Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome

NCT02166736 | Completed DMC

• 1 other identifier: U-2013-044
• Study Type: interventional
• Target: 2,037
• Locations: 3 countries
• Sites: 14

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.

Conditions

Angina Pectoris; Acute Myocardial Infarction

Keywords

Instantaneous wave Free Ratio; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• All cause death, non-fatal Myocardial infarction (MI), Unplanned revascularization

  12 months

Secondary Outcomes (8)

• All cause death

  1-5 years

• Non-fatal MI

  1-5 years

• Unplanned revascularization

  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

Study Arms (2)

Instantaneous wave-free ratio (iFR)

EXPERIMENTAL

Device: iFR

Fractional Flow Reserve (FFR)

ACTIVE COMPARATOR

Device: FFR

Interventions

iFR DEVICE

Treatment guided by Instantaneous wave-free ratio (iFR®)

Instantaneous wave-free ratio (iFR)

FFR DEVICE

Intervention guided by Fractional Flow Reserve

Fractional Flow Reserve (FFR)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (14)

Skejby University Hospital

Aarhus, Denmark

Location

Reykjavik University Hospital

Reykjavik, Iceland

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Halmstad sjukhus

Halmstad, Sweden

Location

Helsingborg County Hospital

Helsingborg, Sweden

Location

Kalmar County Hospital

Kalmar, Sweden

Location

Karlstad County Hospital

Karlstad, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Skane University Hospital

Lund, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

S:t Göran County Hospital

Stockholm, Sweden

Location

Sundsvall County Hospital

Sundsvall, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Västerås County Hospital

Västerås, Sweden

Location

Related Publications (5)

• 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.

  PMID: 37634144 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.

  PMID: 36734349 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.

  PMID: 35272801 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.

  PMID: 28317438 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.

  PMID: 26542503 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: June 18, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

SE (12); IC (1); DK (1)