ORBITA
Trial question
What is the role of PCI in stable angina in patients with severe (≥ 70%) single-vessel stenoses?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 200
200 patients (54 female, 146 male).
Inclusion criteria: patients with severe (≥ 70%) single-vessel stenoses who received medication optimization for 6 weeks after enrollment.
Key exclusion criteria: angiographic stenosis ≥ 50% in a non-target vessel, acute coronary syndrome, previous CABG surgery, left main stem coronary disease, contraindications to drug-eluting stents, chronic total coronary occlusion, severe valvular disease, moderate-to-severe pulmonary hypertension.
Interventions
N=105 PCI (drug-eluting stents to achieve angiographic complete revascularization).
N=95 placebo (coronary catheterization and sedation for 15 minutes without any intervention).
Primary outcome
Exercise time increment
28.4
11.8
28.4
21.3
14.2
7.1
0.0
Percutaneous coronary
intervention
Placebo
No significant
difference ↔
No significant difference in exercise time increment (28.4 vs. 11.8; difference 16.6, 95% CI -8.9 to 42).
Secondary outcomes
No significant difference in increment in peak oxygen uptake (-2 vs. 10.9; difference -12.9, 95% CI -90.2 to 64.3).
Safety outcomes
No significant difference in major bleeding events (2 vs. 3).
Conclusion
In patients with severe (≥ 70%) single-vessel stenoses who received medication optimization for 6 weeks after enrollment, PCI was not superior to placebo with respect to exercise time increment.
Reference
Al-Lamee R, Thompson D, Dehbi HM et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018 Jan 6;391(10115):31-40.
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