FAME 3 sub-study shows no difference in quality of life between FFR-guided PCI and CABG.

By Wally A. Omar, MD on

Key Points

  • PCI has yet to be shown to be superior to CABG with respect to quality of life and angina in those with multivessel coronary artery disease.
  • This substudy of the FAME-3 trial, which randomized participants to FFR-guided PCI versus CABG, sought to understand whether physiology-guided PCI would have an effect on quality of life and angina.
  • Quality of Life was assessed by the EQ-5D questionnaire, and angina was assessed on the Canadian Coronary Symptoms scale.
  • At 1 year, there were no differences in angina and quality of life between those who underwent FFR-guided PCI and those who underwent CABG.

Prior literature has shown that patients with multivessel disease have better quality of life, as measured by relief from angina, after coronary artery bypass grafting, than after percutaneous coronary interventions (PCI). Those studies, however, lack two newer innovations from the past decade: current-generation drug-eluting stents, and widespread use of intracoronary physiology to guide PCI. The FAME 3 Trial demonstrated that fractional flow reserve-guided multivessel PCI did not meet noninferiority to CABG with respect to a composite of cardiovascular outcomes, death, stroke and bleeding. In a Featured Clinical Research session at the 71st Annual American College of Cardiology Scientific Sessions Meeting, Dr. Frederik Zimmermann (Catharina Hospital, Netherlands) presented the results of a sub-study of FAME 3, assessing quality of life and angina in those trial participants.

The design of FAME 3 was previously described. In this multi-center, international study, all comers with three-vessel disease, not involving the left main, were randomized to either receive FFR-guided PCI, in which all lesions with an FFR <0.8 were stented, or CABG guided by the coronary angiogram. Key exclusion criteria were left main involvement, cardiogenic shock, recent STEMI within five days, and LVEF <30%. The study enrolled 1500 patients, approximately 750 to each arm. Patients were mostly white males with an average age of 65 years old. Less than one-third had diabetes, and approximately 40% in each arm presented with acute coronary syndrome. In terms of coronary anatomy, 0% had intermediate SYNTAX scores of 23-32, and more than two-thirds of each arm had bifurcation lesions.

The primary endpoint of this study was a comparison of the EQ-5D summary index between the CABG and PCI arm at 12 months. Data were analyzed on an intention-to-treat basis. At baseline, 30 days, and 1 year, there was no difference in the EQ-5D scores in either arm (0.874 vs. 0.873, p = 0.95). With respect to secondary endpoints, more participants in the PCI group complained of CCS Class ≥ 2 angina at all time points and there was no difference in the working status of those aged ≤ 65.

In the panel discussion, Dr. Allen Jeremias congratulated the authors on their analysis, stating that the findings reinforce the need to have informed discussions with patients for shared-decision making. “Initially I was concerned because FFR-guided PCI was already proven not to be noninferior to CABG, so I did not understand the premise of this substudy,” he stated, “but after seeing the data I do think there is something to be said about discussing work, quality of life, and quickness of recovery with patients”.

The findings were simultaneously published in Circulation.