ORBITA-2
Trial question
What is the role of PCI in patients with stable angina?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 301
301 patients (63 female, 238 male).
Inclusion criteria: patients with stable angina who were receiving little to no antianginal medication and had objective evidence of ischemia.
Key exclusion criteria: age < 18 years or > 85 years; recent acute coronary event; previous CABG surgery; significant left main stem coronary disease; chronic total occlusion in the target vessel.
Interventions
N=151 PCI (angiographic and physiological complete revascularization of the target vessels).
N=150 placebo (sedation without any further intervention for at least 15 minutes).
Primary outcome
Mean angina symptom score at week 12
2.9 points
5.6 points
5.6 points
4.2 points
2.8 points
1.4 points
0.0 points
Percutaneous coronary
intervention
Placebo
Significant
decrease ▼
Significant decrease in mean angina symptom score at week 12 (2.9 points vs. 5.6 points; OR 0.45, 95% CI 0.28 to 0.7).
Secondary outcomes
Significant increase in mean treadmill exercise time (700.9 seconds vs. 641.4 seconds; AD 59.5 seconds, 95% CI 16 to 103).
Significant decrease in mean CCS class (0.9 vs. 1.7; OR 0.26, 95% CI 0.17 to 0.41).
Significant increase in freedom from angina (40 vs. 15; OR 3.69, 95% CI 2.1 to 6.46).
Safety outcomes
No significant difference in acute coronary syndromes.
Conclusion
In patients with stable angina who were receiving little to no antianginal medication and had objective evidence of ischemia, PCI was superior to placebo with respect to mean angina symptom score at week 12.
Reference
Christopher A Rajkumar, Michael J Foley, Fiyyaz Ahmed-Jushuf et al. A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina. N Engl J Med. 2023 Dec 21;389(25):2319-2330.
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