• Matthias Götberg, Evald H Christiansen, Ingibjörg J Gudmundsdottir, Lennart Sandhall, Mikael Danielewicz, Lars Jakobsen, Sven-Erik Olsson, Patrik Öhagen, Hans Olsson, Elmir Omerovic, Fredrik Calais, Pontus Lindroos, Michael Maeng, Tim Tödt, Dimitrios Venetsanos, Stefan K James, Amra Kåregren, Margareta Nilsson, Jörg Carlsson, Dario Hauer, Jens Jensen, Ann-Charlotte Karlsson, Georgios Panayi, David Erlinge, Ole Fröbert, and iFR-SWEDEHEART Investigators.
• From the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (M.G., T.T., M.N., D.E.), the Departments of Cardiology and Radiology, Helsingborg Hospital, Helsingborg (L.S., S.-E.O.), the Department of Cardiology, Karlstad Hospital, Karlstad (M.D., H.O.), the Uppsala Clinical Research Center (P.Ö.) and Department of Medical Sciences (S.K.J.), Uppsala University, Uppsala, the Department of Cardiology, Sahlgrenska University Gothenburg (E.O.), the Department of Cardiology, Faculty of Health, Örebro University, Örebro (F.C., O.F.), the Department of Cardiology, St. Göran Hospital (P.L.), the Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet (J.J.), and the Unit of Cardiology, Capio St. Görans Sjukhus (J.J.), Stockholm, the Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping (D.V., D.H., G.P.), the Department of Internal Medicine, Västmanland Hospital Västerås, Västerås (A.K.), the Department of Cardiology, Kalmar County Hospital, and Linnaeus University, Faculty of Health and Life Sciences, Kalmar (J.C.), the Department of Medicine, Sundsvall Hospital, Sundsvall (J.J.), and the Department of Cardiology, Halmstad Hospital, Halmstad (A.-C.K.) - all in Sweden; the Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark (E.H.C., L.J., M.M.); and the Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland (I.J.G.).
• N. Engl. J. Med. 2017 May 11; 376 (19): 1813-1823.

BackgroundThe 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.MethodsWe 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.ResultsA 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.ConclusionsAmong 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. (Funded by Philips Volcano; iFR SWEDEHEART ClinicalTrials.gov number, NCT02166736 .).

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