ORBITA-2: PCI vs. Placebo in Patients With Stable Angina and No Antianginal Medication
Compared with a placebo procedure, PCI resulted in a lower angina symptom score in patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, based on findings from the ORBITA-2 trial presented Nov. 11 at AHA 2023 and simultaneously published in the New England Journal of Medicine.
Researchers randomized 301 patients to undergo either PCI or a placebo procedure following a two-week symptom assessment phase and a stop to all antianginal medications. The mean age of participants was 64 years, 79% were men and all were followed for 12 weeks. The primary endpoint was the angina symptom score, which ranged from 0 to 79 and was calculated daily based on the number of angina episodes and the number of antianginal medications prescribed, as well as the occurrence of clinical events. Higher scores indicated worse health status with respect to angina.
Overall results showed the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group at the 12-week follow-up (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; p<0.001). According to researchers, patients who had stents were three-times more likely to be free from angina at the end of the trial compared with patients who had the placebo procedure. Exercise time also increased by 60 seconds more among patients in the PCI group vs. the placebo group.
“We expected that PCI would be more effective than a placebo procedure in patients taking little or no chest pain medication, and indeed, the results proved our hypothesis was correct,” said Rasha Al-Lamee, MBBS, PhD. “Going forward, patients and medical teams have a choice of two pathways for chest pain relief: chest pain medication or PCI. The key finding of this trial is that it is the first therapy initiated that seems to have the maximum effect. Although PCI is neither risk-free nor cost-free, its use as an upfront procedure can now be considered evidence based.”
ORBITA-2 is a follow-up study to the 2017 ORBITA study, which showed PCI did not improve exercise tolerance or chest pain more than placebo in patients with stable chest pain and single vessel disease who were taking guideline-directed medication with an average of three chest pain medications.
“The ORBITA and ORBITA-2 trials together suggest the American and European guidelines for stable coronary artery disease may require updating. Perhaps restricting stenting to patients with inadequate response to chest pain medications may inadvertently be selecting the group of patients with the least to gain,” Al-Lamee said.
Keywords: American Heart Association, AHA23, Percutaneous Coronary Intervention, Coronary Artery Disease
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