First patient treated in NOTION-2

​A randomized clinical trial comparing transcatheter and surgical aortic valve replacement in younger low risk patients with aortic stenosis.

Copenhagen June 30th, 2016.

A 64 years old female with severe aortic stenosis and low surgical risk (STS score 1.2%) was today june 30th 2016  treated at Rigshospitalet in Copenhagen with transcatheter aortic valve replacement (TAVR) as the first patient in the NOTION-2 trial. Professor Lars Sondergaard, interventional cardiologist and PI for the trial, successfully implanted a transfemoral Symetis Acurate NeoTM bioprosthesis under local anaesthesia.

The NOTION-2 trial is exploring the borders of TAVR in not only expanding the therapy into patients at lower surgical risk, but also to younger patients. The trial is conducted at several sites in the Nordic countries and will include 992 patients at age ≤75 years and STS score ≤4% randomized 1:1 to TAVR or SAVR.

‘The trial is a logical expansion of NOTION-1, which was the first all-comer trial comparing TAVR and SAVR’ said Lars Søndergaard. NOTION-1 was conducted from 2009 to 2013, and included patients with a mean STS score of 3.0%, which is regarded as low surgical risk. TAVR was non-inferior to SAVR in the composite primary end-point of all-cause mortality, stroke and myocardial infarction. ‘However, the mean age was around 80 years, which is similar to all other randomized TAVR trials. 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’. 

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, the physicians are allowed the use any commercial available bioprosthetic valve in order to utilize the differences among the bioprostheses and thereby gain the optimal outcome for the patients.

Head of Cardiothoracic Department at Rigshospitalet and co-PI for NOTION-2 trial Peter Skov Olsen said the NOTION-2 is important to define the best treatment for younger patients with symptomatic aortic stenosis. ‘This study is important to get evidence a head of clinical practice for potential expansion of TAVR as a treatment option for younger patients with severe aortic stenosis’.

Aortic valve stenosis (AS) is the most common valvular heart disease in developed countries. The prevalence of this condition increases with age, and is reported to range from 2% to 5%. Until recently, the only definitive treatment has been an open heart procedure with surgical aortic valve replacement (SAVR), but now less invasive transcatheter aortic replacement (TAVR) is routinely offered to patients at high surgical risk. 

Although the NOTION-1 trial shows that TAVR is non- inferior to SAVR in patients at low surgical risk, TAVR in younger patients have not yet been studied. NOTION-2 will solely include these patients providing both evidence for potential expansion of TAVR to this age group, but also important information on long-term durability of these bioprostheses.

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