Three-year clinical outcomes of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: A prospective patient-level pooled analysis of NeoVas trials

Catheter Cardiovasc Interv. 2023 May;101(6):967-972. doi: 10.1002/ccd.30518. Epub 2023 Mar 7.

Abstract

Objectives: We aimed to evaluate the long-term outcomes of the novel NeoVas sirolimus-eluting bioresorbable scaffold (BRS) for the treatment of de novo coronary artery disease.

Background: The long-term safety and efficacy of the novel NeoVas BRS are still needed to be elucidated.

Methods: A total of 1103 patients with de novo native coronary lesions for coronary stenting were enrolled. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death (CD), target vessel myocardial infarction (TV-MI), or ischemia-driven-target lesion revascularization (ID-TLR).

Results: A three-year clinical follow-up period was available for 1,091 (98.9%) patients. The cumulative TLF rate was 7.2% with 0.8% for CD, 2.6% for TV-MI, and 5.1% for ID-TLR. Additionally, 128 (11.8%) patient-oriented composite endpoint and 11 definite/probable stent thromboses (1.0%) were recorded.

Conclusions: The extended outcomes of the NeoVas objective performance criterion trial demonstrated a promising 3-year efficacy and safety of the NeoVas BRS in low-risk patients with low complexity in terms of lesions and comorbidities.

Keywords: bioresorbable scaffold; coronary artery disease; objective performance criterion; percutaneous coronary intervention; sirolimus-eluting stents.

MeSH terms

  • Absorbable Implants
  • Cardiovascular Agents* / adverse effects
  • Coronary Artery Disease* / drug therapy
  • Coronary Artery Disease* / therapy
  • Drug-Eluting Stents*
  • Humans
  • Myocardial Infarction* / drug therapy
  • Myocardial Infarction* / etiology
  • Percutaneous Coronary Intervention* / adverse effects
  • Prospective Studies
  • Sirolimus / adverse effects
  • Treatment Outcome

Substances

  • Sirolimus
  • Cardiovascular Agents