The use of fractional flow reserve (FFR) combined with optical coherence tomography (OCT) improves the accuracy of high-risk lesion identification in diabetic patients, a new study indicates.
Presented at Transcatheter Cardiovascular Therapeutics (TCT 2020), the COMBINE (OCT-FFR) trial was a prospective international natural history study that included 483 patients with stable or acute coronary syndromes and diabetes mellitus who were undergoing angiography who had one or more non-culprit lesions with a 40% to 80% diameter stenosis. Depending on the presence of thin cap fibroatheromas (TCFAs), patients were separated into either TCFA negative (Group A) or TCFA positive (Group B) groups. Those with target lesions with FFR <0.80 were revascularized (Group C). The primary endpoint was the incidence of target lesion-related major adverse cardiovascular events (MACE) defined as cardiac death, target vessel myocardial infarction, clinically-driven target lesion revascularization, or hospitalization with unstable angina at 18 months.
According to the results, the primary endpoint occurred in 13.3% of Group B patients vs. 3.1% of Group A patients (HR=4.7; 95% CI, 2.0 to 10.9; P=0.0004). This suggested that the presence of TCFAs was predictive of future events even in the absence of abnormal FFR. The adverse event rate was higher than the rate of events among revascularized lesions with abnormal FFR at baseline, the authors reported.
“In patients with diabetes, COMBINE (OCT-FFR) showed that the presence of a high-risk plaque (TCFA) is a strong predictor of future MACE, despite lack of ischemia,” said Elvin Kedhi, MD, PhD, a professor of cardiology at Liberal University Brussel Hopital Erasme and Silesian Medical University, in Katowice, Poland, said in a press release about the study. “Additionally, patients with high-risk plaques (TCFAs) have a significant increase in target-lesion related MACE and MI compared to patients without TCFA at 18 months. These findings indicate that combining FFR and OCT can improve the accuracy of high-risk lesion and patient identification and should be adopted in practice.”
Kedhi E. Outcomes From The North American COVID-19 STEMI Registry. Presented at TCT 2020.