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

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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.

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