PHILADELPHIA—The Society for Cardiovascular Angiography & Interventions (SCAI) congratulates the investigators of the ORBITA-2 trial on their late-breaking research presented today at the American Heart Association 2023 Scientific Sessions and simultaneously published in the New England Journal of Medicine.

ORBITA-2 is the first placebo-controlled trial to confirm the benefit of percutaneous coronary intervention (PCI) for patients with stable ischemic heart disease. The trial confirmed PCI is feasible and effective at relieving angina and increasing physical performance in appropriately selected patients.

“The ORBITA-2 trial is a well-designed and executed study despite great challenges,” George D. Dangas, MD, PhD, MSCAI, president of SCAI. “While study enrollment was small the results show unequivocal anginal benefit from PCI, without the use of medication in ischemic patients.”

“SCAI recommends the use of PCI for symptom relief in appropriate patients. ORBITA-2 confirms the benefit of PCI in helping stable ischemic heart disease patients, consistent with other prior trials,” he added.

ORBITA 1&2 Trials: Outcomes & Considerations

The first ORBITA trial followed guidelines advocating revascularization as an add-on therapy for symptom relief, not as an initial treatment option, and randomized patients to either PCI or a placebo-controlled procedure on a background of maximally tolerated antianginal medications. To truly test the efficacy of PCI, ORBITA-2 was designed to test PCI without background antianginal medication, in which setting substantial benefit was seen.

It is important to note that despite successful PCI with resolution of ischemia, residual symptoms persist in many patients.

The ORBITA-2 trial findings underscore the importance of shared medical decision-making between physicians and patients. SCAI encourages the development of individualized treatment plans to ensure the best patient-centered care possible.

Ischemic heart disease impacts more than 13 million people in the United States and is the leading cause of death and disability worldwide. During the last 40 years, evidence generated through objective research has defined the benefits of PCI in patients with ischemic heart disease who have limiting symptoms despite appropriate medical therapy and remains an important method of managing advanced ischemia.

SCAI is committed to supporting clinical research and data that translates into better decision-making between physicians and their patients.