ORBITA-2 Saves Interventional Cardiology and Challenges Current Guidance

When Christopher Rajkumar, MD, presented the positive results of ORBITA-2, the second placebo-controlled trial of percutaneous coronary intervention (PCI) in stable angina, you could almost feel the relief of cardiologists at the American Heart Association meeting.

All is right again. Thank goodness.

The first ORBITA trial stunned our community when it showed that PCI compared with a placebo procedure had little to no effect on exercise time or symptoms in patients with severe single-vessel coronary artery disease. It didn't make sense because we had all seen patients feel better after a major obstruction was relieved.

ORBITA-2 also tested the placebo-resistant ability of PCI to improve symptoms, but its design led to different results.

ORBITA-2 found that among patients with stable angina and confirmed evidence of ischemia due to a severe narrowing, PCI significantly reduced angina symptoms and improved exercise time vs a placebo procedure.

The key difference between the two trials is that patients in ORBITA-2 had their antianginal medicines held for 2 weeks before randomization.

The ORBITA-1 and ORBITA-2 Trials

Here are 10 points to remember from the two ORBITA trials.

1. ORBITA allowed only patients with single-vessel disease; ORBITA-2 allowed multivessel disease, but 80% of enrolled patients had single-vessel disease.

2. ORBITA-2 required the lesion in question to be objectively significant by either a noninvasive stress test or hemodynamic test in the lab.