Instantaneous wave-free ratio versus fractional flow reserve to guide PCI

Research output: Contribution to journalArticle

Abstract

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.

Details

Authors
  • M. Götberg
  • Evald H Christiansen
  • I. J. Gudmundsdottir
  • L Sandhall
  • Mikael Danielewicz
  • L. Jakobsen
  • S. E. Olsson
  • P. Öhagen
  • H. Olsson
  • E. Omerovic
  • Fredrik Calais
  • P. Lindroos
  • Michael Maeng
  • T. Tödt
  • Dimitrios Venetsanos
  • S. K. James
  • A. Karegren
  • J. Carlsson
  • D. Hauer
  • J. Jensen
  • A. C. Karlsson
  • Gabriel S Panayi
  • Ole Fröbert
Organisations
External organisations
  • Aarhus University Hospital
  • Reykjavik University
  • Helsingborg Hospital
  • Karlstad Hospital
  • Uppsala University Hospital
  • Sahlgrenska Academy
  • Örebro University
  • Capio St. Görans Sjukhus
  • Linköping University
  • Uppsala University
  • Västmanland Hospital
  • Linnaeus University
  • Karolinska Institutet
  • Sundsvall Hospital
  • Halmstad County Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems
Original languageEnglish
Pages (from-to)1813-1823
Number of pages11
JournalNew England Journal of Medicine
Volume376
Issue number19
Publication statusPublished - 2017 May 11
Publication categoryResearch
Peer-reviewedYes