TY - JOUR
T1 - Quality of Life after Fractional Flow Reserve-Guided PCI Compared with Coronary Bypass Surgery
AU - Fearon, William F.
AU - Zimmermann, Frederik M.
AU - Ding, Victoria Y.
AU - Zelis, Jo M.
AU - Piroth, Zsolt
AU - Davidavicius, Giedrius
AU - Mansour, Samer
AU - Kharbanda, Rajesh
AU - Östlund-Papadogeorgos, Nikolaos
AU - Oldroyd, Keith G.
AU - Wendler, Olaf
AU - Reardon, Michael J.
AU - Woo, Y. Joseph
AU - Yeung, Alan C.
AU - Pijls, Nico H.J.
AU - De Bruyne, Bernard
AU - Desai, Manisha
AU - Hlatky, Mark A.
N1 - Funding Information:
W.F.F. receives research funding from Abbott, Medtronic, and Boston Scientific and has a consulting relationship with Siemens and CathWorks and stock options with HeartFlo. S.M. has a consulting relationship with Abbott, Amgen, Astra Zeneca, Bayer, Boehlinger, Novartis, Opsens, Pfizer, and Servier Affaires Medicales. K.G.O. is employed by Biosensors. M.J.R. has a consulting relationship with Boston Scientific and W.L. Gore Associates. A.C.Y. has a consulting relationship with Medtronic. N.H.J.P. receives research funding from Abbott, has consulting relationships with Abbott and Opsens, and has stock or stock options with ASML, General Electric, HeartFlow, Hexacath, and Philips. B.D.B. has stock or stock options with Edwards LifeSciences, General Electric, HeartFlow, Philips, and Siemens. M.A.H. has a consulting relationship with Blue Cross and Blue Shield and research support from HeartFlow The other authors report no conflicts.
Funding Information:
The FAME 3 trial was funded by research grants to Stanford University from Medtronic and Abbott Vascular.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/5/31
Y1 - 2022/5/31
N2 - Background: Previous studies have shown that quality of life improves after coronary revascularization more so after coronary artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI). This study aimed to evaluate the effect of fractional flow reserve guidance and current generation, zotarolimus drug-eluting stents on quality of life after PCI compared with CABG. Methods: The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) is a multicenter, international trial including 1500 patients with 3-vessel coronary artery disease who were randomly assigned to either CABG or fractional flow reserve-guided PCI. Quality of life was measured using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline and 1 and 12 months. The Canadian Cardiovascular Class angina grade and working status were assessed at the same time points and at 6 months. The primary objective was to compare EQ-5D summary index at 12 months. Secondary end points included angina grade and work status. Results: The EQ-5D summary index at 12 months did not differ between the PCI and CABG groups (difference, 0.001 [95% CI, -0.016 to 0.017]; P=0.946). The trajectory of EQ-5D during the 12 months differed (P<0.001) between PCI and CABG: at 1 month, EQ-5D was 0.063 (95% CI, 0.047 to 0.079) higher in the PCI group. A similar trajectory was found for the EQ (EuroQol) visual analogue scale. The proportion of patients with Canadian Cardiovascular Class 2 or greater angina at 12 months was 6.2% versus 3.1% (odds ratio, 2.5 [95% CI, 0.96-6.8]), respectively, in the PCI group compared with the CABG group. A greater percentage of younger patients (<65 years old) were working at 12 months in the PCI group compared with the CABG group (68% versus 57%; odds ratio, 3.9 [95% CI, 1.7-8.8]). Conclusions: In the FAME 3 trial, quality of life after fractional flow reserve-guided PCI with current generation drug-eluting stents compared with CABG was similar at 1 year. The rate of significant angina was low in both groups and not significantly different. The trajectory of improvement in quality of life was significantly better after PCI, as was working status in those <65 years old. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.
AB - Background: Previous studies have shown that quality of life improves after coronary revascularization more so after coronary artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI). This study aimed to evaluate the effect of fractional flow reserve guidance and current generation, zotarolimus drug-eluting stents on quality of life after PCI compared with CABG. Methods: The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) is a multicenter, international trial including 1500 patients with 3-vessel coronary artery disease who were randomly assigned to either CABG or fractional flow reserve-guided PCI. Quality of life was measured using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline and 1 and 12 months. The Canadian Cardiovascular Class angina grade and working status were assessed at the same time points and at 6 months. The primary objective was to compare EQ-5D summary index at 12 months. Secondary end points included angina grade and work status. Results: The EQ-5D summary index at 12 months did not differ between the PCI and CABG groups (difference, 0.001 [95% CI, -0.016 to 0.017]; P=0.946). The trajectory of EQ-5D during the 12 months differed (P<0.001) between PCI and CABG: at 1 month, EQ-5D was 0.063 (95% CI, 0.047 to 0.079) higher in the PCI group. A similar trajectory was found for the EQ (EuroQol) visual analogue scale. The proportion of patients with Canadian Cardiovascular Class 2 or greater angina at 12 months was 6.2% versus 3.1% (odds ratio, 2.5 [95% CI, 0.96-6.8]), respectively, in the PCI group compared with the CABG group. A greater percentage of younger patients (<65 years old) were working at 12 months in the PCI group compared with the CABG group (68% versus 57%; odds ratio, 3.9 [95% CI, 1.7-8.8]). Conclusions: In the FAME 3 trial, quality of life after fractional flow reserve-guided PCI with current generation drug-eluting stents compared with CABG was similar at 1 year. The rate of significant angina was low in both groups and not significantly different. The trajectory of improvement in quality of life was significantly better after PCI, as was working status in those <65 years old. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.
KW - coronary artery bypass grafting
KW - coronary artery disease
KW - fractional flow reserve
KW - percutaneous coronary intervention
KW - quality of life
KW - Percutaneous Coronary Intervention/adverse effects
KW - Angina Pectoris
KW - Humans
KW - Treatment Outcome
KW - Canada
KW - Fractional Flow Reserve, Myocardial
KW - Quality of Life
KW - Aged
KW - Coronary Artery Bypass/adverse effects
KW - Coronary Artery Disease/surgery
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U2 - 10.1161/CIRCULATIONAHA.122.060049
DO - 10.1161/CIRCULATIONAHA.122.060049
M3 - Article
C2 - 35369704
AN - SCOPUS:85131167953
VL - 145
SP - 1655
EP - 1662
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 22
ER -