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August 27, 2023European Heart Journal54 citationsOpen Access

Instantaneous wave free ratio vs. fractional flow reserve and 5-year mortality: iFR SWEDEHEART and DEFINE FLAIR

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AEAshkan EftekhariEHEmil Nielsen HolckJWJelmer Westra

Key Points

  • To evaluate five-year clinical outcomes and all-cause mortality comparing instantaneous wave-free ratio (iFR) against fractional flow reserve (FFR)-guided coronary revascularization.
  • Conducted a study-level meta-analysis of five-year follow-up data from two randomized clinical trials (iFR-SWEDEHEART [NCT02166736] and DEFINE-FLAIR [NCT02053038]) totaling 4,511 patients (2,254 iFR-guided and 2,257 FFR-guided).
  • Extracted raw Kaplan–Meier estimates to analyze major adverse cardiovascular events (MACE) and its components: all-cause mortality, myocardial infarction, and unplanned revascularization.
  • Five-year all-cause mortality was significantly higher in the iFR group compared to the FFR group (8.3% [188/2254] vs. 6.3% [143/2257]; HR 1.34, 95% CI 1.08–1.67), as was composite MACE (21.5% [484/2254] vs. 18.6% [420/2257]; HR 1.18, 95% CI 1.04–1.34).
  • Revascularization was deferred more frequently with iFR than FFR (50.0% [1128/2254] vs. 45.2% [1021/2257], P = 0.001), while rates remained comparable for unplanned revascularization (10.4% vs. 10.7%; HR 0.99, 95% CI 0.83–1.19) and myocardial infarction (5.5% vs. 5.4%; HR 1.02, 95% CI 0.80–1.32).

Abstract

Abstract Background and Aims Guidelines recommend revascularization of intermediate epicardial artery stenosis to be guided by evidence of ischaemia. Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are equally recommended. Individual 5-year results of two major randomized trials comparing FFR with iFR-guided revascularization suggested increased all-cause mortality following iFR-guided revascularization. The aim of this study was a study-level meta-analysis of the 5-year outcome data in iFR-SWEDEHEART (NCT02166736) and DEFINE-FLAIR (NCT02053038). Methods Composite of major adverse cardiovascular events (MACE) and its individual components all-cause death, myocardial infarction (MI), and unplanned revascularisation were analysed. Raw Kaplan–Meier estimates, numbers at risk, and number of events were extracted at 5-year follow-up and analysed using the ipdfc package (Stata version 18, StataCorp, College Station, TX, USA). Results In total, iFR and FFR-guided revascularization was performed in 2254 and 2257 patients, respectively. Revascularization was more often deferred in the iFR group n = 1128 (50.0%) vs. the FFR group n = 1021 (45.2%); P = .001. In the iFR-guided group, the number of deaths, MACE, unplanned revascularization, and MI was 188 (8.3%), 484 (21.5%), 235 (10.4%), and 123 (5.5%) vs. 143 (6.3%), 420 (18.6%), 241 (10.7%), and 123 (5.4%) in the FFR group. Hazard ratio 95% confidence interval (CI) estimates for MACE were 1.18 1.04; 1.34, all-cause mortality 1.34 1.08; 1.67, unplanned revascularization 0.99 0.83; 1.19, and MI 1.02 0.80; 1.32. Conclusions Five-year all-cause mortality and MACE rates were increased with revascularization guided by iFR compared to FFR. Rates of unplanned revascularization and MI were equal in the two groups.

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Eftekhari et al. (2023) studied this question.

synapsesocial.com/papers/6970ddc7da50910f9664e709https://doi.org/10.1093/eurheartj/ehad582
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