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

Introduction

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.

Clinical investigators

Principal investigator is Elvin Kedhi MD, PhD Isala hospital, Zwolle, The Netherlands.

Participating centers are active in the following countries: The Netherlands, Luxembourg, Germany, Spain, Italy, Switzerland and Belgium. 

Clinical trial information

Trialregister.nl
Clinicaltrials.gov

Main publication

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.