The headline in the New York Times summarized the initial reaction of the cardiology community – “unbelievable” – but still seemed to understate the ground-shaking implications of a recent study of coronary stenting.
The report of The Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA)Trial was published last week in the Lancet. In brief, investigators in the UK (hence “randomised”) enrolled about 200 patients with angina, objective evidence of inducible myocardial ischemia and angiographic and hemodynamic evidence of significant single vessel coronary artery disease. Half the group received a drug eluting stent, with excellent technical results. The other half got a sham angioplasty. Both groups were treated medically. The key finding: “real” stenting produced no measurable benefit in exercise time increment (the primary endpoint) compared with a “placebo procedure.” The study was well done, with true blinding of patients and evaluating physicians, careful selection of endpoints, and sufficient power to support the conclusion. Whoa.