ORBITA
Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 200 patients with stable single-vessel angina, PCI did not improve exercise time at 6 weeks compared with a sham procedure.
N
200
Schéma
Sham-controlled, double-blind RCT
Critère
Δ exercise time at 6 weeks
Pertinence
2
Résultat+28.4 s vs +11.8 s (p=0.20). No symptom advantage on blinded assessment.
Al-Lamee R, et al. Lancet. 2018;391(10115):31-40. 10.1016/S0140-6736(17)32714-9
Discussion et critique
First sham-controlled PCI trial — small, short follow-up, optimised medical therapy. Critics note it was underpowered for the angina-frequency endpoint; defenders point to the placebo effect for procedures.