PCI in patients with stable angina improves angina symptom score

AHA 2023 In the ORBITA-2 study, PCI improved the angina symptom score in patients with stable angina with ischemia but without antianginal medication.

Presented at the AHA Scientific Sessions 2023 by: Christopher Rajkumar - London, UK

Introduction and methods

Background and aim of the study

The 2021 ACC/AHA/SCAI guideline for coronary artery revascularization recommend revascularization as an add on therapy, in patients with refractory angina who continue to have symptoms despite maximal antianginal medical therapy. The previous ORBITA trial randomized patients with single vessel disease to either PCI or a placebo on a background of maximally tolerated antianginal medications. The results showed that PCI offers little symptom relief in comparison to placebo in this setting. The current ORBITA-2 study investigated whether PCI, without antianginal medication, improves angina compared to placebo.

Methods

The ORBITA-2 trial enrolled patients with angina or angina equivalent symptoms, anatomical evidence of a severe coronary stenoses in ≥ 1vessel, and evidence of ischemia confirmed by non-invasive imaging or invasive physiology.

Symptom burden and quality of life were assessed at baseline and antianginal medications were stopped. Participants recorded their angina symptoms each day using a dedicated smartphone app during a 2-week pre-randomization phase and during a 12 week follow-up phase after the procedure. Repeated symptom questionnaires, a treadmill exercise test using the modified Bruce protocol and dobutamine stress echocardiography were performed before randomization and after the 12 week follow-up phase. A total of 301 patients were randomly assigned to PCI or placebo. All participants underwent a research angiogram, followed by FFR and iFR measurements. Participants were then sedated until they were asleep and wore ear headphones for auditory isolation. Participants allocated to PCI underwent revascularization of all ischemic vessels. Participants in the placebo group remained sedated in the cath lab for a minimum of 15 minutes without any intervention. All participants were discharged with DAPT. All antianginal medications were stopped, but medications could be restarted by the blinded trial team based on patient triggers during follow up.

Outcomes

The primary endpoint was angina symptom score. The score consisted of 3 factors: 1) the number of episodes of angina on a given day, 2) the number of standardized doses or units of antianginal medications prescribed on that day, and 3) clinical events (intolerable angina, acute coronary syndromes and death). The score was determined for each patient on each day of follow-up.

Main results

• PCI improved the angina symptom score compared to the placebo procedure with an odds ratio of 2.21 (95%CI 1.41-3.47; P<0.001).
• During every day of follow up, the proportion of patient without angina and on no antianginal therapy was significantly higher in the PCI group compared to the placebo group.
• PCI also significantly improved physician assessed CCS class compared to placebo (OR 3.76, 95% 2.43-5.82, P<0.001).
• The change in modified Bruce exercise time on the treadmill was larger in the PCI group compared to the placebo group (+59.5s, 16 to 113, P=0.008).

Conclusion

In the ORBITA-2 study, PCI improved the angina symptom score in patients with stable angina with ischemia but without antianginal medication. This effect was driven by a reduction in angina frequency. PCI also increased exercise capacity and improved quality of life.

Rasha Al-Lamee said “What we have shown is that PCI is an antianginal monotherapy procedure is feasible and effective.” She further said “I believe that the guidelines that currently reserve PCI to those with optimal antianginal medication may systematically select patients with the least to gain.”

- Our reporting is based on the information provided at the AHA Scientific Session 2023-

The results of this study were simultaneously published in N. Engl. J. Med. Watch a video about the ORBITA-2 trial