Big win for CABG as FFR-guided PCI fails to show non-inferiority
Fractional flow reserve- (FFR) guided percutaneous coronary intervention (PCI) has failed to show non-inferiority to coronary-artery bypass grafting (CABG) in patients with three-vessel coronary artery disease, a clinical trial has shown.
The results, being described by surgeons as a ‘big win for CABG’, come from the FAME 3 trial, which assessed one-year outcomes for 1,500 patients receiving either CABG or FFR-guided PCI with current generation zotarolimus-eluting stents.
FFR-guided PCI patients were more likely to have a major adverse cardiac or cerebrovascular event (MACCE), defined as death from any cause, myocardial infarction, stroke or repeat vascularisation, at follow-up, than those who had CABG (incidence: 10.6% versus 6.9%, hazard ratio [HR]: 1.5, 95% CI: 1.1–2.2).
Patients on FFR-guided PCI also had a higher incidence of death, myocardial infarction or stroke than the CABG group (7.3% versus 5.2%, HR: 1.4, 95% CI: 0.9–2.1), though they were less likely to experience major bleeding, arrhythmia or acute kidney injury.
For patients with three-vessel coronary artery disease, FFR-guided PCI “was not found to be non-inferior to CABG” with regard to MACCE (P = 0.35), the authors concluded in the New England Journal of Medicine.
Myocarditis concerns put Pfizer vax plans on hold for young children
An Australian immunisation expert says he still has concerns about a possible risk of myocarditis with Pfizer’s Covid vaccine in children despite a study involving 1500 children aged 5 to 11 showing no such events.
Published in the NEJM, the results have proved reassuring for countries such as the US where Pfizer’s vaccine has already been authorised for use in this age group by the FDA.
However Professor Robert Booy an infectious diseases and vaccine researcher at the University of Sydney has backed the Australian authorities wait-and-see approach, saying the data on safety with regard to rare side effects was still inadequate.
“We need real-world information on 1000 times as many children (one to 2 million) to be properly reassured that young children do not experience rare but important serious side effects like myocarditis and pericarditis,” he said.
“We know the incidence of myocarditis after mRNA vaccines is higher after the second dose than the first, higher in boys than in girls, and higher in teenagers than in young adults. There remains the real possibility that children aged five to 11 could have an even higher risk of myocarditis, despite the fact that only a 1/3 dose has been used in this study.”
Professor Booy said we do not know the underlying biological processes causing myocarditis in children following an mRNA vaccine and we do not know if these are dose related or not.
“More real world evidence must be collected to give us adequate reassurance, about the safety of this vaccine in large numbers of young children.”
Professor Allen Cheng of the Australian Technical Advisory Group on Immunisation (ATAGI), said vaccination of younger age groups may not start until 2022 as ATAGI awaited more data from larger numbers of double-dosed children in the US to become available.
“Children are only getting their first vaccines now. So by the beginning of December we will start to see more safety data come through,” he told the SMH.
Cardiology tools win innovation awards
A team of cardiology researchers have picked up this year’s Rio Tinto Emerging Innovation award for their advanced coronary artery assessment software, ‘Apricot’.
The software combines intravascular optical coherence tomography and x-ray angiogram images to create an “unrivalled” 3D visualisation of diseased arteries and associated plaques, according to the explanatory video.
It then “performs engineering simulations, similar to what would be used in oil and gas pipelines” to identify mechanical forces that could increase patients’ risk of adverse outcomes and help inform treatment decisions, said cardiologist Associate Professor Barry Doyle and coronary artery and cerebrovascular disease researcher Dr Lachlan Kelsey, who developed the tool, in a statement and the video.
Cardiologists can “simply upload their medical images to a cloud-based portal, and then download the information from out systems”, Associate Professor Doyle said in the video.
“So there’s no new hardware, no new training required, and we think we can just fit seamlessly into clinical practice”.
The software was developed in conjunction with University of Western Australia Chair in Cardiology Professor Carl Schultz, and an interventional cardiologist at Royal Perth Hospital, the statement read.
A portable, hand-held imaging designed to help clinicians find “the right vein, first time, every time” also won the Business News Great for the State — Platinum Award at the WA Innovator of the Year 2021 Awards.
‘Vein Wave’ was developed by biomedical engineer, and VeinTech co-founder and CTO Nikhilesh Bappoo, to help “improve patient and physician experience in vascular access practices”.