Randomized, Placebo-Controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention in Stable Angina: The ORBITA-CTO Trial
Primary result · Angina symptom scoreResult — go to the resultOdds ratio 4.38 95% CrI 1.57–12.69Authors' conclusion
In patients with symptomatic single-vessel CTO, CTO PCI improves angina beyond placebo.
Study context
- Population
- Patients with angina attributable to a single-vessel CTO, without bystander coronary diseaseall 50 in primary analysis
- Participants
- 50 patients
- Comparison
- CTO PCI vs placebo procedure
- CTO PCIn = 25
- Placebon = 25reference
- Primary endpoint
- Angina symptom score (ordinal scale combining daily symptom burden by ORBITA app, antianginal use and over-ride events)
- Follow-up
- 6 months
Methodological detailsmulticentre, blinded, placebo-controlled
- Multicentre
- Blinded
- Placebo-controlled
Primary result
Angina symptom score
Odds ratio
4.38
95% CrI 1.57–12.69
CTO PCI vs Placebo
OR 4.38 (95% CrI 1.57–12.69)
As reported in the abstract
Secondary outcomes
| Outcome | OR (95% CrI) | |
|---|---|---|
| Number of angina episodes · CrI; Pr[Benefit] = 0.997 · CrI | 4.38 (1.55–11.78) | |
| 0.050.21520Odds ratio (log scale) |
Days free of angina
- Additional days free of angina
- 30.6 (95% CrI 11.1-50.7; Pr[Benefit] >0.999)
Seattle Angina Questionnaire angina frequency
- Improvement in SAQ angina frequency
- +10.7 (95% CrI 1.4-20.2; Pr[Benefit] = 0.988)
- Improvements also in SAQ physical limitation, quality of life, summary score and Canadian Cardiovascular Society class
Blinding fidelity
- Blinding of patients, staff and researchers maintained
Safety
Procedural complication leading to withdrawal
- Patient randomized to PCI withdrawn during the procedure because of a complication
- 1
Original publication
Randomized, Placebo-Controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention in Stable Angina: The ORBITA-CTO Trial. J Am Coll Cardiol. Published 29 March 2026. doi:10.
Summarised from the published abstract; every number is checked against it