Patients diagnosed with coronary artery disease, which is caused by plaque accumulation within the arteries leading to chest pain, shortness of breath, and potential heart attacks, frequently undergo percutaneous coronary intervention (PCI). This non-surgical procedure involves the insertion of a catheter by interventional cardiologists to place stents in blocked coronary arteries, thereby restoring blood flow. Approximately one-third of these cases in the United States, which amounts to hundreds of thousands annually, involve moderate to severe calcified lesions, where calcium accumulates within the arteries. Around 10% of these cases are categorized as severe, where the arteries essentially turn to bone, making the stenting procedure more complex and risky. Typically, interventional cardiologists use angiography to guide the PCI catheter, which involves injecting a special dye and using X-rays to visualize blood flow through the heart arteries, helping to highlight blockages.

However, angiography has inherent limitations, such as its inability to accurately assess the true size of the arteries and the composition of the plaque, and its shortcomings in determining whether the stent is fully expanded after PCI. Angiography also struggles to identify other complications that might affect the safety and effectiveness of the procedure. These challenges are amplified when dealing with calcified coronary arteries. New research now shows that using intravascular imaging (IVI) to guide stent implantation during complex stenting procedures provides a safer and more effective solution for patients with severely calcified coronary artery disease compared to traditional angiography. These findings come from the largest clinical trial of its kind, which compared the two methods during PCI.

The ECLIPSE study, funded by Abbott Vascular, Inc. (Santa Clara, CA, USA) and led by Mount Sinai Health System (New York, NY, USA), analyzed the outcomes of PCI in patients with severely calcified lesions, involving 2,005 participants. The goal was to assess whether IVI guidance could improve survival rates free from adverse cardiac events when compared to angiography. Patients with severely calcified coronary lesions were randomized at 104 sites across the U.S. One group of 1,246 patients, or 62%, underwent PCI with guidance from either optical coherence tomography (OCT) or intravascular ultrasound (IVUS), while 759 patients, or 38%, had PCI guided by angiography. The primary endpoint was the one-year rate of target vessel failure, which included cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization.

The results showed that overall rates of target vessel failure were 26% lower in patients who received IVI guidance compared to those who underwent angiography guidance. Additionally, there was a significant reduction in all-cause death, stent thrombosis, and revascularization of target lesions and vessels among those treated with intravascular imaging compared to angiography. Further analysis of the two imaging modalities—IVUS and OCT—was conducted to determine which was more effective. The unadjusted analysis revealed that patients with OCT guidance had better outcomes than those with IVUS; however, when adjusting for factors such as age, diabetes, and the number and severity of lesions, the differences were not statistically significant.

OCT and IVUS provide detailed, high-resolution images of the coronary arteries and blockages, offering a more accurate and specific view than traditional coronary angiography. These imaging techniques also enable a better assessment of the adequacy of the implanted stent. Both imaging methods help in more accurately measuring the dimensions and composition of the vessel and plaque and in better assessing the quality of stent implantation. The findings from the ECLIPSE trial, presented at the American College of Cardiology Scientific Session (ACC.25), could lead to significant changes in treatment strategies for high-risk patients.

“The ECLIPSE trial shows that use of IVI to guide coronary stenting in severely calcified lesions prevents death, stent thrombosis, and unplanned repeat procedures in this high-risk patient population,” said first author Gregg W. Stone, MD. “These results extend the strong recommendations from recent U.S. and European societal guidelines that intravascular imaging with either optical coherence tomography (OCT) or intravascular ultrasound (IVUS) should be routinely used during complex coronary stent procedures.” 

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