Latest Trials on Coronary Optical Coherence Tomography
OCT-guided PCI for complex coronary lesions significantly reduces major adverse cardiovascular events, cardiac death, myocardial infarction, and stent thrombosis compared to angiography-guided PCI alone, with the most recent 2025 meta-analysis demonstrating a 32% reduction in MACE. 1
Key Clinical Outcomes from Recent Trials
The evidence base for OCT-guided PCI has matured substantially, with several pivotal trials now completed:
ILUMIEN IV Trial (Completed Enrollment)
- This large-scale multicenter randomized trial has completed enrollment and is designed to compare OCT-guided versus angiography-guided stent implantation in high-risk patients (those with high-risk clinical characteristics and/or high-risk angiographic lesions). 2
- The trial specifically evaluates whether OCT guidance achieves larger post-PCI lumen dimensions and improves clinical cardiovascular outcomes. 2
Meta-Analysis Evidence (2025)
A 2025 meta-analysis of 4 randomized controlled trials including 5,603 patients with median 2-year follow-up demonstrated that OCT-guided PCI resulted in: 1
- 68% reduction in MACE (RR 0.68,95% CI 0.55-0.84, P<0.001)
- 57% reduction in cardiac death (RR 0.43,95% CI 0.24-0.76, P=0.003)
- 25% reduction in myocardial infarction (RR 0.75,95% CI 0.59-0.96, P=0.02)
- 42% reduction in all-cause mortality (RR 0.58,95% CI 0.38-0.87, P=0.009)
- 51% reduction in stent thrombosis (RR 0.49,95% CI 0.26-0.90, P=0.02)
Specific Trial Results
DOCTORS Trial
- Enrolled 240 patients with non-ST-segment elevation MI. 2
- OCT guidance improved postprocedural fractional flow reserve compared to angiography alone, primarily through better stent expansion. 2
OCTACS Trial
- Randomized acute coronary syndrome patients to OCT-guided versus angiography-only PCI using newer-generation drug-eluting stents. 2
- OCT guidance resulted in significantly fewer uncovered struts at 6 months (4.3% vs 9.0%, P<0.01). 2
DETECT OCT Trial
- Evaluated OCT utility in stable patients. 2
- Demonstrated superior stent coverage at 3 months with OCT guidance (7.5% vs 9.9%, P=0.009). 2
ILUMIEN III Trial
- Compared OCT, IVUS, and angiography guidance for coronary stent implantation. 2
- Minimum and mean stent expansion with OCT was noninferior to IVUS-guided PCI but not superior to angiography alone. 2
OPINION Trial (2017)
- Enrolled 412 patients comparing OCT versus IVUS guidance. 2
- Target vessel failure occurred in 5.2% with OCT-guided PCI versus 4.9% with IVUS-guided PCI, demonstrating noninferiority. 2
- Binary restenosis rates were comparable between groups (in-stent: 1.6% vs 1.6%; in-segment: 6.2% vs 6.0%). 2
Current Guideline Recommendations
The ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization provide Class 2a recommendations for intravascular imaging (including OCT) for: 2
- Lesion assessment of intermediate left main disease
- Procedural guidance to reduce ischemic events, particularly in left main or complex coronary artery PCI
- Determining the mechanism of stent failure
Specific Clinical Applications
Left Main PCI
One single-center randomized trial and several recent nonrandomized registries demonstrate lower rates of cardiac death, MI, target lesion revascularization, and stent thrombosis for both IVUS and OCT compared with angiography for unprotected left main PCI. 2
Stent Optimization Targets
OCT minimum stent area <4.5 to 5.0 mm² is an independent predictor of MACE based on randomized and registry data. 2
Mechanism of Stent Failure
OCT is superior for differentiating between stent-related mechanisms of failure, while IVUS is preferred for in-depth vessel wall characterization. 2
Practical Implementation
OCT has utility across three key procedural phases: 2
- Preintervention: Lesion and vessel assessment, plaque composition evaluation, identification of reference segments and landing zones, selection of optimal stent length and diameter
- Periprocedural: Guidance of lesion preparation and stent deployment strategies and techniques
- Post-PCI: Exclusion of complications, assessment of optimal endpoints, and evaluation of mechanisms of stent failure (stent thrombosis) and restenosis
Technical Considerations
Imaging should be performed after administration of intracoronary nitroglycerin and should begin 20 mm or more distal to the area of interest, ending at the left main or right coronary artery ostium. 2
Important Caveats
Exercise specific caution with intravascular imaging in spontaneous coronary artery dissection due to unique risks of manipulating the dissected coronary artery with hydraulic spread of dissection, especially with contrast injections required for OCT. 2
When employed regularly, intravascular imaging has the potential to optimize procedural speed, efficiency, and overall cost-effectiveness if integrated into standard cardiac catheterization laboratory workflow. 2