Findings not consistent with prespecified noninferiority of fractional flow reserve-guided percutaneous coronary intervention
TUESDAY, Nov. 9, 2021 (HealthDay News) — For patients with three-vessel coronary artery disease, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is not noninferior to coronary artery bypass grafting (CABG) for a primary end point of a major adverse cardiac or cerebrovascular event within one year, according to a study published online Nov. 4 in the New England Journal of Medicine.
William F. Fearon, M.D., from the Stanford University in California, and colleagues conducted a multicenter, international, noninferiority trial involving 1,500 patients at 48 centers with three-vessel coronary artery disease who were randomly assigned to CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents.
Patients assigned to undergo PCI received a mean of 3.7 ± 1.9 stents, while those undergoing CABG received a mean of 3.4 ± 1.0 distal anastomoses. The researchers found that the one-year incidence of the composite end point (major adverse cardiac or cerebrovascular event) was 10.6 and 6.9 percent for those assigned to FFR-guided PCI and CABG, respectively (hazard ratio, 1.6; 95 percent confidence interval, 1.1 to 2.2); this finding did not meet prespecified noninferiority (upper boundary of 95 percent confidence interval of 1.65). The incidence of death, myocardial infarction, or stroke was 7.3 and 5.2 percent in the FFR-guided PCI and CABG groups, respectively (hazard ratio, 1.4; 95 percent confidence interval, 0.9 to 2.1).
“The good news for patients is that both groups did better than what was found in previous studies, and the differences between the two strategies has lessened,” Fearon said in a statement.
Several authors disclosed financial ties to biopharmaceutical and medical device companies, including Medtronic and Abbott Vascular, which supported the study.
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