title: Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial.
abstract: We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.
authors.affiliation: Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, 04012, Brazil. rmvcosta@uol.com.br.
authors.forename: J Ribamar
authors.initials: JR
authors.lastname: Costa
authors.affiliation: Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, 04012, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chamié
authors.affiliation: Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, 04012, Brazil.
authors.forename: Alexandre A C
authors.initials: AA
authors.lastname: Abizaid
authors.affiliation: Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.
authors.forename: Expedito
authors.initials: E
authors.lastname: Ribeiro
authors.affiliation: Hospital do Servidor Público Estadual-IAMSPE, São Paulo, SP, Brazil.
authors.forename: George C
authors.initials: GC
authors.lastname: Meireles
authors.affiliation: Hospital Encore, Aparecida de Goiânia, GO, Brazil.
authors.forename: Maurício
authors.initials: M
authors.lastname: Prudente
authors.affiliation: Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Campos
authors.affiliation: Cardiovascular Research Center, São Paulo, SP, Brazil.
authors.forename: Juliana P
authors.initials: JP
authors.lastname: Castro
authors.affiliation: Department of Cardiology, Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Ibirapuera, São Paulo, SP, 04012, Brazil.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Costa
authors.affiliation: Heart Institute (InCor), University of São Paulo Medical School, São Paulo, SP, Brazil.
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Lemos
mesh_terms: D020341:Absorbable Implants; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000187:drug effects*; D054855:Drug-Eluting Stents; D006801:Humans; D008670:Metals; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus
keywords: Biodegradable polymer; Biolimus A9; Drug-eluting stents; Sirolimus