Author + information
- Elvin Kedhi1,
- Balazs Berta2,
- Tomasz Roleder3,
- Alexander Ijsselmuiden4,
- Fernando Alfonso5,
- Javier Escaned6,
- Holger Nef7 and
- Wojtek Wojakowski8
- 1Isala Klinieken Zwolle, Zwolle, Netherlands
- 2Isala Hospital, Zwolle, Netherlands
- 3Third Division of Cardiology, Medical University of Silesia, Katowice, Poland
- 4Amphia, Breda, Netherlands
- 5Hospital Universitario de la Princesa, Madrid, Spain
- 6Hospital Clínico San Carlos, Madrid, Spain
- 7University of Giessen, Giessen, Germany
- 8Third Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
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. 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.
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 ≤0.80 who underwent complete revascularisation. In addition to TCFA identification, OCT analysis will record the presence of other traits of plaque vulnerability like: calcification nodules, thrombi, and neovascularization. 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.
The baseline data of the first 250 patients enrolled into the study will be presented.
COMBINE (OCT–FFR) is the prospective study to examine whether the addition of OCT plaque morphological evaluation to FFR hemodynamic assessment of intermediate lesions in DM patients will better predict MACE and possibly lead to new revascularisation strategies.
IMAGING: Vulnerable Plaque