Combine Intervene stands for: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Introduction
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 is a randomized international investigator-initiated trial to 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.
Sites and inclusion
The COMBINE-INTERVENE trial is designed to enroll 1222 patients worldwide. The first patient was enrolled on 16 March 2022 in Romania. The trial geography includes about 50-60 centers in Europe, Asia-Pacific and North America. Patients will be followed for 2 years.
Sponsor
Diagram B.V. is the sponsor of the trial.
Clinical investigator
Coordinating principal investigator: Prof. dr. E. Kedhi (Interventional cardiologist at Erasmus Academical Hospital, Université Libre de Bruxelles, Belgium and visiting professor at Silesian Medical University Katowice, Poland).