NOTION: Lower-Risk Patients Undergoing TAVR, SAVR Have Similar Outcomes After Five Years

After five years, there were no differences in all-cause mortality, stroke or myocardial infarction (MI) in lower-risk patients ages 70 and older who had transcatheter or surgical aortic valve replacement (TAVR; SAVR), according to results of the NOTION trial presented in a Featured Clinical Research session Saturday, March 10 at ACC.18 in Orlando, FL.

H. Gustav Hørsted Thyregod, MD, PhD, et al., compared the primary composite outcome of all-cause mortality, stroke and MI five years post surgery for 139 patients who underwent TAVR and 135 who underwent SAVR. Secondary outcomes were safety and efficacy and echocardiographic outcomes. Patients with severe aortic valve stenosis were included in the trial if they were ages 70 or older, had a life expectancy of one year or less, and were candidates for self-expanding TAVR or SAVR.

The results showed that the rate of the primary outcome occurred in 39.2 percent of TAVR patients and 35.8 percent of SAVR patients. Looking at these endpoints individually, the rate of all-cause mortality was 27.7 percent for both SAVR and TAVR patients. In addition, 10.5 percent of TAVR patients and 8.2 percent of SAVR patients had experienced a stroke after five years, while 8.7 percent of TAVR patients and 8.6 percent of SAVR patients had experienced an MI. For patients with an STS score of less than 4 percent, the rate of the primary outcome was 31.5 percent for TAVR and 35.2 percent for SAVR patients.

Undergoing TAVR was associated with higher rates of aortic regurgitation (AR), with 52.9 percent of TAVR patients having mild AR and 8.2 percent having moderate AR, compared with 77.4 percent of SAVR patients not experiencing AR. At five years, the majority of patients in both groups (60.7 percent for TAVR and 62.7 percent for SAVR) were in NYHA class II.

TAVR patients whose surgery included new permanent pacemaker (PPM) implantation had a higher mortality rate after five years (38.2 percent) than those whose surgery did not (21.7 percent). Moderate or severe AR three months post surgery was associated with higher all-cause mortality rate after five years at 30.8 percent, compared with 22.2 percent for patients who had no AR or trace or mild AR three months post surgery. Other variables associated with higher all-cause mortality rates after five years included being age 75 or older, being male, having a BMI of 30 or lower, and an STS of 4 percent of greater.

The NOTION trial is the first to report on five-year outcomes of TAVR versus SAVR in lower-risk patients whose STS was 4 percent or lower. According to the researchers, longer term follow-up is necessary to determine valve duration after TAVR.

Keywords: ACC18, ACC Annual Scientific Session, Angiography, Transcatheter Aortic Valve Replacement, Aortic Valve, Aortic Valve Stenosis, Heart Valve Prosthesis, Risk, Myocardial Infarction, Pacemaker, Artificial, Stroke, Hemodynamics

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