Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

PCI vs Placebo Procedure for Angina Relief

Lancet; ePub 2017 Nov 2; Al-Lamee, et al

In patients with medically treated angina and severe coronary stenosis, percutaneous coronary intervention (PCI) did not increase exercise time by more than the effect of a placebo procedure, a recent study found. 230 patients with ischemic symptoms and enrolled in the ORBITA double-blind, randomized controlled trial of PCI vs placebo procedure for angina relief received 6 weeks of medication optimization. Patients then had pre-randomization assessments with cardiopulmonary exercise testing, symptom questionnaires, and stress echocardiography. Patients were randomized 1:1 to undergo PCI or placebo procedure. After 6 weeks of follow-up, assessment done before randomization were repeated. The primary endpoint was difference in exercise time increment between groups. Researchers found:

  • After the medication optimization phase, 200 patients underwent randomization, with 105 assigned PCI and 95 assigned the placebo procedure.
  • There was no significant difference in the primary endpoints of exercise time increment between groups.
  • There were no deaths and serious adverse events included 4 pressure-wire related complications in the placebo group and 5 major bleeding events, including 2 in the PCI group.


Al-Lamee R, Thompson D, Dehbi HM, et al. Percutaneous coronary intervention in stable angina (ORBITA): A double-blind, randomized controlled trial. [Published online ahead of print November 2, 2017]. Lancet. doi:10.1016/S0140-6736(17)32714-9.


Quite simply, PCI has little or no place in the treatment of stable coronary artery disease except for the control of recalcitrant symptoms. Reported in 2007, the COURAGE trial randomized 2,287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease to PCI with optimal medical therapy (PCI group) or optimal medical therapy alone. The 4.6-year primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group, showing no statistical difference between the 2 groups.1 There were no differences in death, myocardial infarction, or stroke. Optimal medical therapy included aggressive therapy to lower low-density lipoprotein (LDL) cholesterol with a target of 60 to 85 mg/dL, antiplatelet therapy, treatment of hypertension, smoking, and anti-ischemic therapy. Two-thirds of the patients enrolled had multi-vessel coronary disease. The rationale given then for performing PCI in patients with stable coronary disease has been that PCI improves exercise capacity. The current study shows that PCI does not achieve that goal either. For patients with stable coronary artery disease, the evidence supports that optimal medical therapy achieves equal outcome to PCI with regard to both hard outcomes as well as exercise capacity. —Neil Skolnik, MD

  1. Bowden WE, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503­1516. doi:10.1056/NEJMoa070829.