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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
Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland.
Department of Radiology, Helsingborg County Hospital, Helsingborg, Sweden.
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2015 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 170, no 5, 945-950 p.Article in journal (Refereed) Published
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Text
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
Mosby-Elsevier , 2015. Vol. 170, no 5, 945-950 p.
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:oru:diva-47011DOI: 10.1016/j.ahj.2015.07.031ISI: 000364434600015PubMedID: 26542503OAI: oai:DiVA.org:oru-47011DiVA: diva2:878643
Note

Funding Agency:

Volcano Corporation

Available from: 2015-12-09 Created: 2015-12-09 Last updated: 2015-12-09Bibliographically approved

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