Coronary Stenosis
Conditions
Keywords
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Left Main Bifurcation
Brief summary
The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a real world left-main bifurcation population and as compared with a prespecified performance goal.
Interventions
DEVICEBiOSS LIM C
The BiOSS LIM C (Bifurcation Optimization Stent System, Balton, Warsaw, Poland). The BiOSS LIM C is a dedicated bifurcation stent covered with a mixture of a biodegradable polymer and the antiproliferative substance sirolimus. BiOSS LIM C will be used for treatment of the Left-Main bifurcation, according to its instructions for use. The Alex-Plus cobaltchromium sirolimus eluting stent (Balton, Warsaw, Poland) will be used for treatment of distal left-main side branches according to its instructions for use (i.e. proximal segments of the left anterior descending and left circumflex arteries as well as the ramus intermedius if the latter vessel is part of a trifurcation). All other lesions (other than left-main bifurcations) will be treated with XIENCE family everolimus-eluting coronary stent systems.
Sponsors
Cardialysis BV
Balton Sp.zo.o.
ECRI bv
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has distal unprotected Left-Main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥50% requiring revascularization. * Left-Main Medina classification 100, 110, 101, 011, 010, 111 * Clinical and anatomic eligibility for PCI as agreed by the local Heart Team including anatomic SYNTAX Score (\<33). * Distal left main reference vessel diameter ≥3.0 mm and ≤5.5 mm. All target lesions must be located in a native coronary artery. * Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values * Able to understand and provide informed consent and comply with all study procedures including follow-up
Exclusion criteria
* Prior PCI of the left main bifurcation at any time prior to enrollment * Currently participating in another trial and not yet at its primary endpoint. * Prior PCI of any other (non left main bifurcation) coronary artery lesion within 6 months (\<6 months) prior to enrollment. * Left-Main Medina classification 001. * Any segment of the left main bifurcation (distal left main, ostial Left Anterior Descending Artery (LAD) or ostial Left Circumflex Artery (LCX) presenting with a chronic total occlusion, or containing a visible thrombus. * Excessive angulation of the left main bifurcation (i.e. an angulation \>90° between proximal LAD and proximal LCX) * Direct stenting of the left main bifurcation * Prior Coronary Artery Bypass Surgery (CABG) at any time prior to enrollment * Patient requiring or may require additional surgery (cardiac or non-cardiac) within one year * Ongoing myocardial infarction or recent myocardial infarction with cardiac biomarker levels still elevated. * Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30mL/min, or patient on dialysis). * Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor. * Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 12 months. * Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential). * Concurrent medical condition with a life expectancy of less than 12 months. * The patient is unwilling/not able to return for outpatient clinic at 12 month follow-up. * Currently participating in another trial and not yet at its primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC). | 12 months | POCE defined as a composite measure of: All-cause mortality, Stroke (Modified Ranking Scale (mRS) ≥1), Any Myocardial infarction (MI) (includes non target vessel territory), Any unplanned revascularization for ischemia (includes all target and nontarget vessels). OPC based on data collected in Excel-study. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure | 12 months | Target Vessel Failure is defined as the composite of cardiac death, target vessel MI, and clinically indicated target vessel revascularization |
| Target Lesion Failure | 12 months | Target Lesion Failure is defined as a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization |
| Mortality | 12 months | Occurrence of death of any cause |
| Patient-oriented Composite Endpoint (PoCE) | 12 months | PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization |
| Myocardial Infarction | 12 months | Occurrence of myocardial infarction |
| Revascularization | 12 months | Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting) |
| Stent Thrombosis | 12 months | Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium |
| Stroke | 12 months | Occurrence of stroke (with a modified Rankin Scale \>=1) |
Countries
France, Italy, Poland
Participant flow
Recruitment details
The protocol aimed for 260 patients; 130 were enrolled in 14 interventional cardiology centers in Europe: Poland (8), Italy (2), and France (4). The last patient enrolled signed the informed consent on April 15th 2020, and underwent the index procedure on April 16th 2020. The last 12-month follow-up visit took place on 15 April 2021.
Participants by arm
| Arm | Count |
|---|---|
| BiOSS LIM C The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Missed visit | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | BiOSS LIM C |
|---|---|
| Age, Continuous | 67.7 Years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 103 Participants |
| Syntax Score | 19.5 Scores on a scale STANDARD_DEVIATION 8.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 130 |
| other Total, other adverse events | 0 / 130 |
| serious Total, serious adverse events | 43 / 130 |
Outcome results
Primary
Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC).
POCE defined as a composite measure of: All-cause mortality, Stroke (Modified Ranking Scale (mRS) ≥1), Any Myocardial infarction (MI) (includes non target vessel territory), Any unplanned revascularization for ischemia (includes all target and nontarget vessels). OPC based on data collected in Excel-study. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease.
Time frame: 12 months
Population: Intention-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC). | 38.0 Percentage of participants |
Secondary
Mortality
Occurrence of death of any cause
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Mortality | 1.6 Percentage of participants |
Secondary
Myocardial Infarction
Occurrence of myocardial infarction
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Myocardial Infarction | 19.0 Percentage of participants |
Secondary
Patient-oriented Composite Endpoint (PoCE)
PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Patient-oriented Composite Endpoint (PoCE) | 38.0 Percentage of participants |
Secondary
Revascularization
Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting)
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Revascularization | 20.3 Percentage of participants |
Secondary
Stent Thrombosis
Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium
Time frame: 12 months
Population: Intention-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Stent Thrombosis | 0.8 Percentage of participants |
Secondary
Stroke
Occurrence of stroke (with a modified Rankin Scale \>=1)
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Stroke | 1.6 Percentage of participants |
Secondary
Target Lesion Failure
Target Lesion Failure is defined as a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Target Lesion Failure | 27.7 Percentage of participants |
Secondary
Target Vessel Failure
Target Vessel Failure is defined as the composite of cardiac death, target vessel MI, and clinically indicated target vessel revascularization
Time frame: 12 months
Population: Intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BiOSS LIM C Arm | Target Vessel Failure | 28.5 Percentage of participants |