Multivessel Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
PCI FFR STEMI MVD, FFR guided PCI in acute STEMI patients with MVD
Brief summary
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only. Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina. Approximately 885 patients will be entered in the study. Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.
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
Interventions
PROCEDUREFFR-guided revascularisation strategy
FFR-guided revascularisation strategy
PROCEDURErandomised to guidelines group
Staged revascularisation by proven ischemia or persistence of symptoms of angina
Sponsors
Abbott Medical Devices
Maasstad Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in \< 12 h after the onset of symptoms\* and have at least one stenosis of \>50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator. * Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised
Exclusion criteria
1. Left main stem disease (stenosis \> 50%) 2. STEMI due to in-stent thrombosis 3. Chronic total occlusion of a non-IRA 4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery. 5. Non-IRA stenosis not amenable for PCI treatment (operators decision) 6. Complicated IRA treatment, with one or more of the following; * Extravasation, * Permanent no re-flow after IRA treatment (TIMI flow 0-1), * Inability to implant a stent 7. Known severe cardiac valve dysfunction that will require surgery in the follow-up period. 8. Killip class III or IV already at presentation or at the completion of culprit lesion treatment. 9. Life expectancy of \< 2 years. 10. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy. 11. Gastrointestinal or genitourinary bleeding within the prior 3 months, 12. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment. 13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 14. Pregnancy or planning to become pregnant any time after enrolment into this study. 15. Inability to obtain informed consent. 16. Expected lost to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cerebrovascular Event | 12 months | Number of participants with Cerebrovascular event at 12 months between groups |
| Number of Participants With Revascularization - PCI | 12 months | Number of participants with revascularization PCI at 12 months between groups |
| Number of Participants With Revascularization - CABG | 12 months | Number of participants with revascularization CABG at 12 months between groups |
| Number of Participants With the Composite Endpoint of MACCE | 12 months | Number of participants with the composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups |
| Number of Participants With Death From Any Cause | 12 months | Number of participants with all cause mortality at 12 months between groups |
| Number of Participants With Cardiac Death | 12 months | Number of participants with Cardiac mortality at 12 months between groups |
| Number of Participants With Spontaneous MI | 12 months | Number of participants with Spontaneous Myocardial Infarction at 12 months between groups |
| Number of Participants With Periprocedural MI | 12 months | Number of participants with Periprocedural Myocardial Infarction at 12 months between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent Thrombosis | 12 months | Number of participants with Stent Thrombosis - Part of composite endpoint NACE |
| Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year | 3 year | Number of participants with Composite primary endpoint MACCE (any first event) at 3 year |
| Number of Participants With All Cause Death at 3 Year | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year - all cause death |
| Number of Participants With Cardiac Death at 3 Year | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year - Cardiac death |
| Number of Participants With Spontaneous MI at 3 Year | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year - Spontaneous MI |
| Number of Participants With Peri-procedural MI at 3 Year | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year - Peri-procedural MI |
| Number of Participants With Elective Revascularization at 3 Year | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year -elective revascularisation |
| Number of Participants With Cerebrovascular Event | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event |
| Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year | 3 years | Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 3 year (NACE i.e. Net Adverse Clinical Events) |
| Number of Participants With Major Bleeding at 3 Year | 3 year | Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year |
| Number of Participants With Hospitalization at 3 Year | 3 year | Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain |
| Number of Participants With Stent Thrombosis at 3 Year | 3 year | Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE |
| Number of Participants With Any Bleeding at 3 Year | 3 year | Number of participants with any bleeding at 3 year - Part of composite endpoint NACE |
| Number of Participants With Urgent Revascularization at 3 Year | 3 year | Number of participants with Composite endpoint MACCE (any first event) at 3 year - urgent revascularisation |
| Number of Participants With Composite Endpoint of NACE (Any First Event) | 12 months | Number of participants with Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events) |
| Number of Participants With Death From Any Cause or MI | 12 months | Number of participants with Part of composite NACE-Death from any cause or Myocardial Infarction at 12 months |
| Number of Participants With Major Bleeding | 12 months | Number of participants with Major bleeding at 12 months - Part of composite NACE |
| Number of Participants With Any Bleeding at 12 Months | 12 months | Number of participants with any bleeding at 12 months - part of composite endpoint NACE |
| Number of Participants With Any Bleeding at 48 Hours | 48 hours | Number of participants with any bleeding at 48 hours - part of composite endpoint NACE |
| Number of Participants With Hospitalization | 12 months | Number of participants with hospitalization for heart failure, unstable angina or chest pain |
| Number of Participants With Revascularization | 12 months | Number of participants with any revascularization-Part of composite endpoint NACE |
Other
| Measure | Time frame | Description |
|---|---|---|
| A Comparison of the Number of Patients in Both Groups With Treated Lesions With FFR ≤ 0.80 Versus Patients With Untreated Lesions With FFR ≤ 0.80; | 3 year | FFR+/PCI+ vs FFR+/PCI- Comparison of patients having FFR positive lesions that underwent revascularization during index procedure or in staged procedures within 45 days (groups A+C, n=202 patients) with patients having FFR positive lesions that did not undergo revascularization (group D, n=231 patients), |
| Comparison of PCI vs Medical Therapy in FFR Negative Lesions | 3 year | comparison of patients receiving staged PCI treatment of FFR-negative lesions in the non-IRA (decision made by referring physician who was blinded to FFR results) and patients receiving medical therapy for FFR-negative lesions in the non-IRA |
| Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80 | 3 year | Comparison of acute versus staged PCI treatment for lesions with FFR |
Countries
Czechia, Germany, Hungary, Netherlands, Norway, Poland, Singapore, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 295 |
| 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 | 590 |
| Total | 885 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Randomised to Guidelines Group | Total | FFR-guided Revascularisation Strategy |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 10 | 62 years STANDARD_DEVIATION 10 | 62 years STANDARD_DEVIATION 10 |
| BMI | 27.1 kg/m^2 | 27.1 kg/m^2 | 27.2 kg/m^2 |
| current smoker | 287 Participants | 407 Participants | 120 Participants |
| Diabetes Mellitus | 94 Participants | 137 Participants | 43 Participants |
| Family history of premature coronary artery disease | 223 Participants | 326 Participants | 103 Participants |
| FFR procedure successful | 575 Participants | 867 Participants | 292 Participants |
| Hypercholesterolemia | 176 Participants | 271 Participants | 95 Participants |
| Hypertension | 282 Participants | 418 Participants | 136 Participants |
| Killip class >=2 | 30 Participants | 45 Participants | 15 Participants |
| length of hospital stay | 4 days | 4 days | 4 days |
| Location of infarct - Anterior | 206 Participants | 311 Participants | 105 Participants |
| Location of infarct - impossible to determine | 4 Participants | 7 Participants | 3 Participants |
| Location of infarct - Inferior | 307 Participants | 456 Participants | 149 Participants |
| Location of infarct - Lateral | 86 Participants | 127 Participants | 41 Participants |
| Location of infarct - Posterior | 96 Participants | 149 Participants | 53 Participants |
| Maximum creatinine kinase level | 1125 IU/liter | 1083 IU/liter | 1040 IU/liter |
| Mean FFR value | 0.79 Ratio STANDARD_DEVIATION 0.12 | 0.78 Ratio STANDARD_DEVIATION 0.12 | 0.78 Ratio STANDARD_DEVIATION 0.12 |
| Mean time for index procedure - min | 59 minutes STANDARD_DEVIATION 28 | 61 minutes STANDARD_DEVIATION 29 | 65 minutes STANDARD_DEVIATION 31 |
| Mean volume of contract used during index PCI | 202 ml STANDARD_DEVIATION 75 | 209 ml STANDARD_DEVIATION 86 | 224 ml STANDARD_DEVIATION 104 |
| Nr. of arteries with stenosis 2 | 396 Participants | 600 Participants | 204 Participants |
| Nr. of arteries with stenosis 3 | 194 Participants | 285 Participants | 91 Participants |
| Patients receiving predischarge noninvasive stress tests | 71 Participants | 92 Participants | 21 Participants |
| Patients with lesions FFR<=0.80 | 275 Participants | 433 Participants | 158 Participants |
| Patients with lesions FFR>0.80 | 300 Participants | 434 Participants | 134 Participants |
| Patients with treated (FFR-guided) non-IRA lesions | 0 Participants | 163 Participants | 163 Participants |
| Patients with treated (FFR-guided) non-IRA lesions - balloon dilatation only | 0 Participants | 1 Participants | 1 Participants |
| Patients with treated (FFR-guided) non-IRA lesions - bare metal stent only | 0 Participants | 1 Participants | 1 Participants |
| Patients with treated (FFR-guided) non-IRA lesions delayed during index hospitalization | 0 Participants | 27 Participants | 27 Participants |
| Patients with treated (FFR-guided) non-IRA lesions - DES only | 0 Participants | 161 Participants | 161 Participants |
| Patients with treated (FFR-guided) non-IRA lesions during index PCI | 0 Participants | 136 Participants | 136 Participants |
| Patients with treated (FFR-guided) non-IRA lesions - mean diameter of stent | 0 mm STANDARD_DEVIATION 0 | 2.9 mm STANDARD_DEVIATION 0.4 | 2.9 mm STANDARD_DEVIATION 0.4 |
| Patients with treated (FFR-guided) non-IRA lesions -mean length of stent | 0 mm STANDARD_DEVIATION 0 | 34.3 mm STANDARD_DEVIATION 21 | 34.3 mm STANDARD_DEVIATION 21 |
| Patients with treated (FFR-guided) non-IRA lesions - mean nr. of stents used per patient | 0 mm STANDARD_DEVIATION 0 | 1.6 mm STANDARD_DEVIATION 0.9 | 1.6 mm STANDARD_DEVIATION 0.9 |
| Peripheral vessel disease | 23 Participants | 33 Participants | 10 Participants |
| Previous Myocardial Infarction | 48 Participants | 70 Participants | 22 Participants |
| Previous PCI | 44 Participants | 69 Participants | 25 Participants |
| Previous stroke | 26 Participants | 36 Participants | 10 Participants |
| Race/Ethnicity, Customized other races | 44 Participants | 76 Participants | 32 Participants |
| Race/Ethnicity, Customized white race | 545 Participants | 808 Participants | 263 Participants |
| Renal Impairment | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Female | 140 Participants | 202 Participants | 62 Participants |
| Sex: Female, Male Male | 450 Participants | 683 Participants | 233 Participants |
| Time from symptom onset to primary PCI >12 hr | 44 Participants | 67 Participants | 23 Participants |
| Time from symptom onset to primary PCI 6-12 hr | 84 Participants | 131 Participants | 47 Participants |
| Time from symptom onset to primary PCI < 6 hr | 462 Participants | 687 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 295 | 21 / 590 |
| other Total, other adverse events | 12 / 295 | 32 / 590 |
| serious Total, serious adverse events | 92 / 295 | 308 / 590 |
Outcome results
Primary
Number of Participants With Cardiac Death
Number of participants with Cardiac mortality at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Cardiac Death | 3 Participants |
| Randomised to Guidelines Group | Number of Participants With Cardiac Death | 6 Participants |
p-value: 195% CI: [0.25, 4.01]Chi-squared
Primary
Number of Participants With Cerebrovascular Event
Number of participants with Cerebrovascular event at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Cerebrovascular Event | 0 Participants |
| Randomised to Guidelines Group | Number of Participants With Cerebrovascular Event | 4 Participants |
Primary
Number of Participants With Death From Any Cause
Number of participants with all cause mortality at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Death From Any Cause | 4 Participants |
| Randomised to Guidelines Group | Number of Participants With Death From Any Cause | 10 Participants |
p-value: 0.795% CI: [0.25, 2.56]Chi-squared
Primary
Number of Participants With Periprocedural MI
Number of participants with Periprocedural Myocardial Infarction at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Periprocedural MI | 2 Participants |
| Randomised to Guidelines Group | Number of Participants With Periprocedural MI | 11 Participants |
p-value: 0.2995% CI: [0.22, 1.59]Chi-squared
Primary
Number of Participants With Revascularization - CABG
Number of participants with revascularization CABG at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Revascularization - CABG | 3 Participants |
| Randomised to Guidelines Group | Number of Participants With Revascularization - CABG | 5 Participants |
p-value: 0.895% CI: [0.29, 5.02]Chi-squared
Primary
Number of Participants With Revascularization - PCI
Number of participants with revascularization PCI at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Revascularization - PCI | 15 Participants |
| Randomised to Guidelines Group | Number of Participants With Revascularization - PCI | 98 Participants |
p-value: <0.00195% CI: [0.24, 0.57]Chi-squared
Primary
Number of Participants With Spontaneous MI
Number of participants with Spontaneous Myocardial Infarction at 12 months between groups
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Spontaneous MI | 5 Participants |
| Randomised to Guidelines Group | Number of Participants With Spontaneous MI | 17 Participants |
p-value: 0.195% CI: [0.22, 1.13]Chi-squared
Primary
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
Time frame: 12 months
Population: Patients with STEMI and multivessel disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With the Composite Endpoint of MACCE | 23 Participants |
| Randomised to Guidelines Group | Number of Participants With the Composite Endpoint of MACCE | 121 Participants |
p-value: <0.00195% CI: [0.22, 0.55]Chi-squared
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With All Cause Death at 3 Year | 9 Participants |
| Randomised to Guidelines Group | Number of Participants With All Cause Death at 3 Year | 21 Participants |
Secondary
Number of Participants With Any Bleeding at 12 Months
Number of participants with any bleeding at 12 months - part of composite endpoint NACE
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Any Bleeding at 12 Months | 9 Participants |
| Randomised to Guidelines Group | Number of Participants With Any Bleeding at 12 Months | 28 Participants |
Secondary
Number of Participants With Any Bleeding at 3 Year
Number of participants with any bleeding at 3 year - Part of composite endpoint NACE
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Any Bleeding at 3 Year | 4 Participants |
| Randomised to Guidelines Group | Number of Participants With Any Bleeding at 3 Year | 12 Participants |
Secondary
Number of Participants With Any Bleeding at 48 Hours
Number of participants with any bleeding at 48 hours - part of composite endpoint NACE
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Any Bleeding at 48 Hours | 5 Participants |
| Randomised to Guidelines Group | Number of Participants With Any Bleeding at 48 Hours | 8 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Cardiac Death at 3 Year | 5 Participants |
| Randomised to Guidelines Group | Number of Participants With Cardiac Death at 3 Year | 8 Participants |
Secondary
Number of Participants With Cerebrovascular Event
Number of participants with Composite endpoint MACCE (any first event) at 3 year -Cerebrovascular event
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Cerebrovascular Event | 1 Participants |
| Randomised to Guidelines Group | Number of Participants With Cerebrovascular Event | 7 Participants |
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)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Composite Endpoint of NACE (Any First Event) | 25 Participants |
| Randomised to Guidelines Group | Number of Participants With Composite Endpoint of NACE (Any First Event) | 174 Participants |
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)
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year | 45 Participants |
| Randomised to Guidelines Group | Number of Participants With Composite Endpoint of NACE (Any First Event) at 3 Year | 215 Participants |
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Death From Any Cause or MI | 11 Participants |
| Randomised to Guidelines Group | Number of Participants With Death From Any Cause or MI | 38 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Death From Any Cause or MI | 28 Participants |
| Randomised to Guidelines Group | Number of Participants With Death From Any Cause or MI | 73 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Elective Revascularization at 3 Year | 15 Participants |
| Randomised to Guidelines Group | Number of Participants With Elective Revascularization at 3 Year | 64 Participants |
Secondary
Number of Participants With Hospitalization
Number of participants with hospitalization for heart failure, unstable angina or chest pain
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Hospitalization | 13 Participants |
| Randomised to Guidelines Group | Number of Participants With Hospitalization | 47 Participants |
Secondary
Number of Participants With Hospitalization
Number of participants with Hospitalization for heart failure, unstable angina, MI
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Hospitalization | 28 Participants |
| Randomised to Guidelines Group | Number of Participants With Hospitalization | 75 Participants |
Secondary
Number of Participants With Hospitalization at 3 Year
Number of participants with Hospitalization for heart failure, unstable angina, MI and/or chest pain
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Hospitalization at 3 Year | 30 Participants |
| Randomised to Guidelines Group | Number of Participants With Hospitalization at 3 Year | 87 Participants |
Secondary
Number of Participants With Major Bleeding
Number of participants with Major bleeding at 12 months - Part of composite NACE
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Major Bleeding | 3 Participants |
| Randomised to Guidelines Group | Number of Participants With Major Bleeding | 8 Participants |
Secondary
Number of Participants With Major Bleeding at 3 Year
Number of participants with Part of composite endpoint NACE- Major bleeding at 3 year
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Major Bleeding at 3 Year | 3 Participants |
| Randomised to Guidelines Group | Number of Participants With Major Bleeding at 3 Year | 8 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Peri-procedural MI at 3 Year | 3 Participants |
| Randomised to Guidelines Group | Number of Participants With Peri-procedural MI at 3 Year | 13 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year | 46 Participants |
| Randomised to Guidelines Group | Number of Participants With Primary Endpoint Outcome MACCE (Any First Event) at 3 Year | 178 Participants |
Secondary
Number of Participants With Revascularization
Number of participants with any revascularization-Part of composite endpoint NACE
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Revascularization | 19 Participants |
| Randomised to Guidelines Group | Number of Participants With Revascularization | 161 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Spontaneous MI at 3 Year | 17 Participants |
| Randomised to Guidelines Group | Number of Participants With Spontaneous MI at 3 Year | 40 Participants |
Secondary
Number of Participants With Stent Thrombosis
Number of participants with Stent Thrombosis - Part of composite endpoint NACE
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Stent Thrombosis | 2 Participants |
| Randomised to Guidelines Group | Number of Participants With Stent Thrombosis | 1 Participants |
Secondary
Number of Participants With Stent Thrombosis at 3 Year
Number of participants with Stent Thrombosis at 3 year - Part of composite endpoint NACE
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Stent Thrombosis at 3 Year | 4 Participants |
| Randomised to Guidelines Group | Number of Participants With Stent Thrombosis at 3 Year | 12 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Number of Participants With Urgent Revascularization at 3 Year | 22 Participants |
| Randomised to Guidelines Group | Number of Participants With Urgent Revascularization at 3 Year | 85 Participants |
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),
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | 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; | 35 Participants |
| Randomised to Guidelines Group | 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; | 90 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80 | 25 Participants |
| Randomised to Guidelines Group | Comparison of Acute Versus Staged PCI for Lesions With FFR ≤ 0.80 | 10 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Comparison of PCI vs Medical Therapy in FFR Negative Lesions | 6 Participants |
| Randomised to Guidelines Group | Comparison of PCI vs Medical Therapy in FFR Negative Lesions | 91 Participants |
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
Time frame: 3 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFR-guided Revascularisation Strategy | Per Protocol Analysis - Occurence of MACCE at 3 Year | 55 Participants |
| Randomised to Guidelines Group | Per Protocol Analysis - Occurence of MACCE at 3 Year | 168 Participants |