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Randomized, Placebo-Controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention in Stable Angina
Key result
In patients with single-vessel CTO, CTO PCI improved the angina symptom score compared with a placebo procedure (OR 4.38; 95% CrI 1.57-12.69; Pr[Benefit]=0.996).
Why the trial?
Does CTO PCI improve angina symptoms in patients with stable angina attributable to a single-vessel CTO compared to a placebo procedure?
Population
50 patients with angina attributable to a single-vessel chronic total occlusion, without bystander coronary…
Comparison
Percutaneous coronary intervention for coronary… vs Placebo procedure. Antianginal medications were…
Design
RCT, Randomized, Blinded; maintained using auditory isolation and deep…
Follow-up
6 months
Authors
Discussion
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Implication
Supports CTO PCI for symptom relief in single-vessel CTO; confirms benefit in first placebo-controlled RCT and strengthens Class IIa guidance.
Key Points
- This study aims to evaluate the efficacy of chronic total occlusion percutaneous coronary intervention in improving symptoms of stable angina.
- Multicenter, randomized, blinded trial comparing CTO PCI with placebo procedure.
- Patients with single-vessel CTO and angina were included and randomized to CTO PCI or placebo after angiography.
- Symptom assessment continued through the ORBITA app over a 6-month follow-up.
- CTO PCI led to significant improvement in angina symptom score (OR: 4.38; 95% CrI: 1.57-12.69; Pr{Benefit} = 0.996).
- There was a clear reduction in angina episodes resulting in an additional 30.6 days free of angina (95% CrI: 11.1-50.7; Pr[Benefit] >0.999).
- Improvements observed in multiple quality of life metrics and maintained blinding throughout the trial.
Study Design
Type
RCT (n=50)
Blinding
Blinded
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does CTO PCI improve angina symptoms in patients with stable angina attributable to a single-vessel CTO compared to a placebo procedure?
P
Population
50 patients with angina attributable to a single-vessel chronic total occlusion (CTO), without bystander coronary disease.
I
Intervention
Percutaneous coronary intervention for coronary chronic total occlusion (CTO PCI). Antianginal medications were stopped at randomization and reintroduced on a patient-initiated protocol.
C
Comparator
Placebo procedure. Antianginal medications were stopped at randomization and reintroduced on a patient-initiated protocol.
O
Outcome
Angina symptom score (an ordinal scale combining the daily symptom burden assessed by the ORBITA app, antianginal use, and over-ride events) at 6-month follow-up.patient reported
Main Result
Effect estimate: OR 4.38 (95% CI 1.57-12.69)
p-value: Pr[Benefit] = 0.996
In the first placebo-controlled trial of CTO PCI, the procedure significantly improved angina symptoms and quality of life in patients with single-vessel CTO.
Cite This Study
Khan et al. (2026) conducted an RCT in Stable angina with single-vessel chronic total occlusion (n=50). Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI) vs. Placebo procedure was evaluated on Angina symptom score (ordinal scale combining daily symptom burden, antianginal use, and over-ride events) (OR 4.38, 95% CI 1.57-12.69, p=Pr[Benefit] = 0.996). In patients with single-vessel CTO, CTO PCI improved the angina symptom score compared with a placebo procedure (OR 4.38; 95% CrI 1.57-12.69; Pr[Benefit]=0.996).