Intravascular imaging for PCI gets a big boost from recent studies
Four late-breaking studies presented at the 2023 European Society of Cardiology (ESC) meeting supplied additional clinical evidence that intravascular imaging intravascular ultrasound (IVUS) or optical coherence tomography (OCT) enhances clinical outcomes in percutaneous coronary intervention (PCI) procedures. With the strong evidence supporting their use, it is expected that these technologies will become more widely adopted in interventional cardiology and potentially leading to changes in clinical guidelines.
American College of Cardiology (ACC) President Hadley Wilson, MD, who is also the executive vice chair of the Sanger Heart and Vascular Institute, co-chaired the ESC Hot Line session 4, which included four late-breaking studies involving IVUS and OCT. He explained the impact of this new data with Cardiovascular Business.
"I think the results from all of these trials and the meta-analysis will strongly push the guideline writers, I think fairly quickly, to consider elevating that from 2A to a 1A indication, particularly in patients that have complex coronary disease," Wilson explained.
Other countries outside the U.S. have higher usage of intravascular imaging, with the highest being Japan where up to 80% of PCI procedures use it. Hadley said training is widely available and reimbursement is available, but he felt the lack of clear evidence that intravascular imaging improve outcomes and the added cost and time to the procedure is what was hold some people back from using it. Now, he said the evidence is available and seem pretty clear this does help patients.
ESC intravascular imaging trial summaries
The studies included ILUMIEN IV, OCTIVUS, OCTOBER, and an OCT vs. IVUS vs. angiography comparison meta-analysis.
• The OCTOBER trial presented substantial evidence in favor of using OCT as an adjunct imaging tool during PCI procedures. Optical coherence tomography (OCT) demonstrated a clear clinical benefit in improving patient outcomes. OCT provides high-resolution images that enable interventional cardiologists to visualize blood vessels in intricate detail, ensuring precise stent placement and better patient outcomes. Read more about the OCTOBER trial.
• The ILUMIEN IV trial explored the utility of OCT in PCI procedures. It showed that in patients where OCT was used, there was a reduced incidence of stent thrombosis. However, the study narrowly missed its primary endpoints, which included event-free survival from major adverse events and primary patency at 12 months. Nevertheless, the findings emphasize the potential benefits of OCT in improving the safety and efficacy of PCI. Learn more about the ILUMIEN IV trial.
• The OCTIVUS trial examined the role of both IVUS and OCT in guiding PCI procedures and demonstrated that these intravascular imaging techniques were non-inferior to angiography in guiding the interventions. Moreover, the intravascular imaging cohorts had lower-than-expected event rates, highlighting their potential in enhancing PCI outcomes. Find out more about the OCTIVUS trial.
• A meta-analysis of IVUS vs. OCT vs. angiography looked at 20 randomized trials involving 12,428 patients with chronic and acute coronary syndromes showed compelling evidence in favor of intravascular imaging (both IVUS and OCT) compared to angiography alone during PCI. Intravascular imaging resulted in significant reductions in primary composite outcomes, including target lesion failure, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. These findings suggest that intravascular imaging can lead to improved patient outcomes during PCI procedures. Read more about the meta-analysis results.
"I think the meta-analysis results were very impactful because not only did they show there were better outcomes, less major adverse cardiovascular events, but they even showed a mortality difference, which has been hard to be shown before in the randomized trials. But they had an almost 25% reduction in mortality with using intravascular imaging," Wilson explained.
Which intravascular imaging modality is best and which patients need it?
He said a big question interventional operators ask is which intravascular imaging modality, IVUS vs. OCT, is better. Unfortunately that is still unclear from the ESC trials. But what he said is clear is that using either modality improves outcomes.
"I think it is fairly clearly that imaging with one or the other of those two modalities is superior to just using angiography alone," Wilson said.
Which patients need IVUS or OCT is another question that comes up frequently in sessions at conferences like these ACC, AHA and others. Wilson said most experts agree it should be used in very complex PCI patients, such as those those with complex left main lesions and left main bifurcation lesions. He said intravascular imaging can help show a stent has proper apposition up against the walls of the vessel, which is known to help reduce complications later.
"It helps make sure you have the best stent expansion that you should hope for, but also to show that you're not having other sorts of subtle complications, like thrombus, dissection or other problems that could lead to some complications fairly soon thereafter," Wilson explained. "I think we also are starting to see more and more complex patients across the board, and they should have intravascular imaging. You need to be doing this every time you have a complex patient."