Key result
TAVR reduces 2-year cardiovascular death ~64% vs SAVR in intermediate-risk patients with BMI ≥35.
Why the study?
Does TAVR reduce adverse cardiovascular events compared to SAVR in intermediate-risk severe aortic stenosis patients with significant obesity?
RCT (n=2,000)
randomized
Does TAVR reduce adverse cardiovascular events compared to SAVR in intermediate-risk severe aortic stenosis patients with significant obesity?
In intermediate-risk patients with severe aortic stenosis and significant obesity, TAVR is associated with significantly lower 2-year cardiovascular mortality compared to SAVR.
Answers are grounded in this paper and cite their sources.
Supports TAVR over SAVR in obese intermediate-risk severe AS; extends RCT evidence to BMI ≥35 subgroup.
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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Chen et al. (2018) conducted an RCT in severe aortic stenosis (n=2,000). TAVR with the SAPIEN XT valve vs. SAVR was evaluated on cardiovascular death in patients with significant obesity (HR 0.36, 95% CI 0.15-0.88, p=0.02). Among intermediate-risk patients with severe aortic stenosis and BMI ≥35 kg/m2, TAVR reduced the 2-year risk of cardiovascular death compared to SAVR (5.7% vs 15.4%; HR 0.36, 95% CI 0.15-0.88; P=0.02).
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