TCT 2021 | FAME 3: Surprises in a Long-Awaited Study

Angioplasty could not reach non-inferiority to surgery to treat patients with three-vessel lesions.

FAME 3: Sorpresas en un estudio largamente esperado

In this head-to-head study of both revascularization strategies in patients with three-vessel coronary disease, fractional flow reserve (FFR)-guided angioplasty could not reach the performance of myocardial revascularization surgery in relation to a composite of adverse events.

The FAME 3 study was presented during the TCT 2021 scientific sessions, and it was simultaneously published in NEJM. Patients treated with FFR-guided angioplasty had higher all-cause mortality, infarction, stroke, or repeat revascularization rates compared with surgery.

When analyzed individually, none of the composite endpoints indicated a clear advantage in favor of either strategy. Only stroke events were numerically higher using angioplasty: a non-significant outcome that challenges previous evidence.

While patients with a Syntax score below 23 found benefit in angioplasty, this subgroup analysis can only generate hypothesis.

Results account for only one year of follow-up, but—since repeat revascularization is included among the endpoints—results are only bound to gain consistency over time.

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FAME 3 included 1500 patients with three-vessel coronary disease randomized to FFR-guided angioplasty or surgery. All patients had angina or evidence of ischemia, and all were good candidates for either strategy. Left main coronary artery lesion was an exclusion criteria for this study.

Researchers used the classic FFR threshold (0.8) and zotarolimus-releasing stent Resolute Integrity.

After a year of follow-up, the rate for the composite endpoint was 10.6% for angioplasty and 6.9% for surgery (hazard ratio: 1.5; 95% confidence interval: 1.1 to 2.2).

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The risk for major bleeding, arrhythmia, and acute kidney injury was lower with angioplasty.

Considering the group with low Syntax score, the result is 5.5% for angioplasty vs. 8.6% for surgery—but we have previously mentioned the limitations of this analysis.

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Original Title: Fractional flow reserve-guided PCI as compared with coronary bypass surgery.

Reference: Fearon WF et al. N Engl J Med 2021; Epub ahead of print y presentado simultáneamente en TCT 2021. doi: 10.1056/NEJMoa2112299.

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