Heart Diseases, Cardiovascular Diseases, 3 Vessel Coronary Artery Disease
Conditions
Keywords
SYNTAX II Score, Pressure wires, instantaneous wave-free ratio, fractional flow reserve, intravascular ultrasound, Drug eluting stents, Stents, Angioplasty, multi slice computed tomography
Brief summary
Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)
Detailed description
The purpose of the SYNTAX II Trial is to investigate the management of de-novo 3-vessel-disease in order to prospectively assess which patients would have at least comparable short and long term clinical outcomes between coronary artery bypass graft and percutaneous coronary intervention (PCI), using contemporary PCI practice. In SYNTAX II the effectiveness of a contemporary stent (designed with thinner struts, biocompatible and biodegradable polymer, and a limus based drug), the use of pressure wire assessment of lesions to allow for ischemia-driven revascularisation, intravascular ultrasound (IVUS) guidance to optimise drug eluting stent deployment, and the treatment of (chronic) total occlusion lesions with contemporary techniques, will be compared against PCI practice in the original SYNTAX trial. The proposed study would involve the SYNTAX Score II to prospectively recruit subjects on the grounds of patient safety
Interventions
DEVICECoronary stent
RADIATIONMulti Slice Computed Tomography
A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
DEVICEinstantaneous wave-free ratio
Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
DEVICEFractional flow reserve
Pressure-derived index on physiological assessment of stenosis severity
DEVICEIntravascular Ultrasound
Allows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, visualizing the inner wall of blood vessels
Sponsors
Boston Scientific Corporation
Volcano Corporation
ECRI bv
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. These are left descending coronary artery (LAD) and or side branch, proximal circumflex coronary artery (LCX) and or side branch, right descending coronary artery (RCA) and or side branch which are supplying viable myocardium without left main involvement. Patients with ostial LAD or ostial CX Medina 0,0,1 or Medina 0,1,0 may be enrolled * Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and CX territories may be included in the trial as a 3 vessel disease equivalent * Vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram * Patients with 1. stable (Canadian Cardiovascular Society Class 1, 2, 3 or 4) angina pectoris 2. or unstable (Braunwald class) angina pectoris and ischemia 3. or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography * All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II * Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site * Signed Heart Team Decision Form between local cardiologist and surgeon that the selected case meets all of the inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 1 year | MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Death | 1 Year | All-cause death |
| Number of Participants With Stroke | 1 Year | Stroke |
| Number of Participants With Myocardial Infarction | 1 year | Any myocardial infarction |
| Number of Participants With All-cause Death, Stroke, or Myocardial Infarction | 1 Year | Safety endpoint |
| Number of Participants With Definite Stent Thrombosis | 1 Year | Stent Thrombosis - according to ARC definitions. Definite ST can be confirmed with 1) angiography (the presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI); Non-occlusive thrombus or Occlusive thrombus; or 2) Pathological confirmation (evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy). |
| Number of Participants With Probable Stent Thrombosis | 1 year | Stent Thrombosis - according to ARC definitions. Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: 1) Any unexplained death within the first 30 days; 2) Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. |
| Number of Participants With Revascularization | 1 Years | Any coronary revascularization |
Countries
Netherlands, Poland, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Coronary Intervention All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%). | 454 |
| Total | 454 |
Baseline characteristics
| Characteristic | Percutaneous Coronary Intervention | — |
|---|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 9.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Netherlands | 36 participants | — |
| Region of Enrollment Poland | 38 participants | — |
| Region of Enrollment Spain | 150 participants | — |
| Region of Enrollment United Kingdom | 230 participants | — |
| Sex: Female, Male Female | 31 Participants | — |
| Sex: Female, Male Male | 423 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 36 / 454 |
| other Total, other adverse events | 0 / 454 |
| serious Total, serious adverse events | 125 / 454 |
Outcome results
Primary
Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
Time frame: 1 year
Population: All patients enrolled in the SYNTAX II single-arm study were compared with a historical cohort selected from the SYNTAX I PCI arm (NCT00114972). Patients had three-vessel disease at presentation and qualified to enter the study based on equipoise to undergo either PCI or CABG according to the SYNTAX score II calculator (www.syntaxscore.org).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 47 Participants |
| Pre-defined SYNTAX I PCI Cohort | Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 54 Participants |
Secondary
Number of Participants With All-cause Death
All-cause death
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With All-cause Death | 9 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With All-cause Death | 9 Participants |
Secondary
Number of Participants With All-cause Death, Stroke, or Myocardial Infarction
Safety endpoint
Time frame: 1 Year
Population: SYNTAX II PCI cohort vs. SYNTAX I PCI selected cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With All-cause Death, Stroke, or Myocardial Infarction | 17 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With All-cause Death, Stroke, or Myocardial Infarction | 20 Participants |
Secondary
Number of Participants With Definite Stent Thrombosis
Stent Thrombosis - according to ARC definitions. Definite ST can be confirmed with 1) angiography (the presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI); Non-occlusive thrombus or Occlusive thrombus; or 2) Pathological confirmation (evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy).
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With Definite Stent Thrombosis | 3 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With Definite Stent Thrombosis | 8 Participants |
Secondary
Number of Participants With Myocardial Infarction
Any myocardial infarction
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With Myocardial Infarction | 6 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With Myocardial Infarction | 15 Participants |
Secondary
Number of Participants With Probable Stent Thrombosis
Stent Thrombosis - according to ARC definitions. Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: 1) Any unexplained death within the first 30 days; 2) Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With Probable Stent Thrombosis | 1 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With Probable Stent Thrombosis | 0 Participants |
Secondary
Number of Participants With Revascularization
Any coronary revascularization
Time frame: 1 Years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With Revascularization | 36 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With Revascularization | 42 Participants |
Secondary
Number of Participants With Stroke
Stroke
Time frame: 1 Year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYNTAX II PCI Strategy Arm | Number of Participants With Stroke | 2 Participants |
| Pre-defined SYNTAX I PCI Cohort | Number of Participants With Stroke | 2 Participants |