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OCT vs Angiography

OCT vs ANGIO

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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 randomized 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

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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 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:

OCT-guided PCI of complex bifurcation lesions is superior to angiography-guided PCI for major adverse cardiac events 2 years3

  • MACE @ 1 year:
    (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 Angiography OCTOBER Trial Chart

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 performance3,5,7

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.3
ILUMIEN I
(EHJ, 2015)		418 ptsOCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.4
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.5
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.6
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.7

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. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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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