The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

First-in-man randomized comparison of the Angiolite® durable fluoro-acrylate polymer-based sirolimus-eluting stent versus durable fluoropolymer-based everolimus eluting stent in patients with coronary artery disease: The ANGIOLITE trial

DOI: 10.4244/EIJ-D-19-00206

1. Complejo Hospitalario de Toledo, Toledo, Spain, SPAIN
2. Hospital Universitario de la Paz, Madrid, Spain
3. Hospital Universitario de León, León, Spain
4. Hospital Universitario Valle de Hebrón, Barcelona, Spain
5. Hospital Santiago de Compostela, La Coruña, Spain
6. Hospital Virgen de la Arrixaca, Murcia, Spain
7. Hospital Virgen de las Nieves, Granada, Spain
8. Hospital Universitario Marqués de Valdecilla, Santander, Spain
9. Hospital Infanta Cristina, Badajoz, Spain
10. Hospital Juan Ramon Jiménez, Huelva, Spain
11. Hospital Clínico de Valladolid, Valladolid, Spain
Disclaimer:

As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention - has been published immediately upon acceptance as it was received. The content of this article is the sole responsibility of the authors, and not that of the journal or its publishers.

To read the full content of this article, please log in to download the PDF.

Aims: The durable fluoro-acrylate polymer-based sirolimus-eluting stent (Angiolite®SES) has shown promising preclinical and clinical results regarding inflammatory vascular reaction and neointimal healing. We aimed to compare performance between SES and everolimus-eluting (EES) stents in patients with coronary artery disease. 

Methods and results: The ANGIOLITE trial, a prospective, randomized, multicenter trial, compared the restenosis parameters of both stents in de novo coronary lesions. Primary endpoint was late lumen loss at 6-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). Main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomized 1:1 to EES or SES. At 6 months, in-stent late lumen loss was 0.08 mm (±0.38) for EES vs 0.04 mm (±0.39) for SES (Difference=-0.04 mm 95%CI [-0.15, 0.07], p for non-inferiority=0.002). By OCT, rate of uncovered to total number of struts score >30% was comparable between groups whereas neointimal thickness was reduced in the SES arm (9.0% [7.6, 10.6] vs. 9.9% [8.5, 11.3], p=0.41; and 86.4 [81.6, 91.2] µm vs 72.1 [68.2, 76.0] µm; p<0.01, respectively). At 24 months, TLF occurred in 8 patients (7.6% [3.3, 14.5]) in EES arm and in 7 patients (7.1% [2.9, 14.0]) in SES arm (p=0.88). Definite/probable stent thrombosis rate was comparable between groups (1.9% [0.2, 6.7] vs 1.0% [0.0, 5.5] EES vs. SES, respectively; p=0.59). 

Conclusions: This trial demonstrates similar anti-restenotic efficacy at mid-term follow-up of the Angiolite®SES vs. EES. Clinical endpoints were comparable between groups at 2-year follow-up.

Sign in to read and download the full article

Forgot your password?
No account yet? Sign up for free!
Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Read next article

A Continuous Intracoronary Versus A Standard Intravenous Infusion of Adenosine for Fractional Flow Reserve Assessment – the HYPEREMIC Trial