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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01399736
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : July 23, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Maasstad Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myocardial Infarction
Multivessel Coronary Artery Disease
Interventions Procedure: FFR-guided revascularisation strategy
Procedure: randomised to guidelines group
Enrollment 885
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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
Reason Not Completed
Withdrawal by Subject             4             2
Lost to Follow-up             0             2
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group Total
Hide 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 Number of Baseline Participants 295 590 885
Hide Baseline Analysis Population Description
885 patients with STEMI and multivessel disease
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 590 participants 885 participants
62  (10) 61  (10) 62  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
Female
62
  21.0%
140
  23.7%
202
  22.8%
Male
233
  79.0%
450
  76.3%
683
  77.2%
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
white race Number Analyzed 295 participants 589 participants 884 participants
263
  89.2%
545
  92.5%
808
  91.4%
other races Number Analyzed 295 participants 590 participants 885 participants
32
  10.8%
44
   7.5%
76
   8.6%
[1]
Measure Description: Collection of race has been done, but only specified as white race and other
[2]
Measure Analysis Population Description: information missing for 1 patient
BMI  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 295 participants 590 participants 885 participants
27.2
(18.0 to 44.1)
27.1
(17.7 to 54.3)
27.1
(17.7 to 54.3)
Diabetes Mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
43
  14.6%
94
  15.9%
137
  15.5%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
136
  46.1%
282
  47.8%
418
  47.2%
current smoker   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 589 participants 883 participants
120
  40.8%
287
  48.7%
407
  46.1%
[1]
Measure Analysis Population Description: information about smoking missing for few patients
Hypercholesterolemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
95
  32.2%
176
  29.8%
271
  30.6%
Family history of premature coronary artery disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 590 participants 884 participants
103
  35.0%
223
  37.8%
326
  36.9%
[1]
Measure Analysis Population Description: information missing for 1 patient
Previous stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
10
   3.4%
26
   4.4%
36
   4.1%
Previous Myocardial Infarction  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
22
   7.5%
48
   8.1%
70
   7.9%
Previous PCI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
25
   8.5%
44
   7.5%
69
   7.8%
Renal Impairment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
3
   1.0%
7
   1.2%
10
   1.1%
Peripheral vessel disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
10
   3.4%
23
   3.9%
33
   3.7%
Location of infarct - Posterior  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
53
  18.0%
96
  16.3%
149
  16.8%
Location of infarct - Anterior  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
105
  35.6%
206
  34.9%
311
  35.1%
Location of infarct - Inferior  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
149
  50.5%
307
  52.0%
456
  51.5%
Location of infarct - Lateral  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
41
  13.9%
86
  14.6%
127
  14.4%
Location of infarct - impossible to determine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
3
   1.0%
4
   0.7%
7
   0.8%
Time from symptom onset to primary PCI < 6 hr  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
225
  76.3%
462
  78.3%
687
  77.6%
Time from symptom onset to primary PCI 6-12 hr  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
47
  15.9%
84
  14.2%
131
  14.8%
Time from symptom onset to primary PCI >12 hr  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
23
   7.8%
44
   7.5%
67
   7.6%
Nr. of arteries with stenosis 2  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
204
  69.2%
396
  67.1%
600
  67.8%
Nr. of arteries with stenosis 3  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
91
  30.8%
194
  32.9%
285
  32.2%
Killip class >=2  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
15
   5.1%
30
   5.1%
45
   5.1%
Maximum creatinine kinase level  
Median (Full Range)
Unit of measure:  IU/liter
Number Analyzed 295 participants 590 participants 885 participants
1040
(102 to 8182)
1125
(112 to 11052)
1083
(102 to 11052)
Mean time for index procedure - min  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 295 participants 590 participants 885 participants
65  (31) 59  (28) 61  (29)
Mean volume of contract used during index PCI  
Mean (Standard Deviation)
Unit of measure:  Ml
Number Analyzed 295 participants 590 participants 885 participants
224  (104) 202  (75) 209  (86)
FFR procedure successful  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
292
  99.0%
575
  97.5%
867
  98.0%
Patients with lesions FFR<=0.80   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 575 participants 867 participants
158
  54.1%
275
  47.8%
433
  49.9%
[1]
Measure Analysis Population Description: FFR not performed in all patients
Patients with lesions FFR>0.80   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 575 participants 867 participants
134
  45.9%
300
  52.2%
434
  50.1%
[1]
Measure Analysis Population Description: FFR not performed in all patients
Mean FFR value   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 292 participants 590 participants 882 participants
0.78  (0.12) 0.79  (0.12) 0.78  (0.12)
[1]
Measure Analysis Population Description: FFR not performed in all patients
Patients with treated (FFR-guided) non-IRA lesions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
163
  55.3%
0
   0.0%
163
  18.4%
Patients with treated (FFR-guided) non-IRA lesions during index PCI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
136
  46.1%
0
   0.0%
136
  15.4%
Patients with treated (FFR-guided) non-IRA lesions delayed during index hospitalization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
27
   9.2%
0
   0.0%
27
   3.1%
Patients with treated (FFR-guided) non-IRA lesions - DES only  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
161
  54.6%
0
   0.0%
161
  18.2%
Patients with treated (FFR-guided) non-IRA lesions - bare metal stent only  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
1
   0.3%
0
   0.0%
1
   0.1%
Patients with treated (FFR-guided) non-IRA lesions - balloon dilatation only  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
1
   0.3%
0
   0.0%
1
   0.1%
Patients with treated (FFR-guided) non-IRA lesions - mean nr. of stents used per patient  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 295 participants 590 participants 885 participants
1.6  (0.9) 0  (0) 1.6  (0.9)
Patients with treated (FFR-guided) non-IRA lesions -mean length of stent  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 295 participants 590 participants 885 participants
34.3  (21.0) 0  (0) 34.3  (21.0)
Patients with treated (FFR-guided) non-IRA lesions - mean diameter of stent  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 295 participants 590 participants 885 participants
2.9  (0.4) 0  (0) 2.9  (0.4)
length of hospital stay  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 295 participants 590 participants 885 participants
4
(1 to 35)
4
(1 to 71)
4
(1 to 71)
Patients receiving predischarge noninvasive stress tests  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 590 participants 885 participants
21
   7.1%
71
  12.0%
92
  10.4%
1.Primary Outcome
Title Number of Participants With the Composite Endpoint of MACCE
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
23
   7.8%
121
  20.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.22 to 0.55
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Death From Any Cause
Hide Description Number of participants with all cause mortality at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.4%
10
   1.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.25 to 2.56
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Cardiac Death
Hide Description Number of participants with Cardiac mortality at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.0%
6
   1.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.25 to 4.01
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With Spontaneous MI
Hide Description Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
5
   1.7%
17
   2.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.22 to 1.13
Estimation Comments [Not Specified]
5.Primary Outcome
Title Number of Participants With Periprocedural MI
Hide Description Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
11
   1.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.22 to 1.59
Estimation Comments [Not Specified]
6.Primary Outcome
Title Number of Participants With Revascularization - PCI
Hide Description Number of participants with revascularization PCI at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
15
   5.1%
98
  16.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.24 to 0.57
Estimation Comments [Not Specified]
7.Primary Outcome
Title Number of Participants With Revascularization - CABG
Hide Description Number of participants with revascularization CABG at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.0%
5
   0.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FFR-guided Revascularisation Strategy, Randomised to Guidelines Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.29 to 5.02
Estimation Comments [Not Specified]
8.Primary Outcome
Title Number of Participants With Cerebrovascular Event
Hide Description Number of participants with Cerebrovascular event at 12 months between groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with STEMI and multivessel disease
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4
   0.7%
9.Secondary Outcome
Title Number of Participants With Composite Endpoint of NACE (Any First Event)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
25 174
10.Secondary Outcome
Title Number of Participants With Death From Any Cause or MI
Hide Description Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
11
   3.7%
38
   6.4%
11.Secondary Outcome
Title Number of Participants With Major Bleeding
Hide Description Number of participants with Major bleeding at 12 months - Part of composite NACE
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.0%
8
   1.4%
12.Secondary Outcome
Title Number of Participants With Any Bleeding at 12 Months
Hide Description Number of participants with any bleeding at 12 months - part of composite endpoint NACE
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
9
   3.1%
28
   4.7%
13.Secondary Outcome
Title Number of Participants With Any Bleeding at 48 Hours
Hide Description Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
5
   1.7%
8
   1.4%
14.Secondary Outcome
Title Number of Participants With Hospitalization
Hide Description Number of participants with hospitalization for heart failure, unstable angina or chest pain
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
13
   4.4%
47
   8.0%
15.Secondary Outcome
Title Number of Participants With Revascularization
Hide Description Number of participants with any revascularization-Part of composite endpoint NACE
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
19
   6.4%
161
  27.3%
16.Secondary Outcome
Title Number of Participants With Stent Thrombosis
Hide Description Number of participants with Stent Thrombosis - Part of composite endpoint NACE
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: 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
Hide Description Number of participants with Composite primary endpoint MACCE (any first event) at 3 year
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
46
  15.6%
178
  30.2%
18.Secondary Outcome
Title Number of Participants With All Cause Death at 3 Year
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
9
   3.1%
21
   3.6%
19.Secondary Outcome
Title Number of Participants With Cardiac Death at 3 Year
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
5
   1.7%
8
   1.4%
20.Secondary Outcome
Title Number of Participants With Spontaneous MI at 3 Year
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
17
   5.8%
40
   6.8%
21.Secondary Outcome
Title Number of Participants With Peri-procedural MI at 3 Year
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.0%
13
   2.2%
22.Secondary Outcome
Title Number of Participants With Urgent Revascularization at 3 Year
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
22
   7.5%
85
  14.4%
23.Secondary Outcome
Title Number of Participants With Elective Revascularization at 3 Year
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
15
   5.1%
64
  10.8%
24.Secondary Outcome
Title Number of Participants With Cerebrovascular Event
Hide Description Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
45
  15.3%
215
  36.4%
26.Secondary Outcome
Title Number of Participants With Death From Any Cause or MI
Hide Description Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 3 year
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
28
   9.5%
73
  12.4%
27.Secondary Outcome
Title Number of Participants With Major Bleeding at 3 Year
Hide Description Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.0%
8
   1.4%
28.Secondary Outcome
Title Number of Participants With Hospitalization
Hide Description Number of participants with Hospitalization for heart failure, unstable angina, MI
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
28
   9.5%
75
  12.7%
29.Secondary Outcome
Title Number of Participants With Hospitalization at 3 Year
Hide Description Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
30
  10.2%
87
  14.7%
30.Secondary Outcome
Title Number of Participants With Stent Thrombosis at 3 Year
Hide Description Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.4%
12
   2.0%
31.Secondary Outcome
Title Number of Participants With Any Bleeding at 3 Year
Hide Description Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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

Overall Number of Participants Analyzed 295 590
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.4%
12
   2.0%
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;
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR+ and PCI+ FFR+ and PCI-
Hide 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
Overall Number of Participants Analyzed 202 231
Measure Type: Count of Participants
Unit of Measure: Participants
35
  17.3%
90
  39.0%
33.Other Pre-specified Outcome
Title Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80
Hide Description Comparison of acute versus staged PCI treatment for lesions with FFR
Time Frame 3 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Treatment FFR+ Staged Treatement FFR+
Hide 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
Overall Number of Participants Analyzed 155 44
Measure Type: Count of Participants
Unit of Measure: Participants
25
  16.1%
10
  22.7%
34.Other Pre-specified Outcome
Title Comparison of PCI vs Medical Therapy in FFR Negative Lesions
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR- Lesions Treated With PCI FFR- Lesions Treated With Medical Therapy
Hide 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
Overall Number of Participants Analyzed 13 418
Measure Type: Count of Participants
Unit of Measure: Participants
6
  46.2%
91
  21.8%
35.Post-Hoc Outcome
Title Per Protocol Analysis - Occurence of MACCE at 3 Year
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FFR Guided Complete Revascularisation IRA Only Treatment
Hide Arm/Group Description:
Patients who underwent FFR guided complete revascularisation
Patients who underwent IRA only treatment
Overall Number of Participants Analyzed 328 550
Measure Type: Count of Participants
Unit of Measure: Participants
55
  16.8%
168
  30.5%
Time Frame 3 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Hide 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 (%) Affected / at Risk (%)
Total   9/295 (3.05%)      21/590 (3.56%)    
Hide Serious Adverse Events
FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/295 (31.19%)      308/590 (52.20%)    
Cardiac disorders     
Myocardial Infarction   20/295 (6.78%)  20 53/590 (8.98%)  53
PCI   34/295 (11.53%)  34 144/590 (24.41%)  144
Coronary Artery Bypass graft   3/295 (1.02%)  3 5/590 (0.85%)  5
Stent Thrombosis   4/295 (1.36%)  4 12/590 (2.03%)  12
Cardiac Hospitalisations   30/295 (10.17%)  30 87/590 (14.75%)  87
Vascular disorders     
Cerebrovascular event   1/295 (0.34%)  1 7/590 (1.19%)  7
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FFR-guided Revascularisation Strategy Randomised to Guidelines Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/295 (4.07%)      32/590 (5.42%)    
Blood and lymphatic system disorders     
any bleeding  [1]  12/295 (4.07%)  12 32/590 (5.42%)  32
Indicates events were collected by systematic assessment
[1]
any bleeding
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Pieter Smits
Organization: Maasstad Hospital
Phone: +31102913322
EMail: SmitsP@maasstadziekenhuis.nl
Layout table for additonal information
Responsible Party: Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01399736    
Other Study ID Numbers: Compare-Acute
First Submitted: July 20, 2011
First Posted: July 22, 2011
Results First Submitted: May 14, 2020
Results First Posted: July 23, 2020
Last Update Posted: August 11, 2020