Optical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI - ILUMIEN IV: OPTIMAL PCI

Sep 17, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Abbott
Date Presented:
08/27/2023
Date Published:
08/28/2024
Date Updated:
09/17/2024
Original Posted Date:
08/27/2023
References

Contribution To Literature:

Highlighted text has been updated as of September 17, 2024.

The ILUMIEN IV: OPTIMAL PCI trial failed to show that OCT-guided PCI improves clinical outcomes.

Description:

The goal of the trial was to evaluate optical coherence tomography (OCT)-guided revascularization compared with angiography-guided revascularization among patients undergoing percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel
  • Prospective

Patients undergoing PCI were randomized to OCT-guided revascularization (n = 1,233) vs. angiography-guided revascularization (n = 1,254).

  • Total number of enrollees: 2,487
  • Duration of follow-up: median 2 years
  • Mean patient age: 66 years
  • Percentage female: 23%
  • Percentage with diabetes: 41%

Inclusion criteria:

  • ≥18 years of age
  • Undergoing PCI
  • Evidence of myocardial ischemia
  • At high risk or had high-risk coronary artery lesions
  • High-risk characteristic defined as diabetes on medication, and/or non–ST-segment elevation myocardial infarction (NSTEMI) or STEMI, long or multiple lesions (planned total stent length ≥28 mm), bifurcation lesion, severe calcification, chronic total occlusion, in-stent restenosis

Exclusion criteria:

  • STEMI ≤24 hours from onset of ischemic symptoms
  • Creatinine clearance ≤30 ml/min/1.73 m2
  • Hypotension, shock, or need for mechanical support or intravenous vasopressors
  • Heart failure (Killip class ≥2 or New York Heart Association class ≥3)
  • Left ventricular ejection fraction ≤30% by the most recent imaging test within 30 days prior to procedure
  • Unstable ventricular arrhythmias

Principal Findings:

The primary imaging endpoint, acute minimal stent area, was 5.72 mm2 in the OCT group vs. in 5.36 mm2 the angiography group (p < 0.001).

The primary clinical endpoint, target vessel failure at 2 years: 7.4% in the OCT group vs. 8.2% in the angiography group (p = 0.45).

Secondary outcomes:

  • Definite or probable stent thrombosis: 0.5% in the OCT group vs. 1.4% in the angiography group (p = 0.02)

Outcomes in complex lesions:

  • Serious MACE (cardiac death, target vessel myocardial infarction, or stent thrombosis) at 2 years: 3.1% in the OCT group vs. 4.9% in the angiography group (p = 0.04)
  • Target vessel failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization) at 2 years: 7.3% in the OCT group vs. 8.8% in the angiography group (p = 0.2)

OCT predictors of adverse outcomes:

  • Out of 20 candidate variables for predicting target lesion failure, minimal stent area and proximal edge dissection were retained in the multi-variable model
  • Minimal stent area increase per 1 mm2: hazard ratio 0.76 (p < 0.001)
  • Proximal edge dissection: 1.77 (p = 0.004)

Interpretation:

Among patients undergoing coronary revascularization, OCT-guided PCI resulted in a small improvement in acute minimal stent area. Although there was no reduction in the primary clinical endpoint (target vessel failure), OCT was associated with a reduction in stent thrombosis vs. angiography. Among patients with complex lesions, OCT-guided PCI was associated with a reduction in serious MACE (cardiac death, target vessel myocardial infarction, or stent thrombosis vs. angiography-guided PCI). OCT predictors of target lesion failure were small stent area and proximal edge dissection. These results are directionally in line with IVUS studies, which documented a reduction in MACE for IVUS-guided PCI vs. angiography-guided PCI, especially for complex lesions.

References:

Landmesser U, Ali AZ, Maehara A, et al. Optical coherence tomography predictors of clinical outcomes after stent implantation: the ILUMIEN IV trial. Eur Heart J 2024;Aug 28:[Epub ahead of print].

Ali ZA, Landmesser U, Maehara A, et al., on behalf of the ILUMIEN IV Investigators. OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy. J Am Coll Cardiol 2024;84:368-78.

Editorial Comment: Gruberg L. Reluctance: The Ongoing Reality of Intravascular Imaging. J Am Coll Cardiol 2024;84:379-81.

Ali ZA, Landmesser U, Maehara A, et al., on behalf of the ILUMIEN IV Investigators. Optical Coherence Tomography–Guided Versus Angiography-Guided PCI. N Engl J Med 2023;389:1466-76.

Editorial: Dauerman HL. Optical Coherence Tomography — Light and Truth. N Engl J Med 2023;389:1523-5.

Presented by Dr. Ziad Ali at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 27, 2023.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Acute Coronary Syndrome, Coronary Angiography, ESC Congress, ESC23, Percutaneous Coronary Intervention, Tomography, Optical Coherence


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