At the Transcatheter Cardiovascular Therapeutics (TCT) congress the main results of the COMBINE trial have been presented by prof. Kedhi at the late breaking trial (LBT) Session on October 14, 2020.
According to the main results of the COMBINE trial, combined fractional flow reserve (FFR) and optical coherence tomography (OCT) can improve the accuracy of predicting adverse event outcomes in patients with diabetes mellitus (DM).
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 primary endpoint was a composite of cardiac death, target-lesion myocardial infarction (MI), clinically-driven target lesion revascularization or hospitalization due to unstable angina at 1.5 years between groups A and B.
COMBINE (OCT–FFR) showed for the first time that in DM patients:
- More than 25% of all FFR (-) lesions represent high-risk plaques (OCT-assessed TCFA)
- Presence of a high-risk plaque (TFCA) is a strong predictor of future MACE, despite lack of ischemia
- Patients with high-risk plaques (TCFAs) have a significant (HR 4.7) increase in target-lesion related MACE (and MI) as compared to patients without TCFA, already at 18 months
- Ischemia and future adverse events represent, to a large extent, two separate concepts