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ISOLEDSInterventional CardiologyOpen Access
Intravascular ultrasound versus optical coherence tomography guidance for percutaneous coronary intervention of distal left main bifurcation lesions
Key result
OCT-guided PCI proves noninferior to IVUS-guided PCI for target lesion failure.
- HR 0.90
- 95% CI 0.59-1.36
- P=0.0003 for noninferiority
- n=664
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)
Authors
Discussion
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Key expert perspectives
Captured external expert commentary on this trial, strongest first. Original sources are linked where available.
“@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)”
Implication
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
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
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.
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).