In 2017, the results of the ORBITA study, the first randomised, double blind, placebo controlled trial of coronary angioplasty (balloon dilatation and ‘stenting’ of blocked coronary arteries) for patients with chest pain due to angina, were published in The Lancet . This statement in itself is of interest given that angioplasty has been a widely accepted form of therapy for angina since the first procedure was performed by Andreas Gruentzig in Zurich over forty years earlier. Today many millions of these procedures are performed world-wide each year.
On a brief visit to the UK in March I was lucky enough to visit ‘ORBITA HQ’ at Hammersmith Hospital in West London and met with the lead author Dr Rasha Al-Lamee who will be a visiting researcher at the Australian Centre for Health Services Innovation based at QUT in August. As I discovered, it wasn’t the length of time it had taken for someone to undertake a randomised trial of this long established treatment, but the results of the study that, in Rasha’s own words, the cardiology community found to be ‘surprising and shocking’.
In brief, this expertly conducted and adequately powered clinical trial showed that angioplasty, in patients with significant obstruction of a single coronary artery, did not lead to a clinically meaningful improvement in symptoms of angina when compared to a placebo procedure.
The ORBITA study has already been cited over 180 times (at the time of writing) and dominated discussion in the traditional cardiology literature and well beyond for several months. #ORBITA took over many medical threads in social media and the story reached mainstream news in the New York Times, Wall Street Journal and CNN amongst others.
For me as a cardiologist, the ORBITA results are fascinating, but the trial has much broader lessons for everyone involved in medical and health service research. It reminds us as researchers of the importance of constantly challenging even long held positions and raises many other important questions; how is it possible to perform placebo controlled trials for surgical procedures and medical devices? Under what circumstances is it ethical? What happens when your research findings conflict with a widely held consensus?
Dr Al-Lamee will be visiting QUT for two weeks in mid-August 2019. On Wednesday 24th August at 12-1pm in the IHBI seminar room (Q Block 60 Musk Ave) she will deliver a lecture entitled ‘Breaking bad news: Lessons learnt from ORBITA’.
Dr Al-Lamee’s visit is supported by the Institute of Health and Biomedical Innovation Visiting Researcher Scheme. For those wishing to meet Dr Al-Lamee during her visit please contact firstname.lastname@example.org
- Al-Lamee, R., et al., Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet, 2018. 391(10115): p. 31-40.