1. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.
- Author
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Xaplanteris, P., Fournier, S., Pijls, N. H. J., Fearon, W. F., Barbato, E., Tonino, P. A. L., Engstrøm, T., Kääb, S., Dambrink, J.-H., Rioufol, G., Toth, G. G., Piroth, Z., Witt, N., Fröbert, O., Kala, P., Linke, A., Jagic, N., Mates, M., Mavromatis, K., and Samady, H.
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CORONARY heart disease treatment , *ANTIHYPERTENSIVE agents , *PLATELET aggregation inhibitors , *CARDIOVASCULAR system , *COMPARATIVE studies , *CORONARY artery stenosis , *CORONARY circulation , *CORONARY disease , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL care , *MEDICAL cooperation , *MYOCARDIAL infarction , *REOPERATION , *RESEARCH , *EVALUATION research , *RANDOMIZED controlled trials , *DRUG-eluting stents , *KAPLAN-Meier estimator , *THERAPEUTICS , *PREVENTION ,ANGINA pectoris treatment - Abstract
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 [CI], 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. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .). [ABSTRACT FROM AUTHOR]- Published
- 2018
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