Fractional flow reserve–guided PCI reduced major adverse cardiac outcomes compared with angiography-guided PCI in multivessel CAD

摘要

QuestionnnIn patients with multivessel coronary artery disease (CAD) having percutaneous coronary intervention (PCI), does routine measurement of fractional flow reserve (FFR) using angiography improve cardiac outcomes? nnMethodsnnDesign: Randomized controlled trial (Fractional Flow Reserve versus Angiography for Multivessel Evaluation [FAME] study). ClinicalTrials.gov NCT00267774.nnAllocation: {Concealed}†.*nnBlinding: Blinded (outcome assessors).*nnFollow-up period: 1 year.nnSetting: 20 medical centers in the USA and Europe.nnPatients: 1005 patients (mean age 64 y, 74% men) with multivessel CAD (coronary artery stenosis 50% of vessel diameter in 2 of 3 major epicardial coronary arteries) who were having PCI. Exclusion criteria included angiographically significant left main CAD, previous coronary artery bypass surgery, cardiogenic shock, extremely tortuous or calcified coronary arteries, and contraindication to drug-eluting stents.nnIntervention: FFR- (n = 509) or angiography-guided (n = 496) PCI with drug-eluting stents. The FFR group received stents for lesions of FFR 0.8, whereas the angiography group received stents for all lesions. All patients took aspirin and clopidogrel for 1 year after PCI.nnOutcomes: Included major adverse cardiac events (composite of death, myocardial infarction [MI], and repeated revascularization), individual components of the composite endpoint, and health-related quality of life.nnPatient follow-up: 98% (100% included in intention-to-treat analysis).nnnMain resultsnnFewer patients in the FFR group had major adverse cardiac events compared with the angiography group (Table). Groups did not differ for individual components of the composite endpoint (Table) or health-related quality of life. nnConclusionnnMeasurement of fractional flow reserve using angiography reduced a composite of death, myocardial infarction, and repeated revascularization compared with angiography alone in patients with multivessel coronary artery disease having percutaneous coronary intervention.