KEY RESULTS:

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:

CALIPSO³

CALIPSO Trail (Calcified Lesion Intervention Planning Steered by OCT) is the first controlled randomized 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 optimization.

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

KEY RESULTS:

DOCTORS-LM⁵

DOCTORS LM is a randomized 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:

OCTOBER

OCTOBER trial was conducted in 38 heart centres across 13 European countries with n=1,201 patients randomized 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 ischemia-driven target lesion revascularization (ID TLR), after two years.

KEY RESULTS:

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 performance^6,8,10

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.