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Heart stents for stable angina no better than placebo

Heart stents for stable angina no better than placebo

Publication date: Wednesday, 06 December 2017
Contributor(s): Jeremy Bray

Percutaneous coronary intervention (PCI) is not significantly better than a placebo procedure in improving exercise capacity or symptoms even in patients with severe coronary stenosis, according to new UK research. The ORBITA study is the first double blind randomised controlled trial to directly compare stenting with placebo in patients with stable angina who are receiving high quality drug treatment.

Symptomatic relief is the primary goal of PCI in stable angina and is commonly observed clinically. However, there has previously been no evidence from blinded, placebo-controlled randomised trials to show its efficacy.

ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief in 230 patients in the UK with severe (≥70%) single-vessel stenoses. These patients received 6 weeks of medication optimisation and then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. They were then randomised 1:1 to undergo PCI or a placebo procedure. After 6 weeks of follow-up, the assessments were repeated.

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). However, the tests did confirm that stenting considerably relieved narrowing in the coronary artery and improved blood supply to the heart.

Rasha Al-Lamee, lead author of the study, said, “Surprisingly, even though the stents improved blood supply, they didn’t provide more relief of symptoms compared to drug treatments, at least in this patient group.”

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Despite numerous randomised trials and meta-analyses of PCI which have shown no reduction in death or myocardial infarction, its use has grown exponentially. This trial shows no benefit for PCI over placebo in these patients with stable angina, although some may want to have an invasive procedure rather than take long-term medication. The results of the study need to be assessed based on the relatively small numbers and long-term adherence to therapy.

Al-Lamee R, Thompson D, Dehbi H, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double blind, randomised controlled trial. Lancet 2017;(Nov): doi:10. 1016/S0140-6736(17)32714-9. Brown DL et al. Last nail in the coffin for PCI in stable angina? Lancet 2017; Nov: DOI: http://dx.doi.org/10.1016/S0140-6736(17)32757-5
Topics covered:
Category: Evidence in Practice
Edition: Volume 2 Number 11 PCCJ Online 2017
Contributor(s): Jeremy Bray

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