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

Contribution To Literature:

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


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, was: 7.4% in the OCT group vs. 8.2% in the angiography group (p = 0.45).

Secondary outcomes:

  • Stent thrombosis: 0.5% in the OCT group vs. 1.4% in the angiography group (p = 0.45)


Among patients undergoing coronary revascularization, OCT-guided PCI resulted in a small improvement in acute minimal stent area; however, this did not improve clinical outcomes compared with angiography-guided PCI.


Highlighted text has been updated as of October 20, 2023.

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, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Acute Coronary Syndrome, Computed Tomography, Coronary Angiography, Diagnostic Imaging, ESC Congress, ESC23, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Tomography, Optical Coherence

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