Show simple item record

dc.contributor.authorAl-Lamee, Ren_US
dc.contributor.authorThompson, Den_US
dc.contributor.authorDehbi, H-Men_US
dc.contributor.authorSen, Sen_US
dc.contributor.authorTang, Ken_US
dc.contributor.authorDavies, Jen_US
dc.contributor.authorKeeble, Ten_US
dc.contributor.authorMielewczik, Men_US
dc.contributor.authorKaprielian, Ren_US
dc.contributor.authorMalik, ISen_US
dc.contributor.authorNijjer, SSen_US
dc.contributor.authorPetraco, Ren_US
dc.contributor.authorCook, Cen_US
dc.contributor.authorAhmad, Yen_US
dc.contributor.authorHoward, Jen_US
dc.contributor.authorBaker, Cen_US
dc.contributor.authorSharp, Aen_US
dc.contributor.authorGerber, Ren_US
dc.contributor.authorTalwar, Sen_US
dc.contributor.authorAssomull, Ren_US
dc.contributor.authorMayet, Jen_US
dc.contributor.authorWensel, Ren_US
dc.contributor.authorCollier, Den_US
dc.contributor.authorShun-Shin, Men_US
dc.contributor.authorThom, SAen_US
dc.contributor.authorDavies, JEen_US
dc.contributor.authorFrancis, DPen_US
dc.contributor.authorORBITA investigatorsen_US
dc.date.accessioned2017-12-08T12:21:06Z
dc.date.available2017-10-12en_US
dc.date.issued2018-01-06en_US
dc.date.submitted2017-11-09T07:02:13.977Z
dc.identifier.urihttp://qmro.qmul.ac.uk/xmlui/handle/123456789/29383
dc.description.abstractBACKGROUND: 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.en_US
dc.description.sponsorshipRBITA was an investigator-led trial sponsored by Imperial College London. The trial was funded by grants from NIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, and Imperial College Healthcare Charity. Philips Volcano supplied the coronary pressure wires. We acknowledge the support of the NIHR Clinical Research Network (NIHR CRN).en_US
dc.format.extent31 - 40en_US
dc.languageengen_US
dc.language.isoenen_US
dc.relation.ispartofLanceten_US
dc.subjectAgeden_US
dc.subjectAngina, Stableen_US
dc.subjectCoronary Angiographyen_US
dc.subjectCoronary Stenosisen_US
dc.subjectDouble-Blind Methoden_US
dc.subjectExercise Toleranceen_US
dc.subjectFemaleen_US
dc.subjectHumansen_US
dc.subjectMaleen_US
dc.subjectMiddle Ageden_US
dc.subjectPercutaneous Coronary Interventionen_US
dc.subjectTreatment Outcomeen_US
dc.subjectUnited Kingdomen_US
dc.titlePercutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial.en_US
dc.typeArticle
dc.identifier.doi10.1016/S0140-6736(17)32714-9en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/29103656en_US
pubs.issue10115en_US
pubs.notesNot knownen_US
pubs.publication-statusPublisheden_US
pubs.volume391en_US
dcterms.dateAccepted2017-10-12en_US


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record