A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina

The ORBITA-2 trial, a double-blind, randomized, placebo-controlled study evaluated the effect of PCI versus placebo in 301 patients with stable angina, minimal antianginal medication, and objective ischemia. After a 2-week baseline symptom phase, patients were randomized to PCI or a placebo procedure under deep sedation and followed for 12 weeks. The primary endpoint was a novel angina symptom score incorporating daily self-reported symptoms via smartphone, medication usage, and adverse clinical events (range: 0–79). PCI significantly reduced angina scores (mean: 2.9 vs. 5.6; OR 2.21; P<0.001) and angina episodes (mean: 0.3 vs. 0.7/day; OR 3.44), with improved CCS class, treadmill time, SAQ scores, and stress echocardiography ischemia. Serious adverse events were rare and balanced across groups, except for more spontaneous MIs in the placebo group (n=6 vs. 0). Blinding integrity was rigorously assessed and maintained. The trial demonstrated PCI as effective angina monotherapy for symptom relief in stable ischemic heart disease.

The ORBITA-2 trial, a double-blind, randomized, placebo-controlled study evaluated the effect of PCI versus placebo in 301 patients with stable angina, minimal antianginal medication, and objective ischemia. After a 2-week baseline symptom phase, patients were randomized to PCI or a placebo procedure under deep sedation and followed for 12 weeks. The primary endpoint was a novel angina symptom score incorporating daily self-reported symptoms via smartphone, medication usage, and adverse clinical events (range: 0–79). PCI significantly reduced angina scores (mean: 2.9 vs. 5.6; OR 2.21; P<0.001) and angina episodes (mean: 0.3 vs. 0.7/day; OR 3.44), with improved CCS class, treadmill time, SAQ scores, and stress echocardiography ischemia. Serious adverse events were rare and balanced across groups, except for more spontaneous MIs in the placebo group (n=6 vs. 0). Blinding integrity was rigorously assessed and maintained. The trial demonstrated PCI as effective angina monotherapy for symptom relief in stable ischemic heart disease.