ORBITA-CTO Shows PCI Improves Angina in Patients With Symptomatic Single-Vessel Coronary CTO

April 1, 2026—Results from the ORBITA-CTO trial demonstrated that percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) improved angina symptoms compared with a placebo procedure in patients with single-vessel disease. The results were presented at the American College of Cardiology’s Annual Scientific Session (ACC) and published in the Journal of the American College of Cardiology.

According to the announcement from ACC, the multicenter, randomized, blinded study enrolled 50 patients with symptomatic single-vessel CTO and no bystander coronary disease. Participants were assigned to CTO PCI or a placebo procedure, with blinding maintained through auditory isolation and deep conscious sedation. Antianginal medications were discontinued at randomization and reintroduced using a patient-initiated protocol. Outcomes were assessed at 6 months.

The primary efficacy outcome, which was defined as angina symptom score measured by the ORBITA-app along with antianginal use and override events, did improve in the placebo group. However, patients undergoing CTO PCI had greater and sustained improvement compared with placebo, driven largely by fewer angina episodes. Over a mean follow-up of 168 days, the PCI group experienced 31 additional angina-free days versus placebo.

Secondary analyses showed statistically significant improvements in quality-of-life measures and physician-assessed angina severity among patients treated with CTO PCI. No deaths, myocardial infarctions, or withdrawals due to worsening angina were reported during the study period, noted the press release.

“Our results demonstrate in a randomized, double-blinded study design that coronary angioplasty and stenting is an effective treatment for patients who have a chronic total occlusion and chronic anginal chest pain,” stated Principal Investigator John Davies, MRCP, PhD in the announcement from ACC. “These results provide hope for both patients with CTO and their doctors that angioplasty with stenting can be successful and can result in reduced angina pain and better quality of life.”

The press release noted several limitations, including the small sample size and enrollment at specialized centers with experienced operators. Patients with the most complex CTO anatomy were excluded, limiting applicability to higher-risk populations. Dr. Davies also stated that further studies are needed to clarify which patients derive the greatest benefit and to assess outcomes in more complex disease.