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Recent studies of clinical outcomes with other intravascular imaging modalities in similar contemporary
patient populations have shown discordant results. The 2023 ILUMIEN-IV trial, which assessed clinical
outcomes using OCT-guided PCI compared with angiography alone in 2,487 medically or anatomically
[33]
complex patients at 80 sites in 18 countries, showed no reduction in TVF at two years . This failure to
detect differences was attributed to low event rates during the study period (as well as the possible impact of
the COVID pandemic). The simultaneously published OCTOBER trial randomized 1,201 patients in 38
European centers with complex bifurcation lesions to either OCT-guided revascularization vs. angiography,
but in this study, a significant reduction in MACE (death from a cardiac cause, target-lesion myocardial
infarction, or ischemia-driven target-lesion revascularization; HR 0.7, P = 0.035) at two years was
[34]
observed .
Notwithstanding inter-trial variability, the overall body of evidence continues to support a role for
intravascular imaging-guided PCI in select patients with appropriate clinical or anatomic complexity. Most
recently, a network meta-analysis of more than 15,000 patients in 22 RCTs comparing imaging-guided vs.
angiography-only PCI in the DES era demonstrated for the first time a reduction in all-cause mortality in
[35]
patients treated with intravascular imaging guidance . This meta-analysis, as well as the others referenced
above, strongly supports a significant clinical advantage of using these technologies to improve PCI
outcomes in appropriately selected patients.
Limitations
This review is, by its nature, limited in scope and depth. The focus is on summarizing the primary clinical
outcomes of the included studies, in order to provide the practicing clinician with a foundational knowledge
of the evidence. This review is not meant to serve as an in-depth analysis of the methodology or results of
the included studies. It also does not thoroughly describe procedural outcomes included in the studies,
though we acknowledge that the degree and frequency of procedural improvement likely impact the overall
clinical benefit observed. Readers are encouraged to use this review as a starting point for understanding
this body of literature and as a reference for further reading and evaluation.
Looking forward, a number of ongoing trials aim to further refine the practice scenarios in which IVUS
guidance will yield clinical benefits, including trials investigating IVUS guidance in ST-elevation myocardial
infarctions, unprotected left main coronary artery disease, complex coronary artery disease, and bifurcation
lesions [36-40] . Other areas of future focus should also include improved uptake and delivery of IVUS-guided
PCI, including ensuring appropriate integration of IVUS into routine workflow (i.e., with angiographic co-
registration for ease of use), comprehensive training with IVUS modalities during and after interventional
fellowship, and appropriate reimbursement for IVUS-guided PCI.
DECLARATIONS
Authors’ contributions
Study conception and design: Rao SV, Razzouk L
Data collection: Flattery E
Analysis and interpretation of results: Flattery E, Razzouk L, Rao SV
Draft manuscript preparation: Flattery E, Razzouk L, Rao SV
All authors reviewed the results and approved the final version of the manuscript.
Availability of data and materials
Not applicable.