5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve
Matthias Götberg, Karolina Berntorp, Rebecca Rylance, Evald H Christiansen, Troels Yndigegn, Ingibjörg J Gudmundsdottir, Sasha Koul, Lennart Sandhall, Mikael Danielewicz, Lars Jakobsen, Sven-Erik Olsson, Hans Olsson, Elmir Omerovic, Fredrik Calais, Pontus Lindroos, Michael Maeng, Dimitrios Venetsanos, Stefan K James, Amra Kåregren, Jörg Carlsson, Jens Jensen, Ann-Charlotte Karlsson, David Erlinge, Ole Fröbert, Matthias Götberg, Karolina Berntorp, Rebecca Rylance, Evald H Christiansen, Troels Yndigegn, Ingibjörg J Gudmundsdottir, Sasha Koul, Lennart Sandhall, Mikael Danielewicz, Lars Jakobsen, Sven-Erik Olsson, Hans Olsson, Elmir Omerovic, Fredrik Calais, Pontus Lindroos, Michael Maeng, Dimitrios Venetsanos, Stefan K James, Amra Kåregren, Jörg Carlsson, Jens Jensen, Ann-Charlotte Karlsson, David Erlinge, Ole Fröbert
Abstract
Background: Instantaneous wave-free ratio (iFR) is a coronary physiology index used to assess the severity of coronary artery stenosis to guide revascularization. iFR has previously demonstrated noninferior short-term outcome compared to fractional flow reserve (FFR), but data on longer-term outcome have been lacking.
Objectives: The purpose of this study was to investigate the prespecified 5-year follow-up of the primary composite outcome of all-cause mortality, myocardial infarction, and unplanned revascularization of the iFR-SWEDEHEART trial comparing iFR vs FFR in patients with chronic and acute coronary syndromes.
Methods: iFR-SWEDEHEART was a multicenter, controlled, open-label, registry-based randomized clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2,037 patients were randomized to undergo revascularization guided by iFR or FFR.
Results: No patients were lost to follow-up. At 5 years, the rate of the primary composite endpoint was 21.5% in the iFR group and 19.9% in the FFR group (HR: 1.09; 95% CI: 0.90-1.33). The rates of all-cause death (9.4% vs 7.9%; HR: 1.20; 95% CI: 0.89-1.62), nonfatal myocardial infarction (5.7% vs 5.8%; HR: 1.00; 95% CI: 0.70-1.44), and unplanned revascularization (11.6% vs 11.3%; HR: 1.02; 95% CI: 0.79-1.32) were also not different between the 2 groups. The outcomes were consistent across prespecified subgroups.
Conclusions: In patients with chronic or acute coronary syndromes, an iFR-guided revascularization strategy was associated with no difference in the 5-year composite outcome of death, myocardial infarction, and unplanned revascularization compared with an FFR-guided revascularization strategy. (Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome [iFR SWEDEHEART]; NCT02166736).
Keywords: coronary physiology; fractional flow reserve; instantaneous wave-free ratio; percutaneous coronary intervention.
Conflict of interest statement
Funding Support and Author Disclosures This study was funded by an unrestricted research grant from Philips Volcano to the Uppsala Clinical Research Center. Dr Götberg has received lecture fees from Boston Scientific and Volcano; has received consulting fees from Boston Scientific; and has received fees for serving on an advisory board from Medtronic. Dr Sandhall has received lecture fees from Boston Scientific and Philips Volcano; and has received consulting fees from Boston Scientific. Dr Maeng has received speaker and advisory board fees from Novo Nordisk. Dr Omerovic has received grant support from Abbott and AstraZeneca; and has received fees for serving on an advisory board from AstraZeneca. Dr Fröbert has received grant support from Sanofi-Pasteur. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed