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5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve

Götberg, Matthias LU ; Berntorp, Karolina LU orcid ; Rylance, Rebecca LU ; Christiansen, Evald H. ; Yndigegn, Troels LU ; Gudmundsdottir, Ingibjörg J. ; Koul, Sasha LU ; Sandhall, Lennart ; Danielewicz, Mikael and Jakobsen, Lars , et al. (2022) In Journal of the American College of Cardiology 79(10). p.965-974
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... (More)

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)

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@article{dbc348d7-f789-46a0-be12-0727a09ada26,
  abstract     = {{<p>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)</p>}},
  author       = {{Götberg, Matthias and Berntorp, Karolina and Rylance, Rebecca and Christiansen, Evald H. and Yndigegn, Troels and Gudmundsdottir, Ingibjörg J. and Koul, Sasha and Sandhall, Lennart and Danielewicz, Mikael and Jakobsen, Lars and Olsson, Sven Erik and Olsson, Hans and Omerovic, Elmir and Calais, Fredrik and Lindroos, Pontus and Maeng, Michael and Venetsanos, Dimitrios and James, Stefan K. and Kåregren, Amra and Carlsson, Jörg and Jensen, Jens and Karlsson, Ann Charlotte and Erlinge, David and Fröbert, Ole}},
  issn         = {{0735-1097}},
  keywords     = {{coronary physiology; fractional flow reserve; instantaneous wave-free ratio; percutaneous coronary intervention}},
  language     = {{eng}},
  month        = {{03}},
  number       = {{10}},
  pages        = {{965--974}},
  publisher    = {{Elsevier}},
  series       = {{Journal of the American College of Cardiology}},
  title        = {{5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve}},
  url          = {{http://dx.doi.org/10.1016/j.jacc.2021.12.030}},
  doi          = {{10.1016/j.jacc.2021.12.030}},
  volume       = {{79}},
  year         = {{2022}},
}