Article summary : “CABG Still Superior to Stents Despite FAME 3 Endpoint Swap”
Article summary :
“CABG Still Superior to Stents Despite FAME 3 Endpoint Swap”
By: John M. Mandrola, MD
Published: May 6, 2025
Source: Medscape Commentary
Key Summary Points
1. Background – The FAME 3 Trial
• FAME 3 compared FFR-guided PCI vs CABG in patients with multivessel coronary artery disease (CAD).
• It followed three prior trials (SYNTAX, FREEDOM, BEST) that had consistently shown CABG superiority.
2. 1-Year Results (Original Primary Endpoint)
• Composite outcome (death, MI, stroke, revascularization):
• PCI: 10.6% vs CABG: 6.9%.
• HR = 1.5, 95% CI: 1.1–2.2 – not noninferior.
• Conclusion: CABG superior to PCI.
• Editorial titled: “CABG vs PCI — End of the Debate?”
3. 3-Year Results – Endpoint Change Introduced
• New composite endpoint used: death, MI, stroke (excluded revascularization).
• Result: No significant difference (12% PCI vs 9.2% CABG; HR = 1.3; P = 0.07).
• Original endpoint would still show CABG as superior:
• 18.6% PCI vs 12.5% CABG; HR = 1.5, P = 0.002.
4. 5-Year Results – Continued with Revised Endpoint
• Death, MI, stroke:
• 16% PCI vs 14.1% CABG; HR = 1.16, P = 0.27 (NS).
• If original endpoint used:
• 25% PCI vs 18% CABG; HR = 1.44, P = 0.002.
• MI and revascularization rates still higher after PCI.
5. Concerns Over the Endpoint Change
• The change undermines trial integrity and masks clear benefit of CABG.
• Three core objections:
1. Repeat revascularization is clinically meaningful, linked to higher mortality.
2. Changing endpoints mid-study undermines scientific rigor.
3. The new endpoint had wide confidence intervals and wasn’t powered or adjusted for multiple comparisons.
6. Public Messaging & Misleading Interpretation
• ACC 2025 headlines and press releases wrongly framed PCI as equal to CABG.
• This contradicts the data when using the original, more comprehensive endpoint.
7. Author’s Conclusion
• CABG remains superior for patients with multivessel CAD.
• The real change was in presentation, not outcomes.
• FAME 3 supports findings of earlier trials – PCI still carries higher event rates long-term.
Link: Medscape article :https://click.mail.medscape.com/?qs=3900ddeba56641e3de68dd04a7c5cc1fab425551acf4fc1181ddcde4448be1ba33a124f9884d02f1efc8c0072431efd314d2e4bd9e7e7665af3d80f6f7a86cb3
