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Five-Year Outcomes with PCI Guided by Fractional Flow Reserve
Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
Department of Cardiology, Eindhoven University of Technology, Catharina Hospital, Eindhoven, Netherlands.
Stanford University Medical Center and Palo Alto Veterans Affairs (VA) Health Care Systems, Stanford CA, United States.
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2018 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 379, no 3, p. 250-259Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease.

METHODS: Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, <= 0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.

RESULTS: A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval (CIS, 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy.

CONCLUSIONS: In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone.

Place, publisher, year, edition, pages
Massachussetts Medical Society , 2018. Vol. 379, no 3, p. 250-259
National Category
General Practice
Identifiers
URN: urn:nbn:se:oru:diva-68331DOI: 10.1056/NEJMoa1803538ISI: 000439063900008PubMedID: 29785878Scopus ID: 2-s2.0-85049603391OAI: oai:DiVA.org:oru-68331DiVA, id: diva2:1236439
Note

Funding Agencies:

St. Jude Medical  

European Association of Percutaneous Cardiovascular Interventions  

Hellenic Cardiological Society  

Swiss National Science Foundation  

Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases  

Canada Research Chairs Programme 

Available from: 2018-08-02 Created: 2018-08-02 Last updated: 2018-09-14Bibliographically approved

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