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A global registry of fractional flow reserve (FFR)–guided management during routine care: Study design, baseline characteristics and outcomes of invasive management
Author(s) -
Schampaert Erick,
Kumar Gautam,
Achenbach Stephan,
Galli Stefano,
Tanaka Nobuhiro,
Teraphongphom Tarn,
Ginn Greg,
Zhang Zhen,
Somi Samer,
Amoroso Giovanni,
Brueren Guus,
Krasnow Joshua,
Knaapen Paul,
Berry Colin
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28827
Subject(s) - medicine , fractional flow reserve , revascularization , conventional pci , coronary artery disease , observational study , prospective cohort study , cardiology , angiography , acute coronary syndrome , percutaneous coronary intervention , percutaneous , interventional cardiology , coronary angiography , myocardial infarction , emergency medicine
Background The use and clinical outcomes of fractional flow reserve (FFR)–guided revascularization in patients presenting with either stable coronary artery disease (CAD) or an acute coronary syndrome (ACS) in daily clinical practice are uncertain. Objective To prospectively characterize the frequency of the change in treatment plan when FFR is performed compared to the initial decision based on angiography alone and procedure‐related outcomes. Methods We undertook a prospective, multicenter, multinational, open‐label, observational study of coronary physiologic measurements during clinically indicated coronary angiography. The treatment plan, including medical therapy, PCI or CABG, was prospectively recorded before and after performing FFR. Adverse events were pre‐defined and prospectively recorded per local investigators (PRESSUREwire; ClinicalTrials.gov identifier: NCT02935088). Results Two thousand two hundred and seventeen subjects were enrolled in 70 hospitals across 15 countries between October 2016–February 2018. The mean FFR (all measurements) was 0.84. The treatment plan based on angiography‐alone changed in 763/2196 subjects (34.7%) and 872/2931 lesions (29.8%) post‐FFR. In the per‐patient analysis, the initial treatment plan based on angiography versus the final treatment plan post‐FFR were medical management 1,350 (61.5%) versus 1,470 (66.9%) ( p = .0017); PCI 717 (32.7%) versus 604 (27.5%) ( p = .0004); CABG 119 (5.4%) versus 121 (5.5%) ( p = .8951). The frequency of intended revascularization changed from 38.1 to 33.0% per patient ( p = .0005) and from 35.5 to 29.6% per lesion ( p < .0001) following FFR. Conclusions On an individual patient basis, use of FFR in everyday practice changes the treatment plan compared to angiography in more than one third of all‐comers selected for physiology‐guided managements. FFR measurement is safe, providing incremental information to guide revascularization decisions.