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Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

Escaned, Javier ; Ryan, Nicola ; Mejía-Rentería, Hernán ; Cook, Christopher M. ; Dehbi, Hakim Moulay ; Alegria-Barrero, Eduardo ; Alghamdi, Ali ; Al-Lamee, Rasha ; Altman, John and Ambrosia, Alphonse , et al. (2018) In JACC: Cardiovascular Interventions 11(15). p.1437-1449
Abstract

Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in... (More)

Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
ACS, coronary physiology, deferral of revascularization, FFR, iFR, SAP
in
JACC: Cardiovascular Interventions
volume
11
issue
15
pages
13 pages
publisher
Elsevier
external identifiers
  • scopus:85050687646
  • pmid:30093050
ISSN
1936-8798
DOI
10.1016/j.jcin.2018.05.029
language
English
LU publication?
yes
id
6992a4c3-76b3-484e-96b1-93e5a4e52e2a
date added to LUP
2018-08-21 08:10:40
date last changed
2024-04-15 11:27:50
@article{6992a4c3-76b3-484e-96b1-93e5a4e52e2a,
  abstract     = {{<p>Objectives: The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). Background: Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. Methods: The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. Results: Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p &lt; 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). Conclusions: Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year.</p>}},
  author       = {{Escaned, Javier and Ryan, Nicola and Mejía-Rentería, Hernán and Cook, Christopher M. and Dehbi, Hakim Moulay and Alegria-Barrero, Eduardo and Alghamdi, Ali and Al-Lamee, Rasha and Altman, John and Ambrosia, Alphonse and Baptista, Sérgio B. and Bertilsson, Maria and Bhindi, Ravinay and Birgander, Mats and Bojara, Waldemar and Brugaletta, Salvatore and Buller, Christopher and Calais, Fredrik and Silva, Pedro Canas and Carlsson, Jörg and Christiansen, Evald H. and Danielewicz, Mikael and Di Mario, Carlo and Doh, Joon Hyung and Erglis, Andrejs and Erlinge, David and Gerber, Robert T. and Going, Olaf and Gudmundsdottir, Ingibjörg and Härle, Tobias and Hauer, Dario and Hellig, Farrel and Indolfi, Ciro and Jakobsen, Lars and Janssens, Luc and Jensen, Jens and Jeremias, Allen and Kåregren, Amra and Karlsson, Ann Charlotte and Kharbanda, Rajesh K. and Khashaba, Ahmed and Kikuta, Yuetsu and Krackhardt, Florian and Koo, Bon Kwon and Koul, Sasha and Laine, Mika and Lehman, Sam J. and Lindroos, Pontus and Olsson, Sven Erik and Götberg, Matthias}},
  issn         = {{1936-8798}},
  keywords     = {{ACS; coronary physiology; deferral of revascularization; FFR; iFR; SAP}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{15}},
  pages        = {{1437--1449}},
  publisher    = {{Elsevier}},
  series       = {{JACC: Cardiovascular Interventions}},
  title        = {{Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes}},
  url          = {{http://dx.doi.org/10.1016/j.jcin.2018.05.029}},
  doi          = {{10.1016/j.jcin.2018.05.029}},
  volume       = {{11}},
  year         = {{2018}},
}