6/28/23, 11:33 PM IFR-SWEDEHEART Pathway Feedback Search Clinical Topics Home Studies IFR SWEDEHEART IFR SWEDEHEART Disease Coronary artery disease Trial question Is instantaneous wave-free ratio guided revascularization strategy noninferior to fractional flow reserve guided revascularization with respect to the rate of major adverse cardiac events in patients with stable angina or an acute coronary syndrome? Study design Multi-center Open label RCT Population Characteristics of study participants 25.0% female N = 2037 75.0% male 2037 patients (515 female, 1522 male) Inclusion criteria: patients with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary artery stenosis Key exclusion criteria: previous CABG with patent grafts to the interrogated vessel, known terminal disease with a life expectancy of less than a year, multi-vessel disease, unstable hemodynamics, inability to tolerate adenosine, heavily calcified or tortuous vessels Interventions N=1012 iFR-guided revascularization (measurement with coronary-pressure guidewire; iFR 0.89) N=1007 FFR-guided revascularization (measurement with coronary-pressure guidewire and hyperemia induction with the administration of intracoronary or intravenous adenosine; FFR 0.80) https://web.pathway.md/studies/recEeRRN2xiwl0LEl 1/2 6/28/23, 11:33 PM IFR-SWEDEHEART Pathway Primary outcome Death from any cause, nonfatal myocardial infarction, or unplanned revascularization at 12 months 6.7 % 6.7 6.1 5.0 % 3.4 % Difference not exceeding nonferiority margin 1.7 % 0.0 % IFR-guided revascularization FFR-guided revascularization Difference not exceeding nonferiority margin in death from any cause, nonfatal myocardial infarction, or unplanned revascularization at 12 months (6.7% vs. 6.1%; HR 1.12, 95% CI 0.79 to 1.58) Secondary outcomes No significant difference in death from any cause at 12 months (1.5% vs. 1.2%; HR 1.25, 95% CI 0.58 to 2.66) Conclusion In patients with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary artery stenosis, iFR-guided revascularization was noninferior to FFR-guided revascularization with respect to death from any cause, nonfatal myocardial infarction, or unplanned revascularization at 12 months. Reference Gotberg M, Christiansen EH, Gudmundsdottir IJ et al. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. Open reference URL https://web.pathway.md/studies/recEeRRN2xiwl0LEl 2/2