ORBITA-2
A Placebo-Controlled Trial of PCI for Stable Angina
Patient / Population Intervention / Exposure Comparison Outcome
In 301 patients with stable angina on no antianginal medication, PCI improved the angina symptom score compared with a placebo procedure.
N
301
Design
Sham-controlled, double-blind RCT
Endpoint
Angina symptom score
Relevance
2
ResultSymptom score better after PCI (OR 2.21, p<0.001). Corrects the negative ORBITA result.
Rajkumar CA, et al. N Engl J Med. 2023;389(25):2319-2330. 10.1056/NEJMoa2310610
Discussion & critique
Removing background antianginals (unlike ORBITA) unmasked a genuine symptom benefit of PCI. The endpoint is symptom-based rather than exercise time; the procedural placebo effect remains relevant.