Q. Which of the following is false about ORBITA trial:
A. Stable ischemic disease patients were included and were randomized either to PCI or sham procedure.
B. Patients with multi-vessel disease were included whereas acute coronary syndrome patients were not included.
C. PCI did not result in significant improvement in exercise time as compared to sham procedure.
D. Diabetic patients were included.
Answer: B. Patients with multi-vessel disease were included whereas acute coronary syndrome patients were not included.
Explanation:
ORBITA trial: Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina
- Patients with stable angina and severe single-vessel stenosis were randomized in a 1:1 fashion to either PCI or a placebo sham procedure.
- Coronary angiography was done via a radial or femoral arterial approach in all patients.
- In all patients, a research invasive physiological assessment of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) was done.
- Randomization was done after this physiological assessment.
Inclusion criteria:
- 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
Exclusion criteria:
- 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 left ventricular systolic impairment
Primary outcome:
Exercise time at the end of six weeks after the procedure
Result:
The primary outcome, change in exercise time from baseline for PCI vs. sham, was 28.4 vs. 11.8 seconds, p = 0.2.
Interpretation:
PCI does not result in greater improvements in exercise times or anginal frequency compared with a sham procedure in stable CAD patients with significant single vessel disease.
Reference:
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