Abbott Data Shows OCT Imaging Yields Better Stent Placement Outcomes

Abbott released late-breaking data from the first-of-its-kind ILUMIEN IV OPTIMAL PCI clinical study, a randomized global imaging trial, at this year’s European Society of Cardiology (ESC Congress.
 
According to Abbott, the study found during percutaneous coronary interventions (PCI), guidance with optical coherence tomography (OCT) compared to angiography helps to achieve improved stent expansion for greater minimal stent area (MSA). Also according to the study, OCT guidance during PCI is associated with lower stent thrombosis (ST) risk.
 
ILUMIEN IV included patients with medication-treated diabetes or complex artery disease. It evaluated OCT-guided stent placement compared to stenting with angiography alone in 2,487 patients, from 18 countries, at 80 sites across the world. Abbott’s Ultreon OCT intracoronary imaging solution, powered by artificial intelligence, was used for the study.
 
Data showed OCT guidance resulted in a 7% increase in MSA compared to angiography guidance alone. OCT guidance was associated with 64% reduction in ST rates, resulting in a “statistically significant” difference compared to angiographic guidance. OCT guided PCIs vs. angiography was also associated with 39% reduction in cardiac death and 24% reduction in target vessel myocardial infarction, respectively.
 
“The ILUMIEN IV results should have a major impact on clinical practice,” said Gregg W. Stone, MD, ILUMIEN IV study chairman, director of academic affairs for the Mount Sinai Health System, and professor of medicine (cardiology) and population health science and policy at the Icahn Mount Sinai, told the press. “The demonstration that stent thrombosis is reduced by approximately two-thirds with OCT is especially important as most patients who develop stent thrombosis die or have a heart attack. OCT guidance also reduced angiographic complications and led to better stent implantation.”
 
The study met its primary imaging endpoint of improving MSA but did not achieve superiority in reducing the primary clinical endpoint, target vessel failure (TVF), a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR) at two years. Abbott pointed to the COVID-19 pandemic, regional variations in routine practice, and access to healthcare as the possible cause for lack of TVR differentiation.
 
“The ILUMIEN IV data demonstrate the impact that OCT guidance can have when treating patients with complex coronary disease,” said Nick West MD, chief medical officer and divisional vice president of global medical affairs at Abbott’s vascular business. “In these cases, angiography alone simply cannot match the precision afforded by OCT to determine a treatment plan.”