ISOLEDSInterventional CardiologyOpen Access
Optical Coherence Tomography Versus Intravascular Ultrasound in Distal Left Main PCI
Intravascular ultrasound versus optical coherence tomography guidance for percutaneous coronary intervention of distal left main bifurcation lesions
Why the trial?
Intravascular imaging improves outcomes of left main PCI, but IVUS and OCT had never been compared head-to-head for guiding treatment of distal left main bifurcation lesions, where vessel size and ostial assessment challenge each modality differently.
Does OCT-guided PCI reduce target lesion failure compared to IVUS-guided PCI in patients with true distal left main bifurcation lesions?
Population
664 patients with true distal left main bifurcation lesions; mean age 63.5, 22.1% women
Comparison
OCT-guided vs IVUS-guided PCI
Design
Open-label multicenter 1:1 noninferiority trial (24 centres in China)
Follow-up
12 months (median 362 days)
Key result
OCT-guided PCI was noninferior to IVUS-guided PCI for target lesion failure (14.4% vs 19.6%; HR 0.90, 95% CI 0.59-1.36; P=0.0003 for noninferiority).
Authors
Discussion
Member takes
Key expert perspectives
Captured external expert commentary on this trial, strongest first. Original sources linked on every quote.
“@DrDerekConnolly @DLBHATTMD @ESC_President @PZoungas @vass_vassiliou @mmartinezheart @ShelleyZieroth @robmentz @JennaSkowronski @noshreza @gabrielsteg @co_kobo @elmir1omerovic @Aspirinbk @RizosKonsta @escardio @HighSTEACS @SimoneBiscaglia @KardiologieHH @Marta33717088 @Bweber04 @RonBlankstein @purviparwani @MariamElmegaard @ankeetbhatt @kpnorcal @ratika_parkash @DalhousieU @HeartDocSharon @CMichaelGibson @BaimInstitute @mortschou @shaoliang_chen @panniyammakal @dranulala @heartofthemater @mmamas1973 @WGCPMChair @EAPCIPresident @EACVIPresident @BarbaraStahli @j_hausleiter @oyvlie @RigsHeart @HeartcentreC @netta_doc @LiverpoolCCS @RoWachter @CERG_NTNU #HOTLINE 11 #ESCCongress My pick is CorCal #CVPrev Coronary calcium pooled cohort equations for primary prevention? #CorCal has data- @JBMuhlesteinMD ISOLEDS asks if OCT beats IVUS for tricky left main bifurcation PCI (I say we just work on CV prevention)”
Overview
OCT offers a viable alternative to IVUS for left main bifurcation PCI; extends randomized evidence for intravascular guidance in this anatomy.
Key Points
- To determine whether optical coherence tomography (OCT) guidance is noninferior to intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention for distal left main bifurcation lesions.
- Open-label randomized noninferiority trial (ISOLEDS) conducted across 24 centres in China enrolling 664 patients randomized 1:1 to OCT- or IVUS-guided PCI.
- The primary endpoint was target lesion failure at 12 months, composed of cardiac death, target-lesion-related myocardial infarction, or clinically driven target-lesion revascularisation.
- At a median follow-up of 362 days, Kaplan-Meier estimated target lesion failure was 14.4% with OCT versus 19.6% with IVUS (adjusted HR 0.90, 95% CI 0.59 to 1.36; p=0.0003 for noninferiority).
- Findings remained consistent across per-protocol analyses, competing-risk models, and after excluding periprocedural myocardial infarction, though superiority was not established.
Evidence details
What drove the result?
| Outcome | OCT | IVUS |
|---|---|---|
| Target lesion failure at 12 months | 14.4% | 19.6% |
| Primary composite (Kaplan-Meier) · adjusted HR 0.90 (95% CI 0.59-1.36); noninferior (p=0.0003), superiority not established | ||
Limitations & tradeoffs
Statistical certainty
Wide CI (0.59–1.36): the trial establishes noninferiority only, not equivalence or superiority.
Representation
All patients were enrolled in China, which may limit generalisability.
Design limitations
Open-label design, with no safety or procedural complication data reported in the record.
Structured PICO
Does OCT-guided PCI reduce target lesion failure compared to IVUS-guided PCI in patients with true distal left main bifurcation lesions?
P
Population
664 patients with true distal left main bifurcation lesions, mean age 63.5 years, followed for a median of 362 days.
I
Intervention
Optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI)
C
Comparator
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI)
O
Outcome
Target lesion failure (composite of cardiac death, target-lesion-related myocardial infarction, or clinically driven target-lesion revascularisation) at 12 monthscomposite
OCT-guided PCI is noninferior to IVUS-guided PCI with respect to 12-month target lesion failure in patients undergoing intervention for true distal left main bifurcation lesions.
Main Result
Hazard Ratio: 0.9 (95% CI 0.59–1.36)
Absolute Event Rate: 14.4% vs 19.6%
p-value: p=0.0003 for noninferiority
Limitations
- The trial does not establish equivalence or superiority.
Cite This Study
Yong Zeng (2026) conducted an RCT in True distal left main bifurcation lesions (n=664). Optical coherence tomography (OCT) guidance vs. Intravascular ultrasound (IVUS) guidance was evaluated on Target lesion failure (cardiac death, target-lesion-related myocardial infarction, or clinically driven target-lesion revascularisation) (HR 0.90, 95% CI 0.59-1.36, p=0.0003 for noninferiority). OCT-guided PCI was noninferior to IVUS-guided PCI for target lesion failure (14.4% vs 19.6%; HR 0.90, 95% CI 0.59-1.36; P=0.0003 for noninferiority).