Optical coherence tomography (OCT)-guided PCI was the focus of three new trials – ILUMIEN IV, OCTOBER and OCTIVUS – presented during a dedicated Hotline session at ESC Congress 2023 in Amsterdam. Additionally, a meta-analysis looking at OCT vs. intravascular ultrasound (IVUS) vs. angiography guidance was presented during the same session.

In the ILUMIEN IV trial, researchers randomized 2,487 patients at 80 sites in 18 countries to either OCT-guided PCI (n=1,233) or angiography-guided PCI (n=1,254). All patients had medication-treated diabetes and/or complex lesions. According to study author Ziad Ali, MD, of St. Francis Hospital in Roslyn, NY, overall findings showed that OCT-guided PCI led to a larger minimum stent area, enhanced the safety of the PCI procedure and resulted in a nearly two-thirds reduction in stent thrombosis over the two-year follow-up period. However, he said, OCT guidance "did not reduce the two-year rate of target vessel failure compared with angiography-guided PCI because of a low and nearly identical rate of target vessel revascularization in the OCT-guided and angiography-guided PCI arms." The study was simultaneously published in the New England Journal of Medicine (NEJM).

The OCTOBER trial found routine use of OCT-guided PCI reduced adverse cardiac events in technically challenging patients with bifurcation lesions, compared with angiography-guided PCI and optional use of IVUS in left main bifurcations. The trial included 1,201 patients from 38 heart centers across 13 European countries, of which 600 were allocated to OCT-guided PCI and 601 patients were allocated to angiography-guided PCI. The primary endpoint of MACE after two years occurred in 10.1% of patients in the OCT-guided PCI group and 14.1% of patients in the angiography-guided PCI group. Researchers observed no apparent differences in procedural safety, but noted the volume of contrast and the procedure time were both increased with OCT-guided PCI compared with angiography-guided PCI. "The results suggest that routine use of structured OCT guidance during PCI of complex bifurcation lesions should be considered to improve prognosis," said study authors Niels R. Holm, MD; Lene Nyhus Andreasen, MD, et al. The study was also simultaneously published in NEJM.

The OCTIVUS trial randomized 2,008 patients with diverse coronary artery lesions to either OCT-guided PCI (n=1,005) or IVUS-guided PCI (n=1,003). Roughly 20% of patients in both groups were women. Overall results found OCT-guided PCI was noninferior to IVUS-guided PCI with respect to a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at on year. However, in presenting the results, Duk-Woo Park, MD, PhD, FACC, of Asan Medical Center in Seoul, said the selected study population and lower than expected event rates should be considered in interpreting the trial results. For example, the lower-than-expected primary outcomes may possibly be due to improvements in the methods/techniques to perform PCI and general improvements in cardiovascular care during the past few years. Trial results were simultaneously published in Circulation.

In a real-time, updated network meta-analysis integrating data from the ILUMIEN IV and OCTOBER trials with 18 prior studies, researchers compared the overall effects of intravascular imaging (IVUS and OCT) in improving outcomes of the PCI procedure vs. angiography, as well as IVUS vs. angiography, OCT vs. angiography, and IVUS vs. OCT. Findings showed intravascular imaging (IVUS or OCT) guidance of PCI resulted in reductions in the primary composite outcome of target lesion failure by 31% compared with angiography guidance of PCI. Additionally, intravascular imaging guidance of PCI resulted in reductions in cardiac death by 46%, target vessel myocardial infarction by 20%, target lesion revascularization by 29%, and stent thrombosis by 52% compared with angiography-guided PCI. There were also statistically significant reductions in all-cause death, all myocardial infarction and target vessel revascularization with intravascular imaging guidance of PCI. The outcomes were similar for OCT-guided PCI and IVUS-guided PCI when compared individually against angiography and when compared to each other, according to principal investigator Gregg Stone, MD, FACC, of Icahn School of Medicine at Mount Sinai in New York. "The results of this network meta-analysis emphasize the importance of physicians using intravascular imaging with either OCT or IVUS to optimize stent outcomes and improve the long-term prognosis of their patients," he said.

Clinical Topics: Noninvasive Imaging, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: ESC Congress, ESC23, ACC International, Tomography, Optical Coherence, Tomography, X-Ray Computed, Ultrasonography, Interventional

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