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

Abstract

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. 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.

Registro prospectivo del <i>stent</i> liberador de sirolimus con pol�mero estable de fluoroacrilato Angiolite: estudio EPIC02 � RANGO

“…Los resultados del presente registro del mundo real del stent coronario Angiolite revelan un perfil de seguridad y eficacia sobresaliente tal y como reflejaban los resultados del primer estudio realizado en humanos, ANCHOR 5 , y el ensayo clínico aleatorizado ANGIOLITE 6 , comparándose con el stent XIENCE. El perfil clínico revela una población de riesgo relativamente alto con una prevalencia de diabetes mellitus del 30,8%, del 17,6% con anticoagulación oral, del 18,4% en pacientes diagnosticados de infarto de miocardio previo y del 23,4% en pacientes con revascularización coronaria previa.…”

“…Tanto el ANCHOR FIH 5 como el ANGIOLITE RCT 6 confirmaron la extraordinaria eficacia antiproliferativa del stent Angiolite con una pérdida luminal tardía media < 0,05 mm. En consecuencia, nos pareció obligatorio valorar el perfil de seguridad de este stent a través de la incidencia de trombosis del stent.…”

“…Después, el estudio ANCHOR, el primero de su clase realizado en humanos 5 confirmó, mediante OCT, la potente inhibición de la hiperplasia neointimal: el stent Angiolite inhibió eficazmente la respuesta proliferativa (estenosis del área del vaso afectado, 4,4 ± 11,3%), la pérdida luminal intrastent a los 6 meses (0,07 ± 0,37 mm) y tuvo una incidencia más baja de mala aposición de los struts (1,1 ± 6,2%). Por último, el estudio clínico aleatorizado ANGIOLITE 6 comparó el stent Angiolite y el stent XIENCE en 223 pacientes (aleatorización 1:1). En este estudio, el objetivo primario, la pérdida de luz tardía intra-stent a los 6 meses no fue inferior en el grupo Angiolite (0,04 ± 0,39 mm) comparado con el grupo XIENCE (0,08 ± 0,38 mm).…”

Thin, very thin, or ultrathin-strut biodegradable or durable polymer-coated drug-eluting stents

“…The randomized noninferiority ANGIOLITE trial [41] is the first-in-man comparison of the very thin-strut (75 mm) cobalt-chromium durable fluoroacrylate polymer-coated sirolimus-eluting Angiolite stent (iVascular, Barcelona, Spain) vs. the very thin-strut Xience stent, performed in 223 patients with de-novo lesions. Angiolite was noninferior to Xience regarding the primary angiographic endpoint late lumen loss at 6-month follow-up.…”

What constitutes sufficient clinical evidence for stents? SpotLITE on the evaluation of novel coronary devices

“…In this issue of EuroIntervention, Moreu and colleagues report a first-in-man evaluation of the novel durable fluoro-acrylate polymer-based sirolimus-eluting Angiolite stent (iVascular, Barcelona, Spain), which was directly compared with the durable fluoropolymer-based everolimus-eluting XIENCE stent (Abbott Vascular, Santa Clara, CA, USA) in patients with de novo coronary artery disease (CAD) 2 .…”