Meaningful outcome measures in cardiac surgery

Area of Science:

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

Background:

• Common cardiac surgeries include coronary artery bypass graft and valve repair/replacement for conditions like coronary artery disease and heart failure.
• Current clinical studies often rely on surrogate outcome measures with questionable clinical significance.
• Traditional hard endpoints (e.g., death, myocardial infarction, stroke) are infrequent, necessitating large studies or composite endpoints.

Purpose of the Study:

• To critically evaluate the choice of primary outcome measures in clinical studies for cardiac surgery patients.
• To emphasize the importance of patient-centered outcomes aligned with surgical goals of symptom alleviation and survival.
• To question the utility of composite endpoints like major adverse cardiac events (MACE) due to varying definitions and conflicting results.

Main Methods:

• Literature review and critical analysis of outcome measure selection in cardiac surgery research.
• Discussion of the limitations of surrogate and traditional hard endpoints.
• Examination of the concept and definition of major adverse cardiac events (MACE).

Main Results:

• Many studies use surrogate outcomes lacking clear patient benefit.
• Composite endpoints like MACE lack standardized definitions and can yield conflicting results.
• The ultimate goal of cardiac surgery is improved quality of life, suggesting disability-free survival as a superior outcome measure.

Conclusions:

• Outcome measures in cardiac surgery research must align with the primary goals of symptom relief and improved survival.
• Disability-free survival represents a more meaningful ultimate outcome than traditional or composite endpoints.
• Further research is needed to define and quantify disability after cardiac surgery.