Comparison Between FFR Guided Revascularization Versus Co... | NCT01399736

Status Module

Name	Class
Abbott Medical Devices	INDUSTRY

Description Module

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FFR-guided revascularisation strategy	Active Comparator	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
randomised to guidelines group	Placebo Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
FFR-guided revascularisation strategy	Procedure	FFR-guided revascularisation strategy	FFR-guided revascularisation strategy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With the Composite Endpoint of MACCE	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	12 months
Number of Participants With Death From Any Cause	Number of participants with all cause mortality at 12 months between groups	12 months
Number of Participants With Cardiac Death	Number of participants with Cardiac mortality at 12 months between groups	12 months
Number of Participants With Spontaneous MI	Number of participants with Spontaneous Myocardial Infarction at 12 months between groups	12 months
Number of Participants With Periprocedural MI	Number of participants with Periprocedural Myocardial Infarction at 12 months between groups	12 months
Number of Participants With Revascularization - PCI	Number of participants with revascularization PCI at 12 months between groups	12 months
Number of Participants With Revascularization - CABG	Number of participants with revascularization CABG at 12 months between groups	12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Composite Endpoint of NACE (Any First Event)	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)	12 months
Number of Participants With Death From Any Cause or MI

Other Outcomes

Measure	Description	Time Frame
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;	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),

Eligibility Module

Name	Affiliation	Role
Peter Smits, MD. PHD	Maastadhospital / MCR	Principal Investigator
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 Chair

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital BRNO		Brno			Czechia
University Hospital Hradec Králové

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35045732	Derived	Piroth Z, Fulop G, Boxma-de Klerk BM, Abdelghani M, Omerovic E, Andreka P, Fontos G, Neumann FJ, Richardt G, Smits PC. Correlation and Relative Prognostic Value of Fractional Flow Reserve and Pd/Pa of Nonculprit Lesions in ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010796. doi: 10.1161/CIRCINTERVENTIONS.121.010796. Epub 2022 Jan 20.
30823897

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 18, 2012

Arm/Group Information

ID	Title	Description
BG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
BG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00023 OG001121

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		<0.001		Hazard Ratio (HR)	0.35			2-Sided	95	0.22	0.55					Superiority

Primary

Number of Participants With Death From Any Cause

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

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary

Number of Participants With Cardiac Death

Number of participants with Cardiac mortality at 12 months between groups

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary

Number of Participants With Spontaneous MI

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

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary

Number of Participants With Periprocedural MI

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

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary

Number of Participants With Revascularization - PCI

Number of participants with revascularization PCI at 12 months between groups

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary

Number of Participants With Revascularization - CABG

Number of participants with revascularization CABG at 12 months between groups

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Primary

Number of Participants With Cerebrovascular Event

Number of participants with Cerebrovascular event at 12 months between groups

Patients with STEMI and multivessel disease

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Composite Endpoint of NACE (Any First Event)

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)

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Death From Any Cause or MI

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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Major Bleeding

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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Any Bleeding at 12 Months

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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Any Bleeding at 48 Hours

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

Posted

Count of Participants

Participants

48 hours

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Hospitalization

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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Revascularization

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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Stent Thrombosis

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

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With All Cause Death at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Cardiac Death at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Spontaneous MI at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Peri-procedural MI at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Urgent Revascularization at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Elective Revascularization at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Cerebrovascular Event

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year

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)

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Death From Any Cause or MI

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Major Bleeding at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Hospitalization

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Hospitalization at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Stent Thrombosis at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Secondary

Number of Participants With Any Bleeding at 3 Year

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy
OG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina

Other Pre-specified

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;

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),

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	FFR+ and PCI+	patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days
OG001	FFR+ and PCI-	patients having FFR positive lesions that did not undergo revascularization

Units	Counts
Participants	OG000

Other Pre-specified

Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80

Comparison of acute versus staged PCI treatment for lesions with FFR

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	Acute Treatment FFR+	Patients with acute PCI treatment for lesions with FFR ≤ 0.80
OG001	Staged Treatement FFR+	Patients with staged PCI treatment for lesions with FFR ≤ 0.80

Units	Counts
Participants	OG000

Other Pre-specified

Comparison of PCI vs Medical Therapy in FFR Negative Lesions

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

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	FFR- Lesions Treated With PCI	patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results)
OG001	FFR- Lesions Treated With Medical Therapy	patients receiving medical therapy for FFR-negative lesions in the non-IRA

Units	Counts
Participants	OG000

Post-Hoc

Per Protocol Analysis - Occurence of MACCE at 3 Year

post-hoc, per-protocol analysis, 328 underwent FFR-guided complete revascularization and 550 patients underwent IRA-only treatment, occurence of MACCE at 3 year

Posted

Count of Participants

Participants

3 year

ID	Title	Description
OG000	FFR Guided Complete Revascularisation	Patients who underwent FFR guided complete revascularisation
OG001	IRA Only Treatment	Patients who underwent IRA only treatment

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. FFR-guided revascularisation strategy: FFR-guided revascularisation strategy	9	295	92	295	12	295
EG001	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). randomised to guidelines group: Staged revascularisation by proven ischemia or persistence of symptoms of angina	21	590	308	590	32	590

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Myocardial Infarction	Cardiac disorders	Systematic Assessment	EG00020 events20 affected295 at risk EG00153 events53 affected590 at risk
PCI	Cardiac disorders	Systematic Assessment	EG00034 events34 affected295 at risk EG001144 events144 affected590 at risk
Coronary Artery Bypass graft	Cardiac disorders	Systematic Assessment	EG0003 events3 affected295 at risk EG0015 events5 affected590 at risk
Cerebrovascular event	Vascular disorders	Systematic Assessment	EG0001 events1 affected295 at risk EG0017 events7 affected590 at risk
Stent Thrombosis	Cardiac disorders	Systematic Assessment	EG0004 events4 affected295 at risk EG00112 events12 affected590 at risk
Cardiac Hospitalisations	Cardiac disorders	Systematic Assessment	EG00030 events30 affected295 at risk EG00187 events87 affected590 at risk

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis