FFR-Guided PCI Not Shown to Be Noninferior to CABG in Patients with Three-Vessel CAD

January 16, 2022
Connor Iapoce

Connor Iapoce is an assistant editor for HCPLive and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at ciapoce@mjhlifesciences.com.

Data show the 1-year incidence of the composite primary endpoint was 10.6% among patients randomized to FFR-guided PCI and 6.9% in CABG.

Although patients with three-vessel coronary artery disease (CAD) have been shown to have better outcomes with coronary-artery bypass grafting (CABG) compared to percutaneous coronary intervention (PCI), there is little data in which PCI is guided by a measurement of fractional flow reserve.

As a result, a recent study explored CABG compared to FFR-guided PCI in patients with three-vessel CAD, with a primary endpoint as the occurrence within 1 year of a major adverse cardiac or cerebrovascular event.

Led by William F. Fearon, MD, Stanford Cardiovascular Institute, the team of investigators found FFR-guided PCI was not found to be noninferior to CABG in this patient population.

The Study

The study encompassed a multicenter, international, non-inferiority trial, in which patients with three-vessel CAD were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents.

Primary endpoints were considered the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Secondary endpoints were defined as a composite of death, myocardial infarction, or stroke, while safety was additionally assessed.

Investigators prespectified the non inferiority of FFR-guided PCI to CABG as an upper boundary of less than 1.65 for the 95% confidence interval (CI) of the hazard ratio (HR).

Data

Overall, a total of 1500 patients underwent randomization throughout 48 centers. Data show patients assigned to undergo PCI received a mean of 3.7±1.9 stents, while patients assigned to undergo CABG received 3.4±1.0 distal anastomoses.

They observed the 1-year incidence of the composite primary endpoint was 10.6% among patients randomized to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (HR, 1.5; 95% CI, 1.1 - 2.2). This was not consistent with the noninferiority of FFR-guided PCI (P = .35 for noninferiority).

Further, the incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (HR, 1.4; 95% CI, 0.9 - 2.1).

Lastly, incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group compared to the FFR-guided PCI group.

Takeaways

“In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year,” investigators wrote.

The study, “Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery,” was published in The New England Journal of Medicine.


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