https://doi.org/10.55788/c4e0cdfb
Besides influencing long-term results, haemodynamic differences in valve performance can be influential in up to 40% of patients, typically women with small aortic annuli [1,2]. âItâs important to study women separately because they present differently and are at greater risk for complications after both surgery and TAVR,â Prof. Howard Herrmann (Perelman School of Medicine, PA, USA) further explained [1].
Hence, the SMART trial (NCT04722250), conducted at 83 sites across Europe, North America, and the Middle East, set out to compare the Evolut SEV with the BEV SAPIEN platform for TAVR in this cohort of patients with small aortic annulus. The first co-primary endpoint, a clinical outcome composite of mortality, disabling stroke, and heart failure re-hospitalisation through 12 months, tested for non-inferiority between the devices. The second endpoint assessed BVD for superiority within the implanted population.
As can be expected per design, about 87% of the over 700 included participants were women. The mean baseline age was about 80 years and the mean STS-Predicted Risk of Mortality (PROM) score for operative risk was 3.3% (SEV) and 3.2% (BEV). At 1 year, the clinical outcome endpoint was met with 10.6% in the BEV and 9.4% in the SEV arm (Pnon-inferiority<0.001. The valve dysfunction endpoint, in contrast, found rates of 41.6% for BEV and 9.4% for SEV through 12 months, demonstrating significant superiority of BEV (P<0.001).
Secondary endpoints included differences in mean gradient, effective orifice area, haemodynamic structural valve dysfunction, BVD in women, and moderate/severe prosthesis patient mismatch. âAll five of these secondary endpoints were superior for the SEV at a P-value of less than 0.001,â underlined Prof. Herrmann.
Regarding safety outcomes, new pacemaker implants were numerically higher in the SEV group at 1 and 12 months, while prosthetic valve endocarditis after 1 year was higher in the BEV arm. Otherwise, the major safety endpoints were deemed similar between the groups.
âBased on these large differences that we observed in valve performance, we expect that the SEV will demonstrate improved valve durability and outcomes during longer-term follow-up,â Prof. Herrmann concluded.
- Herrmann HC, et al. Self-expanding versus balloon-expandable transcatheter aortic valve replacement in patients with small aortic annuli: primary outcomes from the randomised SMART trial. LB3, Session 406, ACC 2024 Scientific Session, 6â8 April, Atlanta, USA.
- Playford D, et al. J Am Soc Echocardiogr. 2020;33(9):1077-86.
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Table of Contents: ACC 2024
Featured articles
Matters of the heart: late-breaking news from the American College of Cardiology
Heart Failure and Cardiomyopathy
STEP-HFpEF DM: Semaglutide beneficial in patients with HFpEF and diabetes
IMPROVE-HCM: Promising results for ninerafaxstat in non-obstructive HCM
Acute Coronary Syndrome and Acute Myocardial Infarction
ACS: Necessary DAPT after PCI may be shorter than currently advised
AEGIS-II: ApoA-1 did not reduce MACE in patients with myocardial infarction but may provide benefit in patients with high LDL levels
REDUCE-AMI: Re-evaluating the role of routine beta-blockade in patients with acute myocardial infarction
Interventional Cardiology in 2024
Self-expanding versus balloon-expendable TAVR in patients with small aortic annuli
Safety of TAVI non-inferior to SAVR for patients with lower surgical risk
Interatrial shunt for HF: neutral primary endpoint but potential benefit in HFrEF
Peripheral artery disease: procedure-guidance by IVUS superior to angiography
IVUS-guided PCI beats angiography in patients with acute coronary syndrome
Addressing frailty in patients undergoing TAVR
Novel Developments in Risk Factor Management
Preventive PCI of vulnerable intracoronary plaque leads to favourable outcomes
KARDIA-2: Add-on zilebesiran effectively lowers blood pressure
BRIDGE-TIMI 73a: Olezarsen halves triglyceride levels
Plozasiran: A novel approach to severe hypertriglyceridaemia
High-risk and very high-risk patients meet LDL-cholesterol targets with lerodalcibep
No cardioprotective effect of ACE inhibitors in patients with cancer
Best of Posters
SGLT2 inhibition in heart failure more advantageous for women than men
Anxiety and depression: Lifestyle influential in MACE prevention
Meet the Trialists
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