N/A
N=1,500
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Coronary Disease · Coronary Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02100722 ↗Enrolled (actual)
1,500
Serious AEs
14.7%
Results posted
Jan 2022
Primary outcome: Primary: MACCE — 80; 51 Participants — p=0.35
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FFR guided PCI (Procedure); CABG (Procedure); Resolute Integrity Stent (Device); Resolute Onyx Stent (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MACCE |
188; 131 | — |
| SECONDARY Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke |
91; 68 | — |
| SECONDARY Number of Participants Experiencing Death, MI, or Stroke |
55; 39 | — |
| SECONDARY Death |
12; 7; 6; 4 | — |
| SECONDARY Number of Participants Experiencing Myocardial Infarction |
39; 26; 25; 17; 13; 9 | — |
| SECONDARY Number of Participants Experiencing Stroke |
7; 8 | — |
| SECONDARY Number of Participants Requiring Repeat Revascularization |
45; 29; 39; 26; 6; 3 | — |
| SECONDARY Number of Participants Experiencing BARC Type 3-5 Bleeding |
12; 28 | <0.01 sig |
| SECONDARY Number of Participants Experiencing Acute Kidney Injury |
1; 7 | <0.04 sig |
| SECONDARY Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia |
18; 105 | <0.001 sig |
| SECONDARY Number of Participants Experiencing Definite Stent Thrombosis |
6 | — |
| SECONDARY Number of Participants Experiencing Definite Symptomatic Graft Occlusion |
10 | — |
| SECONDARY Number of Participants Requiring Rehospitalization Within 30 Days |
42; 76 | <0.001 sig |
| SECONDARY MACCE |
188; 131 | — |
| SECONDARY Death, MI, or Stroke at 5 Years |
119; 101 | 0.27 |
| SECONDARY Individual Components of Primary Outcome |
53; 51; 60; 38; 14; 21 | — |
| SECONDARY Individual Components of Primary Outcome |
53; 51; 60; 38; 14; 21 | — |
Summary
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).
Eligibility Criteria
Inclusion Criteria
- 1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
- 2. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis
- 3. Willing and able to provide informed, written consent
Exclusion Criteria
- 1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization)
- 2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- 3. Recent STEMI (<5 days prior to randomization)
- 4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
- 5. Known left ventricular ejection fraction <30%
- 6. Life expectancy < 2 years
- 7. Requiring renal replacement therapy
- 8. Undergoing evaluation for organ transplantation
- 9. Participation or planned participation in another clinical trial, except for observational registries
- 10. Pregnancy
- 11. Inability to take dual antiplatelet therapy for six months
- 12. Previous CABG
- 13. Left main disease requiring revascularization
- 14. Extremely calcified or tortuous vessels precluding FFR measurement
- 15. Any target lesion with in-stent drug-eluting stent restenosis
Data sourced from ClinicalTrials.gov (NCT02100722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.