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Page 2 of 11 Flattery et al. Vessel Plus 2024;8:26 https://dx.doi.org/10.20517/2574-1209.2023.130

[2]
coronary anatomy and pathology with micron-level resolution . Among the most important identified uses
[4]
for IVUS is its role in the optimization of percutaneous coronary interventions (PCI) [Table 1] . IVUS-
guided PCI refers specifically to the use of IVUS during coronary interventions to systematically
characterize lesion pathology and guide procedural decision making including lesion preparation, stent
choice and delivery, and post-stenting optimization .
[5]
Evidence for improved procedural and clinical outcomes with IVUS-guided PCI has emerged from real-
world observational studies, clinical trials, and meta-analyses of pooled trial data. In this targeted narrative
review, we summarize and discuss the individual randomized controlled trials (RCTs) that compare clinical
endpoints in IVUS-guided vs. angiography-only PCI in the drug-eluting stent (DES) era. A total of twelve
English-language RCTs evaluating IVUS guidance vs. angiography alone in PCI were identified. Two of
these studies separately published long-term outcomes that were also included. Additionally, four studies
comparing IVUS guidance vs. alternative intracoronary imaging or coronary physiology techniques were
identified and are briefly discussed separately.

The studies comparing IVUS guidance and angiography alone are grouped according to anatomic criteria
that were used for patient selection in the individual trials. Though there is certainly imprecision and
overlap within these divisions, the goal of grouping studies in this manner is to allow readers to better
identify the evidence that most clearly applies to their own real-world patients and procedures.

An important aspect of the studies included in this review is that some individual trials failed to show an
advantage of IVUS guidance. In addition, the effect of IVUS in individual trials is largely, although not
exclusively, limited to vessel- and stent-related outcomes such as target vessel and target lesion
revascularization. We conclude this review with a discussion of these issues and a brief description of major
pooled analyses demonstrating the superiority of IVUS-guided PCI.

IVUS-GUIDED VS. ANGIOGRAPHY-GUIDED PCI: DRUG-ELUTING STENT ERA
In the DES era, studies evaluating clinical outcomes with IVUS-guided PCI expanded beyond stable
coronary artery disease to include patients with a greater degree of clinical and anatomic complexity, in
whom a greater degree of benefits from technical optimization might be expected. Eleven trials are included,
with the separately published long-term outcomes of two larger trials also described [Table 2]. Studies are
grouped according to the anatomic specifications required for inclusion, with unselected patients herein
referring to those with any lesion complexity (as opposed to any clinical syndrome as above). All trials
included clinically unselected patients (those with stable coronary disease or acute coronary syndromes)
unless otherwise described.

All-comer patients
An early trial of IVUS- vs. angiography-guided PCI in procedures utilizing drug-eluting stents (DES) was
[6]
the HOME-DES-IVUS study, a 2010 single-center RCT completed in the Czech Republic . Of note, though
the intention of the study design was for the inclusion of all-comers, due to insurance restrictions at the
performing center, patients were required to meet either angiographic or clinical complexity criteria to be
eligible for DES implantation and, therefore, to be included in this study. Inclusion criteria were American
Heart Association lesion type B2 and C, left main disease, reference vessel diameter < 2.5 mm, lesion length
> 20 mm, in-stent restenosis, insulin-dependent diabetes mellitus, and acute coronary syndrome. Among
the 210 patients included in the study, no between-group differences in event rates of either MACE [defined
as death, myocardial infarction (MI), or target lesion revascularization (TLR)] or late stent thrombosis (ST)
were observed at 18 months.