Clinical outcomes of everolimus bioresorbable scaffolds versus metallic everolimus-eluting stents for coronary arterial disease: A meta-analysis of randomized clinical trials
2021
Background: Bioresorbable Scaffolds (BRS) were previously shown to have no
significant benefit in clinical outcomes versus metallic Drug-Eluting Stents (DES)
at one-year follow-up duration. However, the presence of long-term side effects
is currently unknown. This meta-analysis was conducted to compare the mid-term
clinical outcomes of everolimus BRS versus metallic Everolimus-Eluting Stents (EES)
in patients with coronary arterial disease.
Methods: A comprehensive review of all relevant manuscripts and abstracts studies
from inception to March 2021 were obtained. A meta-analysis was performed using a
random effect model to calculate Odds Ratios (OR) with 95% Confidence Intervals
(CI).
Results: Eleven Randomized Controlled Trials (RCTs) were included with a total of
10,430 patients and a median-weighted follow-up period of 2.66 years. A pooled
analysis of the data showed no significant difference in all-cause mortality (OR 0.99;
95% CI 0.77 to 1.26; p=0.92) or cardiovascular mortality (OR 0.96; 95% CI 0.69
to 1.32; p=0.79). However, myocardial infarction (OR 1.38, 95% CI 1.16 to 1.65,
p=0.0003), stent thrombosis (OR 2.91, 95% CI 1.95 to 4.35, p<0.00001), TLR (OR
1.27, 95% CI 1.06 to 1.54, p=0.01), and TVF (OR 1.22, 95% CI 1.08 to 1.39,
p=0.002) were all determined to be significantly higher in the BRS group.
Conclusion: Mid-term follow-up data reveals that everolimus BRS has no significant
difference in terms of all-cause mortality when compared to EES. However, everolimus
BRS does have an increased rate of cardiovascular events and thrombosis in the mid-
term setting.
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