title: Very long-term follow-up of strut apposition and tissue coverage with Biolimus A9 stents analyzed by optical coherence tomography.
abstract: First generation drug-eluting stents (DES) are associated with reduced in-stent restenosis but significant increased risk of very late stent thrombosis (VLST). The absence of polymer in DES systems may reduce the occurrence of VLST. Optic coherence tomography (OCT) has been used for stent analysis as a surrogate safety endpoint. This study aimed to assess the long-term follow up of strut apposition and tissue coverage of BioMatrix DES by OCT. 20 patients undergoing BioMatrix DES (n = 15) or S-Stent BMS (n = 5) implantation were followed for at least 5 years and evaluated by quantitative coronary angiography, intravascular ultrasound, and OCT. The difference between the stent types was evaluated by nonparametric Mann-Whitney U test while categorical variables were evaluated by Fisher exact test. Rates of in-stent late loss were similar between groups [0.40 (0.21;0.77) vs. 0.68 (0.66; 0.82) mm, p = 0.205, for BioMatrix and S-Stent, respectively]. The vessel, stent and lumen volumes did not differ between groups. Patients treated with BioMatrix had significantly less stent obstruction [5.6 (4.4;9.7) vs. 28.6 (24.7;29.0) %, p = 0.001]. OCT analysis of 12 stents (Biomatrix = 9 and S-Stent = 3) demonstrated 126 (8.7 %) uncovered struts in the BioMatrix group compared to 23 (4.0 %) in the S-Stent group (p = 0.297), being the majority of them well apposed (117/126 and 21/23, respectively, p = 0.292). Only 9 (0.6 %) struts in the DES and 2 (0.4 %) struts in the BMS groups were simultaneously uncovered and malapposed (p = 0.924). BioMatrix DES was associated with lower rates of in-stent obstruction, and similar percentage of neointimal coverage on struts and of complete strut apposition.
authors: Dante Pazzanese Institute of Cardiology, Av Dante Pazzanese, 500, Vila Mariana, São Paulo 04012-180, Brazil. r_staico@hotmail.com
authors: Rodolfo
authors: R
authors: Staico
authors: Marco A
authors: MA
authors: Costa
authors: Daniel
authors: D
authors: Chamié
authors: Hiram
authors: H
authors: Bezerra
authors: Luciana V
authors: LV
authors: Armaganijan
authors: Ricardo A
authors: RA
authors: Costa
authors: José Ribamar
authors: JR
authors: Costa
authors: Dimytri
authors: D
authors: Siqueira
authors: Marinella
authors: M
authors: Centemero
authors: Áurea
authors: Á
authors: Chaves
authors: Luiz Fernando
authors: LF
authors: Tanajura
authors: Alexandre
authors: A
authors: Abizaid
authors: Fausto
authors: F
authors: Feres
authors: J Eduardo M R
authors: JE
authors: Sousa
authors: Amanda G M R
authors: AG
authors: Sousa
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis* / Q000209:etiology / Q000473:pathology; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; C518022:umirolimus; D020123:Sirolimus