Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial
File(s)ORBITA_Article.pdf (434.85 KB)
Accepted version
Author(s)
Type
Journal Article
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. FUNDING: NIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre.
Date Issued
2018-01-06
Date Acceptance
2017-10-12
Citation
Lancet, 2018, 391 (10115), pp.31-40
ISSN
0140-6736
Publisher
Elsevier
Start Page
31
End Page
40
Journal / Book Title
Lancet
Volume
391
Issue
10115
Copyright Statement
© 2017, Elsevier. Licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/
Sponsor
Imperial College Healthcare NHS Trust- BRC Funding
Wellcome Trust
British Heart Foundation
Medical Research Council (MRC)
British Heart Foundation
Medical Research Council (MRC)
British Heart Foundation
Identifier
PII: S0140-6736(17)32714-9
Grant Number
RDB02
PS3162_WHCP
FS/10/38/28268
G1100443
FS/14/27/30752
MR/M018369/1
FS/17/16/32560
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
FRACTIONAL FLOW RESERVE
OPTIMAL MEDICAL THERAPY
GUIDED PCI
REVASCULARIZATION
METAANALYSIS
Aged
Angina, Stable
Coronary Angiography
Coronary Stenosis
Double-Blind Method
Exercise Tolerance
Female
Humans
Male
Middle Aged
Percutaneous Coronary Intervention
Treatment Outcome
United Kingdom
ORBITA investigators
Humans
Coronary Stenosis
Coronary Angiography
Treatment Outcome
Double-Blind Method
Exercise Tolerance
Aged
Middle Aged
Female
Male
Angina, Stable
Percutaneous Coronary Intervention
United Kingdom
General & Internal Medicine
11 Medical and Health Sciences
Publication Status
Published online
Date Publish Online
2017-11-02