Matthias Götberg1, Evald H Christiansen2, Ingibjörg Gudmundsdottir3, Lennart Sandhall4, Elmir Omerovic5, Stefan K James6, David Erlinge7, Ole Fröbert8. 1. Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden. Electronic address: matthias.gotberg@med.lu.se. 2. Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. 3. Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland. 4. Department of Radiology, Helsingborg County Hospital, Helsingborg, Sweden. 5. Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden. 6. Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 7. Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden. 8. Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden.
Abstract
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.
RCT Entities:
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.
Authors: Christopher M Cook; Allen Jeremias; Ricardo Petraco; Sayan Sen; Sukhjinder Nijjer; Matthew J Shun-Shin; Yousif Ahmad; Guus de Waard; Tim van de Hoef; Mauro Echavarria-Pinto; Martijn van Lavieren; Rasha Al Lamee; Yuetsu Kikuta; Yasutsugu Shiono; Ashesh Buch; Martijn Meuwissen; Ibrahim Danad; Paul Knaapen; Akiko Maehara; Bon-Kwon Koo; Gary S Mintz; Javier Escaned; Gregg W Stone; Darrel P Francis; Jamil Mayet; Jan J Piek; Niels van Royen; Justin E Davies Journal: JACC Cardiovasc Interv Date: 2017-12-26 Impact factor: 11.195