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Previous trials have demonstrated that the use of physiological assessment of stenosis severity using fractional flow reserve (FFR) is superior to angiographic assessment in percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost associated with Adenosine.
Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for functional significance. The main benefits of the method compared to FFR are that the measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does not experience any discomfort from the measurement and procedural time could be shortened compared to when using FFR. This could potentially increase the adoption rate of physiologic assessment of coronary lesions.
The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with patients assessed by FFR.
Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT) which is a novel strategy to conduct clinical trials. The randomization will occur online in the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Instantaneous wave-free ratio (iFR) | Experimental |
| |
| Fractional Flow Reserve (FFR) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFR | Device | Treatment guided by Instantaneous wave-free ratio (iFR®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | 1-5 years | |
| Non-fatal MI | 1-5 years | |
| Unplanned revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Götberg, MD,PhD | Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden | Principal Investigator |
| Ole Fröbert, Prof | Department of Cardiology, Örebro University Hospital, Örebro, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skejby University Hospital | Aarhus | Denmark | ||||
| Reykjavik University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37634144 | Derived | Eftekhari A, Holck EN, Westra J, Olsen NT, Bruun NH, Jensen LO, Engstrom T, Christiansen EH. Instantaneous wave free ratio vs. fractional flow reserve and 5-year mortality: iFR SWEDEHEART and DEFINE FLAIR. Eur Heart J. 2023 Nov 1;44(41):4376-4384. doi: 10.1093/eurheartj/ehad582. | |
| 36734349 | Derived | Berntorp K, Rylance R, Yndigegn T, Koul S, Frobert O, Christiansen EH, Erlinge D, Gotberg M. Clinical Outcome of Revascularization Deferral With Instantaneous Wave-Free Ratio and Fractional Flow Reserve: A 5-Year Follow-Up Substudy From the iFR-SWEDEHEART Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e028423. doi: 10.1161/JAHA.122.028423. Epub 2023 Feb 3. |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| FFR | Device | Intervention guided by Fractional Flow Reserve |
|
| 1-5 years |
| Target lesion revascularization | 1-5 years |
| Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR) | 1-5 years |
| Change in physician´s treatment strategy depending on iFR/FFR information | Before randomization, the operators will have to record their angiographic assessment of the coronary lesions and the theoretical treatment strategy based on the angiographic information alone. After randomization and functional assessment of lesion severity, the operators will record how iFR/FFR changed the treatment strategy. | Day 1 |
| Assessment of patient discomfort during the procedure (none/mild/moderate/severe | Day 1 |
| Procedural time | Day 1 |
| Reykjavik |
| Iceland |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Halmstad sjukhus | Halmstad | Sweden |
| Helsingborg County Hospital | Helsingborg | Sweden |
| Kalmar County Hospital | Kalmar | Sweden |
| Karlstad County Hospital | Karlstad | Sweden |
| Linköping University Hospital | Linköping | Sweden |
| Skane University Hospital | Lund | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| S:t Göran County Hospital | Stockholm | Sweden |
| Sundsvall County Hospital | Sundsvall | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Västerås County Hospital | Västerås | Sweden |
| 35272801 | Derived | Gotberg M, Berntorp K, Rylance R, Christiansen EH, Yndigegn T, Gudmundsdottir IJ, Koul S, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Venetsanos D, James SK, Karegren A, Carlsson J, Jensen J, Karlsson AC, Erlinge D, Frobert O. 5-Year Outcomes of PCI Guided by Measurement of Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve. J Am Coll Cardiol. 2022 Mar 15;79(10):965-974. doi: 10.1016/j.jacc.2021.12.030. |
| 28317438 | Derived | Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18. |
| 26542503 | Derived | Gotberg M, Christiansen EH, Gudmundsdottir I, Sandhall L, Omerovic E, James SK, Erlinge D, Frobert O. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2015 Nov;170(5):945-50. doi: 10.1016/j.ahj.2015.07.031. Epub 2015 Aug 15. |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |