- Question
- Does preventive percutaneous coronary intervention of non-flow-limiting vulnerable plaques improve clinical outcomes compared with optimal medical therapy alone?
- Design
- Multicentre, open-label, randomised 1:1 trial at 15 hospitals in four countries (South Korea, Japan, Taiwan and New Zealand), with 1606 patients randomised and annual follow-up until the last patient reached 2 years; randomisation was stratified by diabetes and by PCI in a non-study target vessel.
- Population
- Patients aged 18 years or older with non-flow-limiting vulnerable coronary plaques (fractional flow reserve above 0.80) identified by intracoronary imaging.
- Intervention
- Percutaneous coronary intervention of the vulnerable plaque plus optimal medical therapy (803 patients).
- Control
- Optimal medical therapy alone (803 patients).
- Primary outcome
- Composite of cardiac death, target-vessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalisation for unstable or progressive angina at 2 years, in the intention-to-treat population.
- Results
- At 2 years the primary outcome occurred in 3 patients (0.4%) in the PCI group and 27 (3.4%) in the medical therapy group (absolute difference -3.0 percentage points; 95% CI -4.4 to -1.8; p=0.0003). The effect was directionally consistent for each component of the composite.
- Safety
- Serious clinical or adverse events did not differ between groups: 2-year death occurred in 4 (0.5%) versus 10 (1.3%) patients and myocardial infarction in 9 (1.1%) versus 13 (1.7%).
- Conclusion
- In patients with non-flow-limiting vulnerable plaques, preventive PCI reduced major adverse cardiac events arising from those plaques compared with optimal medical therapy alone.
- Why it matters
- It was the first large trial to suggest a benefit of focal treatment of vulnerable plaques, prompting discussion about expanding PCI indications to high-risk plaques that do not limit flow.
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