Sham-controlled PCI trial does not show symptom relief in stable angina patients
Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trialLiterature - Al-Lamee R, Thompson D, Dehbi H-M, et al. - Lancet 2017; published online ahead of print
- At follow-up, no significant difference was seen between groups in increment in exercise time (16.6; 95% CI: –8.9 to 42.0; P=0.200), nor in peak VO2 uptake change (-12.9 mL/min; 95% CI: -90.2 to 64.3; P=0.741), or in the change in time to 1 mm ST depression (pre-randomization: PCI 479.7±141.4 vs. placebo 471.1±128.7; follow-up: PCI 472.7±129.1 vs. placebo 470.1±176.0; P=0.164).
- There was no significant difference between groups in the proportion of patients with improvements in angina grade from enrolment to pre-randomization (no change: PCI 60% vs. placebo 62%; 1 class improvement: PCI 26% vs. 23%; ≥ 2 class improvement: PCI 14% vs. 15%; P=0.916), and from pre-randomization to follow-up (no change: PCI 49% vs. 55%; 1 class improvement: PCI 26% vs. 24%; ≥ 2 class improvement: PCI 26% vs. 21%; P=0.633).
- During the randomized blinded period there were no significant differences between groups in the change from pre-randomization to follow-up in Seattle physical limitation score (2.4; 95% CI: -3.5 to 8.3; P=0.420), Seattle angina frequency (4.4; 95% CI: -3.3 to 12.0; P=0.260), and Seattle angina stability score (0.9; 95% CI: –8.4 to 10.2; P=0.851).
- There was also no significant difference between the groups in QoL (change in EQ-5D-5L: 0.00; 95% CI: -0.04 to 0.04; P=0.994).
- The change in the Duke treadmill score did not significantly differ between groups (1.12; 95% CI: -0.23 to 2.47; P=0.104).
- The dobutamine stress echocardiography peak stress wall motion score index improved more with PCI than with placebo (-0.09; 95% CI: -0.15 to -0.04; P=0.0011).
- There were 3 peri-procedural major bleeding events, of which 2 were in the PCI group. 4 patients in the placebo group needed PCI for a pressure-wire related complication. During the follow-up phase, in the placebo group, 1 patient developed an ACS, and 2 patients on dual antiplatelet therapy suffered a major bleeding.
In this first blinded, placebo-controlled, randomized trial of PCI in 200 patients with stable angina and 1-vessel-disease (severe coronary stenosis, both anatomically and haemodynamically), PCI did not result in significant short-term improvements of exercise capacity, symptoms and quality of life as compared with a placebo procedure. PCI did yield objective relief of anatomical stenosis, invasive pressure and non-invasive perfusion indices. These data suggest that the physical effects of PCI may be overestimated and confused with placebo effects in clinical practice. These data suggest that PCI might not be essential for symptomatic improvement of these patients in the short-term.