Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial

Al-Lamee, Rasha and Thompson, David and Dehbi, Hakim-Moulay and Sen, Sayan and Tang, Kare and Davies, John and Keeble, Thomas and Mielewczik, Michael and Kaprielian, Raffi and Malik, Iqbal S. and Nijjer, Sukhjinder S. and Petraco, Ricardo and Cook, Christopher and Ahmad, Yousif and Howard, James and Baker, Christopher and Sharp, Andrew and Gerber, Robert and Talwar, Suneel and Assomull, Ravi and Mayet, Jamil and Wensel, Roland and Collier, David and Shun-Shin, Matthew and Thom, Simon A. and Davies, Justin E. and Francis, Darrel P. and Al-Lamee, Rasha and Thompson, David and Sen, Sayan and Tang, Kare and Davies, John and Keeble, Thomas R. and Kaprielian, Raffi and Malik, Iqbal S. and Nijjer, Sukhjinder S. and Petraco, Ricardo and Cook, Christopher and Ahmad, Yousif and Howard, James and Shun-Shin, Matthew and Sethi, Amarjit and Baker, Christopher and Sharp, Andrew and Ramrakha, Punit and Gerber, Robert and Talwar, Suneel and Assomull, Ravi and Foale, Rodney and Mayet, Jamil and Wensel, Roland and Thom, Simon A. and Davies, Justin E. and Francis, Darrel P. and Khamis, Ramzi and Hadjiloizou, Nearchos and Khan, Masood and Kooner, Jaspal and Bellamy, Michael and Mikhail, Ghada and Clifford, Piers and O'Kane, Peter and Levy, Terry and Swallow, Rosie (2018) Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. The Lancet, 391 (10115). pp. 31-40. ISSN 1474-547X

[img]
Preview
Text
Accepted Version
Available under the following license: Creative Commons Attribution Non-commercial No Derivatives.

Download (441kB) | Preview
[img] Text (Tables and Figures)
Supplemental Material
Available under the following license: Creative Commons Attribution Non-commercial No Derivatives.

Download (21kB)
[img] Other (Correspondence)
Other
Restricted to Repository staff only

Download (17kB)
Official URL: https://doi.org/10.1016/S0140-6736(17)32714-9

Abstract

Background: Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy. Methods: ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593. Findings: ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI −8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group. Interpretation: In patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.

Item Type: Journal Article
Faculty: ARCHIVED Faculty of Medical Science (until September 2018)
Depositing User: Ian Walker
Date Deposited: 02 Feb 2018 11:07
Last Modified: 04 Jan 2019 14:06
URI: http://arro.anglia.ac.uk/id/eprint/702697

Actions (login required)

Edit Item Edit Item