1. Fractional flow reserve-guided PCI for stable coronary artery disease
- Author
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De Bruyne B, Fearon WF, Pijls NH, Tonino P, Piroth Z, Jagic N, Mobius Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstr?m T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, N?esch E, J?ni P, FAME 2 Trial Investigators, BARBATO, EMANUELE, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), De Bruyne, B, Fearon, Wf, Pijls, Nh, Barbato, Emanuele, Tonino, P, Piroth, Z, Jagic, N, Mobius Winckler, S, Rioufol, G, Witt, N, Kala, P, Maccarthy, P, Engstr?m, T, Oldroyd, K, Mavromatis, K, Manoharan, G, Verlee, P, Frobert, O, Curzen, N, Johnson, Jb, Limacher, A, N?esch, E, J?ni, P, Fame, 2 Trial Investigators, and Cardiovascular Biomechanics
- Subjects
Coronary Disease/drug therapy/mortality/physiopathology/*therapy ,medicine.medical_specialty ,medicine.medical_treatment ,Fractional Flow Reserve ,[SDV]Life Sciences [q-bio] ,610 Medicine & health ,Fractional flow reserve ,Kaplan-Meier Estimate ,Revascularization ,Coronary artery disease ,360 Social problems & social services ,Internal medicine ,medicine ,Myocardial Infarction/epidemiology/prevention & control ,Humans ,Myocardial ,Myocardial infarction ,Instantaneous wave-free ratio ,Proportional Hazards Models ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,General Medicine ,medicine.disease ,Adrenergic beta-Antagonists/therapeutic use ,Combined Modality Therapy ,Angiotensin Receptor Antagonists/therapeutic use ,3. Good health ,Surgery ,Angiotensin-Converting Enzyme Inhibitors/therapeutic use ,Conventional PCI ,Cardiology ,Percutaneous Coronary Intervention/adverse effects/*methods ,business - Abstract
International audience; BACKGROUND: We hypothesized that in patients with stable coronary artery disease and stenosis, percutaneous coronary intervention (PCI) performed on the basis of the fractional flow reserve (FFR) would be superior to medical therapy. METHODS: In 1220 patients with stable coronary artery disease, we assessed the FFR in all stenoses that were visible on angiography. Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years. RESULTS: The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval [CI], 0.26 to 0.57; P\textless0.001). This reduction was driven by a lower rate of urgent revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI, 0.14 to 0.38; P\textless0.001), with no significant between-group differences in the rates of death and myocardial infarction. Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group (3.4% vs. 7.0%, P=0.01). In a landmark analysis, the rate of death or myocardial infarction from 8 days to 2 years was lower in the PCI group than in the medical-therapy group (4.6% vs. 8.0%, P=0.04). Among registry patients, the rate of the primary end point was 9.0% at 2 years. CONCLUSIONS: In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome. Patients without ischemia had a favorable outcome with medical therapy alone. (Funded by St. Jude Medical; FAME 2 ClinicalTrials.gov number, NCT01132495.).
- Published
- 2014
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