Unveiling the ILUMIEN IV Trial: A New Era of Percutaneous Coronary Intervention
The ILUMIEN IV: OPTIMAL PC Trial, conducted in 2023, is a landmark study that compares the efficacy of Optical Coherence Tomography (OCT)-guided coronary stent implantation to the traditional angiography-guided approach in patients undergoing percutaneous coronary intervention (PCI).
Objective of the ILUMIEN IV Trial
The objective of this prospective, randomized, single-blind trial was to evaluate whether OCT-guided revascularization could improve the procedural outcomes compared to angiography-guided revascularization among patients undergoing PCI.
Study Population and Criteria
The ILUMIEN IV Trial enrolled 2,487 patients, with inclusion criteria encompassing individuals aged ≥18 years, undergoing PCI, presenting evidence of myocardial ischemia, and at high risk or with high-risk coronary artery lesions. Notably, patients with STEMI within 24 hours, low creatinine clearance, hypotension, shock, or heart failure with a left ventricular ejection fraction (LVEF) ≤30% were excluded from participation.
Trial Groups and Methods
Patients were divided into two cohorts: 1,233 received OCT-guided revascularization, while 1,254 underwent angiography-guided revascularization.
Outcomes of the ILUMIEN IV Trial
Primary Outcomes
The study revealed the following primary outcomes:
- Acute minimal stent area was larger in the OCT-guided group (5.72 mm2) compared to the angiography-guided group (5.36 mm2), with a mean difference of 0.36 mm2, which was statistically significant (P < 0.001).
- There was no significant difference in target vessel failure within 2 years between the OCT-guided (7.4%) and angiography-guided (8.2%) groups.
Secondary Outcome
- Stent thrombosis within 2 years occurred in 0.5% of the OCT-guided group and 1.4% of the angiography-guided group, with no statistically significant difference (P = 0.45).
Conclusion and Clinical Implications
The ILUMIEN IV Trial concluded that OCT guidance resulted in a larger minimum stent area compared to angiography guidance. However, there was no significant difference in the rate of target vessel failure at 2 years between the two groups. This suggests that while OCT can improve certain procedural metrics, overall long-term outcomes may be unaffected.
The results of the ILUMIEN IV Trial contribute to the evolving body of evidence in cardiac care, suggesting that OCT could be a valuable tool in the optimization of PCI procedures.