ORBITA-2 Clarifies the Role of PCI for Stable Angina

The American Heart Association’s Scientific Sessions 2023 (AHA23) was a hub of groundbreaking clinical trials, including the ORBITA-2 trial, which emerged as a key highlight. Presented by Dr. Christopher Rajkumar under the mentorship of Dr. Rasha Al-Lamee, this trial marked a significant advancement in understanding and treating stable angina.

The original ORBITA trial showed no significant difference in exercise capacity between percutaneous coronary intervention (PCI) or sham procedure in stable patients with angina on maximum antianginal therapy. While these findings contributed important data to the management of stable angina, recent literature revealed that 47% of patients were on 0 or 1 antianginal therapies at the time of elective cardiac catheterization. Dr. Al-Lamee’s revelation from a patient survey further sparked curiosity, indicating that the majority of patients preferred enduring pain over being on multiple antianginal medications.

This revelation set the stage for the ORBITA-2 trial, which demonstrated substantial improvements in the angina symptom score with PCI, compared with a sham procedure, for patients with stable angina and objective evidence of ischemia who were not on antianginal therapy. Notably, the use of an angina symptom score, which took into account the number of angina episodes on a daily basis, in addition to the number of units of antianginal medications used per day, was one of the aspects that stood out. Furthermore, daily symptoms were tracked by a smartphone application that patients used to answer questions about the presence of angina, the number of episodes, and the intensity of symptoms, facilitating data collection and evaluation. This approach offered insights into stable angina symptoms and provided a practical way to monitor patient activity and optimize antianginal medication prescription algorithms.

As Dr. Al-Lamee eloquently emphasized, ORBITA-2 suggests a second pathway in the management of stable angina, which differs from what we already have in the guidelines. It proposes considering angioplasty upfront, before antianginals, for maximum benefit. Both pathways have their own pros, cons, limitations, and, of course, their own costs, leaving physicians to decide which suits their patients best.

Dr. Al-Lamee and her team shared that this is only the start of a series of trials set to better understand stable angina. Beyond the ongoing meta-analysis of the ORBITA and ORBITA-2 trials, ORBITA-STAR and ORBITA-COSMIC stand out by leveraging the use of technology in clinical trials. In these trials, smartwatch technology is being used to track daily activity levels along with parameters such as daily heart rate variability. This deliberate embrace of wearable health technology highlights a dedicated commitment to unraveling the complexities of stable angina.

By adopting a patient-centric approach, integrating technological solutions, and incorporating a sham procedure as the placebo comparator, the ORBITA-2 trial deepened our understanding and paved the way for more extensive trial designs.

The journey continues, with future trials and ongoing research shaping the stable angina treatment landscape and offering hope for enhanced outcomes and improved patient quality of life.

Dr. Nazli Okumus, a third-year cardiology fellow at the Allegheny Health Network in Pittsburgh, served as a CardioNerds Conference Scholar for the American Heart Association’s Scientific Sessions 2023.

References

1. Al-Lamee R, Thompson D, Dehbi HM, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31-40. doi:10.1016/S0140-6736(17)32714-9
2. Ganesananthan S, Rajkumar CA, Foley M, Francis D, Al-Lamee R. (2022). Remote digital smart device follow-up in prospective clinical trials: early insights from ORBITA-2, ORBITA-COSMIC, and ORBITA-STAR. Eur Heart J Suppl.  doi:10.1093/eurheartjsupp/suac058
3. Rajkumar CA, Foley MJ, Ahmed-Jushuf F, et al., on behalf of the ORBITA-2 investigators. A placebo-controlled trial of percutaneous coronary intervention for stable angina.N Engl J Med. 2023. doi:10.1056/NEJMoa2310610
4. Shen L, Vavalle JP, Broderick S, Shaw LK, Douglas PS. Antianginal medications and long-term outcomes after elective catheterization in patients with coronary artery disease. Clin Cardiol. 2016;39(12):721-727. doi: 10.1002/clc.22594