CompareAcute: Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.

• Sponsor: Maasstad Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01399736
• Collaborator: Abbott Medical Devices (Industry)
• Enrollment: 885
• Locations: 26
• Arms: 2
• Duration (Months): 88
• Patients Per Site: 34
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.

Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.

Approximately 885 patients will be entered in the study.

Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction; Multivessel Coronary Artery Disease	Procedure: FFR-guided revascularisation strategy; Procedure: randomised to guidelines group	N/A

Detailed Description

Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.

Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)

Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.

Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months

Study Design

• Study Type: Interventional
• Actual Enrollment: 885 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Oct 31, 2016
• Actual Study Completion Date: Oct 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FFR-guided revascularisation strategy In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.	Procedure: FFR-guided revascularisation strategy; FFR-guided revascularisation strategy
Placebo Comparator: randomised to guidelines group In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).	Procedure: randomised to guidelines group; Staged revascularisation by proven ischemia or persistence of symptoms of angina

Outcome Measures

Primary Outcome Measures

1. Number of Participants With the Composite Endpoint of MACCE [12 months]

   Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups

2. Number of Participants With Death From Any Cause [12 months]

   Number of participants with all cause mortality at 12 months between groups

3. Number of Participants With Cardiac Death [12 months]

   Number of participants with Cardiac mortality at 12 months between groups

4. Number of Participants With Spontaneous MI [12 months]

   Number of participants with Spontaneous Myocardial Infarction at 12 months between groups

5. Number of Participants With Periprocedural MI [12 months]

   Number of participants with Periprocedural Myocardial Infarction at 12 months between groups

6. Number of Participants With Revascularization - PCI [12 months]

   Number of participants with revascularization PCI at 12 months between groups

7. Number of Participants With Revascularization - CABG [12 months]

   Number of participants with revascularization CABG at 12 months between groups

8. Number of Participants With Cerebrovascular Event [12 months]

   Number of participants with Cerebrovascular event at 12 months between groups

Secondary Outcome Measures

1. Number of Participants With Composite Endpoint of NACE (Any First Event) [12 months]

   Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)

2. Number of Participants With Death From Any Cause or MI [12 months]

   Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months

3. Number of Participants With Major Bleeding [12 months]

   Number of participants with Major bleeding at 12 months - Part of composite NACE

4. Number of Participants With Any Bleeding at 12 Months [12 months]

   Number of participants with any bleeding at 12 months - part of composite endpoint NACE

5. Number of Participants With Any Bleeding at 48 Hours [48 hours]

   Number of participants with any bleeding at 48 hours - part of composite endpoint NACE

6. Number of Participants With Hospitalization [12 months]

   Number of participants with hospitalization for heart failure, unstable angina or chest pain

7. Number of Participants With Revascularization [12 months]

   Number of participants with any revascularization-Part of composite endpoint NACE

8. Number of Participants With Stent Thrombosis [12 months]

   Number of participants with Stent Thrombosis - Part of composite endpoint NACE

9. Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year [3 year]

   Number of participants with Composite primary endpoint MACCE (any first event) at 3 year

10. Number of Participants With All Cause Death at 3 Year [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death

11. Number of Participants With Cardiac Death at 3 Year [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death

12. Number of Participants With Spontaneous MI at 3 Year [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI

13. Number of Participants With Peri-procedural MI at 3 Year [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI

14. Number of Participants With Urgent Revascularization at 3 Year [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation

15. Number of Participants With Elective Revascularization at 3 Year [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation

16. Number of Participants With Cerebrovascular Event [3 year]

    Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event

17. Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year [3 years]

    Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events)

18. Number of Participants With Death From Any Cause or MI [3 year]

    Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year

19. Number of Participants With Major Bleeding at 3 Year [3 year]

    Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year

20. Number of Participants With Hospitalization [3 year]

    Number of participants with Hospitalization for heart failure, unstable angina, MI

21. Number of Participants With Hospitalization at 3 Year [3 year]

    Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain

22. Number of Participants With Stent Thrombosis at 3 Year [3 year]

    Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE

23. Number of Participants With Any Bleeding at 3 Year [3 year]

    Number of participants with any bleeding at 3 year - Part of composite endpoint NACE

Other Outcome Measures

1. A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80; [3 year]

   FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients),

2. Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80 [3 year]

   Comparison of acute versus staged PCI treatment for lesions with FFR

3. Comparison of PCI vs Medical Therapy in FFR Negative Lesions [3 year]

   comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of

50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.

• Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised

Exclusion Criteria:

1. Left main stem disease (stenosis > 50%)

2. STEMI due to in-stent thrombosis

3. Chronic total occlusion of a non-IRA

4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery.

5. Non-IRA stenosis not amenable for PCI treatment (operators decision)

6. Complicated IRA treatment, with one or more of the following;

• Extravasation,

• Permanent no re-flow after IRA treatment (TIMI flow 0-1),

• Inability to implant a stent

1. Known severe cardiac valve dysfunction that will require surgery in the follow-up period.

2. Killip class III or IV already at presentation or at the completion of culprit lesion treatment.

3. Life expectancy of < 2 years.

4. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.

5. Gastrointestinal or genitourinary bleeding within the prior 3 months,

6. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.

7. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

8. Pregnancy or planning to become pregnant any time after enrolment into this study.

9. Inability to obtain informed consent.

10. Expected lost to follow-up.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital BRNO	Brno		Czechia
2	University Hospital Hradec Králové	Hradec Králové		Czechia
3	Liberec Regional Hospital	Liberec		Czechia
4	Herz-Zentrum Bad Krozingen	Bad Krozingen		Germany	79189
5	Herzzentrum Bad Segeberger Klinik	Bad Segeberg		Germany	23795
6	Klinikum Links der Weser	Bremen		Germany	28277
7	Medizinische Klinik IV	Ingolstadt		Germany	85049
8	Medical University Rostock	Rostock		Germany	18057
9	Gottsegen György Országos Kardiológiai Intézet	Budapest		Hungary
10	Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital	Nyíregyháza		Hungary
11	Szent-Györgyi Albert Klinika	Szeged		Hungary
12	Zala Megyei Korhaz	Zalaegerszeg		Hungary
13	Rijnstate Hospital	Arnhem		Netherlands
14	University Medical Center Groningen	Groningen		Netherlands
15	Atrium MC Parkstad	Heerlen		Netherlands
16	Maastricht Universitair Medical center	Maastricht		Netherlands
17	Maasstadhospital	Rotterdam		Netherlands	3079DZ
18	Medisch Centrum Haaglanden	The Hague		Netherlands	2512 VA
19	Oslo University Hospital	Oslo		Norway
20	Miedziowe Centrum Zdrowia Lubin	Lubin		Poland
21	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw		Poland
22	Kliniki Kardiologii Allenort	Warsaw		Poland
23	4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ	Wroclaw		Poland
24	Tan Tock Seng Hospital	Singapore		Singapore	308433
25	Khoo Teck Puat Hospital	Singapore		Singapore	768828
26	Sahlgrenska Götheborg University Hospital	Goteborg		Sweden	41315

Sponsors and Collaborators

• Maasstad Hospital
• Abbott Medical Devices

Investigators

• Principal Investigator: Peter Smits, MD. PHD, Maastadhospital / MCR
• Study Chair: Elmir Omerovic, MD PhD, Sahlgrenska Hospital Götheborg
• Study Chair: Gert Richardt, MD PhD, Herzzentrum Segeberger Kliniken
• Study Chair: Franz-Josef Neumann, MD PhD, Herz-Zentrum Bad Krozingen

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 18, 2012

More Information

Publications

None provided.

• Responsible Party: Maasstad Hospital
• ClinicalTrials.gov Identifier: NCT01399736
• Other Study ID Numbers: Compare-Acute
• First Posted: Jul 22, 2011
• Last Update Posted: Aug 11, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Maasstad Hospital: PCI FFR STEMI MVD; FFR guided PCI in acute STEMI patients with MVD
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Period Title: Overall Study
STARTED	295	590
COMPLETED	291	586
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group	Total
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina	Total of all reporting groups
Overall Participants	295	590	885
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (10)	61 (10)	62 (10)
Sex: Female, Male (Count of Participants)
Female	62 21%	140 23.7%	202 22.8%
Male	233 79%	450 76.3%	683 77.2%
Race/Ethnicity, Customized (Count of Participants)
white race	263 89.2%	545 92.4%	808 91.3%
other races	32 10.8%	44 7.5%	76 8.6%
BMI (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	27.2	27.1	27.1
Diabetes Mellitus (Count of Participants)
Count of Participants [Participants]	43 14.6%	94 15.9%	137 15.5%
Hypertension (Count of Participants)
Count of Participants [Participants]	136 46.1%	282 47.8%	418 47.2%
current smoker (Count of Participants)
Count of Participants [Participants]	120 40.7%	287 48.6%	407 46%
Hypercholesterolemia (Count of Participants)
Count of Participants [Participants]	95 32.2%	176 29.8%	271 30.6%
Family history of premature coronary artery disease (Count of Participants)
Count of Participants [Participants]	103 34.9%	223 37.8%	326 36.8%
Previous stroke (Count of Participants)
Count of Participants [Participants]	10 3.4%	26 4.4%	36 4.1%
Previous Myocardial Infarction (Count of Participants)
Count of Participants [Participants]	22 7.5%	48 8.1%	70 7.9%
Previous PCI (Count of Participants)
Count of Participants [Participants]	25 8.5%	44 7.5%	69 7.8%
Renal Impairment (Count of Participants)
Count of Participants [Participants]	3 1%	7 1.2%	10 1.1%
Peripheral vessel disease (Count of Participants)
Count of Participants [Participants]	10 3.4%	23 3.9%	33 3.7%
Location of infarct - Posterior (Count of Participants)
Count of Participants [Participants]	53 18%	96 16.3%	149 16.8%
Location of infarct - Anterior (Count of Participants)
Count of Participants [Participants]	105 35.6%	206 34.9%	311 35.1%
Location of infarct - Inferior (Count of Participants)
Count of Participants [Participants]	149 50.5%	307 52%	456 51.5%
Location of infarct - Lateral (Count of Participants)
Count of Participants [Participants]	41 13.9%	86 14.6%	127 14.4%
Location of infarct - impossible to determine (Count of Participants)
Count of Participants [Participants]	3 1%	4 0.7%	7 0.8%
Time from symptom onset to primary PCI < 6 hr (Count of Participants)
Count of Participants [Participants]	225 76.3%	462 78.3%	687 77.6%
Time from symptom onset to primary PCI 6-12 hr (Count of Participants)
Count of Participants [Participants]	47 15.9%	84 14.2%	131 14.8%
Time from symptom onset to primary PCI >12 hr (Count of Participants)
Count of Participants [Participants]	23 7.8%	44 7.5%	67 7.6%
Nr. of arteries with stenosis 2 (Count of Participants)
Count of Participants [Participants]	204 69.2%	396 67.1%	600 67.8%
Nr. of arteries with stenosis 3 (Count of Participants)
Count of Participants [Participants]	91 30.8%	194 32.9%	285 32.2%
Killip class >=2 (Count of Participants)
Count of Participants [Participants]	15 5.1%	30 5.1%	45 5.1%
Maximum creatinine kinase level (IU/liter) [Median (Full Range) ]
Median (Full Range) [IU/liter]	1040	1125	1083
Mean time for index procedure - min (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	65 (31)	59 (28)	61 (29)
Mean volume of contract used during index PCI (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	224 (104)	202 (75)	209 (86)
FFR procedure successful (Count of Participants)
Count of Participants [Participants]	292 99%	575 97.5%	867 98%
Patients with lesions FFR<=0.80 (Count of Participants)
Count of Participants [Participants]	158 53.6%	275 46.6%	433 48.9%
Patients with lesions FFR>0.80 (Count of Participants)
Count of Participants [Participants]	134 45.4%	300 50.8%	434 49%
Mean FFR value (Ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Ratio]	0.78 (0.12)	0.79 (0.12)	0.78 (0.12)
Patients with treated (FFR-guided) non-IRA lesions (Count of Participants)
Count of Participants [Participants]	163 55.3%	0 0%	163 18.4%
Patients with treated (FFR-guided) non-IRA lesions during index PCI (Count of Participants)
Count of Participants [Participants]	136 46.1%	0 0%	136 15.4%
Patients with treated (FFR-guided) non-IRA lesions delayed during index hospitalization (Count of Participants)
Count of Participants [Participants]	27 9.2%	0 0%	27 3.1%
Patients with treated (FFR-guided) non-IRA lesions - DES only (Count of Participants)
Count of Participants [Participants]	161 54.6%	0 0%	161 18.2%
Patients with treated (FFR-guided) non-IRA lesions - bare metal stent only (Count of Participants)
Count of Participants [Participants]	1 0.3%	0 0%	1 0.1%
Patients with treated (FFR-guided) non-IRA lesions - balloon dilatation only (Count of Participants)
Count of Participants [Participants]	1 0.3%	0 0%	1 0.1%
Patients with treated (FFR-guided) non-IRA lesions - mean nr. of stents used per patient (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	1.6 (0.9)	0 (0)	1.6 (0.9)
Patients with treated (FFR-guided) non-IRA lesions -mean length of stent (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	34.3 (21.0)	0 (0)	34.3 (21.0)
Patients with treated (FFR-guided) non-IRA lesions - mean diameter of stent (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	2.9 (0.4)	0 (0)	2.9 (0.4)
length of hospital stay (days) [Median (Full Range) ]
Median (Full Range) [days]	4	4	4
Patients receiving predischarge noninvasive stress tests (Count of Participants)
Count of Participants [Participants]	21 7.1%	71 12%	92 10.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With the Composite Endpoint of MACCE
Description	Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	23 7.8%	121 20.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95%; 0.22 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants With Death From Any Cause
Description	Number of participants with all cause mortality at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	4 1.4%	10 1.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.25 to 2.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Number of Participants With Cardiac Death
Description	Number of participants with Cardiac mortality at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	3 1%	6 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.25 to 4.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Number of Participants With Spontaneous MI
Description	Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	5 1.7%	17 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95%; 0.22 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Number of Participants With Periprocedural MI
Description	Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	2 0.7%	11 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; 0.22 to 1.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Number of Participants With Revascularization - PCI
Description	Number of participants with revascularization PCI at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	15 5.1%	98 16.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; 0.24 to 0.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Number of Participants With Revascularization - CABG
Description	Number of participants with revascularization CABG at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	3 1%	5 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.20
	Confidence Interval	(2-Sided) 95%; 0.29 to 5.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Primary Outcome

Title	Number of Participants With Cerebrovascular Event
Description	Number of participants with Cerebrovascular event at 12 months between groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Patients with STEMI and multivessel disease

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	0 0%	4 0.7%

9. Secondary Outcome

Title	Number of Participants With Composite Endpoint of NACE (Any First Event)
Description	Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	25 8.5%	174 29.5%

10. Secondary Outcome

Title	Number of Participants With Death From Any Cause or MI
Description	Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	11 3.7%	38 6.4%

11. Secondary Outcome

Title	Number of Participants With Major Bleeding
Description	Number of participants with Major bleeding at 12 months - Part of composite NACE
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	3 1%	8 1.4%

12. Secondary Outcome

Title	Number of Participants With Any Bleeding at 12 Months
Description	Number of participants with any bleeding at 12 months - part of composite endpoint NACE
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	9 3.1%	28 4.7%

13. Secondary Outcome

Title	Number of Participants With Any Bleeding at 48 Hours
Description	Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	5 1.7%	8 1.4%

14. Secondary Outcome

Title	Number of Participants With Hospitalization
Description	Number of participants with hospitalization for heart failure, unstable angina or chest pain
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	13 4.4%	47 8%

15. Secondary Outcome

Title	Number of Participants With Revascularization
Description	Number of participants with any revascularization-Part of composite endpoint NACE
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	19 6.4%	161 27.3%

16. Secondary Outcome

Title	Number of Participants With Stent Thrombosis
Description	Number of participants with Stent Thrombosis - Part of composite endpoint NACE
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	2 0.7%	1 0.2%

17. Secondary Outcome

Title	Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year
Description	Number of participants with Composite primary endpoint MACCE (any first event) at 3 year
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	46 15.6%	178 30.2%

18. Secondary Outcome

Title	Number of Participants With All Cause Death at 3 Year
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	9 3.1%	21 3.6%

19. Secondary Outcome

Title	Number of Participants With Cardiac Death at 3 Year
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	5 1.7%	8 1.4%

20. Secondary Outcome

Title	Number of Participants With Spontaneous MI at 3 Year
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	17 5.8%	40 6.8%

21. Secondary Outcome

Title	Number of Participants With Peri-procedural MI at 3 Year
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	3 1%	13 2.2%

22. Secondary Outcome

Title	Number of Participants With Urgent Revascularization at 3 Year
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	22 7.5%	85 14.4%

23. Secondary Outcome

Title	Number of Participants With Elective Revascularization at 3 Year
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	15 5.1%	64 10.8%

24. Secondary Outcome

Title	Number of Participants With Cerebrovascular Event
Description	Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	1 0.3%	7 1.2%

25. Secondary Outcome

Title	Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year
Description	Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	45 15.3%	215 36.4%

26. Secondary Outcome

Title	Number of Participants With Death From Any Cause or MI
Description	Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	28 9.5%	73 12.4%

27. Secondary Outcome

Title	Number of Participants With Major Bleeding at 3 Year
Description	Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	3 1%	8 1.4%

28. Secondary Outcome

Title	Number of Participants With Hospitalization
Description	Number of participants with Hospitalization for heart failure, unstable angina, MI
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	28 9.5%	75 12.7%

29. Secondary Outcome

Title	Number of Participants With Hospitalization at 3 Year
Description	Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	30 10.2%	87 14.7%

30. Secondary Outcome

Title	Number of Participants With Stent Thrombosis at 3 Year
Description	Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	4 1.4%	12 2%

31. Secondary Outcome

Title	Number of Participants With Any Bleeding at 3 Year
Description	Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR-guided Revascularisation Strategy	Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
Measure Participants	295	590
Count of Participants [Participants]	4 1.4%	12 2%

32. Other Pre-specified Outcome

Title	A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80;
Description	FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients),
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR+ and PCI+	FFR+ and PCI-
Arm/Group Description	patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days	patients having FFR positive lesions that did not undergo revascularization
Measure Participants	202	231
Count of Participants [Participants]	35 11.9%	90 15.3%

33. Other Pre-specified Outcome

Title	Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80
Description	Comparison of acute versus staged PCI treatment for lesions with FFR
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Treatment FFR+	Staged Treatement FFR+
Arm/Group Description	Patients with acute PCI treatment for lesions with FFR ≤ 0.80	Patients with staged PCI treatment for lesions with FFR ≤ 0.80
Measure Participants	155	44
Count of Participants [Participants]	25 8.5%	10 1.7%

34. Other Pre-specified Outcome

Title	Comparison of PCI vs Medical Therapy in FFR Negative Lesions
Description	comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR- Lesions Treated With PCI	FFR- Lesions Treated With Medical Therapy
Arm/Group Description	patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results)	patients receiving medical therapy for FFR-negative lesions in the non-IRA
Measure Participants	13	418
Count of Participants [Participants]	6 2%	91 15.4%

35. Post-Hoc Outcome

Title	Per Protocol Analysis - Occurence of MACCE at 3 Year
Description	post-hoc, per-protocol analysis, 328 underwent FFR-guided complete revascularization and 550 patients underwent IRA-only treatment, occurence of MACCE at 3 year
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FFR Guided Complete Revascularisation	IRA Only Treatment
Arm/Group Description	Patients who underwent FFR guided complete revascularisation	Patients who underwent IRA only treatment
Measure Participants	328	550
Count of Participants [Participants]	55 18.6%	168 28.5%

Adverse Events

Time Frame	3 year
Arm/Group Title	FFR-guided Revascularisation Strategy		Randomised to Guidelines Group
Arm/Group Description	In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy		In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
All Cause Mortality
	FFR-guided Revascularisation Strategy		Randomised to Guidelines Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/295 (3.1%)		21/590 (3.6%)
Serious Adverse Events
	FFR-guided Revascularisation Strategy		Randomised to Guidelines Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/295 (31.2%)		308/590 (52.2%)
Cardiac disorders
Myocardial Infarction	20/295 (6.8%)	20	53/590 (9%)	53
PCI	34/295 (11.5%)	34	144/590 (24.4%)	144
Coronary Artery Bypass graft	3/295 (1%)	3	5/590 (0.8%)	5
Stent Thrombosis	4/295 (1.4%)	4	12/590 (2%)	12
Cardiac Hospitalisations	30/295 (10.2%)	30	87/590 (14.7%)	87
Vascular disorders
Cerebrovascular event	1/295 (0.3%)	1	7/590 (1.2%)	7
Other (Not Including Serious) Adverse Events
	FFR-guided Revascularisation Strategy		Randomised to Guidelines Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/295 (4.1%)		32/590 (5.4%)
Blood and lymphatic system disorders
any bleeding	12/295 (4.1%)	12	32/590 (5.4%)	32

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.