Percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains a topic of ongoing debate in stable angina, with persistent uncertainty regarding its role in European and North American guidelines.
The aim of the ORBITA-CTO trial was to determine whether CTO-PCI improves angina symptoms compared with a placebo procedure in patients with stable angina, ischemia, and viability, using a randomized, placebo-controlled design.
Patients with single-vessel CTO, evidence of ischemia and viability, symptoms of angina or angina equivalent, and anatomy deemed feasible for treatment by consensus, with a J-CTO score ≤3, were included. The protocol included a 2-week pre-randomization phase of medical optimization and symptom assessment, with antianginal therapy titration and daily angina frequency recording using a smartphone application. Antianginal medications were discontinued prior to invasive randomization.
All patients underwent bilateral access, dual angiography, sedation, and auditory isolation. They were randomized to CTO-PCI or a placebo procedure, followed by protocolized recovery and blinded follow-up for 24 weeks, with reintroduction of antianginal therapy at the patient’s discretion and daily symptom tracking via the app. The primary endpoint was the angina symptom score (including angina episodes, antianginal medication use, and unacceptable coronary events).
A total of 50 patients were randomized: 25 to CTO-PCI and 25 to placebo. CTO-PCI significantly improved the angina symptom score, with an odds ratio of 4.38 (credible interval [CrI] 1.57 to 12.69) and a 99.6% probability of benefit. Additionally, the invasive strategy was associated with 30.6 additional angina-free days compared with placebo (CrI 11.1 to 50.7), with a probability of benefit >99.9%.
Regarding secondary endpoints, no clear differences were observed in antianginal medication use (estimate 1.54; CrI 0.37 to 6.46; probability of benefit 71.5%).
Conclusions: CTO-PCI significantly improves angina symptoms compared to placebo
In patients with stable angina, ischemia and viability, and lesions with J-CTO ≤3, CTO-PCI improved angina symptoms according to the angina symptom score, with an immediate effect sustained at 24 weeks and consistent across endpoints.
Presented by Sarosh Khan at Late-Breaking Clinical Trials, ACC.26, March 28–30, New Orleans, USA.
Subscribe to our weekly newsletter
Get the latest scientific articles on interventional cardiology
 de las oclusiones coronarias crónicas totales (CTO) continúa siendo un terreno de debate en el contexto de la angina estable, con persistente incertidumbre en su manejo según las guías europeas y norteamericanas.){kind=link}