Coronary Disease2018The Lancet

ORBITA

Objective Randomised Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina

Sample Size

200

Study Design

Single-center, double-blind, randomized, sham-controlled trial

Year Published

2018

Clinical Question

Does PCI improve exercise capacity beyond optimal medical therapy in patients with stable angina and single-vessel coronary disease when compared with a sham procedure?

Population

Patients with angina, single-vessel coronary disease with ≥70% stenosis, and evidence of ischemia on stress echocardiography, after a 6-week optimization phase on maximally tolerated antianginal medication.

Intervention

PCI with drug-eluting stent implantation

Control

Sham procedure (cardiac catheterization with no intervention, with patients sedated and unaware of assignment)

Primary Endpoint

Increment in exercise time from baseline to 6 weeks post-procedure

Key Findings

Exercise time improved by 28.4 seconds in the PCI group vs 11.8 seconds in the sham group (difference 16.6 seconds; 95% CI, -8.9 to 42.0; p=0.20).

There was no significant difference in peak oxygen consumption, angina frequency, or quality of life between PCI and sham at 6 weeks.

Fractional flow reserve (FFR) improved significantly more with PCI (from 0.69 to 0.90) than sham (0.72 to 0.76).

Duke treadmill score and dobutamine stress echo wall motion improved more with PCI, confirming physiologic benefit despite no symptom improvement.

Seattle Angina Questionnaire scores improved similarly in both groups, suggesting a substantial placebo effect.

Impact on Clinical Practice

ORBITA was a provocative trial that challenged one of the most fundamental assumptions in interventional cardiology: that opening a blocked artery relieves angina. By using a sham procedure as the control, ORBITA isolated the true effect of PCI from the placebo response and demonstrated that much of the perceived benefit of PCI for stable angina may be due to placebo effect. The trial generated intense debate. Critics pointed to its small size, short follow-up, and the fact that patients were already on optimized medical therapy. Supporters argued that it exposed an uncomfortable truth about the limits of PCI in stable disease and highlighted the power of the placebo effect in procedural medicine. ORBITA reinforced the ISCHEMIA trial's message that revascularization for stable coronary disease may not provide the symptomatic benefits traditionally assumed. It stimulated important conversations about evidence-based practice, patient expectations, and the need for rigorous trial design in interventional cardiology. The subsequent ORBITA-2 trial (2023) showed a modest angina benefit of PCI when patients were taken off antianginal medications.

Guideline Impact

ORBITA contributed to the growing evidence base supporting a medical-therapy-first approach in stable angina. It is cited in the 2021 ACC/AHA Chest Pain Guideline as supporting conservative management in patients with stable symptoms adequately controlled on medical therapy.

Limitations

Very small sample size (200 patients) limits statistical power and generalizability.

Six-week follow-up is extremely short and may miss longer-term symptom benefits of revascularization.

Single-vessel disease only; results may not apply to multivessel disease or more complex anatomy.

Reviewed by Sandeep M. Patel, MD

Structural & Interventional Cardiologist

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ISCHEMIA

2020 · New England Journal of Medicine

FAME 2

2012 · New England Journal of Medicine

stable angina coronary artery disease pci vs medical therapy

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