A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease (NCT02100722), a randomized na study. The primary outcome is MACCE.

2. Clinical Question

FAME 3 frames the clinical comparison as a question about two revascularization strategies for multivessel coronary artery disease. In the PCI group, the registry description says a pressure wire was used to measure FFR. It describes PCI for lesions with an FFR at or below 0.80 and indicates that PCI would be deferred when FFR was above 0.80. The CABG group received surgery according to clinical routine at each participating center.

The main outcome combines events that differ in type and clinical meaning: death, myocardial infarction, stroke, and any repeat revascularization. A composite can capture whether participants experience at least one of several specified events, but its overall result does not by itself show which component accounts for the observed pattern. The registry’s primary outcome timeframe is one year. Eligibility criteria beyond the broad description of multivessel disease, and further details on how the study defined similarity between strategies, are not reported in the registry record.

3. Trial Design

FAME 3 is listed as a randomized, parallel-group trial with no masking. The registry lists an enrollment of 1500 and a completed status. The recorded start date is 2014-08-25, and the primary completion date is 2020-12-01. The phase is listed as not applicable. Stanford University is the listed sponsor.

The two groups were FFR-guided PCI and CABG. The primary outcome data list 757 participants in the PCI group and 743 in the CABG group. The PCI strategy used FFR measurements across lesions, with the registry describing drug-eluting stent use when FFR was at or below 0.80 and PCI deferral when it was above 0.80. The named devices are Resolute Integrity and Resolute Onyx stents. CABG was to be carried out according to the participating center’s clinical routine; both off-pump and on-pump approaches were acceptable when the surgeon and site had experience with the approach. The description says an internal mammary graft to the LAD should be attempted when feasible.

The primary outcome timeframe was one year. Its description says participants contributed data from randomization until the first MACCE event or one year of follow-up, whichever came first. Participants who died or were lost to follow-up before one year were to be censored at their last recorded activity. The registry record does not report further details about eligibility, randomization procedures, allocation concealment, or the original sample-size justification. It also does not report the trial’s full statistical analysis plan or interim-analysis procedures. Those details should not be inferred from the posted outcome counts or from the separate planning illustrations.

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

Reasons for not completing this period:

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 MACCE, measured over 1 year.

The primary endpoint is MACCE, defined in the registry as death, myocardial infarction, stroke, or any repeat revascularization, assessed at one year. The outcome is recorded as a count of participants experiencing the composite. Its description sets follow-up from randomization until a MACCE event or one year, whichever occurred first, and says participants who died or were lost to follow-up before one year were censored at their last recorded activity.

A composite endpoint is used to assess whether participants experience any event from a prespecified group of outcomes. Combining components can represent a broader picture of events than any single component alone, but it also means that the composite result does not identify which component is driving the pattern. Death, myocardial infarction, stroke, and repeat revascularization are distinct outcomes, so their contribution and frequency matter when interpreting an overall composite.

The registry lists 80 participants with an event among 757 in the FFR-guided PCI group and 51 among 743 in the CABG group. These are the posted counts for the primary endpoint. The record’s endpoint description specifies censoring for death or loss to follow-up before one year, but further information about how incomplete follow-up was handled in the reported sponsor analysis is not reported in the registry record.

7. Results Posted in the Registry

• CABG: 6.9% (51/743) versus 10.6% (80/757) on control; risk difference -3.7 percentage points (95% CI -6.6 to -0.9), risk ratio 0.65 (0.46–0.91); unadjusted two-proportion z-test p = 0.011.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • CABG: 9.2% (68/743) versus 12.0% (91/757) on control; risk difference -2.9 percentage points (95% CI -6.0 to 0.2), risk ratio 0.76 (0.57–1.03); unadjusted two-proportion z-test p = 0.071.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CABG and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants Experiencing Death, MI, or Stroke

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • CABG: 5.2% (39/743) versus 7.3% (55/757) on control; risk difference -2.0 percentage points (95% CI -4.5 to 0.4), risk ratio 0.72 (0.49–1.08); unadjusted two-proportion z-test p = 0.107.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CABG and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants Experiencing Stroke

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • CABG: 1.1% (8/741) versus 0.9% (7/755) on control; risk difference 0.2 percentage points (95% CI -0.9 to 1.2), risk ratio 1.16 (0.42–3.19); unadjusted two-proportion z-test p = 0.767.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CABG and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcomes spanning a three-year composite of death, myocardial infarction, or stroke; one-year counts for death, myocardial infarction, or stroke; stroke; death; myocardial infarction; repeat revascularization; serious bleeding; and acute kidney injury. Taken together, these outcomes broaden the description beyond the one-year primary composite, but they do not all measure the same event or follow-up period. Their numerical results should be considered in their own timeframes and definitions rather than combined into a single conclusion.

The posted secondary results do not establish a clear, uniform pattern that can be treated as a replication of the primary endpoint. A secondary composite omits repeat revascularization, while other outcomes isolate particular events. Their estimates therefore address different questions from the primary MACCE result. The registry lists 16 secondary outcomes; numerical results for secondary outcomes not detailed in the posted results are not reported in the registry record.

General statistical explanation: secondary outcomes are often interpreted with caution because multiple outcomes create multiple opportunities to observe a result that appears notable by chance. Unless a multiplicity strategy is specified and the results are interpreted under it, unadjusted secondary p-values carry less weight than a prespecified primary analysis. A secondary outcome can be informative about the pattern of events, but it should not be treated as an independent confirmation of the primary result without considering its role in the analysis plan, its precision, and the number of comparisons made. The multiplicity plan is not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke
• Number of Participants Experiencing Death, MI, or Stroke
• Death
• Number of Participants Experiencing Myocardial Infarction
• Number of Participants Experiencing Stroke
• Number of Participants Requiring Repeat Revascularization
• Number of Participants Experiencing BARC Type 3-5 Bleeding
• Number of Participants Experiencing Acute Kidney Injury

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary at the participant level: each participant is counted as experiencing or not experiencing the composite during the stated timeframe. The registry provides event counts and group denominators. A simple unadjusted comparison can express the difference in event proportions as a risk difference. In the posted recalculation, the contrast is CABG relative to FFR-guided PCI, so the estimate is -0.037. A negative value in that orientation means the observed proportion in CABG is lower than the observed proportion in PCI; it does not adjust for other factors or account for event timing.

The recalculated risk difference has a 95% confidence interval from -0.066 to -0.009, with p = 0.011. General statistical explanation: a confidence interval describes a range of values compatible with the data and the calculation’s assumptions. Its width indicates precision; it is not a guarantee that the underlying value lies in that particular interval. A p-value describes how unusual data at least as incompatible with a null hypothesis would be under that hypothesis and the test’s assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect.

The registry’s sponsor-reported analysis uses regression and Cox methods and reports a hazard ratio of 1.5, with a 95% confidence interval from 1.1 to 2.2 and p = 0.35. General explanation: a Cox model is a time-to-event method that uses the timing of events and can account for participants whose follow-up ends before an event is observed, subject to assumptions about censoring and the model. A hazard ratio compares event rates over time as represented by the model; it is not the same quantity as a risk difference based on proportions with events. The registry labels the analysis non-inferiority, but its margin, model specification, and analysis population are not reported in the registry record. The sponsor’s own analysis takes precedence over the simple recalculation because the record flags a discrepancy.

The recalculation also reports relative risk and odds-ratio statistics. General explanation: a relative risk compares the event probabilities between groups, while an odds ratio compares event odds. Each expresses a relative contrast and differs from the absolute risk difference. These measures can convey different aspects of the same binary outcome, and their interpretation depends on which group is the reference. They should not be substituted for one another or for the time-to-event hazard ratio. The posted results and their uncertainty should be considered in the context of the specified outcome and comparison.

The primary composite combines death, myocardial infarction, stroke, and repeat revascularization. General explanation: combining outcomes can increase the number of participants contributing an event to the composite, but the total result can be influenced by components with different frequencies and meanings. A composite estimate does not reveal the component-specific effect. Component counts and definitions are therefore important context, though the registry record does not provide a complete component-level account for the primary endpoint.

The record describes participants as followed from randomization until a MACCE event or one year, whichever occurred first, with censoring at last recorded activity for those who died or were lost to follow-up before one year. General explanation: censoring means that complete event-time information is not available after a specified point. A time-to-event analysis relies on assumptions about how censoring relates to the chance of an event. The registry does not report enough detail about missingness, follow-up completeness, or censoring checks to assess those assumptions independently.

Finally, interpretation of repeated outcomes and multiple comparisons requires care. The record lists several secondary outcomes, but a full multiplicity strategy is not reported in the registry record. General explanation: when many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase if each is assessed without adjustment. That is why individual secondary p-values, especially unadjusted ones, are generally less conclusive than a prespecified primary analysis. The sample-size illustrations use stated planning assumptions and observed effect sizes; they do not establish the trial’s original design rationale or demonstrate the power actually achieved.

11. Confidence Intervals and Precision

The primary recalculated risk difference is -0.037, with a 95% confidence interval from -0.066 to -0.009. The interval describes uncertainty around the unadjusted contrast based on the posted event counts and the calculation’s assumptions. It does not capture every source of uncertainty, such as possible differences in analysis populations, endpoint handling, or follow-up that cannot be evaluated from the registry record.

General explanation: a narrower confidence interval indicates greater statistical precision for the quantity being estimated, while a wider interval indicates less precision. An interval that includes the null value for a risk difference is compatible with no difference under the interval’s assumptions; an interval that does not include it is less compatible with that value. This is not a complete interpretation of trial evidence, and it does not show whether an effect is important in clinical terms. The interval applies to the recalculated unadjusted risk difference, not to the sponsor’s hazard-ratio analysis.

The sponsor reports a hazard ratio of 1.5 with a 95% confidence interval from 1.1 to 2.2. That interval is on a different scale and comes from the reported regression and Cox analysis. It should not be directly compared with the risk-difference interval as if both estimated the same quantity. The registry’s analysis details do not identify the reference-group coding or report the non-inferiority margin, so the sponsor estimate cannot be fully interpreted from the posted information alone.

The secondary results also illustrate varying precision: estimates based on fewer events may be less precise, as reflected in their reported intervals. General explanation: sparse outcomes can produce wide intervals, leaving substantial uncertainty about the direction and size of a contrast. The interval and point estimate should be read together, rather than treating a p-value as a complete summary of certainty. For the primary endpoint, the discrepancy flag means the sponsor’s own analysis takes precedence over the unadjusted recalculation.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations are planning calculations, not a report of the trial’s original design assumptions. For these binary outcomes, the displayed figures are participants per arm. The general note for the illustrations says they use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is set to the stated fraction of the observed effect. The original sample-size justification and assumptions are not reported in the registry record.

The 80% power column describes the number of participants per arm estimated to give an 80% chance of detecting the assumed effect under the planning model and its assumptions. The 90% power column uses a higher probability of detecting that effect, and therefore generally requires more participants. The rows for 100%, 75%, and 50% of the observed effect show how the planning estimate changes when the assumed effect is reduced. Smaller effects need more participants to detect under the same assumptions.

These figures are not observed power. They are illustrations of sample sizes for hypothetical future planning scenarios based on the observed effect, not evidence about the probability that this completed trial detected an effect. They also do not establish that the trial was originally designed with these assumptions. The original protocol’s significance level, allocation assumptions, target effect, and sample-size rationale are not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.106; treatment proportion p₁ = 0.069; average p̄ = 0.087.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.3989 = 0.7818.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.3980 = 0.3350.
4. n = (0.7818 + 0.3350)² / (-0.0370)² = 909.2, rounded up to 910 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.105680317040951                          # control proportion
p1 <- 0.0686406460296097                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(2100722)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 910 (80% power), 1,217 (90% power)
 75% of observed effect: n per arm = 1,695 (80% power), 2,269 (90% power)
 50% of observed effect: n per arm = 3,987 (80% power), 5,337 (90% power)
power.prop.test: 909.2 
Simulated power at n = 910 per arm: 0.803 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports a sponsor analysis for the primary outcome using regression and Cox methods. It is classified as non-inferiority and gives a hazard ratio of 1.5, a 95% confidence interval from 1.1 to 2.2, and p = 0.35. The record does not report the non-inferiority margin or enough analytic detail to reconstruct the sponsor’s test and its interpretation.

A separate unadjusted recalculation from the posted event counts gives a risk difference of -0.037, a 95% confidence interval from -0.066 to -0.009, and p = 0.011. This calculation compares the posted proportions and is not the same analysis as a Cox model. It does not account for event timing and may not use the same analytic conventions or population as the sponsor analysis.

The registry marks a discrepancy between these results. Accordingly, the sponsor’s own analysis takes precedence; the simple recalculation should be treated as a descriptive check on the posted counts, not as a substitute for the trial’s reported analysis. Because the registry does not report the non-inferiority margin, the hazard-ratio reference coding, or the full analysis plan, the sponsor result cannot be independently reconstructed or fully evaluated from the record alone.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome and 16 secondary outcomes. It does not report a multiplicity adjustment strategy, a hierarchy for testing secondary outcomes, or which secondary analyses were intended to be confirmatory. Without those details, the degree to which the reported secondary findings were protected against the effects of multiple testing is not reported in the registry record.

General explanation: when several outcomes are tested, each test creates an opportunity for a result to appear notable even if there is no underlying difference. A prespecified strategy can control or organize interpretation of those comparisons. In its absence, secondary results are best viewed as descriptive or exploratory unless the analysis plan establishes otherwise. This does not make the outcomes irrelevant, but it limits how strongly an isolated unadjusted result should be interpreted.

The primary endpoint description states that participants who died or were lost to follow-up before one year were censored at their last recorded activity. More detailed information on missing outcome data, follow-up completeness, imputation, sensitivity analyses, or the assumptions used to handle incomplete observations is not reported in the registry record. The record also does not report whether the primary analysis followed an intention-to-treat population, a per-protocol population, or another defined analysis population.

The sponsor analysis is described as a regression and Cox non-inferiority analysis, but its full statistical plan, non-inferiority margin, and analysis-population details are not reported in the registry record. The record does not report interim analyses or stopping rules. These omissions limit independent assessment of multiplicity, missing-data handling, and the conduct of the sponsor’s non-inferiority analysis. They should not be filled in by assuming standard practices.

16. 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: death, mi or stroke (15.7%).

The registry lists serious adverse events affecting 119 of 757 participants in the FFR-guided PCI group and 101 of 743 in the CABG group. It lists other adverse events affecting 112 of 757 and 55 of 743, respectively. Deaths are listed as 53 in the PCI group and 51 in the CABG group. These are safety counts, distinct from the primary endpoint counts; the registry record does not explain how these categories overlap or relate to the endpoint analyses.

The most common serious adverse event term listed is Death, MI or stroke, at 15.7%. The record does not give an arm-specific value for that term in the information. These safety figures describe reported events in the groups; they do not, by themselves, establish that an event was caused by a treatment or provide an adjusted comparison. The registry record does not report further details about event attribution or the analysis of these safety outcomes.

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

The posted primary endpoint counts describe participants with the one-year composite of death, myocardial infarction, stroke, or repeat revascularization in each randomized group. The unadjusted recalculation gives a risk difference of -0.037 for CABG relative to FFR-guided PCI, with a 95% confidence interval from -0.066 to -0.009. This is a summary of the posted proportions, not the trial’s sponsor-reported time-to-event analysis.

The registry’s sponsor analysis is classified as non-inferiority and reports a hazard ratio of 1.5, with a 95% confidence interval from 1.1 to 2.2 and p = 0.35. Because the record flags a discrepancy, the sponsor’s own analysis takes precedence over the simple recalculation. The non-inferiority margin and important details needed to interpret that test are not reported in the registry record. The available information therefore does not support replacing the sponsor’s analysis with a conclusion based solely on the recalculated risk difference.

General explanation: an estimate describes the observed data through a particular statistical model, while its confidence interval describes uncertainty under that model. Neither an estimate nor a p-value alone determines clinical importance. A composite endpoint also cannot show which component contributed most to the overall result. Interpretation depends on the endpoint definition, analysis population, follow-up, and prespecified analysis plan.

The record does not provide all information needed to assess missing data, multiplicity, the non-inferiority margin, or the sponsor’s analysis in detail. Consequently, the results should be understood as the posted registry counts and analyses, with the discrepancy and reporting gaps kept in view. They do not establish a broader conclusion beyond the specific trial comparison and outcomes recorded, and they do not provide a basis for individual treatment decisions.

18. Why This Trial Matters Statistically

FAME 3 is statistically notable as a randomized, parallel-group comparison of two revascularization strategies, with a primary outcome that combines several clinically distinct events. Its design makes the contrast interpretable as a randomized group comparison, while the composite endpoint captures more than one type of outcome. At the same time, the combined measure requires attention to its components and to the way event timing and censoring were handled.

The registry presents both a sponsor-reported Cox non-inferiority analysis and a simple recalculation from posted participant counts. These are different statistical quantities, not competing versions of the same calculation. The record flags a discrepancy, making it important to distinguish a transparent unadjusted summary from the trial’s own analysis. The sponsor analysis takes precedence, but its non-inferiority margin and further methodological details are not reported in the registry record.

The record also illustrates why precision, multiplicity, and analysis transparency matter. Confidence intervals provide information about uncertainty, while multiple secondary outcomes require caution when no multiplicity plan is reported. Planning illustrations based on observed effects can help readers understand how assumptions affect sample-size requirements, but they do not reveal the original design rationale or observed power. Together, these features make the registry a useful example of reading posted trial results without treating a single p-value or estimate as a complete account.

19. 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 trial-specific limitations of interpretation arise from what is not reported in the registry record. The non-inferiority margin is absent, as are details needed to reconstruct the sponsor’s Cox analysis, including reference-group coding and the full analysis population. The registry flags a discrepancy between the sponsor analysis and the unadjusted recalculation, so the latter should not be treated as a replacement for the trial’s own analysis.

The primary endpoint combines death, myocardial infarction, stroke, and repeat revascularization. The posted primary counts do not show the contribution of each component, limiting interpretation of what drives the composite. The record describes censoring for death or loss to follow-up before one year but does not provide follow-up completeness, missing-data methods, or sensitivity analyses. Eligibility details beyond multivessel coronary artery disease are also not reported.

The registry lists many secondary outcomes, but a multiplicity strategy and testing hierarchy are not reported. Numerical results for secondary outcomes not detailed in the posted results are not reported in the registry record. Safety counts are listed, but further event-attribution and analysis details are not reported. The record also does not report the original sample-size justification, interim-analysis procedures, stopping rules, or detailed allocation methods. These gaps constrain independent evaluation; they do not establish that a particular method was or was not used.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease — NCT02100722.
• Registry record last updated 2026-04-07; status last verified 2025-03.
• Results first posted 2022-01-20.
• 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.

23. Record Summary

FAME 3 (NCT02100722) is listed as a completed, randomized, unmasked, parallel-group trial sponsored by Stanford University. It compared FFR-guided PCI with CABG in patients with multivessel coronary artery disease and lists an enrollment of 1500. The primary endpoint was one-year MACCE: death, myocardial infarction, stroke, or repeat revascularization.

The registry posts primary event counts of 80 among 757 participants assigned to PCI and 51 among 743 assigned to CABG. It also reports a sponsor Cox non-inferiority analysis and a separate unadjusted recalculation; the record flags a discrepancy, so the sponsor’s analysis takes precedence. Further details required for full independent assessment, including the non-inferiority margin and multiplicity plan, are not reported in the registry record.