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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,223
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.
PCI revascularization strategy based FFR assessment (all lesions with FFR≤0.80 will be treated)
Cardiac death, any MI or any clinically driven revascularization at 24 months between FFR&OCT guided revascularization versus FFR-guided revascularization
Cardiac death, any MI or any clinically driven revascularization at 24 months between FFR\&OCT guided revascularization versus FFR-guided revascularization
Time frame: 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 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
Time frame: 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
Time frame: 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
Time frame: 24 months
Analysis of corelab-approved primary endpoints, as per protocol analysis
Analysis of corelab-approved primary endpoints, as per protocol analysis
Time frame: 24 months
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