- Question
- Does PCI guided by optical coherence tomography (OCT) achieve a better stent result and better clinical outcomes than PCI guided by angiography alone?
- Design
- Prospective, randomized, single-blind trial conducted at 80 sites in 18 countries. A total of 2487 patients were randomized; in the angiography group, a blinded final OCT was performed to measure the stent result.
- Population
- Patients undergoing percutaneous coronary intervention (PCI) who had medication-treated diabetes or complex coronary lesions.
- Intervention
- OCT-guided PCI (1233 patients), with imaging before and after stent implantation following a protocol-defined algorithm and a final OCT run at the end of the procedure.
- Control
- Angiography-guided PCI according to local standard practice (1254 patients), with a blinded final OCT to document stent dimensions.
- Primary outcome
- Two primary efficacy end points: minimum stent area after PCI as assessed by OCT, and target-vessel failure at 2 years, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization.
- Results
- Minimum stent area was 5.72±2.04 mm2 with OCT and 5.36±1.87 mm2 with angiography (mean difference 0.36 mm2; 95% CI 0.21 to 0.51; P<0.001). Target-vessel failure at 2 years occurred in 88 patients in the OCT group and 99 in the angiography group (Kaplan-Meier estimates 7.4% and 8.2%; HR 0.90; 95% CI 0.67 to 1.19; P=0.45).
- Safety
- OCT-related adverse events occurred in 1 patient in the OCT group and 2 in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) with OCT and 17 (1.4%) with angiography.
- Conclusion
- OCT guidance produced a larger minimum stent area than angiography guidance, but there was no apparent difference in target-vessel failure at 2 years.
- Why it matters
- It provided randomized evidence on the use of intracoronary imaging to optimize stent implantation, showing better stent expansion without a clear difference in the main clinical events.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026