Abstract

Clinical outcomes of everolimus bioresorbable scaffolds versus metallic everolimus-eluting stents for coronary arterial disease: A meta-analysis of randomized clinical trials

Author(s): Rohan Madhu Prasad, Abdullah Al-abcha, Yasser Amr Radwan, Ahmed Elshafie, Mohammad Fahad Salam, Zulfiqar Qutrio Baloch, Sandeep Banga, Yehia Saleh, George S Abela

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.