A 64-year old female with severe aortic stenosis and low surgical risk (STS score 1.2%) has been treated at Rigshospitalet in Copenhagen, Denmark, with transcatheter aortic valve replacement (TAVI), becoming the first patient in the NOTION-2 trial. Lars Søndergaard, interventional cardiologist and principle investigator for the trial, and team successfully implanted a Symetis Acurate Neo bioprosthesis.
The NOTION-2 trial is investigating the opportunity of expanding TAVI therapy into patients at lower surgical risk, and to younger patients. The trial is being conducted across the Nordic countries, and will include 992 patients at age ≤75 years and STS score ≤4% randomised 1:1 to TAVR or SAVR.
“The trial is a logical expansion of NOTION-1, which was the first all-comers trial comparing TAVI and SAVR,” says Søndergaard. NOTION-1 was conducted from 2009 to 2013, and included patients with a mean STS score of 3%, which is regarded as low surgical risk.
In NOTION-1, there was no difference between TAVR and SAVR for the primary composite outcome; all-cause mortality, stroke and myocardial infarction after one year. “However, the mean age was around 80 years, which is similar to all other randomised TAVI trials,” says Søndergaard.
“In my opinion, we need trials including younger patients with aortic stenosis planned treated with a bioprosthetic aortic valve. Such trials will also provide important information on long-term durability of the bioprosthetic valves”.
According to a press release, the NOTION-2 trial is unique in not only including younger patients, but also patients with bicuspid aortic valve which is more common among younger patients with aortic stenosis. Furthermore, investigators are allowed to use any commercial available bioprosthetic valve for TAVI and SAVR in order to optimise prosthesis performance and patient outcomes.
Co-principle investigator and head of Cardiothoracic Department of Rigshospitalet, Peter Skov Olsen, says, “The NOTION-2 is important to define the best treatment for younger patients with symptomatic aortic stenosis. This study is important to get evidence ahead of clinical practise, for potential expansion of TAVI as a treatment option for younger patients with severe aortic stenosis”.