Surgical association withdraws support for stent controversy over study and surgical association backup remark


 

The European Association for Cardiothoracic Surgery (EACTS) has withdrawn support for guidance on stents that it coauthored, following controversy over the research paper it was based on.

Concerns about the 2016 study, published in the New England Journal of Medicine1 and funded by stent maker Abbott, were raised by the BBC’s Newsnight,2 which obtained unpublished data from the trial.

The data reportedly showed that, when using the universal definition of heart attack, patients with left main coronary artery disease treated with stents are 35% more likely to die than those treated with conventional open heart surgery.

In the paper, the researchers only published the findings using an alternative definition of heart attack. Using this definition, the paper claimed that stents and heart surgery are equally effective for people with left main coronary artery disease.

Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial.

The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population.

Assumption

In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation.