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Stenting NOT better than Placebo in stable angina : ORBITA Trial


Stenting NOT better than Placebo in stable angina : ORBITA Trial
Clinically the primary goal of percutaneous coronary intervention (PCI) in stable angina is a symptomatic relief but there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.Dr.Rasha Al-Lamee and associates of ORBITA Trial team conducted a double-blind, randomised controlled trial found that 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.This infers that Stenting is no better than Placebo in stable angina.Their findings have been published in Lancet.

ORBITA Trial is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief conducted at five study sites in the UK. The researchers  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.

 

In the Trial  230 patients with ischaemic symptoms were enrolled. 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.

The autors concluded that 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.

For further reference log on to : DOI: https://doi.org/10.1016/S0140-6736(17)32714-9 

 

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Dr. Kamal Kant Kohli

Dr. Kamal Kant Kohli

A Medical practitioner with a flair for writing medical articles, Dr Kamal Kant Kohli joined Medical Dialogues as an Editor-in-Chief for the Speciality Medical Dialogues. Before Joining Medical Dialogues, he has served as the Hony. Secretary of the Delhi Medical Association as well as the chairman of Anti-Quackery Committee in Delhi and worked with other Medical Councils of India. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751
Source: self

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