New Delhi/ Chicago: Abbott is all set to break a better new ground for heart patients. The American stent maker major has initiated a study that might prove game changer for the treatment of Coronary Artery Disease (CAD).
Announced on April 11, this study named ILUMIEN IV is going to be the largest-ever randomized trial to evaluate superiority of light-based, three-dimensional imaging (optical coherence tomography (OCT)) versus X-ray-based angiography in patients with complex coronary artery disease receiving a stent. The study will enrol up to 3,650 patients with high-risk, complex disease at 125 centres in North America, Europe and Asia.
Trial will assess if stent procedures guided by high-resolution imaging result in larger vessel diameters and improved patient clinical outcomes versus stent procedures that use standard of-care imaging. Use of OCT imaging may help doctors be more precise in stent implantation.
It is a clinical trial for evaluation of long-term outcomes of patients who undergo stent implantation guided by high resolution light-based imaging technology—called optical coherence tomography (OCT)— compared to a common X-ray-guided technique called angiography.
The trial (ILUMIEN IV) is the first large-scale randomized global study using Abbott’s OCT imaging in patients with high risk, complex coronary artery disease. Patients in the study will be randomized to either OCT guided or traditional angiography to guide placement of one or more XIENCE everolimus eluting coronary stents. The first patient was enrolled by Franco Fabbiocchi, M.D., director of Invasive Cardiology Unit IV at IRCCS Centro Cardiologico Monzino in Milan, Italy. During stent implantation guided by one of Abbott’s OCT platforms, physicians use high resolution images taken directly inside the patient’s vessels to accurately measure dimension and choose a stent that best fits the vessel. OCT is also used to help physicians ensure the stent is fully expanded and is flush against a vessel wall, which are both important factors in reducing stent failure.
Patients with complex disease may have multiple, or totally blocked arteries, or other diseases such as diabetes; and these patients account for an increasing number of cases. “Today, most of the world uses angiography for stent implantation using a two-dimensional view of the coronary artery to assess a complex three-dimensional structure. Physicians need new technology to help optimize percutaneous coronary intervention, and OCT provides just that, the ability to look at the artery from the outside-in and the inside-out,” said Ziad A. Ali, M.D., director of Intravascular Imaging and Physiology at Columbia University Medical Center’s Center for Interventional Vascular Therapy and co-principal investigator of the study. “I’m confident this technology will have a positive impact on clinical practice around the world and we hope to provide evidence for leading medical organizations to update clinical guidelines for stent implantation based on the results of this study
“Abbott is committed to providing doctors and patients with life-changing technology, and there is a growing body of evidence that OCT-guided stent implantation may result in better outcomes for patients,” said Charles Simonton, M.D., chief medical officer and divisional vice president of Medical Affairs for Abbott’s vascular business.