Sham-Controlled Trial Questions Benefit of Stents for Stable Angina.

Abstract

A sham-controlled trial has raised questions about the benefit of percutaneous coronary intervention (PCI) for patients with stable angina and has demonstrated the need for more sham-controlled trials in interventional cardiology. The results of the ORBITA trial (Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina) were presented at the Transcatheter Cardiovascular Therapeutics meeting in November and simultaneously published in the Lancet . Patients who received PCI did not perform significantly better than the control group on exercise time. It was the first time a sham-controlled arm has been used in a trial of PCI in stable angina despite the fact that more than half a million patients undergo the procedure worldwide each year, explained lead author Rasha Al-Lamee, MD, an interventional cardiologist at the National Heart & Lung Institute at Imperial College London. The results of the ORBITA trial (Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina) add to doubts about the value of percutaneous coronary intervention in patients with stable angina. Sham-controlled trials are necessary and feasible for cardiology interventions with symptomatic or subjective end points. “In 40 years of performing angioplasty for stable angina, we’ve never done this trial,” Al-Lamee said. The results add to doubts about the value of PCI in patients with stable angina, although experts disagree about whether …