NOTION: 5-year Outcomes from the All-Comers Nordic Aortic Valve Intervention Randomised Clinical Trial in patients with Severe Aortic Valve Stenosis
Reported from the ACC Scientific Sessions 2018 (ACC.18) in Orlando, United States
NOTION a prospective, multicentre, non-blinded, randomized trial compared TAVI vs. Surgery (TAVR versus SAVR) in all comer severe aortic stenosis patients aged 70 years and over who were suitable for self-expanding TAVI and surgery
What is the aim of this trial?
TAVI in the last decade has taken over interventional cardiology like a storm. The technology and the procedures continue to evolve. So far many trials comparing TAVI vs. surgery in severe aortic stenosis have been in the setting of high-risk cases.
NOTION a prospective, multicentre, non-blinded, randomized trial compared TAVI vs. Surgery in all comer severe aortic stenosis patients aged 70 years and over conducted in Sweden and Denmark who were suitable for self-expanding TAVI and surgery. The trial excluded patients with aortic regurgitation, coronary artery disease needing revascularisation, previous open-heart surgery, myocardial infarction or percutaneous coronary intervention within the last year, cerebral infarction within the last 30 days, severe lung or renal disease. The primary outcome consisted of all cause mortality, stroke or MI at 1 year (VARC II defined).
What are the results?
280 patients were randomised (139 had TAVI, 135 had surgery). 5-year follow-up was achieved in 100% of the patients. Mean patient age was 79 years. STS score of 2.9 +/- 1.6, log EuroScore I of 8.4 +/- 4.0.
At 5 years there was no difference in the primary endpoint 39.2% (TAVI) vs. 35.8% (Surgery), p=0.78; all cause mortality, (27.7% vs. 27.7%, p=0.90) and MI (8.6% vs. 8.7%, p=0.87). This was also seen in patients with STS score less than 4% (primary endpoint 31.5% vs. 35.2%, p=0.51). AF occurred more in surgical patients vs. TAVI (25.2 % vs. 62.2%, p<0.001), pacemaker use was more frequent in TAVI patients vs. surgical patients (41.8% vs. 8.4%, p<0.001).
Mortality with new PPM was higher in TAVI vs. no new PPM surgery patients (38.2% vs. 21.7%, p=0.07). The valve area and mean gradient was better with TAVI vs. surgical valve (1.66 vs. 1.23 cm2, p<0.001, Mean Gradient at 5 years 8.22 v 13.71 mm Hg, p<0.001). Severe AR was more with TAVI 8.2%, p<0.001. No difference in NYHA class at 1 year p=0.75. The authors concluded that Notion trial showed no difference in the primary endpoint. There was an increase in new PPM implantation with TAVI.
My take on NOTION
NOTION has shown that TAVI is an option for low risk severe aortic stenosis patients. TAVI is associated with an increase in the use of pacemaker. It is of note that surgical patients had higher rate of AF. Further studies with long-term follow-up evaluating this approach are needed to impact practice and patient care!
PCRonline cardio poll results
Prior to the releae of the results at ACC.18, we asked our website audience which results they were expecting - view the NOTION Cardio Poll results here.