The FAVOR V AMI Trial

September 10, 2023 updated by: China National Center for Cardiovascular Diseases

Functional and Angiography-Derived Strain Guided Multi-Vessel/Lesion Revascularization Strategy in Patients With Acute ST-Segment Elevation Myocardial Infarction (FAVOR V AMI)

The FAVOR V AMI study is a prospective, multicenter, blinded, randomized, sham-controlled trial comparing the long-term clinical outcomes of the "Functional and Angiography-derived Strain inTegration (FAST)" technique (next-generation quantitative flow ratio [μQFR] and radial wall strain [RWS]) guided percutaneous coronary intervention (PCI) strategy, with standard treatment strategy, in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary disease (MVD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The FAVOR V AMI study is a prospective, multicenter, blinded, randomized, sham-controlled trial comparing the long-term clinical outcome of the two PCI strategies, the FAST guided strategy (test group) versus standard treatment strategy (control group), in a high-risk population with STEMI and MVD who underwent successful primary PCI of the infarct-related artery. The primary endpoint is major adverse cardiac events (MACE), defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization when the last patient reaches 6-month follow-up. The major secondary endpoint is cardiovascular death and MI when at least 395 total events have accrued. The study hypothesis is the FAST (μQFR+RWS) guided PCI strategy is superior to a standard treatment strategy by the primary and major secondary endpoint.

For the patients randomized to μQFR+RWS group, μQFR will be measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed percentage diameter stenosis (DS%) ≥50% and ≤90% with reference vessel diameter (RVD) ≥2.5 mm. If μQFR ≤0.80 or RWS ≥13%, PCI will be performed; if μQFR >0.80 and RWS <13%, the procedure will deferral; if DS% >90%, PCI should be performed without the need of μQFR or RWS. For all patients undergoing PCI, post-PCI μQFR measurement is recommended; if μQFR <0.90, if the reason is obvious post-dilation with a non-compliant balloon or bail-out stenting should be considered; if the reason is not obvious intravascular imaging should be considered. For the patients randomized to standard treatment group, PCI should be performed of all non-culprit lesions with visual DS% ≥70% in all non-infarct related arteries with RVD ≥2.5 mm; for a non-culprit lesion with visually DS% 50-70%, PCI can be performed if fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. All patients will be followed by either telephone or clinic visit at 1 month, 6 months,1 year, 2 years, 3 years, 4 years and 5 years.

The sample size will be about 5,000 using an event-driven sample calculation. An adaptive design will be implemented for sample size re-estimation when 90% of patients have been enrolled. All principal analyses will take place in the intention-to-treat (ITT) population. The primary and major secondary endpoints will be analyzed in prespecified subgroups, including age (≥65 vs. <65), sex (men vs. women), diabetes (yes vs. no), time from symptom onset to primary PCI (≤ vs. > median), planned number of NCLs for PCI in the control arm (0/1 vs. 2 vs. 3), infarct related artery (LM/LAD vs, others), untreated CTOs with RVD ≥2.5 mm in non-infarct related artery (yes vs. no), timing of elective PCI (same hospitalization as the emergency PCI vs. during an elective readmission), P2Y12 inhibitor therapy (Clopidogrel vs. Ticagrelor), treatment of any non-infarct lesion with DS >90% prior to randomization (yes vs. no), LVEF (echo post primary PCI, prior to randomization) (>40% vs. ≤40%), Killip Class (I vs. ≥II), lesion location of non-culprit lesion (LM/LAD vs. others), diseased vessels (two-vessel disease vs. LM/three-vessel disease), moderate or severe calcification in any NCL (yes vs. no), bifurcation lesion with planned main vessel and SB treatment in any NCL (yes vs. no), intravascular guidance during the randomized procedure (yes vs. no), μQFR grayzone (μQFR < 0.75 vs. = 0.75-0.85 vs. > 0.85 [by core laboratory]), μQFR-based functional SYNTAX score (FSSQFR, low tertile vs. mid tertile vs. high tertile [by core laboratory]), post-PCI μQFR (≥0.90 vs. <0.90 [by core laboratory]), angiography-derived IMR (≥2.5 mmHgs/cm vs. <2.5 mmHgs/cm [by core laboratory]), residual physiology pattern (PPG diffuse vs. local [by core laboratory]), μQFR-based residual functional SYNTAX score (rFSSQFR, 0 vs. ≥ 1 [by core laboratory]), learning experience of μQFR/RWS (first half vs. second half of enrolled cases in each center).

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bo Xu, MBBS
  • Phone Number: +86-10-88322562
  • Email: bxu@citmd.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • General inclusion

    1. Age ≥18 years
    2. STEMI ≤30d
    3. Successful primary PCI of all culprit lesion(s) responsible for the STEMI (visually-assessed residual stenosis <30% in stent-treated lesions or <50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in all treated vessels)
    4. No MACE event between the index PCI and the staged randomized procedure
    5. Able to understand the trial design and provide written informed consent

  • Angiographic inclusion:

    1. The presence of at least 1 non-culprit lesion with DS% 50%-90% in any non-infarct related artery with RVD ≥2.5 mm by visual assessment
    2. Non-culprit lesions are potentially eligible for PCI Note: All lesions in the infarct related arteries with DS ≥70% and RVD ≥2.5 mm by visual assessment must be successfully treated either during the index primary PCI or the staged procedure prior to randomization Note: There may also be 1 or more NCL with DS% >90% (including a CTO) as long as there is at least 1 NCL with DS% 50%-90% as above. Any such lesions in which PCI is intended must be treated successfully either during the index primary PCI or the staged procedure prior to randomization.

Exclusion Criteria:

  • General exclusion

    1. Cardiogenic shock or refractory hypotension (Killip IV)
    2. On pressors or use of or need for intra-aortic balloon pump or other mechanical circulatory support devices
    3. Intubated
    4. Prior thrombolytic therapy for this admission
    5. Cockcroft-Gault-calculated CrCl <30 ml/kg
    6. Pregnant or woman of child-bearing potential
    7. Life expectancy less than 1 year for non-cardiac causes
    8. Allergy to iodine-containing contrast agents which cannot be adequately premedicated
    9. Unable to tolerate DAPT for at least 6 months
    10. Prior CABG or planned CABG
    11. Any planned surgery within 6 months
    12. Any condition that may interfere with any follow-up procedures (e.g. dementia, drug use)

  • Angiographic exclusion

    1. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μQFR or RWS measurement
    2. Unable to judge culprit lesion or infarct-related artery according to current evidence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FAST Guided Strategy (μQFR+RWS)

  1. μQFR is measured in all non-infarct related arteries containing any non-culprit lesion with visually-assessed DS% ≥50% and ≤90% with RVD ≥2.5 mm.

    1. μQFR ≤0.80: PCI
    2. RWS ≥13%: PCI
    3. μQFR >0.80 and RWS <13%: Deferral
    4. DS% >90%: PCI without the need of μQFR or RWS
  2. For all patients undergoing PCI, post-PCI μQFR measurement is recommended; if μQFR <0.90, if the reason is obvious post-dilation with a non-compliant balloon or bail-out stenting should be considered; if the reason is not obvious intravascular imaging should be considered.
Diagnostic test: FAST Technique
The next-generation QFR (μQFR) introduces a more intelligent algorithm and supports single-projection rapid calculation with a diagnostic accuracy of 93.0% compared with FFR; Computational RWS technique facilitates the assessment of lesion vulnerability.
Other Names:
  • The next-generation quantitative flow ratio and radial wall strain
Diagnostic test: Angiography
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries.
Other Names:
  • Coronary angiography
Sham Comparator: Standard Treatment Strategy
  1. PCI should be performed of all non-culprit lesions with visual DS% ≥70% in all non-infarct related arteries with RVD ≥2.5 mm;
  2. For a non-culprit lesion with visually DS% 50-70%, PCI can be performed if FFR ≤0.80 or iFR ≤0.89.
Diagnostic test: Angiography
Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries.
Other Names:
  • Coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major adverse cardiac events (MACE)
Time Frame: From the date of first randomization until a total number of 395 events of MACE is reached (median follow-up of approximately 1.5 years)
Defined as a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization
From the date of first randomization until a total number of 395 events of MACE is reached (median follow-up of approximately 1.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiovascular death and MI (Major secondary endpoint）
Time Frame: From the date of first randomization until a total number of 395 events of cardiovascular death and MI is reached (median follow-up of approximately 3 years)
Defined as a composite of cardiovascular death and MI
From the date of first randomization until a total number of 395 events of cardiovascular death and MI is reached (median follow-up of approximately 3 years)
Rate of lesion success
Time Frame: Immediately post the PCI procedure
Defined as: 1) angiographic success (core laboratory-assessed residual stenosis <30% in stent-treated lesions or <50% in DCB-treated or PTCA-treated lesions, with TIMI-3 flow in the treated vessel); and 2) physiological success (post-PCI μQFR ≥0.80 assessed by core lab)
Immediately post the PCI procedure
Rate of procedural success
Time Frame: Maximum of 7 days
Defined as lesion success in all treated lesions without in-hospital MACE
Maximum of 7 days
Incidence of death
Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Including cardiovascular, non-cardiovascular or undetermined
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of all MI
Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Including periprocedural MI (SCAI definition) and spontaneous MI (target vessel-related or non-target vessel-related, culprit lesion-related or non-culprit lesion-related)
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of any revascularization
Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Including ischemia-driven or non-ischemia driven, target vessel-related or non-target vessel-related, culprit lesion-related or non-culprit lesion-related
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Incidence of definite/probable stent thrombosis (ARC-2)
Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
By ARC-2 definition and including acute, subacute, late and very late stent thrombosis
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Angina status evaluation
Time Frame: 6 months, 1 year, 3 years, 5 years
As assessed by the Seattle Angina Questionnaire (SAQ)
6 months, 1 year, 3 years, 5 years
Health-related quality of life evaluation
Time Frame: 6 months, 1 year, 3 years, 5 years
As assessed by the European Quality of Life-5 Dimensions (EQ-5D)
6 months, 1 year, 3 years, 5 years
Cost-effectiveness evaluation
Time Frame: 6 months, 1 year, 3 years, 5 years
As assessed by the Incremental cost effectiveness ratio (ICER) using the composite endpoint (including myocardial infarction, any revascularization, stent thrombosis, cerebrovascular and major bleeding events)
6 months, 1 year, 3 years, 5 years
Cost-utility evaluation
Time Frame: 6 months, 1 year, 3 years, 5 years
As assessed by the Incremental cost-utility ratio (ICUR) using quality-adjusted life years (QALYs)
6 months, 1 year, 3 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Bo Xu, MBBS, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing; Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen, Shenzhen
  • Principal Investigator: Lei Song, MD, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 18, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAVOR V AMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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