ORBITA

About the Trial

ORBITA enrolled 230 patients with single vessel stable angina and, after a medication optimization phase, randomized 200 to PCI or a sham procedure, coronary catheterization without balloon or stent, with 6 weeks of blinded follow up. The difference in exercise time increment, the primary endpoint, was 16.6 seconds and not significant. PCI did reduce ischemia on stress echocardiography, but not patient reported angina frequency. As the first sham controlled PCI trial, ORBITA put interventional placebo effects on the map, echoing the angina debates of 1950s internal mammary ligation. It reframed stents in stable disease as symptom relief therapy, not life extending intervention, complementing COURAGE and ISCHEMIA.