The ORBITA Trial

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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. 

Results:

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)

 

Comments 1

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    Author

    SCAI President Dr. Kirk Garratt must have forgotten the results of other trials that reached similar conclusions:

    As reported in the COURAGE Trial in 2007, an initial management strategy involving 2287 patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy.

    Although the addition of PCI to optimal medical therapy reduced the prevalence of angina, it did not reduce long term rates of death, non-fatal myocardial infarction, and hospitalization for acute coronary syndromes.

    Likewise, in 2009 the BARI 2D Trial showed that 5 year survival rates of 2368 patients with both diabetes and coronary disease did not differ significantly between the revascularization (PCI or CABG) group (88.3%) and the medical-therapy group (87.8%, P=0.97).

    BARI 2D shows that for many patients with both diabetes and coronary disease, optimal medical therapy rather than any intervention is an excellent first-line strategy, particularly for those with less severe disease. When revascularization is indicated, both BARI 2D and other studies support the use of CABG as the preferred approach, unless or until future studies indicate otherwise.

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