Long‐Term Safety and Efficacy of Ultrathin Bioabsorbable‐Polymer Sirolimus‐Eluting Stents Versus Thin Durable‐Polymer Everolimus‐Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta‐Analysis

Abstract

First-generation drug-eluting stents (DES) with thick polymers may contribute to local vascular inflammation and late stent thrombosis. Thinner-strut DES, particularly those with biodegradable polymers and ultrathin struts, aim to reduce this risk by minimizing flow disturbance and vascular injury. Nonetheless, the long-term safety and efficacy of ultrathin biodegradable polymer sirolimus-eluting stents (BP-SES) compared to durable polymer everolimus-eluting stents (DP-EES) are still uncertain. Thus, we performed a meta-analysis with the aim of comparing outcomes of these two stents. Inclusion criteria comprised randomized controlled trials (RCTs) that compared ultrathin/thin BP-SES and thin DP-EES in patients undergoing percutaneous coronary interventions (PCI) and had long-term follow-up reports of at least 3 years. We excluded cohort studies, case reports, editorials, conference abstracts, and animal studies. Our primary outcomes were target lesion failure (TLF), cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). We systematically searched PubMed, Cochrane CENTRAL, and Scopus. Cochrane's ROB 2.0 tool was used for assessing the quality of all included RCTs. RevMan software (5.4) was used to perform the meta-analysis. Our analysis included 10 RCTs, totaling 16,216 patients, with 9108 in the BP-SES group and 7108 in the DP-EES group. TLF occurred in 905 patients (9.94%) in the BP-SES group and 821 patients (11.55%) in the DP-DES group, with no statistically significant differences between the groups (RR = 0.92, 95% CI = 0.85-1.01, p = 0.08). Additionally, there were no significant differences in CD (RR = 1.00, 95% CI = 0.84-1.19, p = 1.00), TV-MI (RR = 0.91, 95% CI = 0.78-1.05, p = 0.19), and CI-TLR (RR = 0.88, 95% CI = 0.78-1.01, p = 0.06) between the two groups. BP-SES and DP-EES showed comparable long-term safety and efficacy in most PCI patients and lesion subsets. A significant reduction in TLF with BP-SES was observed in STEMI, without increased thrombotic risk, while outcomes were consistent across other subgroups. Head-to-head analyses confirmed no major long-term differences between Orsiro BP-SES and Xience DP-EES. In practice, either stent can be used with confidence, with BP-SES favored in settings such as STEMI, where its potential advantages may offer additional clinical benefit.