- Question
- Does percutaneous coronary intervention (PCI) improve symptoms and exercise capacity in patients with stable angina and severe single-vessel stenosis compared with a placebo procedure?
- Design
- Multicentre, 1:1 randomised, double-blind trial conducted at five UK sites. After 6 weeks of medication optimisation, 200 patients were randomised (105 to PCI and 95 to a placebo procedure) and reassessed after 6 weeks of follow-up.
- Population
- Patients with ischaemic symptoms and severe (â„70%) single-vessel coronary stenoses. Lesions had a mean area stenosis of 84.4%, fractional flow reserve of 0.69 and instantaneous wave-free ratio of 0.76.
- Intervention
- PCI plus optimised medical therapy.
- Control
- A placebo (sham) procedure plus optimised medical therapy, with risk factor modification and anti-anginal treatment.
- Primary outcome
- Between-group difference in exercise time increment (cardiopulmonary exercise testing) from the pre-randomisation assessment to the final assessment.
- Results
- There was no significant difference in exercise time increment: PCI minus placebo 16.6 s (95% CI -8.9 to 42.0; p=0.200).
- Safety
- There were no deaths. Four pressure-wire related complications in the placebo group required PCI, and there were five major bleeding events (two in the PCI group and three in the placebo group).
- Conclusion
- In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time beyond the effect of a placebo procedure.
- Why it matters
- It was the first blinded, placebo-controlled trial of PCI in stable angina and showed that the efficacy of an invasive procedure can be assessed with a sham control, prompting a reappraisal of the role of PCI for symptom relief.
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