P5867COMBINE OCT and FFR assessment of non culprit lesions to better predict adverse event outcomes in diabetes mellitus patients. Rationale, design and initial OCT results

Abstract

Background: Fractional flow reserve (FFR) is a widely used tool for the identification of ischaemia-generating stenoses and to guide decisions on coronary revascularisation. However, the safety of FFR-based decisions in high-risk subsets, such as patients with Diabetes Mellitus (DM) or vulnerable stenoses presenting thin-cap fibro-atheroma (TCFA), is unknown. Purpose(s): This study will examine the impact of optical coherence tomography (OCT) plaque morphological assessment and the identification of TCFA, in combination with FFR to better predict clinical outcomes in DM patients. Method(s): COMBINE (OCT-FFR) is a prospective, multi-centre study 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, revascularized lesions (group C). The study 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 <0.01). Group A patients had smaller lipid arc as compared to group B patients (167+/-64 vs. 218+/-85; p=0.01), with a trend towards the less frequent presentation of cholesterol clefts [26 (48%) vs. 11 (73%); p=0.08]. There were no differences in the presence of thrombus [15 (27%) vs. 7 (47%); p=0.15], calcification nodules [19 (36%) vs. 4 (27%); p=0.51], and neovascularization [35 (64%) vs. 8 (53%); p=0.47] between group A and B. There were also no differences in the magnitude of calcium arc (176+/-91 vs. 138+/-107; p=0.28) between group A and B. Conclusion(s): First OCT analysis presented that FFR negative lesions pose traits of plaque vulnerability like a thin fibrous cap, neovascularization, ruptured caps, and calcification nodules. Some of these traits occur with the same frequency in thin- and thick fibrous cap atheromas. Further prospective patients examination will evaluate weather combine OCT-FFR assessment may help to predict MACE in non-ischemic lesions of diabetic patients.