COMBINE stands for: Combined Optical coherence tomography Morphologic and fractional flow reserve hemodynamic assessment of non-culprit lesions to better predict adverse event outcomes in diabetes mellitus patients
COMBINE (OCT–FFR) is a prospective, multi-centre trial investigating the natural history of DM patients with ≥1 angiographically intermediate target lesion in three subgroups of patients; patients with FFR negative lesions without TCFA (group A) and patients with FFR negative lesions with TCFA (group B) as detected by OCT and to compare these two groups with each other, as well as to a third group with FFR-positive, PCI-treated intermediate lesions (group C). The trial aims to enrol 500 patients.
The hypothesis is that DM patients with TCFA (group B) have a worse outcome than those without TCFA (group A) and also when compared to those patients with lesions FFR ≤0.80 who underwent complete revascularisation.
The primary endpoint is the incidence of target lesion major adverse cardiac events (MACE); a composite of cardiac death, myocardial infarction or rehospitalisation for unstable/progressive angina in group B vs. group A.
First patient was included by The Isala Hospital in Zwolle, The Netherlands, in March 2015.
Principal investigator is prof. Elvin Kedhi MD, PhD Hopital Erasme, Brussels, Belgium.
Participating centers are active in the following countries: The Netherlands, Ireland, Luxembourg, Germany, Spain, Italy, Switzerland, United Arab Emirates and Belgium.
Clinical trial information
Kennedy MV, Fabris E, Ijsselmuiden AJ et al. Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) prospective study. Rationale and design. Cardiovascular Diabetology 2016;15:144.
Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT–FFR trial. European Heart Journal, ehab433, published: 29 July 2021.