Two‐year safety evaluation of a biodegradable polymer sirolimus‐eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort

Abstract

Objectives: The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions.Background: The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF).Methods: In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients.Results: Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patientoriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).Conclusions: Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population.

The Recent Applications of PLGA-Based Nanostructures for Ischemic Stroke

“…Researchers have demonstrated the phenomenon of PLGA-based nanostructures promoting drug therapeutic efficacy, but their specific mechanisms of action have not been investigated in depth. Extensive clinical research has been conducted on PLGA-based nanostructures for tumors [ 148 , 149 ], oral diseases [ 150 , 151 , 152 ], and cardiovascular diseases [ 153 , 154 ]. However, clinical research on ischemic stroke is extremely limited, focusing on intracranial arterial stents [ 155 ].…”

Sirolimus Release from Biodegradable Polymers for Coronary Stent Application: A Review

“…BuMa (Sino Medical, Rotterdam, Netherlands) comprises a stent platform with a PLGA and sirolimus coating, and an electro-grafted layer of poly-butyl methacrylate (PBMA) is added between the polymer and the stent platform for resistance to flaking, peeling, and cracking [ 61 ]. According to two-year clinical trials, BuMa exhibits superior endothelization and presents a lower incidence of stent thrombosis compared with Excel [ 62 ]. Further clinical trials are ongoing.…”