Clinical Safety and Efficacy of New-Generation Single-Layer Polytetrafluorethylene Covered Coronary Stents

Cardiovasc Revasc Med. 2023 Jul:52:30-36. doi: 10.1016/j.carrev.2023.02.013. Epub 2023 Feb 18.

Abstract

Background: Early-generation "sandwich-design" polytetrafluorethylene (PTFE) covered coronary stents (CS) are associated with a high frequency of adverse events. New-generation single layer PTFE-CS offers the potential to enhanced procedural efficacy and improves clinical safety. Data from a dedicated study, concerning outcomes after treatment with single-layer PTFE-CS in patients undergoing percutaneous coronary intervention are scant.

Methods: This is a retrospective multicenter registry including 30 patients undergoing implantation of 39 single-layer PTFE-CS (BeGraft-coronary Stent Graft System, Bentley InnoMed GmbH, Hechingen, Germany) in native coronary arteries or saphenous bypass grafts, in 3 centers in Europe, between May 2013 and May 2019. Endpoints of interest were procedural success (placement of covered stent), binary-angiographic restenosis (BAR), percent diameter stenosis (% DS) and late-lumen loss at 6-8 months follow-up angiography, rates of target lesion revascularization (TLR), myocardial infarction (MI), stent thrombosis (ST) and mortality at 12 months.

Results: 28 patients underwent implantation of 37 CS due to coronary artery perforation 2 patients due to coronary artery aneurysm. Technical success was achieved in all patients (100 %). More than one stent was implanted in 7 patients (25 %) all in the perforation group. Follow-up angiography was available in 23 patients (77 %) showing favorable results: BAR = 21.8 %, %DS = 30.3 ± 27.5; LLL = 0.16 ± 0.81 mm. At 12 months all patients were alive, rates of TLR were low (3 patients, 10.0 %), there was one case of late stent thrombosis (3.3 %) and one MI (3.3 %).

Conclusions: In this dedicated study, implantation of a new single layer PTFE-CS for the treatment of native coronary arteries or saphenous vein grafts after perforation or due to aneurysm showed high technical success rates and favorable angiographic and clinical efficacy. Clinical safety outcomes are encouraging, but larger prospective studies are needed to determine long-term safety of this device.

Keywords: Coronary perforation; Covered coronary stents; Percutaneous coronary intervention, coronary artery aneurysm.

Publication types

  • Multicenter Study

MeSH terms

  • Coronary Angiography
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / surgery
  • Coronary Restenosis* / diagnostic imaging
  • Coronary Restenosis* / etiology
  • Coronary Restenosis* / therapy
  • Humans
  • Myocardial Infarction* / etiology
  • Polytetrafluoroethylene
  • Prosthesis Design
  • Stents / adverse effects
  • Thrombosis* / etiology
  • Treatment Outcome

Substances

  • Polytetrafluoroethylene