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.
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, 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)
Interpretation:
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.
References:
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;Aug 27:[Epub ahead of print].
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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