Key result
Percutaneous coronary intervention for stable coronary artery disease remains debated, as the ORBITA trial was deemed underpowered and inconclusive compared with medical therapy.
Why the study?
Does percutaneous coronary intervention (PCI) improve outcomes compared to medical therapy in patients with stable coronary artery disease?
Does percutaneous coronary intervention (PCI) improve outcomes compared to medical therapy in patients with stable coronary artery disease?
This editorial highlights the ongoing debate and inconclusive evidence regarding the benefits of PCI over medical therapy for stable coronary artery disease, specifically critiquing the ORBITA trial as underpowered.
For the podcast associated with this article, please visit https://academic.oup.com/eurheartj/pages/Podcasts. In the 41st year after introduction of percutaneous coronary intervention (PCI) by Andreas R. Grüntzig,1 there is still debate about its place in the management of cardiac patients. The place of primary PCI in patients with acute coronary syndromes is indisputable, and indeed it contributed considerably to the currently very low mortality rate in this patient population.2 In contrast, in patients with stable coronary artery disease, the indication, success rates, and the effects of PCI on angina and hard endpoints are less clear. The disappointing effects of PCI on hard endpoints in COURAGE3 were partially outweighed by the somewhat better results in terms of quality of life during 36 months.4 A more recent meta-analysis suggested, however, that the newest generation of drug-eluting stents, particularly those coated with everolimus, might prevent hard endpoints.5 Later last year, the ORBITA trial again questioned the superiority of the anti-anginal effects of PCI compared with medical therapy in patients with stable coronary artery disease.6 In a Viewpoint entitled ‘ORBITA revisited: what it really means and what it does not?’, Bernard Chaitman and colleagues undertook a critical analysis of this complex trial.7 In particular, the authors systematically analysed the statistical power of the trial to come up with convincing results. Although the authors have to be complemented for finishing such a complex protocol successfully in <200 patients with stable coronary artery disease, it appears that the ORBITA trial is substantially underpowered. There is a clear trend towards better exercise performance of patients undergoing PCI compared with those receiving anti-anginal drugs alone and, furthermore, the authors found a significantly better left ventricular performance in the PCI group. Thus, the ORBITA trial is unfortunately not conclusive, and it is not certain that the ongoing ISCHEMIA trial will provide a convincing answer as the trial has stopped recruiting with far fewer patients recruited than planned.
No takes yet. Share an insight, caveat, or question.
Thomas F. Lüscher (2018) conducted an editorial in Stable coronary artery disease. Percutaneous coronary intervention (PCI) vs. Medical therapy was evaluated. Percutaneous coronary intervention for stable coronary artery disease remains debated, as the ORBITA trial was deemed underpowered and inconclusive compared with medical therapy.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: