Clinical Question

Do patients with stable angina and severe coronary artery stenosis treated with percutaneous interventions (PCIs) have greater improvement in exercise tolerance than those treated with sham PCI?

Bottom Line

In patients with stable angina and severe coronary artery disease (CAD), PCI plus optimal medical treatment does not improve exercise tolerance or angina more than sham PCI plus optimal medical treatment. (Level of Evidence = 1b)

Synopsis

We have reported multiple studies for approximately 20 years that have shown that mortality and cardiac events are comparable for patients with stable angina who are treated medically, with PCI, or with bypass. These authors wanted to see if the exercise tolerance of patients with stable angina and severe coronary stenosis (at least 70% stenosis in one or more vessels) improved more with PCI compared with aggressive guideline-guided medical treatment. All patients completed a six-week medical optimization period followed by a prerandomization baseline assessment. The researchers then randomized patients to receive PCI (n = 105) or placebo intervention (catheterization without intervention). Including a sham intervention makes this study unique. All patients received dual antiplatelet therapy until the final assessment at six weeks after intervention. Four of the placebo-treated patients had a procedural complication that resulted in PCI but were analyzed in the placebo group. After six weeks, each group had a few seconds of increased exercise time but the difference in improvement was not significant. Additionally, there were no differences in physical limitation, angina frequency, or angina stability. Finally, the authors found no differences in quality of life.

Study design: Randomized controlled trial (double-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (specialty)

Reference: Al-LameeRThompsonDDehbiHMet alORBITA investigatorsPercutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial [published correction appears in Lancet. 2018;391(10115):30]. Lancet2018;391(10115):31–40.