BibTex format
@article{Al-Lamee:2018:10.1016/S0140-6736(17)32714-9,
author = {Al-Lamee, R and Thompson, D and Dehbi, H-M and Sen, S and Tang, K and Davies, J and Keeble, T and Mielewczik, M and Kaprielian, R and Malik, IS and Nijjer, SS and Petraco, R and Cook, C and Ahmad, Y and Howard, J and Baker, C and Sharp, A and Gerber, R and Talwar, S and Assomull, R and Mayet, J and Wensel, R and Collier, D and Shun-Shin, M and Thom, SA and Davies, JE and Francis, DP and ORBITA, investigators},
doi = {10.1016/S0140-6736(17)32714-9},
journal = {Lancet},
pages = {31--40},
title = {Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial},
url = {http://dx.doi.org/10.1016/S0140-6736(17)32714-9},
volume = {391},
year = {2018}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - 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
AU - Al-Lamee,R
AU - Thompson,D
AU - Dehbi,H-M
AU - Sen,S
AU - Tang,K
AU - Davies,J
AU - Keeble,T
AU - Mielewczik,M
AU - Kaprielian,R
AU - Malik,IS
AU - Nijjer,SS
AU - Petraco,R
AU - Cook,C
AU - Ahmad,Y
AU - Howard,J
AU - Baker,C
AU - Sharp,A
AU - Gerber,R
AU - Talwar,S
AU - Assomull,R
AU - Mayet,J
AU - Wensel,R
AU - Collier,D
AU - Shun-Shin,M
AU - Thom,SA
AU - Davies,JE
AU - Francis,DP
AU - ORBITA,investigators
DO - 10.1016/S0140-6736(17)32714-9
EP - 40
PY - 2018///
SN - 0140-6736
SP - 31
TI - Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial
T2 - Lancet
UR - http://dx.doi.org/10.1016/S0140-6736(17)32714-9
UR - http://hdl.handle.net/10044/1/55536
VL - 391
ER -