The COMBINE trial, published in the European Heart Journal and recently presented as a Late Breaking Trial during TCT Connect 2020, shows that patients with a OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia.
COMBINE (OCT–FFR) was a prospective, international trial investigating the clinical outcomes of medically treated diabetes mellitus patients carrying non-ischemic lesions depending on presence or absence vulnerable lesion morphology as assessed by Optical Coherence Tomography. The trial enrolled 550 patients in different European countries and followed these patients for 1.5 years. The primary endpoint was cardiac death, myocardial infarction, clinical driven revascularization and hospitalization for unstable angina pectoris.
Quoting Prof. Elvin Kedhi MD, PhD, Hopital Erasme, Brussels, Belgium and principal investigator of the COMBINE (OCT-FFR) Trial:
The most important finding of this trial is that not ischemia, but underlying lesion morphology could be the most important factor that predicts future adverse events.
Together with the recently published ISCHEMIA trial, where ischemia guided revascularization failed to improve clinical outcomes compared to medical treatment, the COMBINE trial leads to a new way of thinking in interventional cardiology and also opens the door for new treatment strategies where a combined ischemic and morphologic assessment could lead to better clinical outcomes.
Indeed, we are excited to announce that we have started to work on the design of COMBINE 2 trial, a large, randomised trial which we hope to start in the near future.“
Diagram Research is the Contract Research Organisation (CRO) of the COMBINE (OCT-FFR) Trial.
Authors and co-authors: Elvin Kedhi, Balazs Berta, Tomasz Roleder, Renicus S Hermanides, Enrico Fabris, Alexander J J IJsselmuiden, Floris Kauer, Fernando Alfonso, Clemens von Birgelen, Javier Escaned, Cyril Camaro, Mark W Kennedy, Bruno Pereira, Michael Magro, Holger Nef, Sebastian Reith, Arif Al Nooryani, Fernando Rivero, Krzysztof Malinowski, Giuseppe De Luca, Hector Garcia Garcia, Juan F Granada, Wojciech Wojakowski.
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