Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina - ORBITA
Contribution To Literature:
The ORBITA trial showed that among patients with stable angina, PCI does not result in greater improvements in exercise times or anginal frequency compared with a sham procedure, despite the presence of anatomically and functionally significant stenoses.
The goal of the trial was to assess the efficacy of percutaneous coronary intervention (PCI) compared with a sham placebo procedure for angina relief among patients with stable angina.
Patients with stable angina and evidence of severe single-vessel stenosis were randomized in a 1:1 fashion to either PCI or a placebo sham procedure. After enrollment, patients received 6 weeks of medication optimization. Coronary angiography was done via a radial or femoral arterial approach with auditory isolation achieved by placing over-the-ear headphones playing music on the patient throughout the procedure. In all patients, a research invasive physiological assessment of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) was done. The operator was blinded to the physiology values and therefore did not use them to guide treatment. Randomization occurred after this physiological assessment.
For patients allocated to PCI, the clinical operator used drug-eluting stents (DES) to treat all lesions that were deemed to be angiographically significant, with a mandate to achieve angiographic complete revascularization. After PCI, iFR and FFR were measured again. In the placebo group, patients were kept sedated for at least 15 minutes on the catheter laboratory table and the coronary catheters were withdrawn with no intervention having been done.
- Total number of enrollees: 200
- Duration of follow-up: 6 weeks
- Mean patient age: 66 years
- Percentage female: 27%
- Age 18-85 years
- Stable angina/angina equivalent
- At least one angiographically significant lesion (≥70%) in a single vessel that was clinically appropriate for PCI
- Angiographic stenosis ≥50% in a nontarget vessel
- Acute coronary syndrome
- Previous coronary artery bypass graft surgery
- Left main stem coronary disease
- Contraindications to DES
- Chronic total coronary occlusion
- Severe valvular disease
- Severe left ventricular systolic impairment
- Moderate-to-severe pulmonary hypertension
- Life expectancy <2 years
- Inability to give consent
Other salient features:
- Previous PCI: 13%
- Left ventricular ejection fraction normal: 92%
- Canadian Cardiovascular Society angina severity grading class: I (3%), II (59%), III (39%)
- Angina duration: 9 months
- Vessel involved: left anterior descending (69%)
- Median area stenosis by quantitative coronary angiography: 85%
- Median baseline FFR value: 0.72; median post-PCI FFR value: 0.9
The primary outcome, change in exercise time from baseline for PCI vs. sham, was 28.4 vs. 11.8 seconds, p = 0.2.
Secondary outcomes for PCI vs. sham:
- Change in Seattle Angina Questionnaire (SAQ)-physical limitation from baseline: 7.4 vs. 5.0, p = 0.42
- Change in SAQ-angina frequency from baseline: 14.0 vs. 9.6, p = 0.26
- Change in Duke treadmill score from baseline: 1.22 vs. 0.1, p = 0.10
The results of this trial indicate that among patients with stable angina, PCI does not result in greater improvements in exercise times or anginal frequency compared with a sham procedure. This was despite the presence of anatomically and functionally significant stenoses.
This is clearly a landmark trial, but several issues need to be considered. The trial was extremely well done, with careful assessments of ischemia pre- and post-procedure, and appropriate use of antianginal medications. Although powered for exercise treadmill-based endpoints, the trial appears to be too small to address a question of this magnitude. The COURAGE trial, for instance, enrolled 2,300 patients with stable angina. Moreover, changes in Duke treadmill score and exercise time were both numerically higher in the PCI arm, and it is unknown if a larger sample size would have detected more modest improvements in exercise capacity.
Accordingly, these findings need to be validated in a larger randomized controlled trial. This trial also highlights the value of sham controls for procedure-oriented trials, where a procedural placebo effect is balanced out. A similar benefit of using sham controls was noted in the SYMPLICITY HTN-3 trial earlier.
Al-Lamee R, Thompson D, Dehbi HM, et al., on behalf of the ORBITA Investigators. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet 2017;Nov 2:[Epub ahead of print].
Editorial Comment: Brown DL, Redberg RF. Last nail in the coffin for PCI in stable angina. Lancet 2017;Nov 2:[Epub ahead of print].
Presented by Dr. Rasha Al-Lamee at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2017), Denver, CO, November 2, 2017.
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