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OCT-guided PCI Improved Procedural Outcomes and Safety Results compared to Angiography-Guided PCI as Demonstrated in ILUMIEN IV1, OCTOBER2

ILUMIEN IV

ILUMIEN IV is the largest global imaging randomised clinical trial with n=2,487 patients in 80 global centers. The trial compared OCT-guided stent implantation vs. angiography guided in high-risk or complex lesions. Primary endpoint was achieving larger post-PCI lumen dimensions and improving clinical outcomes.

ILUMIEN IV OVERVIEW

PCI OCT ILUMIEN IV Overview

KEY RESULTS:

OCT-guided PCI significantly reduced stent thrombosis (ST) by 64%

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OCT Angiography ILUMIEN Trial Chart

No statistical difference in TVF between OCT-guided and angio-guided PCI at 2 years

OCT ILUMIEN IV TVF Chart

ILUMIEN IV SUBSTUDY: COMPLEX LESIONS3

ILUMIEN IV Substudy: Complex Lesions aimed to specifically examine if OCT-guided PCI improves procedural and clinical outcomes compared with angio-guided PCI outcomes in the complex angiographic lesions subgroup (N=1,973)

 

KEY RESULTS:

OCT-guided PCI reduced serious MACE (Cardiac Death, TV-MI, or Stent Thrombosis) compared with angio-guided PCI at 2 years (p=0.042)3

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OCT ILUMIEN IV TVF Chart

Source: Ali Z., et al. ILUMIEN IV: OCT-guided vs. angio-guided coronary stent implantation in complex lesions (Sub-group). EuroPCR2024.

OCT ILUMIEN IV TVF Chart

Source: Ali Z., et al. ILUMIEN IV: OCT-guided vs. angio-guided coronary stent implantation in complex lesions (Sub-group). EuroPCR2024.

OCT-guided PCI led to a larger MSA ( 5.56 ± 1.95 mm 5.26 ± 1.81 mm2; p< 0.001) compared to angio-guided PCI3

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CALIPSO3

CALIPSO Trail (Calcified Lesion Intervention Planning Steered by OCT) is the first controlled randomised trial (n=134) that compared OCT-guided PCI to angio-guided PCI in moderate to severe calcified lesions using pre-defined algorithm for plaque modification, stent sizing and optimisation.

  • Primary endpoint: post-PCI Minimal Stent Area (MSA) on final OCT
  • Secondary endpoints: Efficiency and Safety

 

KEY RESULTS:

OCT-guided PCI was superior to angio-guided PCI with greater MSA 6.5 (5.5-8.1) vs. 5.0 (4.1-6.1) mm2, p<0.0014.

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OCT-guided PCI achieved greater stent expansion and lower malapposition than angio-guided PCI4

 

 

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 OCT guidance group
(n=65)		Angio guidance group
(n=69)		p
Stent length, mm33.0 (24.0-48.0)38.0 (25.0-48.0)0.35
Average stent area, mm28.4 (7.0-10.3)7.4 (6.4-8.6)0.01
Successful geometrical expansion, n (%)49 (75)20 (29)<0.001
Major malapposition, n (%)23 (35)34 (49)0.10
Malapposition maximal distance, µm535 (352-700)570 (330-790)0.13
Major malapposition length, mm0 (0-2)0 (0-4)0.03
Malapposed stent percentage, %0 (0-8.3)0 (0-14.5)0.02
Average stent eccentricity1.21 (1.16-1.25)1.19 (1.17-1.24)0.87
Maximal stent eccentricity1.43 (1.35-1.55)1.51 (1.36-1.60)0.47
Major dissection, n (%)7 (11)13 (19)0.19

No difference in contrast use, procedure time & radiation dose between OCT-guided and angio-guided PCI4

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 OCT guidance group
(n=65)		Angio guidance group
(n=69)		p
Procedure duration, mins63 (51-87)64 (46-82)0.22
Fluoroscopy duration, mins17 (11-21)17 (12-27)0.95
Total X ray dose, cGy/cm24148 (2550-7155)4403 (2630-7333)0.65
Contrast medium volume, ml180 (140-233)184 (150-219)0.88

Source: Adapted from Amabile N., et al. OCT vs. angiography for guidance of calcified lesions PCI: the CALIPSO (CAlcified Lesion Intervention Planning Steered by OCT) trial. EuroPCR2024.

DOCTORS-LM5

DOCTORS LM is a randomised open label trial to assess if OCT-guided PCI of the Left Main is superior to angio-guided PCI of the Left Main, assessed by Fractional Flow Reserve (FFR)

  • Primary endpoint: FFR value measured at the end of the procedure in the main vessel
  • Secondary endpoints:
    • Proportion of patients with optimal post-PCI FFR (≥90)
    • Minimal Stent Area
    • Procedural Success (optimal stent deployment, absence of malapposition, edge dissection or crushed stent)
    • MACE at 1 year

 

KEY RESULTS:

OCT-guided PCI showed similar functional outcomes in left main lesions compared to angio-guided PCI5

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OCT ILUMIEN IV TVF Chart

The incidence of TLR at 1 year was significantly lower in the OCT-guided PCI (p=0.020) than angio-guided PCI5

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OCT ILUMIEN IV TVF Chart

OCTOBER

OCTOBER trial was conducted in 38 heart centres across 13 European countries with n=1,201 patients randomised in a 1:1 ratio to undergo OCT-guided or angiography-guided PCI of bifurcation coronary lesions. A step-wise protocol was use in the OCT arm; in the angiography arm, intravascular ultrasound use was discouraged but could be pursued for left main (LM) PCI.

The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, target lesion myocardial infarction (TL-MI), and ischaemia-driven target lesion revascularisation (ID TLR), after two years.

 

KEY RESULTS:

OCT-guided PCI of complex bifurcation lesions is superior to angiography-guided PCI for major adverse cardiac events at 2 years2

  • MACE @ 2 years:
    (10.1% vs 14.1%, p=0.035)
  • Cardiac death:
    1.4% vs. 2.6% (HR 0.53, 95% CI 0.22–1.25)
  • ID TLR:
    2.8% vs. 4.6% (HR 0.60, 95% CI 0.32–1.13)
  • TL-MI:
    7.8% vs. 8.5% (HR 0.90, 95% CI 0.60–1.34)
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OCT ILUMIEN IV TVF Chart

From Evidence to Practice: A Pragmatic Approach to OCT.

Watch Dr. Johnson demonstrate how to apply OCT-guidance to a complex bifurcation case from a participant in the OCTOBER Trial with a highly challenging left main stent.

Additional body of evidence in support of OCT-guided PCI

Multiple other studies of OCT-guided PCI vs. angiography alone suggest that intravascular imaging with OCT is associated with better clinical performance6,8,10

STUDYSIZEOUTCOMES
CLI-OPCI I
(EuroIntervention, 2012)		335 pts OCT guided vs 335 pts angio-guidedReduced rate of cardiac death and MACE in patients who underwent OCT-guided stent intervention.6
ILUMIEN I
(EHJ, 2015)		418 ptsOCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.7
ILUMIEN III
(LANCET, 2016)		450 pts (158 OCT, 146 IVUS, 146 ANGIO)OCT- guided PCI resulted in superior stent expansion and procedural success compared to angiography-guided PCI.8
DOCTORS
(CIRC 2016)		240 pts NSTEMIIn patients with non-ST-segment elevation acute coronary sydromes, OCT-guided PCI is associated with higher post-procedure FFR than angio-guided PCI.9
PAN-LONDON
(JACC CARD INT, 2018)		1,149 pts OCT, 10,971 pts IVUS 75,046 pts angioOCT-guided PCI was associated with improved procedural outcomes, in-hospital events and long term survival compared with standard angiography-guided PCI.10

References

  1. Ali Z. et al., Optical Coherence Tomography–Guided versus Angiography-Guided PCI, NEJM, DOI: 10.1056/NEJMoa230586
  2. Holm N.R. et al., OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions, NEJM, DOI: 10.1056/NEJMoa2307770 (OCTOBER)
  3. Ali Z., et al. ILUMIEN IV: OCT-guided vs. angio-guided coronary stent implantation in complex lesions (Sub-group). EuroPCR2024.
  4. Amabile N., et all. OCT vs angiography for guidance of calcified lesions PCI: the CALIPSO trial. EuroPCR 2024 ​
  5. Meneveau N et al. Does OCT Optimise Results of Stenting on the Left Main: The randomized, controlled, multicentre DOCTORS-LM trial. EuroPCR 2024.
  6. Prati F. et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: (CLI-OPCI) study. EuroIntervention, 2012.
  7. Wijns W. et al. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. European Heart Journal (2015) 36, 3346–3355 doi:10.1093/eurheartj/ehv367.
  8. Z. Ali et al. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet: https://doi.org/10.1016/S0140-6736(16)31922-5.
  9. Menevue N. et al. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non–ST-Elevation Acute Coronary Syndrome DOCTORS: https://doi.org/10.1161/CIRCULATIONAHA.116.024393 Circulation. 2016;134:906–917.
  10. Jones, D. et al. Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention: Outcomes From the Pan-London PCI CohortPan London: JACC Cardiovasc Interv. 2018 Jul 23;11(14):1313-1321. doi: 10.1016/j.jcin.2018.01.274.

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