Percutaneous coronary intervention in stable angina (ORBITA): a double-blind randomised controlled trial
File(s)
Author(s)
Al-Lamee, Rasha Kadem
Type
Thesis
Abstract
Percutaneous coronary intervention (PCI) is widely believed to reduce angina in stable coronary artery disease but this has never been tested in a blinded randomised controlled trial. Such a study design exposed another highly credible therapy, renal denervation for hypertension, to be far less efficacious than unblinded evidence suggested.
The results of Simplicity HTN3 study highlighted the placebo effects of interventional procedures, and there is increasing recognition for the need for placebo-controlled studies to investigate the effects of interventional therapies. The evidence for PCI in stable coronary artery disease in the reduction of myocardial infarction and mortality remains uncertain. The remit of coronary intervention in this setting may primarily be to offer symptom relief and improvement in quality of life. However, the clinical effects of PCI for these goals will be contributed to by both a true physical and a placebo component. The magnitude of the placebo-controlled effect of PCI on symptoms and exercise capacity has never been tested before.
In order to scientifically address this question a double blind trial of coronary angioplasty versus a placebo procedure in patients with stable coronary artery disease was required. I designed, conducted and led the first placebo-controlled trial of PCI in stable coronary artery disease. In this thesis I will present the primary and secondary outcomes from the Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) trial. I will also present the results of subsequent analyses stratifying the results of ORBITA by pre-randomisation invasive physiology using fractional flow reserve and instantaneous wave-free ratio and by pre-randomisation dobutamine stress echocardiography score. The results of this trial may have far-reaching consequences for the management of stable angina.
The results of Simplicity HTN3 study highlighted the placebo effects of interventional procedures, and there is increasing recognition for the need for placebo-controlled studies to investigate the effects of interventional therapies. The evidence for PCI in stable coronary artery disease in the reduction of myocardial infarction and mortality remains uncertain. The remit of coronary intervention in this setting may primarily be to offer symptom relief and improvement in quality of life. However, the clinical effects of PCI for these goals will be contributed to by both a true physical and a placebo component. The magnitude of the placebo-controlled effect of PCI on symptoms and exercise capacity has never been tested before.
In order to scientifically address this question a double blind trial of coronary angioplasty versus a placebo procedure in patients with stable coronary artery disease was required. I designed, conducted and led the first placebo-controlled trial of PCI in stable coronary artery disease. In this thesis I will present the primary and secondary outcomes from the Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina (ORBITA) trial. I will also present the results of subsequent analyses stratifying the results of ORBITA by pre-randomisation invasive physiology using fractional flow reserve and instantaneous wave-free ratio and by pre-randomisation dobutamine stress echocardiography score. The results of this trial may have far-reaching consequences for the management of stable angina.
Version
Open Access
Date Issued
2018-02
Date Awarded
2018-09
Advisor
Francis, Darrel
Davies, Justin
Sponsor
Imperial College London
Publisher Department
National Heart & Lung Institute
Publisher Institution
Imperial College London
Qualification Level
Doctoral
Qualification Name
Doctor of Philosophy (PhD)