Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCIDepartment of Cardiology, Karlstad Hospital, Karlstad, Sweden.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Departments of Cardiology and Radiology, Helsingborg Hospital, Helsingborg, Sweden.
Uppsala Clinical Research Center, Uppsala, Sweden.
Department of Cardiology, Karlstad Hospital, Karlstad, Sweden.
Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
Department of Cardiology, St. Göran Hospital, Stockholm, Sweden.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.
Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Department of Internal Medicine, Västmanland Hospital, Västerås, Sweden.
Department of Cardiology, Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.
Department of Cardiology, Kalmar County Hospital, Kalmar, Sweden; Faculty of Health and Life Sciences, Linnaeus University, Kalmar, Sweden.
Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet,Stockholm, Sweden; Unit of Cardiology, Capio St. Görans Sjukhus, Stockholm, Sweden; Department of Medicine, Sundsvall Hospital, Sundsvall, Sweden.
Department of Cardiology, Halmstad Hospital, Halmstad, Sweden.
Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Department of Cardiology, Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.
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2017 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 376, no 19, p. 1813-1823Article in journal (Refereed) Published
Abstract [en]
Background: The instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events.
Methods: We conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary-artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure.
Results: A primary end-point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], -1.5 to 2.8%; P=0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P=0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target-lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure.
Conclusions: Among patients with stable angina or an acute coronary syndrome, an iFR-guided revascularization strategy was noninferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months.
Place, publisher, year, edition, pages
Massachussetts Medical Society , 2017. Vol. 376, no 19, p. 1813-1823
National Category
Cardiology and Cardiovascular Disease
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:oru:diva-57370DOI: 10.1056/NEJMoa1616540ISI: 000400891100007PubMedID: 28317438Scopus ID: 2-s2.0-85019438253OAI: oai:DiVA.org:oru-57370DiVA, id: diva2:1095751
Note
Funding Agency:
Philips Volcano
2017-05-152017-05-152025-02-10Bibliographically approved