The ILUMIEN IV OPTIMAL PCI study evaluated the use of OCT during percutaneous coronary interventions (PCI). OCT imaging offers additional high-definition images that improve the visualization of vessel structure. This provides doctors with actionable data that translate into patient benefits, potentially shifting future approaches.
Abbott’s Ultreon OCT software, powered by AI, guides stents for precision placement. It provides enhanced views of coronary anatomy and blockages, supporting physician decision-making in real-time.
Compared to angiography, the study showed that this method helps improve stent expansion for a greater minimal stent area (MSA). Abbott says OCT guidance during PCI is associated with a lower risk of stent thrombosis (ST), a potentially fatal complication.
The company presented data as a late-breaking clinical trial at the European Society of Cardiology (ESC) Congress 2023 in Amsterdam.
“The ILUMIEN IV data demonstrate the impact that OCT guidance can have when treating patients with complex coronary disease,” said Dr. Nick West, chief medical officer and divisional VP 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.”
Details from the Abbott study
ILUMIEN IV included patients with medication-treated diabetes and/or complex-artery disease, exclusively. The study evaluated OCT-guided stent implantation compared to stenting using angiography alone. It evaluated 2,487 patients from 18 countries at 80 sites across the world, including in the U.S., India, Japan and Europe.
The study demonstrated improved stent expansion, with a statistically significant 7% increase in MSA compared to angiography guidance alone. Larger MSA previously showed a correlation to a reduction in future adverse events.
Abbott also reported a reduced risk of future blockages. OCT guidance was associated with a 64% reduction in ST rates, resulting in a statistically significant difference compared to angiography. OCT-guided PCIS vs. angiography also associated with a 39% reduction in cardiac death. It showed a 24% reduction in target vessel myocardial infarction, too.
The study met its primary imaging endpoint of improving MSA. However, it failed to achieve superiority in reducing the primary clinical endpoint. Abbott defined that as reducing target vessel failure (TVF), a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) at two years. The company said COVID-19, regional variations in routine practice and access to healthcare may have affected the lack of TVR differentiation.
“The ILUMIEN IV results should have a major impact on clinical practice,” said Dr. Gregg W. Stone, M.D., the ILUMIEN IV study chair, 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. “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.”
