Clinical trial NCT02166736: Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome
Official title: Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome. A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the Swedish Angiography and Angioplasty Registry (SWEDEHEART) Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Acute Myocardial Infarction
Keywords: Instantaneous wave Free Ratio
Fractional Flow Reserve
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 2037
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected stable angina pectoris or unstable angina pectoris/non-ST-segment elevation myocardial infarction (NSTEMI) who are scheduled to undergo coronary angiography, and who has an indication for physiology guided assessment of coronary lesions (usually 30-80% stenosis grade). In patients with suspected stable angina pectoris, any lesion may be assessed. In patients with unstable angina pectoris/NSTEMI, only the non-culprit lesion may be assessed.

Exclusion Criteria:

* Inability to provide informed consent
* Age below 18 years
* Previous randomization in the iFR-SWEDEHEART trial
* Known terminal disease with a life expectancy of less than one year.
* In patients with multi-vessel disease and other indication than stable angina pectoris, difficulty in assessing which the culprit lesion is.
* Patient with unstable hemodynamics (Killip class III-IV)
* Inability to tolerate Adenosine
* Previous Coronary artery bypass graft (CABG) with patent grafts to the interrogated vessel.
* Heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire is expected.

Primary outcomes:
measure: All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization
timeFrame: 12 months
Secondary outcomes:
measure: All cause death
timeFrame: 1-5 years
measure: Non-fatal MI
timeFrame: 1-5 years
measure: Unplanned revascularization
timeFrame: 1-5 years
measure: Target lesion revascularization
timeFrame: 1-5 years
measure: Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions as reported in Swedish Coronary Angiography and Angioplasty Registry (SCAAR)
timeFrame: 1-5 years
measure: Change in physician´s treatment strategy depending on iFR/FFR information
timeFrame: Day 1
measure: Assessment of patient discomfort during the procedure (none/mild/moderate/severe
timeFrame: Day 1
measure: Procedural time
timeFrame: Day 1
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby University Hospital
city: Reykjavik
country: Iceland
facility: Reykjavik University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Halmstad sjukhus
city: Helsingborg
country: Sweden
facility: Helsingborg County Hospital
city: Kalmar
country: Sweden
facility: Kalmar County Hospital
city: Karlstad
country: Sweden
facility: Karlstad County Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: S:t Göran County Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall County Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Västerås County Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden
name: Matthias Götberg, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Örebro University Hospital, Örebro, Sweden
name: Ole Fröbert, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.