Introduction: Whether sirolimus-eluting stents constituted with ultrathin-strut and biodegradable polymers (BP-SESs) can achieve a preferable effect over current drug-eluting stents with durable polymers (DP-DESs) remains highly controversial. The aim of this analysis based on randomized controlled trials (RCTs) was to detect the clinical and angiographic differences between ultrathin (defined as a strut thickness <70 µm) BP-SESs and DP-DESs.
Evidence acquisition: We searched seven databases to identify eligible articles. Late lumen loss (LLL) and target lesion failure (TLF) were assessed as the primary endpoints for angiographic and clinical outcomes, respectively.
Evidence synthesis: Nineteen articles containing thirteen RCTs with 14801 patients were analyzed. For the 9-month angiographic outcomes, similar results were discovered between BP-SESs and DP-DESs in terms of in-stent LLL (mean difference [MD]: -0.02 [-0.05, 0.01], P=0.23), in-segment LLL (MD: -0.01 [-0.04, 0.03], P=0.74), in-stent minimum lumen diameter (MLD) (MD: -0.01 [-0.06, 0.04], P=0.72), in-segment MLD (MD: -0.01 [-0.06, 0.05], P=0.75), in-stent diameter stenosis (DS) (MD: -1.10 [-3.36, 1.15], P=0.34), in-segment DS (MD: -0.78 [-1.97, 0.40], P=0.20), in-stent binary restenosis (BR) (risk ratio [RR]: 2.27 [0.99, 5.21], P=0.05) and in-segment BR (RR: 1.46 [0.78, 2.75], P=0.24). Regarding the 12-month clinical outcomes, there was a significant decrease in TLF and a trend of a lower incidence of target vessel failure (RR: 0.89 [0.78,1.01], P=0.08), myocardial infarction (MI) and target vessel MI.
Conclusions: With similar angiographic results, BP-SESs appeared to be superior to DP-DESs with better clinical prognoses, especially for female patients, patients with STEMI and ACS and patients without diabetes. More high-quality randomized controlled trials are needed to confirm these results.