Findings presented by NewYork-Presbyterian/Columbia researchers indicate OCT-guided stent implantation has favorable procedural outcomes

Oct 30, 2016

Optical coherence tomography (OCT) provides safe and improved guidance for patients undergoing percutaneous coronary intervention to treat coronary artery disease, according to results from the ILLUMIEN III: OPTIMIZE PCI trial. The trial sought to determine whether a novel OCT-based stent sizing strategy would result in a comparable or superior minimal stent area (MSA) as achieved with former stent implant imaging techniques.

Researchers from NewYork-Presbyterian/Columbia University Medical Center will present the results as part of the late-breaking clinical trials session at the Transcatheter Cardiovascular Therapeutics (TCT) conference this weekend in Washington, D.C. The study has also been published in The Lancet and is available online.

“The trial shows that OCT-guided stent implantation provides equally large luminal dimensions as other techniques with enhanced accuracy and precision,” said Dr. Gregg W. Stone, director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Irving Medical Center, professor of medicine at Columbia University Medical Center and study chairman of the trial. “Specifically, OCT allowed stenting to be performed with fewer dissections and malappositon, findings that have been associated with poor long-term results.”

Percutaneous coronary intervention (PCI) is a minimally invasive procedure that is primarily used to open a blocked coronary artery in order to restore blood flow to the heart. PCI is most commonly guided by angiography, which uses x-rays to view the blood vessels. However, the angiogram does not take into account details of the disease process of atherosclerosis, which happens in the wall of the artery. Angiography-guided PCI is imprecise, and is poor at identifying residual dissections, thrombus (blood clots) and plaque protrusion. Intravascular ultrasound (IVUS) can overcome these limitations by allowing for tomographic cross-sectional imaging of the vessel wall and has shown to reduce major adverse cardiovascular events. OCT is a newer imaging modality that provides higher resolution images than IVUS.

“We used a specific protocol of OCT which sized the coronary artery precisely, to see if it could provide advantages over angiography and be as good as or better than IVUS,” said Dr. Ziad A. Ali, associate director of translational medicine at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, assistant professor of medicine and the Louis V. Gerstner Scholar at Columbia University College of Physicians and Surgeons and principal investigator of the trial. “The superior resolution of OCT identified more dissections, malapposition and tissue protrusion compared with angiography or IVUS alone – while achieving improved stent expansion and procedural success when directly compared to angiography.”

OCT-guided PCI was non-inferior to IVUS for the primary study endpoint of acute procedural minimal stent area.

The study examined outcomes of 450 patients at 29 hospitals in eight countries between May 2015 and April 2016. Patients were randomly assigned to receive either OCT-guided PCI, IVUS-guided PCI or angiography-guided PCI. It is the first study of its kind to compare all three modalities. All patients received clinical follow-up at 30 days and again at one year.

“ILUMIEN III: OPTIMIZE PCI is an important step toward our ultimate goal of improving patient outcomes with imaging during stenting.” said Dr. Stone. “These results have set the stage for a larger randomized trial, ILUMIEN IV, which is currently being planned to determine whether OCT-guidance results in superior clinical outcomes compared to angiography-guidance.”

Dr. Ali will be presenting these findings at the TCT conference on Sunday, Oct. 30 and will be available to speak about the trial’s results.

The study was funded by St. Jude Medical. See the paper for declaration of interests.

NewYork-Presbyterian

NewYork-Presbyterian is one of the nation’s most comprehensive healthcare delivery networks, focused on providing innovative and compassionate care to patients in the New York metropolitan area and throughout the globe. In collaboration with two renowned medical school partners, Weill Cornell Medicine and Columbia University College of Physicians & Surgeons, NewYork-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research and clinical innovation.

NewYork-Presbyterian has four major divisions: NewYork-Presbyterian Hospital is ranked #1 in the New York metropolitan area by U.S. News and World Report and repeatedly named to the magazine’s Honor Roll of best hospitals in the nation; NewYork-Presbyterian Regional Hospital Network is comprised of leading hospitals in and around New York and delivers high-quality care to patients throughout the region; NewYork-Presbyterian Physician Services connects medical experts with patients in their communities; and NewYork-Presbyterian Community and Population Health features the hospital’s ambulatory care network sites and operations, community care initiatives and healthcare quality programs, including NewYork Quality Care, established by NewYork-Presbyterian, Weill Cornell and Columbia.

NewYork-Presbyterian is one of the largest healthcare providers in the U.S. Each year, nearly 29,000 NewYork-Presbyterian professionals deliver exceptional care to more than 2 million patients.

For more information, visit www.nyp.org and find us on Facebook, Twitter and YouTube.

Columbia University Medical Center

Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org.

Media Contact:

Jessica Mikulski     212-305-5587     pr@nyp.org

Karin Eskenazi     212-342-0508     cumcnews@columbia.edu