Cardiac doctors ‘held back stent death data’

It has been revealed that doctors working on a clinical trial for treatment of heart disease held back key information.

The Excel trial tested to see whether stents were as effective as open heart surgery at treating patients with a heart problem called left main disease.

The data was eventually published, but only following treatment guidelines that partly relied on the trial had been written, the guidelines recommending both stents and heart surgery for certain patients with left main disease.

During the trial, half the patients had open heart surgery and half were given stents. Not all patients were recruited at the same time, some in 2011 and others over the years that followed.

Therefore, when the first results were published in 2016, the doctors conducting the trial knew there was data about what had happened to some of the patients five years following their stent or heart surgery procedure. However, they chose to only look at what had occurred up to three years following the patients’ procedures and publish that data.

A spokesman from the trial said “The study’s execution, data collection, analysis and interpretation were entirely performed by independent research organisations. The publication of three-year Excel data reflects the original follow-up period and endpoints the study was powered to assess.”

Professor Nick Freemantle, biostatistician at University College London, said “If somebody had died three years and one day into the trial, that death wouldn’t have been counted in the results. I’m absolutely appalled that they’ve done this. I’ve taken a straw poll of my professional colleagues and it draws disbelief that people would do this.”

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Posted by Tony May, Partner/head of Clinical Negligence Department, Chadwick Lawrence LLP (tonymay@chadlaw.co.uk ), medical negligence lawyers and clinical negligence solicitors in Huddersfield, Leeds, Wakefield and Halifax, West Yorkshire.

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