First-in-man randomised comparison of the Angiolite durable fluoroacrylate polymer-based sirolimus-eluting stent versus a durable fluoropolymer-based everolimus-eluting stent in patients with coronary artery disease: the ANGIOLITE trial
EuroIntervention 2019;15:e1081-e1089. DOI: 10.4244/EIJ-D-19-00206
José Moreu1, MD, PhD; Raúl Moreno-Gómez2, MD, PhD; Armando Pérez de Prado3, MD, PhD, FESC; Bruno García del Blanco4, MD, PhD; Ramiro Trillo5, MD; Eduardo Pinar6, MD, PhD; Eduardo Molina7, MD; Javier Zueco8, MD; Antonio Merchán9, MD; José Francisco Díaz-Fernández10, MD; Ignacio Amat11, MD
1. Complejo Hospitalario de Toledo, Toledo, 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
Aims: The durable fluoroacrylate 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 the Angiolite SES and an everolimus-eluting stent (EES) in patients with coronary artery disease.
Resultado principal del ensayo Angiolite
Methods and results: The ANGIOLITE trial, a prospective, randomised, multicentre trial, compared the restenosis parameters of both stents in de novo coronary lesions. The primary endpoint was late lumen loss at six-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). The main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomised 1:1 to EES or SES. At six 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, the rate of uncovered to total number of struts score >30% was comparable between the 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 eight patients (7.6% [3.3, 14.5]) in the EES arm and in seven patients (7.1% [2.9, 14.0]) in the SES arm (p=0.88). The definite/probable stent thrombosis rate was comparable between the 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 antirestenotic efficacy at midterm follow-up of the Angiolite SES vs an EES. Clinical endpoints were comparable between the groups at two-year follow-up.