Safety and efficacy of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: One-year results from a prospective patient-level pooled analysis of NeoVas trials.

Abstract

OBJECTIVES:

This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial.

BACKGROUND:

Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated.

METHODS:

Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.

RESULTS:

The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded.

CONCLUSIONS:

This pooled, patient-level analysis indicates that the NeoVas BRS has promising 1-year efficacy and safety profiles.

• Authors: Kai Xu, Guosheng Fu, Bo Xu, Yujie Zhou, Xi Su, Huiliang Liu, Zheng Zhang, Bo Yu, Xiaozeng Wang, Yaling Han, NeoVas OPC Investigators
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 93 Issue S1 Pg. 832-838 (02 15 2019) ISSN: 1522-726X [Electronic] United States
• PMID: 30888736 (Publication Type: Journal Article)
• Copyright: © 2019 Wiley Periodicals, Inc.

Chemical References

• Cardiovascular Agents
• Coated Materials, Biocompatible
• Sirolimus

Topics

• Absorbable Implants
• Acute Coronary Syndrome (diagnostic imaging, mortality, therapy)
• Adolescent
• Adult
• Aged
• Cardiovascular Agents (administration & dosage, adverse effects)
• China
• Coated Materials, Biocompatible
• Coronary Artery Disease (diagnostic imaging, mortality, therapy)
• Female
• Humans
• Male
• Middle Aged
• Myocardial Infarction (epidemiology)
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Prospective Studies
• Prosthesis Design
• Randomized Controlled Trials as Topic
• Registries
• Risk Factors
• Sirolimus (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome
• Young Adult