Percutaneous Coronary Intervention in stable angina
PCI was no better than a sham procedure at providing relief to stable angina patients, the ORBITA trial showed.
Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.
The ORBITA trial studied 230 patients with ischemic symptoms, randomizing 105 patients to PCI and 95 to a placebo procedure.
In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure.
The Society for Cardiovascular Angiography and Interventions (SCAI) quickly signaled that it doesn’t agree.
“We applaud the investigators for their innovative use of a sham procedure, but we’re concerned about the reliability and interpretation of the findings. The number of patients studied was very small, so the study is far from conclusive. The primary endpoint used, exercise tolerance, is imprecise and very subjective: patient tolerance of exercise normally varies from week to week, so differences of a few seconds in exercise tolerance are hard to interpret,” SCAI President Kirk Garratt, MD, said in a statement.
ORBITA lead author Rasha Al-Lamee, MD, of Imperial College London, disagreed with the editorialists. “This is the first placebo-controlled trial of PCI. It may be used in guideline discussions, but guidelines should be used for whole populations.”
Importantly, the ORBITA population was relatively low-risk at baseline and presented with good exercise scores to begin with.
“To extrapolate the results to patients with high risk would be perhaps an overimplication of these results,” Al-Lamee said at a press conference. “To use this to downgrade guidelines would be an incredibly large overreach.”
(From: Source Reference: Al-Lamee R, et al “Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial” The Lancet 2017; DOI: 10.1016/S0140-6736(17)32714-9)