A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina
Authors' conclusion
Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina.
Study context
- Population
- Patients with stable angina off all antianginal medications, with objective evidence of ischemia
- Participants
- 301 patients
- Comparison
- Percutaneous coronary intervention (PCI) vs placebo procedure
- PCIn = 151
- Placebon = 150reference
- Primary endpoint
- Angina symptom score (daily; angina episodes, antianginal medications, clinical events; range 0–79, higher = worse)
- Follow-up
- 12 weeks
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
Mean angina symptom score
Odds ratio
2.21
95% CI 1.41–3.47
P < 0.001
By group
PCI
2.9
mean
Placebo
5.6
mean
PCI vs Placebo
OR 2.21 (95% CI 1.41–3.47); P < 0.001
As reported in the abstract
Safety
Events
| Outcome | PCI | Placebo | |
|---|---|---|---|
| ACS | 4 | 6 | |
| Unacceptable angina leading to unblinding | Not reported in the abstract | 1 | PCI: not reported in the abstract |
Original publication
A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina. N Engl J Med. Published 11 November 2023. doi:10. 1056/ nejmoa2310610
Summarised from the published abstract; every number is checked against it