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INTRAVASCULAR IMAGING COMPARISON OF TWO METALLIC LIMUS-ELUTING STENTS ABLUMINALLY COATED WITH BIODEGRADABLE POLYMERS: IVUS AND OCT RESULTS OF THE DESTINY TRIAL
1108 JACC March 21, 2017 Volume 69, Issue 11
Interventional Cardiology INTRAVASCULAR IMAGING COMPARISON OF TWO METALLIC LIMUS-ELUTING STENTS ABLUMINALLY COATED WITH BIODEGRADABLE POLYMERS: IVUS AND OCT RESULTS OF THE DESTINY TRIAL Poster Contributions Poster Hall, Hall C Friday, March 17, 2017, 3:45 p.m.-4:30 p.m. Session Title: Coronary Intervention in Interventional Cardiology: Advanced Device Use Abstract Category: 21. Interventional Cardiology: Coronary Intervention: Devices Presentation Number: 1155-149 Authors: Jose de Ribamar Costa, Daniel Chamie, Alexandre Abizaid, Expedito Ribeiro, George Meireles, Mauricio Prudente, Ricardo Costa, Pedro Lemos, IDPC, São Paulo, Brazil, INCOR, São Paulo, Brazil
Background: Although first-generation drug-eluting stents (DES) have effectively achieved their main goal, reducing restenosis across virtually all lesions and patients’ subsets, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization leading to late and very late thrombosis, and local drug toxicity, which ultimately prompted the development of new generation DES, with more biocompatible or even biodegradable polymers. 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. Methods: 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 nine-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at nine months.
Results: Patients treated with both DES had very little NIH formation at nine 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 nine-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). Conclusions: 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.
Interventional Cardiology INTRAVASCULAR IMAGING COMPARISON OF TWO METALLIC LIMUS-ELUTING STENTS ABLUMINALLY COATED WITH BIODEGRADABLE POLYMERS: IVUS AND OCT RESULTS OF THE DESTINY TRIAL Poster Contributions Poster Hall, Hall C Friday, March 17, 2017, 3:45 p.m.-4:30 p.m. Session Title: Coronary Intervention in Interventional Cardiology: Advanced Device Use Abstract Category: 21. Interventional Cardiology: Coronary Intervention: Devices Presentation Number: 1155-149 Authors: Jose de Ribamar Costa, Daniel Chamie, Alexandre Abizaid, Expedito Ribeiro, George Meireles, Mauricio Prudente, Ricardo Costa, Pedro Lemos, IDPC, São Paulo, Brazil, INCOR, São Paulo, Brazil
Background: Although first-generation drug-eluting stents (DES) have effectively achieved their main goal, reducing restenosis across virtually all lesions and patients’ subsets, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization leading to late and very late thrombosis, and local drug toxicity, which ultimately prompted the development of new generation DES, with more biocompatible or even biodegradable polymers. 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. Methods: 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 nine-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at nine months.
Results: Patients treated with both DES had very little NIH formation at nine 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 nine-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). Conclusions: 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.