Coronary Artery Disease, Ischemia, Multivessel Coronary Artery Disease, Vulnerable Plaque
Conditions
Brief summary
The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.
Detailed description
The published COMBINE trial shows that patients carrying an OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia. The most important finding of this trial is that not ischemia, but underlying lesion morphology could be the most important factor that predicts future adverse events. Together with the recently published ISCHEMIA trial, where ischemia guided revascularization failed to improve clinical outcomes compared to medical treatment, the COMBINE trial leads to a new way of thinking in interventional cardiology and also opens the door for new treatment strategies where a combined ischemic and morphologic assessment could lead to better clinical outcomes. The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation. The COMBINE-INTERVENE Trial is the first in line trial that will test focal percutaneous stenting for vulnerable plaque lesions independently from ischemia.
Interventions
PROCEDUREPCI revascularization strategy based on combined FFR and OCT assessment
PCI revascularization strategy based on combined FFR and OCT assessment All FFR ≤ 0.75 and Vulnerable plaque will be treated. VP defined as TCFA ( cap thickness ≤ 75 micron); Ruptured plaque; or Plaque erosion with \> 70 % AS or MLA \< 2.5 mm2.
PROCEDUREPCI revascularization strategy based FFR assessment
PCI revascularization strategy based FFR assessment (all lesions with FFR≤0.80 will be treated)
Sponsors
Diagram B.V.
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single blind
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing PCI, aged 30-80 years with any clinical presentation 2. Angiographic criteria: presence of ≥ 2 de novo target lesions\* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision) Angiographic criteria target lesion\* (all criteria I-IV should be applicable): I. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation) \*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.
Exclusion criteria
1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision) 2. Lesion located in a grafted segment or in a vein graft 3. In-stent restenosis lesions 4. Left main trifurcation 5. Left main lesion stand-alone (without other lesions) 6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous) 7. Chronic total occlusion 8. Spontaneous coronary dissection 9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years 10. Patients with left ventricle (LV) function less than 30% 11. Renal insufficiency (Glomerular Filtration Rate (GFR) \< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5) 12. Life expectancy less than 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death, any MI or any clinically driven revascularization at 24 months between FFR&OCT guided revascularization versus FFR-guided revascularization | 24 months | Cardiac death, any MI or any clinically driven revascularization at 24 months between FFR\&OCT guided revascularization versus FFR-guided revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events occurring from medically treated lesions with a FFR between 0.76-0.80 in the experimental arm | 24 months | Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events occurring from medically treated lesions with a FFR between 0.76-0.80 in the experimental arm |
| Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months | 24 months | Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months |
| Cardiac death, any spontaneous MI or any clinically driven revascularization at 24 months | 24 months | Cardiac death, any spontaneous MI or any clinically driven revascularization at 24 months |
| Analysis of corelab-approved primary endpoints, as per protocol analysis | 24 months | Analysis of corelab-approved primary endpoints, as per protocol analysis |
Countries
Australia, Canada, Denmark, Estonia, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, Taiwan
Contacts
PRINCIPAL_INVESTIGATORElvin Kedhi, Prof.dr.
Professor of Medicine McGill University; Director Intervention Cardiology, McGill University Health Center, Canada; Visiting Professor, Silesian Medical University Katowice, Poland
Outcome results
None listed