- Abbott said optical coherence tomography (OCT) imaging improved physicians' ability to place and expand stents, compared to angiography, in a clinical trial.
- OCT intravascular guidance during stent procedures also was associated with a lower risk of stent thrombosis, or blood clots, the company said in a statement.
- While the study met its primary imaging endpoint of improving stent expansion for a greater minimal stent area, it did not prove superiority in reducing the primary clinical endpoint of target vessel failure, a composite of death, heart attack and repeat procedure at two years.
Angiography, which is an X-ray to assess blood vessels, is the standard of care for imaging when physicians implant stents to treat patients with coronary heart disease. OCT offers doctors additional high-definition images to help improve visualization of blood vessel structures.
The intravascular imaging technique uses near-infrared light to provide cross-sectional and three-dimensional pictures of the vessel during a stent procedure.
Abbott said that despite reductions in both cardiac death and heart attack when OCT was used, similar rates of repeat procedures across the two study groups may have been due to regional variations in routine practice and the impact of the COVID-19 pandemic on access to healthcare.
Results from the ILUMIEN IV trial were presented this week at the European Society of Cardiology Congress in Amsterdam and published in the New England Journal of Medicine. Abbott funded the study.
Abbott said the findings have the potential to shift physicians’ approaches to treating patients with complex coronary disease.
"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,” said Gregg Stone, the study’s chairman and director of academic affairs for the Mount Sinai Health System.
The trial evaluated 2,487 patients from 18 countries and included people with medication-treated diabetes and complex artery disease.