First-in-Human Evaluation of a Polymer-Free Everolimus-Eluting Stent Using a Titanium Dioxide Film

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Polymer-coated drug-eluting stents (DES) may impede arterial healing due to persistent polymer presence.
• Polymer-free DES offer potential for improved clinical outcomes and shorter dual antiplatelet therapy (DAPT).

Purpose of the Study:

• To evaluate the safety and efficacy of a novel polymer-free everolimus-eluting stent (EES) in patients with de novo coronary lesions.
• This first-in-human study assessed the TIGERevolutioN® stent in a clinical setting.

Main Methods:

• Twenty patients with de novo coronary lesions were enrolled.
• Angiographic, optical coherence tomography (OCT), and clinical assessments were performed at 8 months.
• The primary endpoint was in-stent late lumen loss (LLL) at 8 months.

Main Results:

• The TIGERevolutioN® stent showed a mean in-stent LLL of 0.7 ± 0.4 mm at 8 months.
• OCT revealed 29.2 ± 9.4% in-stent area stenosis with complete stent strut coverage in all lesions.
• No adverse cardiovascular events were reported within the 8-month follow-up period.

Conclusions:

• The polymer-free EES (TIGERevolutioN®) demonstrated safety and effectiveness.
• Low LLL and excellent stent strut coverage were observed at 8-month follow-up.