Self-expanding transcatheter heart valves did not significantly differ from balloon-expandable valves in the 2-year rate of major adverse cardiac and cerebrovascular events (17.0% vs. 13.4%, HR 1.18).
Cohort (n=1,256)
Yes
Does a self-expanding transcatheter heart valve compared to a balloon-expandable transcatheter heart valve improve clinical outcomes in patients undergoing successful TAVI?
In patients undergoing successful TAVI, the choice between self-expanding and balloon-expandable valves did not significantly impact the 2-year risk of major adverse cardiac and cerebrovascular events.
Effect estimate: HR 1.18 (95% CI 0.82-1.69)
Absolute Event Rate: 17% vs 13.4%
p-value: p=0.382
BACKGROUND: Midterm data comparing clinical outcomes after successful implantation of self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. We aimed to compare 2-year outcomes after successful transcatheter aortic valve implantation (TAVI) with the Edwards balloon-expandable or the Medtronic self-expanding THV. METHODS: Two-year outcomes were analyzed according to the implanted THV in the GALILEO trial. Major adverse cardiac and cerebrovascular events (MACCE) was a composite of all-cause death or thromboembolic events including stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism. RESULTS: Among 1644 patients recruited in 136 centers across 16 countries between 2015 and 2018, 499 received a self-expanding and 757 patients received a balloon-expandable THV. Patients treated with a self-expanding THV were more likely to be female, and had higher surgical risk, lower hemoglobin levels, and more frequent valve-in-valve procedures than those with a balloon-expandable THV. After multivariable adjustment, there were no significant differences in major clinical outcomes between self-expanding versus balloon-expandable THV: MACCE (17.0% vs. 13.4%, adjusted-hazard ratios HR 1.18, 95% confidence intervals CI: 0.82-1.69); all-cause death (11.4% vs. 9.3%, adjusted-HR 1.26; 95% CI: 0.78-2.05); cardiovascular death (8.5% vs. 4.0%, adjusted-HR 1.53; 95% CI: 0.82-2.86), any stroke (5.1% vs. 3.7%, adjusted-HR 0.86; 95% CI: 0.43-1.73); major or life-threatening bleeding (5.9% vs. 6.8%, adjusted-HR 0.93; 95% CI: 0.53-1.63). CLINICAL TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov. NCT02556203. CONCLUSIONS: Two-year follow-up data from the GALILEO trial indicate that successful TAVI either with self-expanding or balloon-expandable THVs according to physician discretion did not show difference in rates of MACCE.
Okuno et al. (Tue,) conducted a cohort in Severe symptomatic aortic valve stenosis (n=1,256). Self-expanding transcatheter heart valves vs. Balloon-expandable transcatheter heart valves was evaluated on Major adverse cardiac and cerebrovascular events (MACCE) (HR 1.18, 95% CI 0.82-1.69, p=0.382). Self-expanding transcatheter heart valves did not significantly differ from balloon-expandable valves in the 2-year rate of major adverse cardiac and cerebrovascular events (17.0% vs. 13.4%, HR 1.18).