The ORBITA-2 trial (NCT03742050) investigated the efficacy of Percutaneous Coronary Intervention (PCI) compared to placebo in 301 patients with stable angina. The primary endpoint was the angina symptom score (0-79 scale), incorporating daily angina episodes, antianginal medication use, and clinical events such as unblinding due to severe angina, acute coronary syndrome (ACS), or death.
Results revealed ischemia in one cardiac territory in 80% of patients, two territories in 17%, and three territories in 2%. The median Fractional Flow Reserve (FFR) for the target vessel was 0.63, and the instantaneous wave-free ratio (iFR) was 0.78. At the 12-week mark, the PCI group exhibited a significantly lower mean angina score (2.9) compared to the placebo group (5.6; odds ratio, 2.21; 95% CI, 1.41-3.47; p<0.001). Unblinding due to angina occurred in one placebo patient, while ACS was reported in 4 PCI and 6 placebo patients.
The investigators concluded that in patients with stable angina and minimal medication, confirmed ischemia, and randomized to PCI, the procedure led to better angina outcomes compared to the placebo.
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Original article: Rajkumar CA et al. N Engl J Med. 2023;Epub ahead of print. doi: 10.1056/NEJMoa2310610