FAME 3: A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

• Sponsor: Stanford University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02100722
• Collaborator: VZW Cardiovascular Research Center Aalst (Other), Catharina Ziekenhuis Eindhoven (Other), Golden Jubilee National Hospital (Other), University of California, Irvine (Other), Medtronic (Industry), Abbott Medical Devices (Industry), Genae (Industry), King's College Hospital, London (Other), Houston Methodist DeBakey Heart and Vascular Center, Houston (Other)
• Enrollment: 1,500
• Locations: 46
• Arms: 2
• Anticipated Duration (Months): 123.2
• Patients Per Site: 32.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease; Coronary Stenosis	Procedure: FFR guided PCI; Procedure: CABG; Device: Resolute Integrity Stent; Device: Resolute Onyx Stent	N/A

Detailed Description

The FAME 3 trial is a multicenter, international, randomized, controlled noninferiority trial. All patients with multivessel CAD (not involving the left main) will be screened by the site's Heart Team (including but not limited to an interventional cardiologist, cardiac surgeon and research coordinator). If all agree that the patient can be treated either with FFR-guided PCI or CABG, and all inclusion criteria are met and no exclusion criteria are met, then the patient will be randomized.

Baseline clinical, functional, laboratory and electrocardiographic data will be obtained. Patients will receive treatment within 4 weeks of randomization. Patients randomized to CABG will receive state of the art therapy at the discretion of the local surgeon with a strong emphasis on arterial revascularization. Patients undergoing PCI will have 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 drug-eluting stent (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred.

All patients will receive medical therapy as per published guidelines. Patients will follow-up at 1 and 6 months, and 1 and 3 years with an evaluation of clinical status, functional status, medications and events. Follow-up may be extended to 5 years, if funding allows.

Core lab analyses will include formal quantitative coronary angiography (QCA) of the baseline angiograms with calculation of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score and Functional SYNTAX Score.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Trial A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
• Actual Study Start Date: Aug 25, 2014
• Actual Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FFR guided PCI Patients undergoing PCI will have 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 (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred. Only those sites with prior experience measuring FFR will be included in the FAME 3 trial. These patients in whom FFR of a particular lesion was not possible will be included in all analyses based on the intention to treat principle.	Procedure: FFR guided PCI; Other Names: Fractional Flow Reserve-Guided PCI ; Device: Resolute Integrity Stent; Durable polymer zotarolimus-eluting stent; Device: Resolute Onyx Stent; Durable polymer zotarolimus-eluting stent
Active Comparator: CABG CABG will be performed as per clinical routine at each participating center. Both off-pump and on-pump surgery are acceptable, as long as the surgeon and the site are experienced in the particular technique. An internal mammary graft to the LAD should be attempted in all cases, if feasible. Complete arterial revascularization is strongly recommended, however, each center should use a conduit strategy with which they are most comfortable. All vessels ≥ 1,5 mm in diameter and with ≥ 50% stenosis should be bypassed, if technically feasible.	Procedure: CABG; Coronary Artery Bypass Graft Surgery (CABG)

Outcome Measures

Primary Outcome Measures

1. MACCE [1 year]

   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.

Secondary Outcome Measures

1. Number of Participants Experiencing Death, MI, or Stroke [1 year]

   Subjects who died or are lost to follow up before this time were censored at their last recorded activity.

2. Death [1 year]

   Death evaluated excluding patients lost to follow-up from each arm

3. Number of Participants Experiencing Myocardial Infarction [1 year]

   MI evaluated excluding patients lost to follow-up from each arm

4. Number of Participants Experiencing Stroke [1 year]

   Stroke evaluated excluding patients lost to follow-up from each arm.

5. Number of Participants Requiring Repeat Revascularization [1 year]

   Any repeat revascularization evaluated excluding patients lost to follow-up from each arm

6. Number of Participants Experiencing BARC Type 3-5 Bleeding [1 year]

   Bleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding.

7. Number of Participants Experiencing Acute Kidney Injury [1 year]

8. Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia [1 year]

9. Number of Participants Experiencing Definite Stent Thrombosis [1 year]

10. Number of Participants Experiencing Definite Symptomatic Graft Occlusion [1 year]

11. Number of Participants Requiring Rehospitalization Within 30 Days [30 days]

12. MACCE [2 years, 3 years, 5 years]

    Death, MI, stroke and any repeat revascularization (MACCE) rate at 2 years, 3 years and 5 years

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
• 1. 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
• 1. 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)
• 1. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
• 1. Recent STEMI (<5 days prior to randomization)
• 1. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
• 1. Known left ventricular ejection fraction <30%
• 1. Life expectancy < 2 years
• 1. Requiring renal replacement therapy
• 1. Undergoing evaluation for organ transplantation
• 1. Participation or planned participation in another clinical trial, except for observational registries
• 1. Pregnancy
• 1. Inability to take dual antiplatelet therapy for six months
• 1. Previous CABG
• 1. Left main disease requiring revascularization
• 1. Extremely calcified or tortuous vessels precluding FFR measurement
• 1. Any target lesion with in-stent drug-eluting stent restenosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto VA	Palo Alto	California	United States
2	Stanford University	Stanford	California	United States	94305-2004
3	Atlanta VA Medical Center	Decatur	Georgia	United States
4	Jesse Brown VA Medical Center	Chicago	Illinois	United States
5	University of Kansas Medical Center	Lawrence	Kansas	United States
6	Lexinton VA	Lexington	Kentucky	United States
7	University of Kentucky Medical Center	Lexington	Kentucky	United States
8	Baystate Medical Center	Springfield	Massachusetts	United States
9	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota	United States
10	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States
11	Centennial Heart	Nashville	Tennessee	United States
12	Houston Methodist Hospital	Houston	Texas	United States
13	University of Virginia	Charlottesville	Virginia	United States
14	Peninsula Health	Frankston		Australia
15	St. Vincent's Hospital Melbourne	Melbourne		Australia
16	Concord Hospital	Sydney		Australia
17	Royal North Shore	Sydney		Australia
18	University of Sydney	Sydney		Australia
19	Cardiovascular Center Aalst	Aalst		Belgium	9300 Aalst
20	Le'Centre Hospitalier de l'Universite de Montreal	Montreal		Canada
21	York PCI Group INC	Ontario		Canada
22	University of Ottawa Heart Institute	Ottawa		Canada
23	Masaryk University and University Hospital Brno	Brno		Czechia
24	Rigshospitalet University Hospital	Copenhagen		Denmark
25	Cardiovascular Hospital	Lyon		France
26	Hungarian Institute of Cardiology	Budapest		Hungary
27	Asan Medical Center	Seoul		Korea, Republic of
28	Vilnius University Hospital Santariskiu Klinikos	Vilnius		Lithuania
29	Catharina Hospital Eindhoven	Eindhoven		Netherlands	5623 EJ
30	HagaZiekenhuis	The Hague		Netherlands
31	Isala Klinieken	Zwolle		Netherlands
32	Waikato Hospital	Hamilton		New Zealand
33	Stavanger University Hospital	Stavanger		Norway
34	University Clinical Center of Serbia	Belgrade		Serbia
35	Clinical Center Kragujevac	Kragujevac		Serbia
36	Sahlgrenska University Hospital	Goteborg		Sweden
37	Danderyds Sjukhus	Stockholm		Sweden
38	Karolinska Institutet, Dep of clinical science and education, Södersjukhuset	Stockholm		Sweden
39	Wales Heart Research Institute	Cardiff		United Kingdom
40	University Hospitals Coventry and Warwickshire	Coventry And Warwickshire		United Kingdom
41	Golden Jubilee National Hospital	Glasgow		United Kingdom
42	Kings College Hospital	London		United Kingdom
43	St. Thomas' Hospital	London		United Kingdom
44	Wythenshawe Hospital	Manchester		United Kingdom
45	Oxford University Hospital NHS Trust	Oxford		United Kingdom
46	Southampton University Hospitals NHS Trust	Southhampton		United Kingdom

Sponsors and Collaborators

• Stanford University
• VZW Cardiovascular Research Center Aalst
• Catharina Ziekenhuis Eindhoven
• Golden Jubilee National Hospital
• University of California, Irvine
• Medtronic
• Abbott Medical Devices
• Genae
• King's College Hospital, London
• Houston Methodist DeBakey Heart and Vascular Center, Houston

Investigators

• Study Chair: William F Fearon, MD, Stanford University
• Principal Investigator: Nico HJ Pijls, MD, PhD, Catharina Hospital Eindhoven, The Netherlands
• Principal Investigator: Bernard De Bruyne, MD, PhD, VZW Cardiovascular Research Center Aalst

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 27, 2018

More Information

Additional Information:

• Related Info

Publications

• Zimmermann FM, De Bruyne B, Pijls NH, Desai M, Oldroyd KG, Park SJ, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2015 Oct;170(4):619-626.e2. doi: 10.1016/j.ahj.2015.06.024. Epub 2015 Jul 9.
• Zimmermann FM, De Bruyne B, Pijls NHJ, Desai M, Oldroyd KG, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. A protocol update of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial: A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2019 Aug;214:156-157. doi: 10.1016/j.ahj.2019.04.012. Epub 2019 Apr 29.

• Responsible Party: William Fearon, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02100722
• Other Study ID Numbers: FAME 3
• First Posted: Apr 1, 2014
• Last Update Posted: Jan 20, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis

Study Results

Participant Flow

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	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.	Coronary-artery bypass grafting (CABG) performed per clinical routine (both off-pump and on-pump surgery acceptable).
Period Title: Overall Study
STARTED	757	743
Underwent Alternate Procedure	11	37
COMPLETED	0	0
NOT COMPLETED	757	743

Baseline Characteristics

Arm/Group Title	FFR Guided PCI	CABG	Total
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).	Total of all reporting groups
Overall Participants	757	743	1500
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.2 (8.6)	65.1 (8.3)	65.2 (8.5)
Sex: Female, Male (Count of Participants)
Female	141 18.6%	124 16.7%	265 17.7%
Male	616 81.4%	619 83.3%	1235 82.3%
Race/Ethnicity, Customized (Count of Participants)
White	711 93.9%	686 92.3%	1397 93.1%
Non-white	46 6.1%	57 7.7%	103 6.9%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.6 (4.5)	28.7 (4.3)	28.7 (4.4)
Diabetes (Count of Participants)
Overall	214 28.3%	214 28.8%	428 28.5%
Insulin-dependent	55 7.3%	61 8.2%	116 7.7%
Non-insulin-dependent	159 21%	153 20.6%	312 20.8%
Hypertension (Count of Participants)
Count of Participants [Participants]	538 71.1%	556 74.8%	1094 72.9%
Smoking Status (Count of Participants)
Current tobacco user	145 19.2%	136 18.3%	281 18.7%
Previous tobacco user	296 39.1%	296 39.8%	592 39.5%
Family history of coronary artery disease (Count of Participants)
Count of Participants [Participants]	246 32.5%	213 28.7%	459 30.6%
Previous myocardial infarction (Count of Participants)
Count of Participants [Participants]	252 33.3%	248 33.4%	500 33.3%
Previous PCI (Count of Participants)
Count of Participants [Participants]	98 12.9%	104 14%	202 13.5%
History of transient ischemic attack (TIA) or cerebral vascular accident (CVA) (Count of Participants)
Count of Participants [Participants]	49 6.5%	56 7.5%	105 7%
Kidney disease (Count of Participants)
Count of Participants [Participants]	37 4.9%	44 5.9%	81 5.4%
Noninvasive test for ischemia (Count of Participants)
Count of Participants [Participants]	311 41.1%	301 40.5%	612 40.8%
Left ventricular ejection fraction (LVEF) ≤50% (Count of Participants)
Count of Participants [Participants]	137 18.1%	130 17.5%	267 17.8%
Hospitalized with Non-ST elevation-acute coronary syndrome (NSTE-ACS) (Count of Participants)
Count of Participants [Participants]	300 39.6%	287 38.6%	587 39.1%

Outcome Measures

1. Primary Outcome

Title	MACCE
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	757	743
Count of Participants [Participants]	80 10.6%	51 6.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments	A sample of 712 patients per group (1424 for the entire trial) would be required in order to achieve 90% power to claim noninferiority
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio.
Statistical Test of Hypothesis	p-Value	0.35
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 1.1 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants Experiencing Death, MI, or Stroke
Description	Subjects who died or are lost to follow up before this time were censored at their last recorded activity.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	757	743
Count of Participants [Participants]	55 7.3%	39 5.2%

3. Secondary Outcome

Title	Death
Description	Death evaluated excluding patients lost to follow-up from each arm
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	755	741
Death	12 1.6%	7 0.9%
Death from cardiac causes	6 0.8%	4 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; 0.7 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants Experiencing Myocardial Infarction
Description	MI evaluated excluding patients lost to follow-up from each arm
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	755	741
Overall	39 5.2%	26 3.5%
Spontaneous	25 3.3%	17 2.3%
Procedural	13 1.7%	9 1.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 0.9 to 2.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio for overall number of participants experiencing MI.

5. Secondary Outcome

Title	Number of Participants Experiencing Stroke
Description	Stroke evaluated excluding patients lost to follow-up from each arm.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	755	741
Count of Participants [Participants]	7 0.9%	8 1.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.3 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Number of Participants Requiring Repeat Revascularization
Description	Any repeat revascularization evaluated excluding patients lost to follow-up from each arm
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	755	741
Overall	45 5.9%	29 3.9%
PCI	39 5.2%	26 3.5%
CABG	6 0.8%	3 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) 95%; 0.9 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio for overall number of participants experiencing repeat revascularization.

7. Secondary Outcome

Title	Number of Participants Experiencing BARC Type 3-5 Bleeding
Description	Bleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	757	743
Count of Participants [Participants]	12 1.6%	28 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Fisher Exact
	Comments

8. Secondary Outcome

Title	Number of Participants Experiencing Acute Kidney Injury
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	755	741
Count of Participants [Participants]	1 0.1%	7 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.04
	Comments
	Method	Fisher Exact
	Comments

9. Secondary Outcome

Title	Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	757	743
Count of Participants [Participants]	18 2.4%	105 14.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments

10. Secondary Outcome

Title	Number of Participants Experiencing Definite Stent Thrombosis
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Outcome not assessed in CABG group (did not receive stent).

Arm/Group Title	FFR Guided PCI
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.
Measure Participants	757
Count of Participants [Participants]	6 0.8%

11. Secondary Outcome

Title	Number of Participants Experiencing Definite Symptomatic Graft Occlusion
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Outcome not assessed in FFR guided PCI group (did not receive CABG).

Arm/Group Title	CABG
Arm/Group Description	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	743
Count of Participants [Participants]	10 1.3%

12. Secondary Outcome

Title	Number of Participants Requiring Rehospitalization Within 30 Days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided PCI	CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.	CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
Measure Participants	757	743
Count of Participants [Participants]	42 5.5%	76 10.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR Guided PCI, CABG
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	MACCE
Description	Death, MI, stroke and any repeat revascularization (MACCE) rate at 2 years, 3 years and 5 years
Time Frame	2 years, 3 years, 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	1 year
Arm/Group Title	FFR Guided PCI		CABG
Arm/Group Description	Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent.		CABG performed per clinical routine (both off-pump and on-pump surgery acceptable).
All Cause Mortality
	FFR Guided PCI		CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/757 (1.6%)		7/743 (0.9%)
Serious Adverse Events
	FFR Guided PCI		CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	55/757 (7.3%)		39/743 (5.2%)
Cardiac disorders
Death, MI or stroke	55/757 (7.3%)		39/743 (5.2%)
Other (Not Including Serious) Adverse Events
	FFR Guided PCI		CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/757 (5.9%)		29/743 (3.9%)
Cardiac disorders
Repeat revascularization	45/757 (5.9%)		29/743 (3.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.