For the first time, a network meta-analysis showed reduced all-cause mortality and myocardial infarction (MI) rates with percutaneous coronary intervention (PCI) guided by intravascular imaging than with angiography guidance alone. Gregg W. Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, presented these findings Sunday at the European Society of Cardiology (ESC) 2023 congress in Amsterdam. Previous meta-analyses comparing guidance of PCI procedures with intravascular imaging to that of angiography alone generally showed lower rates of major adverse cardiovascular events with intravascular imaging guidance. However, none of these studies showed reduced all-cause mortality or MI, and few included optimal coherence tomography (OCT) guidance. During a press conference, Stone said this might be why the European and U.S. guidelines only have a Class IIa recommendation for intravascular imaging guidance in PCI. The current meta-analysis includes patient-level data from previous studies and two major randomized controlled trials presented Sunday at ESC – ILUMIEN IV and OCTOBER – which compared PCI with OCT guidance to PCI with angiography alone. Stone added during the press conference that this meta-analysis will soon be updated with data from a third randomized trial presented Sunday at ESC, OCTIVUS, which compared PCI guided by OCT to PCI guided by intravascular ultrasound (IVUS). The real-time network meta-analysis Stone presented Sunday includes 20 randomized trials covering 12,428 patients with a mean follow-up of 26.4 months. Nine trials compared IVUS with angiography guidance, six compared OCT with angiography (including ILUMIEN IV and OCTOBER), two compared OCT with IVUS, two compared OCT vs. IVUS vs. angiography, and one compared OCT or IVUS with angiography. The oldest trial in the meta-analysis was HOME DES IVUS (2010). The primary endpoint was target lesion failure (TLF), which included 18 trials, 11,502 patients and 963 events. (The OPINION and MISTIC trials, which compared OCT vs. IVUS without an angiography arm, were not included in this measure.) Primary analysis using the random-effect model favored intravascular imaging over angiography (relative risk [RR]: 0.69; 95% confidence interval [CI]: 0.61-0.78; p<0.0001). Analysis using the fixed-effect model had an RR and CI identical to that of the random-effect model, with 6.8% of intravascular imaging patients and 10.1% of angiography patients experiencing TLF. These trials, including ILUMIEN IV and OCTOBER, showed no heterogeneity, Stone said. Examining the components of TLF, the meta-analysis showed a 46% reduced risk of cardiac death (RR: 0.54; 95% CI: 0.40-0.74), 20% reduced risk of target vessel myocardial infarction (RR: 0.80; 95% CI: 0.66-0.97) and 29% reduced risk of target lesion revascularization (TLR; RR: 0.71; 95% CI: 0.59-0.85) in the intravascular imaging-guided arm. There was no difference in non-cardiac death between intravascular imaging and angiography guidance, and all-cause mortality was 25% lower in the intravascular imaging arm (RR: 0.75; 95% CI: 0.60-0.93; p=0.009). “So, this is the first time that we have seen a reduction in all-cause death with intravascular imaging,” Stone said. In addition, the meta-analysis showed an 18% reduction in all MI in the intravascular imaging arm (RR: 0.82; 95% CI: 0.69-0.98), which Stone said was driven by a 52% reduction in stent thrombosis in the intravascular imaging arm (RR: 0.48; 95% CI: 0.31-0.76). Comparing OCT vs. IVUS guidance, which was done in four trials (1,316 patients) included in the meta-analysis, showed no significant difference between these modalities in TLF (RR: 1.22; 95% CI: 0.96-1.56), cardiac death (RR: 1.15; 95% CI: 0.60-2.20); TLR (RR: 1.28; 95% CI: 0.91-1.79). “Of course, we’ll be adding the OCTIVUS data to this immediately after ESC, and that will even further bring the estimates down very close to 1,” he said. This is because the OCTIVUS trial included about 2,000 patients, about 50% larger than the four trials already included in the meta-analysis, Stone said. OCTIVUS showed that OCT was non-inferior to IVUS for the primary endpoint of TLF at 1 year. Answering questions during the press conference, Stone said that the use of intravascular imaging has reached about 20% in the U.S., about 5% in Europe and as high as 98% in Japan. He said the finding from this meta-analysis of lower all-cause mortality and lower MI in the intravascular imaging arm, “hopefully, this will impact the guidelines – and if it gets a Class I recommendation in the guidelines, that will make a difference.” Answering a question about whether it is highly selected patients who benefit, Stone said the trials included in the meta-analysis covered a range of patients. Some trials included all-comers, some included only patients with high-risk complex or highly calcified lesions, some only non-complex lesions, some with left main lesions, some with bifurcation lesions, some included chronic coronary artery disease, and others included patients with acute MI. “I’m not even recommending that intravascular imaging be used in every single case, but I do think it should be used in the majority of patients,” he said. Image Caption: Gregg W. Stone, MD, speaks during a press conference at the European Society of Cardiology congress 2023 in Amsterdam. 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