6/28/23, 11:44 PM ORBITA Pathway Feedback Search Clinical Topics Home Studies ORBITA ORBITA Disease Coronary artery disease 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 26.7% female N = 230 73.3% male 230 patients (54 female, 146 male) Inclusion criteria: patients with severe ( 70%) single-vessel stenoses who received medication optimization for 6 weeks after enrolment 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) https://web.pathway.md/studies/recWhpd4ILrhnjo3k 1/2 6/28/23, 11:45 PM ORBITA Pathway Primary outcome Exercise time increment 28.4 28.4 21.3 14.2 11.8 7.1 No significant difference 0.0 Percutaneous coronary intervention Placebo 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 enrolment, 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. Open reference URL https://web.pathway.md/studies/recWhpd4ILrhnjo3k 2/2