Zsolt Piroth1, Gabor G Toth1, Pim A L Tonino1, Emanuele Barbato1, Soheila Aghlmandi1, Nick Curzen1, Gilles Rioufol1, Nico H J Pijls1, William F Fearon1, Peter Jüni1, Bernard De Bruyne2. 1. From the Hungarian Institute of Cardiology, Budapest, Hungary (Z.P.); University Heart Centre Graz, Medical University Graz, Austria (G.G.T.); Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands (P.A.L.T., N.H.J.P.); Cardiovascular Center Aalst, Belgium (G.G.T., E.B., B.D.B.); Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.); Institute of Social and Preventive Medicine, University of Bern, Switzerland (S.A.); Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Switzerland (S.A.); Southampton University Hospital NHS Trust, England (N.C.); Cardiovascular Hospital, Lyon, France (G.R.); Department of Biomedical Engineering, Eindhoven University of Technology, the Netherlands (N.H.J.P.); Division of Cardiovascular Medicine, Stanford University Medical Center, CA (W.F.F.); and St. Michael's Hospital, University of Toronto, Canada (P.J.). 2. From the Hungarian Institute of Cardiology, Budapest, Hungary (Z.P.); University Heart Centre Graz, Medical University Graz, Austria (G.G.T.); Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands (P.A.L.T., N.H.J.P.); Cardiovascular Center Aalst, Belgium (G.G.T., E.B., B.D.B.); Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.); Institute of Social and Preventive Medicine, University of Bern, Switzerland (S.A.); Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Switzerland (S.A.); Southampton University Hospital NHS Trust, England (N.C.); Cardiovascular Hospital, Lyon, France (G.R.); Department of Biomedical Engineering, Eindhoven University of Technology, the Netherlands (N.H.J.P.); Division of Cardiovascular Medicine, Stanford University Medical Center, CA (W.F.F.); and St. Michael's Hospital, University of Toronto, Canada (P.J.). bernard.de.bruyne@olvz-aalst.be.
Abstract
BACKGROUND: The predictive value of fractional flow reserve (FFR) measured immediately after percutaneous coronary intervention (PCI) with drug-eluting stent placement has not been prospectively investigated. We investigated the potential of post-PCI FFR measurements to predict clinical outcome in patients from FAME 1 and 2 trials (Fractional Flow Reserve or Angiography for Multivessel Evaluation). METHODS AND RESULTS:All patients of FAME 1 and FAME 2 who had post-PCI FFR measurement were included. The primary outcome was vessel-oriented composite end point at 2 years, defined as vessel-related cardiovascular death, vessel-related spontaneous myocardial infarction, and ischemia-driven target vessel revascularization. Eight hundred thirty-eight vessels in 639 patients were analyzed. Baseline FFR values did not differ between vessels with versus without vessel-oriented composite end point (0.66±0.11 versus 0.63±0.14, respectively; P=0.207). Post-PCI FFR was significantly lower in vessels with vessel-oriented composite end point (0.88±0.06 versus 0.90±0.06, respectively; P=0.019). Comparing the 2-year outcome of lower and upper tertiles of post-PCI FFR significant difference was found favoring upper tertile in terms of overall vessel-oriented composite end point (9.2% versus 3.8%, respectively; hazard ratio, 1.46; 95% confidence interval, 1.02-2.08; P=0.037) and target vessel revascularization (7.0% versus 2.4%, respectively; hazard ratio, 1.59; 95% confidence interval, 1.03-2.46; P=0.037). When adjusted to sex, hypertension, diabetes mellitus, target vessel, serial stenosis, and baseline percentage diameter stenosis, a strong trend was preserved in terms of target vessel revascularization (harzard ratio, 1.55; 95% confidence interval, 0.97-2.46; P=0.066), favoring the upper tertile. Post-PCI FFR of 0.92 was found to have the highest diagnostic accuracy; however, the positive likelihood ratio remained low (<1.4). CONCLUSIONS: A higher post-PCI FFR value is associated with a better vessel-related outcome. However, its predictive value is too low to advocate its use as a surrogate clinical end point.
RCT Entities:
BACKGROUND: The predictive value of fractional flow reserve (FFR) measured immediately after percutaneous coronary intervention (PCI) with drug-eluting stent placement has not been prospectively investigated. We investigated the potential of post-PCI FFR measurements to predict clinical outcome in patients from FAME 1 and 2 trials (Fractional Flow Reserve or Angiography for Multivessel Evaluation). METHODS AND RESULTS: All patients of FAME 1 and FAME 2 who had post-PCI FFR measurement were included. The primary outcome was vessel-oriented composite end point at 2 years, defined as vessel-related cardiovascular death, vessel-related spontaneous myocardial infarction, and ischemia-driven target vessel revascularization. Eight hundred thirty-eight vessels in 639 patients were analyzed. Baseline FFR values did not differ between vessels with versus without vessel-oriented composite end point (0.66±0.11 versus 0.63±0.14, respectively; P=0.207). Post-PCI FFR was significantly lower in vessels with vessel-oriented composite end point (0.88±0.06 versus 0.90±0.06, respectively; P=0.019). Comparing the 2-year outcome of lower and upper tertiles of post-PCI FFR significant difference was found favoring upper tertile in terms of overall vessel-oriented composite end point (9.2% versus 3.8%, respectively; hazard ratio, 1.46; 95% confidence interval, 1.02-2.08; P=0.037) and target vessel revascularization (7.0% versus 2.4%, respectively; hazard ratio, 1.59; 95% confidence interval, 1.03-2.46; P=0.037). When adjusted to sex, hypertension, diabetes mellitus, target vessel, serial stenosis, and baseline percentage diameter stenosis, a strong trend was preserved in terms of target vessel revascularization (harzard ratio, 1.55; 95% confidence interval, 0.97-2.46; P=0.066), favoring the upper tertile. Post-PCI FFR of 0.92 was found to have the highest diagnostic accuracy; however, the positive likelihood ratio remained low (<1.4). CONCLUSIONS: A higher post-PCI FFR value is associated with a better vessel-related outcome. However, its predictive value is too low to advocate its use as a surrogate clinical end point.
Authors: Juan Luis Gutiérrez-Chico; Carlos Cortés; Miłosz Jaguszewski; Michele Schincariol; Ignacio J Amat-Santos; Juan A Franco-Peláez; Grzegorz Żuk; Dariusz Ciećwierz; Wojciech Wojakowski; Felipe Navarro; Shengxian Tu; Borja Ibáñez Journal: Cardiol J Date: 2019-07-01 Impact factor: 2.737
Authors: Stephane Fournier; Giovanni Ciccarelli; Gabor G Toth; Anastasios Milkas; Panagiotis Xaplanteris; Pim A L Tonino; William F Fearon; Nico H J Pijls; Emanuele Barbato; Bernard De Bruyne Journal: JAMA Cardiol Date: 2019-04-01 Impact factor: 14.676
Authors: Bhavik N Modi; Matthew Ryan; Anjalee Chattersingh; Kseniia Eruslanova; Howard Ellis; Nicholas Gaddum; Jack Lee; Brian Clapp; Phil Chowienczyk; Divaka Perera Journal: J Am Heart Assoc Date: 2018-10-16 Impact factor: 5.501