Abstract
ABSTRACT Background: Patients with severe aortic stenosis (AS) at intermediate surgical risk, treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) have similar 2-year survival. Significant obesity (SigOb), defined as body mass index (BMI) ≥ 35 kg/m2, has been associated with increased surgical risk and post-operative complications. There are no data comparing clinical outcomes after SAVR versus TAVR in patients with SigOb. Methods: In the PARTNER 2A trial, 2032 patients with severe AS and intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. After excluding 32 patients who had very low BMI < 18.5 kg/m2, the remaining 2000 patients were categorized based on BMI at baseline to SigOb or not SigOb, and compared in regards to 2-year risk of adverse cardiovascular events. Results: A total of 250 patients (12.5%) were SigOb and were younger, more often female, and more frequently diabetic. The 30-day and 2-year rates of the primary composite endpoint death and disabling stroke as well as the risks of its components, were similar for patients with versus without SigOb. However, the 2-year relative risk of cardiovascular death was lower with TAVR versus SAVR for SigOb patients (5.7% vs 15.4%, p = 0.02; HR 0.36, 95% CI 0.15–0.88) but not for not SigOb patients (10.6% vs 10.7%, p = 0.91; HR 0.98, 95% CI 0.73–1.32; p interaction = 0.03). These results remained consistent after multivariable adjustment. Conclusions: In the PARTNER 2A Trial, intermediate-risk patients with severe AS and BMI ≥ 35 kg/m2 undergoing TAVR experienced significantly lower cardiovascular mortality than similar patients undergoing SAVR.
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