Safe and effective profile of the VSTENT bioresorbable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary artery lesions: a prospective, cohort, multicenter study

Abstract

Background The drug-eluting stent was a significant stride forward in the development of enhanced therapeutic therapy for coronary intervention, with three generations of increased advancement. VSTENT is a newly developed stent manufactured in Vietnam that aims to provide coronary artery patients with a safe, effective, and cost-efficient option. The purpose of this trial was to determine the efficacy and safety of a new bioresorbable polymer sirolimus-eluting stent called VSTENT. Methods This is a prospective, cohort, multicenter research in 5 centers of Vietnam. A prespecified subgroup received intravascular ultrasound (IVUS) or optical coherence tomography (OCT) imaging. We determined procedure success and complications during index hospitalization. We monitored all participants for a year. Six-month and 12-month rates of major cardiovascular events were reported. All patients had coronary angiography after 6 months to detect late lumen loss (LLL). Prespecified patients also had IVUS or OCT performed. Results The rate of device success was 100% (95% CI: 98.3–100%; P<0.001). Major cardiovascular events were 4.7% (95% CI: 1.9–9.4%; P<0.001). The LLL over quantitative coronary angiography (QCA) was 0.08±0.19 mm (95% CI: 0.05–0.10; P<0.001) in the in-stent segment and 0.07±0.31 mm (95% CI: 0.03–0.11; P=0.002) in 5 mm within the two ends of the stent segment. The LLL recorded by IVUS and OCT at 6 months was 0.12±0.35 mm (95% CI: 0.01–0.22; P=0.028) and 0.15±0.24 mm (95% CI: 0.02–0.28; P=0.024), respectively. Conclusions This study’s device success rates were perfect. IVUS and OCT findings on LLL were favorable at 6-month follow-up. One-year follow-up showed low in-stent restenosis (ISR) and target lesion revascularization (TLR) rates, reflecting few significant cardiovascular events. VSTENT’s safety and efficacy make it a promising percutaneous intervention option in developing nations.