IFR-SWEDEHEART
Trial question
Is instantaneous wave-free ratio guided revascularization strategy noninferior to FFR 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
75.0% male
N = 2037
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).
Primary outcome
Death from any cause, nonfatal MI, or unplanned revascularization at 12 months
6.7%
6.1%
6.7 %
5.0 %
3.4 %
1.7 %
0.0 %
IFR-guided
revascularization
FFR-guided
revascularization
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death from any cause, nonfatal MI, 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 MI, 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.
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