Trial Outcomes & Findings for A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease (NCT NCT02100722)
NCT ID: NCT02100722
Last Updated: 2026-04-07
Results Overview
Death, MI, stroke and any repeat revascularization (MACCE) will be evaluated at 1 year, where subjects contribute data from time of randomization until the occurrence of MACCE or one year follow-up, whichever occurs first. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1500 participants
Primary outcome timeframe
1 year
Results posted on
2026-04-07
Participant Flow
Participant milestones
| Measure |
FFR Guided PCI
Patients undergoing Percutaneous Coronary Intervention (PCI) will have Fractional Flow Reserve (FFR) measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent as per usual routine.
|
CABG
Coronary-artery bypass grafting (CABG) performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
|---|---|---|
|
Overall Study
STARTED
|
757
|
743
|
|
Overall Study
Underwent alternate procedure
|
11
|
37
|
|
Overall Study
COMPLETED
|
724
|
696
|
|
Overall Study
NOT COMPLETED
|
33
|
47
|
Reasons for withdrawal
| Measure |
FFR Guided PCI
Patients undergoing Percutaneous Coronary Intervention (PCI) will have Fractional Flow Reserve (FFR) measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent as per usual routine.
|
CABG
Coronary-artery bypass grafting (CABG) performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
|---|---|---|
|
Overall Study
Withdrawal pre-procedure
|
4
|
9
|
|
Overall Study
Withdrawal post-procedure
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
26
|
30
|
Baseline Characteristics
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
Total
n=1500 Participants
Total of all reporting groups
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.3 • n=527 Participants
|
65.2 years
STANDARD_DEVIATION 8.5 • n=1054 Participants
|
65.2 years
STANDARD_DEVIATION 8.6 • n=527 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=527 Participants
|
265 Participants
n=1054 Participants
|
141 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
619 Participants
n=527 Participants
|
1235 Participants
n=1054 Participants
|
616 Participants
n=527 Participants
|
|
Race/Ethnicity, Customized
White
|
686 Participants
n=527 Participants
|
1397 Participants
n=1054 Participants
|
711 Participants
n=527 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
57 Participants
n=527 Participants
|
103 Participants
n=1054 Participants
|
46 Participants
n=527 Participants
|
|
Body Mass Index (BMI)
|
28.7 kg/m^2
STANDARD_DEVIATION 4.3 • n=527 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 4.4 • n=1054 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=527 Participants
|
|
Diabetes
Overall
|
214 Participants
n=527 Participants
|
428 Participants
n=1054 Participants
|
214 Participants
n=527 Participants
|
|
Diabetes
Insulin-dependent
|
61 Participants
n=527 Participants
|
116 Participants
n=1054 Participants
|
55 Participants
n=527 Participants
|
|
Diabetes
Non-insulin-dependent
|
153 Participants
n=527 Participants
|
312 Participants
n=1054 Participants
|
159 Participants
n=527 Participants
|
|
Hypertension
|
556 Participants
n=527 Participants
|
1094 Participants
n=1054 Participants
|
538 Participants
n=527 Participants
|
|
Smoking Status
Current tobacco user
|
136 Participants
n=527 Participants
|
281 Participants
n=1054 Participants
|
145 Participants
n=527 Participants
|
|
Smoking Status
Previous tobacco user
|
296 Participants
n=527 Participants
|
592 Participants
n=1054 Participants
|
296 Participants
n=527 Participants
|
|
Family history of coronary artery disease
|
213 Participants
n=527 Participants
|
459 Participants
n=1054 Participants
|
246 Participants
n=527 Participants
|
|
Previous myocardial infarction
|
248 Participants
n=527 Participants
|
500 Participants
n=1054 Participants
|
252 Participants
n=527 Participants
|
|
Previous PCI
|
104 Participants
n=527 Participants
|
202 Participants
n=1054 Participants
|
98 Participants
n=527 Participants
|
|
History of transient ischemic attack (TIA) or cerebral vascular accident (CVA)
|
56 Participants
n=527 Participants
|
105 Participants
n=1054 Participants
|
49 Participants
n=527 Participants
|
|
Kidney disease
|
44 Participants
n=527 Participants
|
81 Participants
n=1054 Participants
|
37 Participants
n=527 Participants
|
|
Noninvasive test for ischemia
|
301 Participants
n=527 Participants
|
612 Participants
n=1054 Participants
|
311 Participants
n=527 Participants
|
|
Left ventricular ejection fraction (LVEF) ≤50%
|
130 Participants
n=527 Participants
|
267 Participants
n=1054 Participants
|
137 Participants
n=527 Participants
|
|
Hospitalized with Non-ST elevation-acute coronary syndrome (NSTE-ACS)
|
287 Participants
n=527 Participants
|
587 Participants
n=1054 Participants
|
300 Participants
n=527 Participants
|
PRIMARY outcome
Timeframe: 1 yearDeath, MI, stroke and any repeat revascularization (MACCE) will be evaluated at 1 year, where subjects contribute data from time of randomization until the occurrence of MACCE or one year follow-up, whichever occurs first. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity.
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
MACCE
|
51 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: FFR-guided PCI vs CABG
Death, MI, or stroke at 3-year follow-up
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke
|
68 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 1 yearSubjects who died or are lost to follow up before this time were censored at their last recorded activity.
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Death, MI, or Stroke
|
39 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 1 yearDeath evaluated excluding patients lost to follow-up from each arm
Outcome measures
| Measure |
CABG
n=741 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=755 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Death
Death
|
7 Participants
|
12 Participants
|
|
Death
Death from cardiac causes
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearMI evaluated excluding patients lost to follow-up from each arm
Outcome measures
| Measure |
CABG
n=741 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=755 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Myocardial Infarction
Overall
|
26 Participants
|
39 Participants
|
|
Number of Participants Experiencing Myocardial Infarction
Spontaneous
|
17 Participants
|
25 Participants
|
|
Number of Participants Experiencing Myocardial Infarction
Procedural
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 yearStroke evaluated excluding patients lost to follow-up from each arm.
Outcome measures
| Measure |
CABG
n=741 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=755 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Stroke
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearAny repeat revascularization evaluated excluding patients lost to follow-up from each arm
Outcome measures
| Measure |
CABG
n=741 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=755 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Requiring Repeat Revascularization
Overall
|
29 Participants
|
45 Participants
|
|
Number of Participants Requiring Repeat Revascularization
PCI
|
26 Participants
|
39 Participants
|
|
Number of Participants Requiring Repeat Revascularization
CABG
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearBleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding.
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing BARC Type 3-5 Bleeding
|
28 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
CABG
n=741 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=755 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Acute Kidney Injury
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia
|
105 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Outcome not assessed in CABG group (did not receive stent).
Outcome measures
| Measure |
CABG
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Definite Stent Thrombosis
|
—
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Outcome not assessed in FFR guided PCI group (did not receive CABG).
Outcome measures
| Measure |
CABG
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=743 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Experiencing Definite Symptomatic Graft Occlusion
|
—
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Number of Participants Requiring Rehospitalization Within 30 Days
|
76 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Intention-to-Treat Population
Death, MI, stroke and any repeat revascularization (MACCE) rate at 5 years
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
MACCE
|
131 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Intention-to-Treat Population
Death, MI, or stroke at 5 years
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Death, MI, or Stroke at 5 Years
|
101 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: At year 3Population: FFR-guided PCI
Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Individual Components of Primary Outcome
Death
|
29 Participants
|
31 Participants
|
|
Individual Components of Primary Outcome
Myocardial Infarction
|
31 Participants
|
53 Participants
|
|
Individual Components of Primary Outcome
Stroke
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At year 5Population: FFR-guided PCI
Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke
Outcome measures
| Measure |
CABG
n=743 Participants
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
FFR Guided PCI
n=757 Participants
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
|---|---|---|
|
Individual Components of Primary Outcome
Death
|
51 Participants
|
53 Participants
|
|
Individual Components of Primary Outcome
Myocardial Infarction
|
38 Participants
|
60 Participants
|
|
Individual Components of Primary Outcome
Stroke
|
21 Participants
|
14 Participants
|
Adverse Events
FFR Guided PCI
Serious events: 119 serious events
Other events: 112 other events
Deaths: 53 deaths
CABG
Serious events: 101 serious events
Other events: 55 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
FFR Guided PCI
n=757 participants at risk
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
CABG
n=743 participants at risk
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
|---|---|---|
|
Cardiac disorders
Death, MI or stroke
|
15.7%
119/757 • 5 years
|
13.6%
101/743 • 5 years
|
Other adverse events
| Measure |
FFR Guided PCI
n=757 participants at risk
Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
|
CABG
n=743 participants at risk
CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
|
|---|---|---|
|
Cardiac disorders
Repeat revascularization
|
14.8%
112/757 • 5 years
|
7.4%
55/743 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place