Last week, the results of ORBITA were published. This clinical trial tested coronary angioplasty and stenting versus optimal medical management in patients with single-vessel coronary artery disease. It was a resoundingly negative trial, meaning that adding stenting to drug management didn’t result in detectable clinical improvement. What was distinctive about this trial is that it used a sham procedure (i.e., placebo) control, which few trials testing surgery or a procedure use. The results of ORBITA emphasize how important sham procedure controls are, whenever they can be ethically used, and how resistant physicians can be to change.
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