Heart Surgery Still Beats Stents Despite New Study Findings
A critical look at the endpoint adjustments (changes in how researchers measured outcomes) in the FAME 3 trial and their impact on coronary artery disease treatment guidelines.
Topline:
Despite changes to the outcomes measured that altered conclusions in recent reports, the 5-year results of the FAME 3 trial confirm coronary artery bypass graft surgery (CABG) remains superior to percutaneous coronary intervention (PCI) with stents for multivessel coronary artery disease (CAD).
Study Details:
The FAME 3 trial initially aimed to compare the effectiveness of modern stenting (PCI) against traditional surgery (CABG) in patients with multivessel coronary artery disease, a condition involving significant blockage in multiple arteries of the heart. Prior studies consistently favored CABG, but advancements in PCI techniques, such as fractional flow reserve (FFR) guidance - a technique used to measure blood flow and pressure in the arteries to identify blockages needing treatment suggested the potential for improved outcomes.
Methodology:
The original trial was designed as a noninferiority study with a primary endpoint of all-cause death, myocardial infarction (MI), stroke, and repeat revascularization at one year, with follow-ups planned at 3 and 5 years if funded. Crucially, the investigators later changed the primary endpoint at subsequent follow-ups by excluding repeat revascularization, impacting the statistical outcomes significantly.
Key Findings:
At 1 year, PCI showed a 50% higher rate of adverse events compared to CABG, failing the noninferiority test.
At 3 years, changing the endpoint (excluding repeat revascularization) showed statistically insignificant differences, misleadingly suggesting parity between PCI and CABG.
At 5 years, using the revised endpoint (death, MI, stroke), PCI again appeared comparable to CABG. However, including repeat revascularization, as originally intended CABG demonstrated a clear advantage, reinforcing its superiority.
Implications for Practice:
The findings underscore that CABG should remain the preferred method of revascularization for patients with severe multivessel coronary artery disease. Repeat revascularization typically indicates a need for additional procedures due to persistent or recurrent artery blockages, often linked with acute coronary syndromes (such as heart attacks or unstable angina), emphasizing its clinical importance and reinforcing CABG’s superior durability and long-term benefit.
Healthcare providers must critically evaluate endpoint adjustments in clinical trials to avoid misinterpretations that could negatively influence patient care and guideline recommendations.