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Recent research indicates that utilizing intravascular imaging (IVI) for stent implantation during complex coronary procedures offers enhanced safety and effectiveness for patients facing severe calcification in coronary artery disease, outperforming conventional angiography, which is the standard approach.
These conclusions stem from the comprehensive ECLIPSE trial, hailed as the largest of its kind to juxtapose these two methodologies in the context of percutaneous coronary intervention (PCI). The trial’s findings were unveiled during the Late Breaking Clinical Trial Session at the American College of Cardiology Scientific Session (ACC.25) held in Chicago on March 31. These insights could revolutionize treatment pathways for patients at high risk.
“The ECLIPSE trial demonstrates that employing IVI to direct coronary stenting in patients with severely calcified lesions significantly lowers the risks of death, stent thrombosis, and the need for unplanned repeat procedures,” stated Dr. Gregg W. Stone, a primary author and expert from the Mount Sinai Health System. He emphasized that these findings align with the latest recommendations outlined in U.S. and European medical guidelines, advocating for the routine application of intravascular imaging—whether using optical coherence tomography (OCT) or intravascular ultrasound (IVUS)—during intricate stent placements. Currently, the adoption of IVI remains limited, being utilized in only 20 to 25 percent of such cases in the U.S. However, the growing evidence supporting its benefits may accelerate its integration into standard practice.
Coronary artery disease, characterized by the accumulation of plaque within the arteries, is a common cause of chest pain, breathlessness, and heart attacks. PCI is a minimally invasive procedure where interventional cardiologists implant stents in blocked arteries to restore blood flow. In the U.S., approximately one-third of these procedures involve moderate to severe calcification of lesions, with 10 percent classified as severe, where artery walls become so calcified that they resemble bone. This condition complicates stenting, heightening the associated risks. Traditionally, angiography—a technique that utilizes a dye and X-ray to visualize blood flow and identify obstructions—serves as the guiding method for PCI.
Despite its widespread use, angiography has significant limitations, particularly in accurately gauging artery size and plaque characteristics. It proves less effective in evaluating whether a stent has been properly expanded or in recognizing complications that may compromise the procedure’s safety and success. These shortcomings are even more pronounced in the context of calcified coronary arteries. In contrast, IVUS and OCT provide finely detailed two-dimensional and three-dimensional images of arteries and blockages, delivering a far clearer picture than angiography alone. These advanced imaging modalities also allow for a more thorough assessment of stent placement and the intricacies of vessel and plaque dimensions.
In the ECLIPSE trial, the researchers investigated outcomes among 2,005 patients with severely calcified lesions, aiming to determine if IVI guidance led to improved survival rates and reduced incidences of adverse cardiac events compared to traditional angiography. Participants were randomized across 104 hospitals within the United States. Among them, 1,246 patients (62 percent) underwent PCI with either OCT or IVUS guidance, while 759 patients (38 percent) received guidance solely through angiography. The main measure of success was the one-year rate of target vessel failure, encompassing cardiac death, target-vessel myocardial infarctions, or the need for further surgical interventions.
The study revealed that the rate of target vessel failure was reduced by 26 percent in patients who received IVI guidance compared to those guided by angiography. Furthermore, significant decreases in all-cause mortality, stent thrombosis incidents, and the need for revascularization procedures were observed among patients who benefited from intravascular imaging.
Upon further examination of the two imaging techniques, IVUS and OCT, researchers initially noted better outcomes with OCT. However, when adjusted for variables such as age, diabetes, and the severity of lesions, the distinctions in effectiveness between the two technologies were not statistically significant.
“Both OCT and IVUS are effective tools; however, further investigations are necessary to ascertain whether OCT holds additional advantages specifically for severely calcified lesions,” Dr. Stone commented. “Nonetheless, it is imperative that intravascular imaging is utilized over angiography to guide PCI procedures for patients with these high-risk calcified lesions.”
The ECLIPSE trial was conducted with the support of Abbott Vascular, Inc., located in Santa Clara, California.
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