This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
WOEST was a randomized, parallel-design phase 4 trial evaluating treatment strategies involving antiplatelet and anticoagulant therapy in patients undergoing percutaneous coronary intervention with coronary stenting.
| Feature | WOEST |
|---|---|
| NCT ID | NCT00769938 |
| Title | WOEST (What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing) |
| Status | Completed |
| Start date | 2008-12 |
| Primary completion date | 2012-08 |
| Lead sponsor | R&D Cardiologie |
| Allocation | Randomized |
| Masking | None |
2. Clinical Question
Population
Patients with oral anticoagulation undergoing coronary stenting.
Intervention
Antiplatelet and anticoagulant therapy strategy evaluated in the trial.
Comparator
Alternative randomized treatment strategy.
Primary question
How did randomized treatment strategies compare for bleeding complications during hospitalization and one year follow-up?
3. Trial Design
573 patients
2 arms
PCI setting
Bleeding
1 year
4. Endpoints
| Endpoint | Definition | Time frame |
|---|---|---|
| Primary endpoint | The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). | 1 year |
5. Planned Analysis
The registry identifies the primary endpoint as a combined bleeding outcome measured during the initial hospitalization and one year follow-up using TIMI and GUSTO criteria. For a randomized comparison of a binary composite bleeding endpoint, analyses would typically compare event proportions between treatment groups using an appropriate hypothesis test and estimate treatment differences with measures of uncertainty.
6. Statistical Methodology
Composite endpoints
The primary endpoint combines minor, moderate, and major bleeding complications. Composite endpoints allow multiple clinically relevant events to be evaluated together, but interpretation depends on understanding the contribution of each component.
Randomized comparison
Randomization creates treatment groups intended to be comparable at baseline. The primary statistical goal is to compare outcomes while preserving the advantages of randomized allocation.
Time-frame based outcomes
The endpoint includes events during initial hospitalization and through one year follow-up. The timing definition determines which observations contribute to the analysis.
7. Statistical Methods Explained
Why use a composite bleeding endpoint?
A composite endpoint can increase the number of observed events by combining related outcomes. Interpretation requires attention to whether the components represent similar levels of clinical importance.
What do TIMI and GUSTO criteria represent?
They are standardized bleeding classifications used to define bleeding severity categories for clinical research outcomes.
Why does randomization matter?
Random allocation reduces systematic differences between groups, allowing differences in outcomes to be attributed more directly to the treatment comparison.
Why is follow-up time important?
The one-year timeframe defines the period in which bleeding events contribute to the primary endpoint.
8. Limitations
- The registry does not provide posted statistical analyses or numerical outcome results for this record.
- A composite endpoint may combine events with different clinical severity.
- The registry information does not provide component-specific bleeding results.
- Interpretation of treatment effects requires the full statistical analysis plan and reported results.
9. Why This Trial Matters Statistically
| Concept | How it appears in WOEST |
|---|---|
| Randomization | Randomized parallel-group design |
| Composite endpoint | Combined minor, moderate, and major bleeding outcome |
| Clinical outcome classification | TIMI and GUSTO bleeding criteria |
| Longitudinal follow-up | Initial hospitalization through one year |
10. Sources
- ClinicalTrials.gov: WOEST NCT00769938
- PubMed: PubMed record
- PubMed: PubMed record
- PubMed: PubMed record