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ORBITA: What Goes Around, Comes Around… Or Does It?

Matthew Jackson¹, Azfar Zaman¹

¹Freeman Hospital, High Heaton Newcastle-Upon-Tyne, UK.

Interventional Cardiology (London, England)

|November 17, 2018

Summary

Percutaneous coronary intervention (PCI) did not improve exercise time for stable angina patients on optimal medical therapy (OMT). The ORBITA trial suggests PCI may not be superior to placebo for symptom relief in select CAD patients.

Keywords:

ORBITA Stable angina coronary artery disease fraction-flow reserve percutaneous coronary intervention placebo controlled

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Area of Science:

Cardiology
Interventional Cardiology
Clinical Trials

Background:

Current guidelines suggest percutaneous coronary intervention (PCI) for stable angina despite optimal medical therapy (OMT).
Previous trials have not demonstrated a reduction in death or myocardial infarction with PCI.
The ORBITA trial investigated the efficacy of PCI in patients with stable angina and single-vessel coronary artery disease (CAD).

Purpose of the Study:

To compare the effectiveness of OMT plus PCI versus OMT plus a 'placebo' PCI in patients with stable angina and CAD.
To assess the impact of PCI on exercise capacity in patients with ongoing symptoms despite OMT.

Main Methods:

The ORBITA trial randomized patients with stable angina and single-vessel CAD to either OMT + PCI or OMT + 'placebo' PCI.
Exercise treadmill testing was used to measure the primary endpoint of change in exercise time after six weeks.
Patients were carefully selected, and invasive physiological testing was performed.

Main Results:

No significant difference in treadmill exercise time was observed between the OMT + PCI group and the OMT + 'placebo' PCI group.
The trial demonstrated the feasibility of placebo-controlled trials for invasive cardiac procedures.
Despite the methodology, the results were interpreted by some as questioning the role of PCI in stable angina management.

Conclusions:

While methodologically significant, the ORBITA trial's highly selected population and specific patient characteristics limit its generalizability.
The trial does not negate the potential benefit of ischaemia-guided revascularisation for patients whose symptoms persist despite optimal medical therapy.
Further research is needed to clarify the role of PCI in managing stable angina symptoms refractory to medical treatment.