is COMPLETED. The recorded start is 2009-04, and primary completion is 2011-04.

Enrollment was 318. Participants were treated with the Presillion stent in up to two de novo coronary artery lesions. The condition listed is coronary arteriosclerosis. The study’s brief description states that its purpose was to evaluate device safety and performance in routine clinical practice. This design can describe outcomes among treated participants, but it does not create a randomized comparison with another treatment.

Allocation is not stated, and a randomized comparator is not described. The registry record therefore does not support a like-for-like treatment comparison. Although the primary endpoint description refers to a bare-metal-stent performance goal, details of the goal-based analysis are not reported in the registry record. The protocol, eligibility criteria beyond the arm description, follow-up procedures, and any interim analyses are also not reported in the registry record.

The primary endpoint is described as a composite measured at 12 months follow-up. Other listed outcomes include device success, lesion success, procedural success, clinically driven target lesion revascularization, clinically driven target vessel revascularization, target vessel failure, myocardial infarction, and major bleeding. The registry lists 18 outcome measures in total, but does not report the individual results for those measures in the information summarized for this 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

Analysis population for the primary outcome, as defined in the registry: No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.

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 Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)), measured over at 12 months follow-up.

The primary endpoint is described as major adverse cardiac events (MACE) at 12 months follow-up. The title names cardiac death, myocardial infarction (Q-wave and non-Q-wave), and clinically driven target lesion revascularization. The accompanying description defines the adjudicated composite as cardiac death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary artery bypass surgery, and target vessel revascularization. These descriptions differ in the revascularization terms, and the precise endpoint coding or reconciliation is not reported in the registry record.

A composite endpoint combines multiple event types into a single outcome. General: this can capture several clinically important events in one measure, but the total alone may not show which component occurred or how often each component contributed. The interpretation depends on knowing the endpoint definition and the component results.

The record identifies MACE as the primary safety measure and says its rate was compared with a performance goal for bare metal stents. It describes the expected 12-month MACE rate for that goal as about 25.0%. However, the primary endpoint’s observed count or rate and the result of the goal comparison are not reported in the registry record. Without those results, the degree of precision around the primary outcome cannot be assessed from the posted information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes its statistical approach as descriptive rather than based on formal statistical significance testing. For continuous variables, it says means, standard deviations, medians, and ranges were calculated; for discrete variables, it says frequencies and percentages were calculated. No participant-level data or complete outcome summaries are reported in the registry record, so these methods can be described but their application to particular results cannot be checked from the posted information.

What does a descriptive analysis show?

General: descriptive statistics characterize the observed data. A frequency reports how many observations fall into a category, and a percentage expresses that count relative to a stated denominator. A mean and standard deviation describe a distribution using its center and spread; a median and range provide other summaries of its location and extent. These summaries do not, on their own, estimate a treatment effect relative to a concurrent control group.

For the adverse-event summary, the treated group has 318 participants at risk, with 39 recorded in the serious adverse-event field and 17 in the other adverse-event field. Those counts describe the posted group-level data. They do not show the timing of events, the duration each participant was observed, or whether an individual had more than one event. Such details are not reported in the registry record.

What does the primary composite represent?

The primary outcome is a composite MACE measure at 12 months follow-up. General: a composite endpoint treats the occurrence of any defined component as an event for the combined measure. Its interpretation depends on the exact component list, the follow-up window, and how events are adjudicated. The registry describes an adjudicated composite, but its title and description use different revascularization terms. The precise operational definition used for analysis is not reported in the registry record.

The description states that the MACE rate was compared with a performance goal, with about 25.0% cited as the 12-month rate suggested by experience with bare metal stents in clinical trials. The goal-comparison method, the observed primary result, and any uncertainty estimate are not reported in the registry record. No formal significance testing was performed, according to the statistical description. It is therefore not appropriate to infer a test statistic, confidence interval, or conclusion about meeting the goal.

How should uncertainty be understood?

General: a confidence interval is a range of values compatible with the data under a specified statistical model and procedure. It communicates uncertainty in an estimate; it is not a guarantee that the true value lies inside the interval. The registry record does not report a confidence interval for the primary endpoint or the adverse-event summaries. Precision for those results therefore cannot be judged from the posted information.

General: with a single treated group, observed outcomes describe that group, while comparison with an external benchmark relies on the relevance and definition of that benchmark. Differences in populations, event definitions, follow-up, and ascertainment can affect such comparisons. The record identifies a bare-metal-stent performance goal but does not report the details needed to evaluate how closely its source or implementation matches this registry.

What do the planning assumptions mean?

Planning illustrations associated with the registry are described as calculations based on the observed effect, not as the trial’s own design. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such illustrations are not observed power and do not show that this single-arm registry was planned or conducted as a two-arm comparison. No actual sample-size justification is reported in the registry record.

General: sample-size planning asks how much information a proposed design may need to detect a specified effect under stated assumptions. It does not establish that the effect is real, that the assumptions fit a study, or that a completed study had a particular probability of detecting an effect. In this registry, the stated illustration assumptions should be read separately from the observed enrollment and the descriptive safety summaries.

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("Treated With Presillion Stent")
n      <- c(308)
events <- c(9)
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  Treated With Presillion Stent  308  9  2.9  1.3  5.5  1.5  5.5  1.6  5.5

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 18 outcome measures, including the primary MACE measure and secondary outcomes such as device success, lesion success, procedural success, clinically driven target lesion revascularization, clinically driven target vessel revascularization, target vessel failure, myocardial infarction, and major bleeding. The registry record does not report a multiplicity-adjustment procedure or a hierarchy for interpreting the secondary outcomes. General: when many outcomes are examined, the chance of finding an apparently notable result by chance can increase; prespecified outcome priorities and suitable analysis plans help readers interpret multiple results. No formal significance testing was performed, according to the record’s statistical description.

The registry lists 0 analyses, but also describes calculation of descriptive statistics. This count does not supply an analysis plan or participant-level outcome results. Whether additional analyses were conducted, and how any were selected, is not reported in the registry record.

Missing-data handling and the analysis population are not fully described. The statistical description begins a statement about participants who discontinued prematurely, but the text is incomplete. Whether such participants were included in particular endpoint denominators, how incomplete follow-up was handled, and whether any imputation or censoring was used are not reported in the registry record. The recorded number at risk for the adverse-event summaries is 318; this alone does not establish that all participants had complete follow-up for every outcome.

General: incomplete outcome data can affect both the event count and the interpretation of a rate. Readers need to know the number assessed for each outcome, how missing observations were handled, and whether those with missing follow-up differed from those with complete data. Those details are not reported in the registry record for the primary endpoint.

12. Safety Results

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

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: revascularization (4.1%), serious adverse events not related to the study device (2.8%), myocardial infarction (2.5%), mortality (1.6%), bleeding or vascular event (1.3%).

The safety summary lists 39 participants with a serious adverse event among 318 at risk in the Presillion-treated group. It separately lists 17 participants in the other adverse-event field among 318 at risk. These are counts of participants with an event, not a comparison between treatment groups. The registry record does not report the timing, duration, or participant-level overlap of these categories.

The listed serious adverse-event terms and percentages are Revascularization, 4.1%; Serious Adverse Events not related to the study device, 2.8%; Myocardial infarction, 2.5%; Mortality, 1.6%; and Bleeding or vascular event, 1.3%. The record does not state whether these categories are mutually exclusive, how each term was classified, or the corresponding participant counts. The percentages should therefore be read as separate reported summaries, not added together to obtain a total.

These summaries are not a substitute for the primary MACE result. The registry’s primary endpoint description and adverse-event summaries may use different definitions and groupings; the record does not identify the serious-event counts as the primary endpoint counts. General: adverse-event counts are descriptive, and interpretation depends on the event definitions, observation period, and completeness of follow-up.

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

The registry documents a completed postmarket evaluation of the Presillion stent in a group of 318 treated participants. It reports a primary safety question centered on MACE at 12 months follow-up and provides some serious and other adverse-event summaries. These registry entries describe what the registry set out to assess and some of the safety information recorded for the treated group.

The posted information does not include the primary MACE count or rate, its uncertainty, or the result of the stated performance-goal comparison. It therefore cannot establish from the reported primary outcome whether the goal was met. The adverse-event counts and percentages offer separate descriptive information, but they do not fill in the missing primary endpoint result.

Because the registry does not describe a randomized comparator, the recorded outcomes cannot establish a causal difference between the Presillion stent and another device or treatment. A performance-goal comparison is not the same as a concurrent randomized comparison. General: external benchmarks can provide context, but their interpretation depends on whether patient characteristics, endpoint definitions, follow-up, and event ascertainment are sufficiently comparable. The relevant details are not reported in the registry record.

The record also does not provide enough information to assess missing follow-up, endpoint-specific denominators, or whether adverse-event categories overlap. Those omissions limit interpretation of both event frequencies and their precision. The results should be understood as descriptive registry information, not as proof of comparative effectiveness or a complete estimate of long-term safety.

No medical conclusion about an individual participant follows from these group-level summaries. The registry’s stated purpose, its single treated group, and the available adverse-event entries define what can be described; the absent primary endpoint result and incomplete methodological details define what remains uncertain.

14. Why This Trial Matters Statistically

This registry is statistically informative as an example of the distinction between describing outcomes and estimating comparative effects. A single treated group can provide information about events observed among participants exposed to a device in routine clinical practice. Without a randomized comparator, it cannot by itself separate outcomes associated with the device from other influences on those outcomes.

The primary endpoint is a composite safety measure, while the registry also lists a range of device, lesion, procedural, and clinical outcomes. Such endpoint breadth can make a registry useful for characterizing different aspects of performance and safety. At the same time, interpretation requires clear definitions, complete outcome reporting, and an account of how multiple outcomes are handled. The registry lists 18 outcome measures, but it does not report the primary endpoint result in the information available for this record.

The record illustrates why a stated benchmark and an observed result must be considered together. It identifies about 25.0% as the 12-month MACE rate suggested by experience with bare metal stents in clinical trials, but the observed MACE rate and the method of comparison are not reported. The benchmark alone cannot show how the registry’s participants fared relative to it.

The available adverse-event counts and percentages are useful descriptive entries, but their meaning depends on event definitions, follow-up, and overlap. The registry’s incomplete information about missing data and participant disposition further limits assessment. These points matter because statistical interpretation depends not only on a study’s objective, but also on the denominator, endpoint specification, and precision of reported estimates.

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 direct limitation is that the primary MACE result is not reported in the registry record. Although the endpoint is described at 12 months follow-up and a bare-metal-stent performance goal is mentioned, the observed count or rate, its precision, and the result of the comparison are absent. This prevents assessment of the main stated safety measure from the posted information.

The endpoint wording is not fully consistent: the title names clinically driven target lesion revascularization, while the definition describes target vessel revascularization and emergent coronary artery bypass surgery. The precise endpoint definition used in the analysis is not reported in the registry record. This makes it difficult to know exactly which events would contribute to the primary composite.

The registry describes one treated group, with no randomized comparator and allocation not stated. It cannot provide a randomized treatment contrast. The external performance-goal context is not accompanied by sufficient detail to assess comparability between the benchmark and registry participants.

The methods description says formal statistical significance testing was not performed and describes descriptive statistics. It does not provide a complete account of the analysis population or missing-data handling. The statement about participants who discontinued prematurely is incomplete, and outcome-specific denominators are not reported. Follow-up completeness and the handling of discontinuation therefore remain unclear.

The serious-event percentages are listed without category counts or an explanation of overlap. The record also does not provide event timing or participant-level detail. Finally, although 18 outcome measures are listed, multiplicity procedures and the full results for those measures are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent — NCT00968019.
• Registry record last updated 2013-03-13; status last verified 2013-03.
• Results first posted 2013-03-06.
• 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

NCT00968019 is a completed multicenter postmarket surveillance registry evaluating the Presillion stent in de novo native coronary artery lesions. The registry lists 318 participants treated in up to two lesions and names Johnson and Johnson, S.A. as sponsor. Its recorded start is 2009-04, with primary completion at 2011-04.

The primary safety measure was a MACE composite at 12 months follow-up, with a stated bare-metal-stent performance-goal context of about 25.0%. The primary endpoint result is not reported in the registry record. The adverse-event summary lists 39 participants with a serious adverse event and 17 in another adverse-event category, among 318 at risk. The registry describes descriptive statistics and says no formal statistical significance testing was performed. A randomized comparator, complete missing-data rules, and a full account of the primary analysis are not reported in the registry record.