Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. (NCT01113892), a randomized na study. The primary outcome is Number of Participants With Primary Patency.

2. Clinical Question

3. Trial Design

FINEST was a randomized, single-masked, parallel-group device trial comparing EXXCEL Soft with FUSION Bioline in patients with peripheral arterial occlusive disease who required artery bypass. The registry lists the study phase as NA and the allocation as randomized. It records enrollment of 207 and a completed status. Maquet Cardiovascular is listed as the sponsor.

The registry records a start date of 2010-05-17 and a primary completion date of 2012-12-18. It describes the intervention as vascular grafts. The comparison focused on graft safety and primary patency, with primary patency assessed at 6 months. The endpoint description says patency was assessed by duplex ultrasound imaging and ankle brachial index.

The reported primary outcome counts were 70 participants with primary patency among 100 in the EXXCEL Soft group and 89 among 103 in the FUSION Bioline group. These are the denominators and counts posted for the primary outcome, not a statement that every enrolled participant contributed data to that analysis. The registry describes the endpoint population as a subset with available data for analysis.

The record does not report the randomization method, allocation concealment, the identity of the masked party, or details of how masking was maintained. It also does not report the original sample-size justification or the trial's planned assumptions for statistical power. Those omissions limit how fully the design and analysis can be reconstructed from the registry record alone.

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: Subjects (209) were randomly assigned to FUSION Bioline (108) or EXXCEL (101) - 2 subjects in the FUSION Bioline group did not undergo surgery and are excluded from all analysis. One (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months.

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: Of the 207 subjects treated, 203 were included in the efficacy analysis population. Four subjects were excluded due to data being unavailable for analysis.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Primary Patency, measured over 6 months.

The primary endpoint was the number of participants with primary patency at 6 months. A graft counted as patent when it had maintained blood flow continuously from implantation and had not undergone a procedure on the graft or a procedure to address disease progression in the adjacent native vessel. Stenosis within the graft, by itself, was not considered a loss of primary patency if it had not been remediated and had not led to occlusion.

This definition makes the outcome more specific than simply whether a graft had blood flow at a single assessment. It incorporates both continued flow and the absence of certain procedures. Assessment used duplex ultrasound imaging and ankle brachial index. The registry identifies the endpoint population as participants with available data in a subset of the efficacy analysis population; the efficacy analysis population included randomized subjects who met a study endpoint at 6 months.

General: A patency endpoint can capture whether a vascular conduit remains open over a stated follow-up period. A clearly defined endpoint is important because different rules about procedures, stenosis, or missing assessments can classify the same clinical course differently. The registry's definition specifies which procedures count against primary patency, while details about adjudication and missing assessments are not reported in the registry record.

7. Results Posted in the Registry

• FUSION Bioline: 86.4% (89/103) versus 70.0% (70/100) on control; risk difference 16.4 percentage points (95% CI 5.3 to 27.6), risk ratio 1.23 (1.06–1.43); unadjusted two-proportion z-test p = 0.005.

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.

Number of Participants With Primary Assisted Patency

• 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:
  • FUSION Bioline: 86.4% (89/103) versus 73.0% (73/100) on control; risk difference 13.4 percentage points (95% CI 2.5 to 24.3), risk ratio 1.18 (1.03–1.36); unadjusted two-proportion z-test p = 0.017.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for FUSION Bioline than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Number of Participants With Secondary Patency

• 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:
  • FUSION Bioline: 88.3% (91/103) versus 80.8% (80/99) on control; risk difference 7.5 percentage points (95% CI -2.4 to 17.5), risk ratio 1.09 (0.97–1.23); unadjusted two-proportion z-test p = 0.137.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FUSION Bioline and the control. The interval gives the range of effects that remain compatible with the data.

Time to Hemostasis of Suture Hole Bleeding (Min)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • FUSION Bioline: mean 3.50 versus 11.00 on control; difference -7.50 (95% CI -9.78 to -5.22), standardized effect d = -0.92; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for FUSION Bioline than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Across the secondary outcomes, the posted group comparisons generally point in the same direction as the primary endpoint, but their strength and precision are not uniform. The secondary patency comparison is less conclusive by its unadjusted interval and p-value than the results for primary assisted patency and time to hemostasis. This pattern offers supporting context, not an independent confirmation of the primary finding.

Primary assisted patency and secondary patency are related to graft status but are not identical to primary patency. Their definitions and the role of procedures can distinguish them from the primary endpoint. Time to hemostasis is a different, continuous measure assessed post-procedure, rather than a 6-month patency count. Thus, agreement in direction across outcomes does not mean that all outcomes represent the same clinical or statistical question.

The registry posts an unadjusted chi-squared test for each of the patency secondary outcomes and a Wilcoxon (Mann-Whitney) test for time to hemostasis. The posted recalculations are also unadjusted. Because several outcomes are examined, chance findings become more likely if each is treated as a separate confirmatory test without adjustment. The registry does not report a multiplicity plan or a hierarchy for interpreting the secondary outcomes. Their results therefore carry less weight than the primary question and should be viewed as supporting or exploratory evidence.

The registry lists additional outcomes beyond the secondary results described in detail, but the analysis information available in the record does not establish how all outcomes were selected, prioritized, or handled statistically. That limits the degree to which a pattern across endpoints can be used to make a single overall claim.

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

• Number of Participants With Primary Assisted Patency
• Number of Participants With Secondary Patency
• Time to Hemostasis of Suture Hole Bleeding (Min)

9. Statistical Interpretation

10. Statistical Methods Explained

What does a risk difference describe?

General: For a binary outcome, a risk difference compares the proportions with the outcome in two groups by subtracting one group's proportion from the other's. It expresses an absolute contrast on the probability scale. For the primary outcome, the unadjusted recalculation reports a risk difference of 0.164, with the comparison oriented as FUSION Bioline relative to EXXCEL Soft. This estimate is based on the posted summary counts and is not an adjusted model estimate.

A relative risk and an odds ratio describe the same binary outcome using different scales. The posted primary comparison gives a relative risk of 1.234, with a 95% confidence interval from 1.063 to 1.433, and an odds ratio of 2.724, with a 95% confidence interval from 1.343 to 5.527. Relative risk compares outcome proportions; odds ratio compares outcome odds. They should not be read as interchangeable measures, and neither is an absolute percentage-point difference.

What does the sponsor's non-inferiority analysis test?

General: A non-inferiority analysis evaluates whether the result is compatible with the new intervention being no worse than a comparator by more than a prespecified margin. The margin is essential to interpreting that question. The registry classifies the sponsor's primary analysis as non-inferiority and reports an exact 1-sided test, but the non-inferiority margin is not reported in the registry record. Consequently, the estimate, interval, and p-value can be described, but the decision rule cannot be independently reconstructed from the record.

The sponsor reports a mean difference (net) of 16.4, a 95% confidence interval from 2.7 to 29.9, and p < 0.001. The posted unadjusted recalculation instead reports a risk difference of 0.164 and its own confidence interval and p-value. The different methods and scales matter: the sponsor's result is the registry's reported trial analysis, while the recalculation is a simple unadjusted comparison of posted summary statistics.

Why do the methods differ across endpoints?

The primary endpoint is binary because each participant is counted according to whether primary patency was achieved. Its reported sponsor analysis uses an exact 1-sided test, while the unadjusted recalculation uses a risk difference and associated interval. For primary assisted patency and secondary patency, the registry reports chi-squared tests. The recalculated comparisons also express these outcomes as risk differences. These tests address group differences in binary outcome data, but the record does not report adjustment for other characteristics.

Time to hemostasis is continuous in the posted summary, with means and standard deviations reported for the two groups. The unadjusted recalculation estimates a mean difference of -7.5, with a confidence interval from -9.776 to -5.224 and p < 0.001. The sponsor's posted test is Wilcoxon (Mann-Whitney), which is a rank-based method rather than a test of means. General: Rank-based methods compare the ordering of observations and can be useful when distributional assumptions for a mean-based comparison are not appropriate. The registry does not report why that method was selected or provide participant-level data to examine the distribution.

The binary recalculations are unadjusted and use only the posted outcome counts. The continuous recalculation uses the posted means, standard deviations, and group sizes. Such summary-data recalculations cannot account for covariates, stratification, or analytic choices not represented in the posted summaries. The record does not report whether the sponsor's analyses used additional model terms or other adjustments.

How should p-values be read?

General: A p-value describes how unusual data at least as incompatible with a specified null model would be if that model and the analysis assumptions were true. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of an effect. The posted unadjusted primary p-value is 0.005. The sponsor's p-value is from a separate exact 1-sided non-inferiority analysis. The two p-values answer questions under different analysis procedures and should not be treated as interchangeable.

Confidence intervals add information about uncertainty and plausible effect values under the associated method. They do not correct for missing data, multiple testing, or an unsuitable endpoint definition. Those concerns require design and analysis details beyond the interval itself. The registry record does not provide a full statistical analysis plan, so the prespecified status of each analysis and the handling of other design features cannot be established from the posted information.

11. Confidence Intervals and Precision

The primary unadjusted risk difference is 0.164, with a 95% confidence interval from 0.052 to 0.276. The interval lies on the positive side of zero under this recalculation, while its width indicates that the exact size of the group contrast is uncertain. It is an interval for the unadjusted risk difference based on the posted summary statistics, not an interval adjusted for other variables or for missing outcomes.

The sponsor's reported estimate is 16.4, with a 95% confidence interval from 2.7 to 29.9. It comes from an exact 1-sided non-inferiority analysis, which is distinct from the recalculated risk-difference analysis. The non-inferiority margin is not reported in the registry record, so the interval cannot be compared with that decision threshold using the available record.

For primary assisted patency, the recalculated risk difference is 0.134, with a 95% confidence interval from 0.025 to 0.243. For secondary patency, the risk difference is 0.075, with a 95% confidence interval from -0.024 to 0.175; that interval includes zero. For time to hemostasis, the recalculated mean difference is -7.5, with a 95% confidence interval from -9.776 to -5.224.

General: A confidence interval gives a range of effect estimates compatible with the data and the method at the stated confidence level. A wider interval generally indicates less precision, while a narrower interval indicates more precision for that estimate. An interval containing zero for a difference is compatible with no group difference under that analysis, but it does not prove equality. The intervals also do not account for multiplicity unless a method for doing so is used; such a method is not reported in the registry record.

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 display is a planning illustration based on the observed effect, not a report of the trial's original design calculation. The assumptions listed for the illustration are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is a stated fraction of the observed effect.

For binary outcomes, the displayed values are participants per arm. For time-to-event outcomes, the stated convention is total events, but the posted secondary outcomes are binary or continuous rather than time-to-event outcomes. The continuous time-to-hemostasis planning values are also participants per arm, consistent with the stated rule that all outcomes other than time-to-event outcomes use participants per arm.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% probability of detecting the specified effect under the listed assumptions, if that effect and those assumptions were true. The 90% power column gives the corresponding planning number for a 90% probability. These are design-planning quantities, not probabilities that the observed trial result is correct. The values depend on the assumed effect size, significance level, allocation, and approximation.

Rows planning for 75% or 50% of the observed effect posit a smaller effect than the row using 100% of the observed effect. Smaller effects generally require more participants to detect under otherwise similar assumptions, which is why those rows have larger planning values. The original trial's sample-size assumptions and justification are not reported in the registry record. These illustrations are not observed power.

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 = 0.700; treatment proportion p₁ = 0.864; average p̄ = 0.782.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.5839 = 1.1444.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5722 = 0.4816.
4. n = (1.1444 + 0.4816)² / (0.1641)² = 98.2, rounded up to 99 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 <- 0.7                          # control proportion
p1 <- 0.864077669902913                          # 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(1113892)
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 = 99 (80% power), 131 (90% power)
 75% of observed effect: n per arm = 188 (80% power), 250 (90% power)
 50% of observed effect: n per arm = 447 (80% power), 598 (90% power)
power.prop.test: 98.2 
Simulated power at n = 99 per arm: 0.813 (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's primary analysis is the sponsor-reported exact 1-sided test of mean difference (net), classified as non-inferiority. It reports an estimate of 16.4, a 95% confidence interval from 2.7 to 29.9, and p < 0.001. This is the trial's own reported analysis and should be kept distinct from the unadjusted recalculation based on the posted participant counts.

The recalculation expresses the primary comparison as a risk difference of 0.164, with a 95% confidence interval from 0.052 to 0.276 and p = 0.005. It is a simple, unadjusted comparison of the summary counts, not a reproduction of the sponsor's exact test. Differences in analysis method and reporting scale mean that the two estimates and p-values should not be compared as though they came from the same procedure.

Both analyses point in the direction of a higher primary patency result for FUSION Bioline, but the registry does not report the non-inferiority margin. Without that margin, the sponsor's stated non-inferiority framework cannot be fully evaluated from the registry record. The recalculation is useful as a transparent descriptive comparison, but it does not replace the sponsor's analysis or supply the missing decision criterion.

15. Multiplicity, Missing Data and Analysis Populations

The registry reports a primary endpoint and multiple secondary outcomes, with several statistical tests. It does not report a plan for controlling multiplicity, such as an adjustment procedure or a prespecified testing hierarchy. General: When researchers test multiple outcomes, the chance of obtaining at least one apparently notable result by chance can increase. Adjustment strategies or a clear hierarchy can help define how much confirmatory weight to place on each test. Without the planned approach, secondary p-values should not be read as if each were the only test conducted.

The primary endpoint population is described as a subset of the efficacy analysis population with available data. The efficacy analysis population included randomized subjects who met a study endpoint at 6 months. The record does not specify how many participants lacked primary endpoint data, why data were unavailable, or how missing outcomes were handled. It does not report imputation methods, sensitivity analyses, or a detailed rule for inclusion in each outcome analysis. These details are important because exclusions or assumptions about missing observations can affect the comparison.

The record does not report a full statistical analysis plan, detailed analysis populations for all outcomes, adjustment for baseline characteristics, or whether any interim analyses were conducted. It also does not report the original sample-size justification. These are unknowns rather than evidence that a particular method was or was not used.

The sponsor's primary analysis is identified as a non-inferiority analysis, but the non-inferiority margin is not reported in the registry record. The direction of the test, estimate, interval, and p-value are available, but the threshold needed to judge the intended non-inferiority criterion is not. The unadjusted recalculation can describe the posted counts, but it cannot resolve these missing design and analysis details.

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: vascular graft thrombosis / vascular graft occlusion (31.7%), peripheral ischaemia (4.0%), implant site effusion (4.0%), wound dehiscence (3.8%), postoperative wound infection (3.8%).

The registry lists serious adverse event figures for EXXCEL Soft with 101 at risk and 50 affected, and for FUSION Bioline with 105 at risk and 44 affected. For other adverse events, it lists 101 at risk and 14 affected for EXXCEL Soft, and 105 at risk and 24 affected for FUSION Bioline. Deaths are listed as 2 for EXXCEL Soft and 4 for FUSION Bioline. These are registry-reported safety figures, not a causal comparison adjusted for differences in follow-up or other factors.

The listed serious adverse event terms include vascular graft thrombosis / vascular graft occlusion at 31.7%, peripheral ischaemia at 4.0%, implant site effusion at 4.0%, wound dehiscence at 3.8%, postoperative wound infection at 3.8%, and intermittent claudication at 3.8%. The registry does not provide enough detail in these figures to determine overlap among participants or whether each event was judged related to a graft. Affected-participant figures should not be added across categories.

These safety data should be read descriptively. The registry record does not report a statistical comparison for these figures, the event follow-up detail needed to assess exposure time, or further adjudication information. They do not by themselves establish that a device caused an event or provide a complete account of the safety profile.

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

The posted primary outcome is a comparison of the number of participants meeting a specific primary patency definition at 6 months. The observed counts and the unadjusted risk-difference estimate favor a higher count in the FUSION Bioline group. The confidence interval describes uncertainty around that recalculated contrast, while the sponsor separately reports a non-inferiority analysis. These results are evidence about the recorded outcome under the trial's definitions and analysis populations.

They do not establish that one graft is superior for every outcome, patient, or clinical setting. The registry's primary sponsor analysis is a non-inferiority test, and its margin is not reported, preventing a full assessment of the stated decision framework. The simple recalculation is unadjusted, and the record does not report the missing-data approach or detailed analysis plan needed to assess all possible sources of bias and uncertainty.

Primary patency is not the only relevant measure. The registry also reports primary assisted patency, secondary patency, time to hemostasis, and safety outcomes. Those outcomes measure different aspects of the study and have different analyses. The secondary comparisons are unadjusted, and no multiplicity strategy is reported, so they should not be treated as independent confirmatory proof.

General: Statistical evidence describes how observed data relate to a defined question and model. It does not, by itself, establish clinical importance, long-term performance, or causation. The registry record contains a bounded set of endpoint summaries and test results; it does not provide all information needed to assess generalizability, measurement procedures, or the clinical meaning of every difference. The results should be interpreted in that limited context rather than as a universal conclusion about vascular grafts.

18. Why This Trial Matters Statistically

This trial illustrates why the choice and definition of an endpoint matter. Primary patency was not simply a single observation of blood flow: it included continuity from implantation and rules about procedures on the graft and adjacent vessel. Those rules shape which participants are classified as meeting the endpoint and therefore shape the resulting group comparison.

It also illustrates the distinction between a trial's reported analysis and a transparent recalculation from summary counts. The sponsor's analysis uses an exact 1-sided non-inferiority framework, while the recalculation gives an unadjusted risk difference. Each can be described, but they answer statistical questions through different methods. The missing non-inferiority margin demonstrates why a test label and p-value alone are insufficient to reconstruct a decision rule.

The registry's outcome summaries also show why confidence intervals and missing-data descriptions matter. A point estimate alone does not convey the range of uncertainty, while a confidence interval does not resolve uncertainty about who was analyzed or how unavailable outcomes were handled. The available-data subset is explicitly relevant to the primary endpoint, yet details about the missing observations and their treatment are not reported.

Finally, the secondary outcomes raise the issue of multiplicity. Multiple tests can provide a broader view of a study, but their evidential weight depends on a prespecified strategy for interpreting them. The record's lack of a reported multiplicity plan makes it important to distinguish supportive patterns from confirmatory conclusions. These are general statistical lessons grounded in the specific reporting features of this trial.

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 limitations are specific to the available registry record. The primary endpoint is reported for a subset with available data, but the number and reasons for unavailable assessments and the handling of missing data are not reported in the registry record. The efficacy analysis population is described in relation to subjects meeting an endpoint at 6 months, but fuller population definitions and analysis rules are not posted by the record.

The trial's primary analysis is classified as non-inferiority, but the non-inferiority margin is not reported in the registry record. This prevents assessment of the sponsor's decision threshold. The sample-size assumptions used for the original trial are also not reported; the displayed planning illustrations instead use the observed effect and stated assumptions, so they cannot establish what the original design intended to detect.

Randomization is identified, but the method of sequence generation, allocation concealment, and identity of the masked party are not reported. The record also does not report an analysis plan, multiplicity strategy, interim analyses, covariate adjustment, or sensitivity analyses. Their absence from the registry entry means they cannot be evaluated from this record; it does not establish whether they were used elsewhere.

The safety summaries do not give enough information to determine overlap among affected participants, event relatedness, or event rates over comparable follow-up. The device description for FUSION Bioline ends mid-sentence after mentioning a heparin coating, so that detail is incomplete in the registry record. The outcome summaries are useful for describing the posted results, but these reporting gaps limit assessment of bias, precision, and broader applicability.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. — NCT01113892.
• Registry record last updated 2020-05-22; status last verified 2020-05.
• Results first posted 2020-05-22.
• 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

FINEST was a completed, randomized, single-masked, parallel-group study sponsored by Maquet Cardiovascular. It compared EXXCEL Soft with FUSION Bioline vascular grafts in patients with peripheral arterial occlusive disease requiring artery bypass. The registry records enrollment of 207 and a primary patency endpoint assessed at 6 months.

The posted primary counts were 70 of 100 for EXXCEL Soft and 89 of 103 for FUSION Bioline. The sponsor reported an exact 1-sided non-inferiority analysis; an unadjusted recalculation provides a risk-difference comparison. The non-inferiority margin, original sample-size assumptions, multiplicity plan, and details of missing-data handling are not reported in the registry record. Secondary and safety outcomes provide additional descriptive context but require cautious interpretation.