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Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial
Lund Univ, Skane Univ Hosp, Dept Cardiol, S-22185 Lund, Sweden..
Aarhus Univ Hosp, Dept Cardiol, Skejby, Denmark..
Reykjavik Univ Hosp, Dept Cardiol, Reykjavik, Iceland..
Helsingborg Cty Hosp, Dept Radiol, Helsingborg, Sweden..
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2015 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 170, no 5, p. 945-950Article in journal (Refereed) Published
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Abstract [en]

Background Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. Design/Methods iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1: 1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. Discussion The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.

Place, publisher, year, edition, pages
2015. Vol. 170, no 5, p. 945-950
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Cardiac and Cardiovascular Systems
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URN: urn:nbn:se:uu:diva-268792DOI: 10.1016/j.ahj.2015.07.031ISI: 000364434600015PubMedID: 26542503OAI: oai:DiVA.org:uu-268792DiVA, id: diva2:881122
Available from: 2015-12-09 Created: 2015-12-09 Last updated: 2017-12-01Bibliographically approved

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James, Stefan K.

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