One-year outcomes of a NeoHexa sirolimus-eluting coronary stent system with a biodegradable polymer in all-comers coronary artery disease patients: Results from NeoRegistry in India

BACKGROUND: Biodegradable polymer drug-eluting stents (BP-DES) have shown to reduce restenosis rates and have low rates of stent thrombosis. The present postmarketing surveillance assessed 1-year clinical outcomes of patients who had received NeoHexa DES in real practice. AIM: To investigate 1-year clinical outcomes of Neohexa DES in real practice. METHODS: Data obtained from a single-center cohort of patients who had received NeoHexa stents as part of routine treatment of coronary artery disease (CAD) were retrospectively investigated. The primary study endpoint was the rate of major adverse cardiac events (MACEs) defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) during the follow-up at 1 mo, 6 mo, and 1 year after the index procedure. RESULTS: A total of 129 patients with 172 lesions were enrolled. The most common comorbid conditions were hypertension (49.61%) and diabetes mellitus (39.53%). Procedural success was achieved in all patients, and no in-hospital MACE was reported. The incidence of composite MACE at 30 d, 6 mo, and 1 year was 0.78%, 3.94%, and 4.87%, respectively. The rate of possible and probable late stent thrombosis was 0.78%. The cumulative incidences of death, MI, and TLR at 1 year were 2.44%, 0.81%, and 1.63%, respectively. CONCLUSION: The relatively low rates of MACE and stent thrombosis in this study support safety and performance of NeoHexa stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.