Effect of Rivaroxaban and Clopidogrel Combination Therapy on In-Stent Responses After Everolimus-Eluting Stent Implantation in a Porcine Coronary Model

J Atheroscler Thromb. 2022 Jan 1;29(1):69-81. doi: 10.5551/jat.56549. Epub 2020 Nov 18.

Abstract

Aim: According to recent clinical trials, a combination of direct oral anticoagulants with antiplatelet drugs is often recommended for atrial fibrillation patients who receive drug-eluting stents (DESs). Although the optimal combination comprises direct factor Xa inhibitors and a P2Y12 receptor antagonist (or aspirin), their influence on vascular responses to DESs remains unclear.

Methods: Pigs were given either aspirin and clopidogrel (dual antiplatelet therapy [DAPT] group), aspirin and rivaroxaban (AR group), or clopidogrel and rivaroxaban (CR group), followed by everolimus-eluting stent (Promus Element) implantation into the coronary artery. Stented coronary arteries were evaluated via intravascular optical coherence tomography (OCT) and histological analysis at 1 and 3 months.

Results: OCT revealed lower neointimal thickness in the DAPT group and comparable thickness among all groups at 1 and 3 months, respectively. Histological analyses revealed comparable neointimal area among all groups and the smallest neointimal area in the CR group at 1 and 3 months, respectively. In the DAPT and AR groups, the neointima continued to grow from 1 to 3 months. A shortened time course for neointima growth was observed in the CR group, with rapid growth within a month (maintained for 3 months). A higher incidence of in-stent thrombi was observed in the AR group at 1 month; no thrombi were found in either group at 3 months. More smooth muscle cells with contractile features were found in the CR group at both 1 and 3 months.

Conclusions: Our results proved the noninferiority of the combination of rivaroxaban with an antiplatelet drug, particularly the dual therapy using rivaroxaban and clopidogrel, compared to DAPT after DES implantation.

Keywords: Atrial fibrillation; Clopidogrel; Drug-eluting stent; Histology; Optical coherence tomography; Porcine model; Rivaroxaban.

MeSH terms

  • Animals
  • Aspirin / administration & dosage
  • Clopidogrel / administration & dosage*
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / pathology
  • Coronary Stenosis / prevention & control
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / pathology
  • Coronary Vessels / surgery
  • Drug Therapy, Combination
  • Drug-Eluting Stents*
  • Everolimus / administration & dosage
  • Factor Xa Inhibitors / administration & dosage*
  • Graft Occlusion, Vascular / diagnostic imaging
  • Graft Occlusion, Vascular / pathology
  • Graft Occlusion, Vascular / prevention & control*
  • Immunosuppressive Agents / administration & dosage
  • Male
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Rivaroxaban / administration & dosage*
  • Swine
  • Tomography, Optical Coherence

Substances

  • Factor Xa Inhibitors
  • Immunosuppressive Agents
  • Platelet Aggregation Inhibitors
  • Everolimus
  • Rivaroxaban
  • Clopidogrel
  • Aspirin