Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials

Area of Science:

• Cardiovascular Medicine
• Patient-Reported Outcomes
• Clinical Trial Design

Background:

• Composite endpoints in cardiovascular trials aggregate multiple outcomes.
• Patient perspectives on the severity of individual adverse events are not always aligned with clinical weighting.
• Understanding patient preferences is vital for patient-centered care and trial interpretation.

Purpose of the Study:

• To investigate patient perspectives on composite endpoints in revascularization procedures.
• To determine the utility patients assign to various adverse outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Main Methods:

• The PRECORE study utilized Best-Worst Scaling (BWS), a stated preference method.
• 160 patients with coronary artery disease who underwent PCI or CABG participated.
• Eight component endpoints (CEs) were evaluated, including redo procedures, stroke, myocardial infarction, angina, and death.

Main Results:

• Patients assigned varying Importance Weights (IWs) to different CEs.
• Death within 24 hours (IW: 1.000) and major stroke causing permanent disability (IW: 1.209) were weighted most heavily.
• Need for redo PCI within 1 year (IW: 0.008) and minor stroke (IW: 0.017) were weighted least.
• Preferences varied across subgroups based on gender, age, and education.

Conclusions:

• Patients attribute significantly different values to individual component endpoints.
• These varying patient preferences have critical implications for interpreting clinical trial data and designing future cardiovascular studies.
• Incorporating patient-reported outcomes enhances the relevance and applicability of clinical research.