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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.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.

Authors

Al-Lamee, Rasha;  Thompson, David;  Dehbi, Hakim-Moulay;  Sen, Sayan;  Tang, Kare;  Davies, John;  Keeble, Thomas;  Mielewczik, Michael;  Kaprielian, Raffi;  Malik, Iqbal S.;  Nijjer, Sukhjinder S.;  Petraco, Ricardo;  Cook, Christopher;  Ahmad, Yousif;  Howard, James;  Baker, Christopher;  Sharp, Andrew;  Gerber, Robert;  Talwar, Suneel;  Assomull, Ravi;  Mayet, Jamil;  Wensel, Roland;  Collier, David;  Shun-Shin, Matthew;  Thom, Simon A.;  Davies, Justin E.;  Francis, Darrel P.

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  • Abstract, title and references ● Is the aim clear? Yes ● Is it clear what the study found and how they did it? Yes ● Is the title informative and relevant? Yes ● Are the references: ● Relevant? Yes ● Recent? Yes ● Referenced correctly? Yes ● Are appropriate key studies included? Yes Introduction/ background ● Is it clear what is already known about this topic? Yes ● Is the research question clearly outlined? Yes ● Is the research question justified given what is already known about the topic? Yes Methods ● Is the process of subject selection clear? Yes ● Are the variables defined and measured appropriately? Yes ● Are the study methods valid and reliable? To some Extent ● Is there enough detail in order to replicate the study? Yes Results ● Is the data presented in an appropriate way? Yes ● Tables and figures relevant and clearly presented? Yes ● Appropriate units, rounding, and number of decimals? Yes ● Titles, columns, and rows labelled correctly and clearly? Yes ● Categories grouped appropriately? Yes ● Does the text in the results add to the data or is it repetitive? repetitive ● Are you clear about what is a statistically significant result? Yes ● Are you clear about what is a practically meaningful result? Yes Discussion and Conclusions ● Are the results discussed from multiple angles and placed into context without being over interpreted? Yes ● Do the conclusions answer the aims of the study? To some extent ● Are the conclusions supported by references or results? Yes ● Are the limitations of the study fatal or are they opportunities to inform future research? Needs Future Research.

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