RESUMO
OBJECTIVES: This study sought to report the late multimodality imaging and clinical outcomes of the novel poly-l-lactic-acid-based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions. BACKGROUND: Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events. METHODS: Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients. RESULTS: The scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%. CONCLUSIONS: Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System-The DESolve Nx Trial; NCT02086045).
Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Vasos Coronários/efeitos dos fármacos , Macrolídeos/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Tomografia de Coerência Óptica , Ultrassonografia de Intervenção , Idoso , Brasil , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Vasos Coronários/diagnóstico por imagem , Europa (Continente) , Feminino , Humanos , Hiperplasia , Macrolídeos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Neointima , Nova Zelândia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Valor Preditivo dos Testes , Estudos Prospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES:This study sought to report the late multimodality imaging and clinical outcomes of the novel poly-l-lactic-acid-based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions. BACKGROUND: Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events...
Assuntos
Doença das Coronárias , Stents FarmacológicosRESUMO
AIMS: First generation DES have markedly reduced restenosis. However, there is a major interest in developing new DES with greater flexibility, radiopacity and safety profile. The Elixir Medical drug eluting stent is a novel DES that combines a chromium-cobalt platform with novolimus (an antiproliferative sirolimus-analogue drug) and a polymer from the methacrylate family. As potential advantages, it provides a lower drug dose as compared to Cypher (85 microg of novolimus vs. 140 microg of sirolimus) and therefore has a lower polymer load. We sought to evaluate the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS. METHODS AND RESULTS: In April 2007 a consecutive cohort of patients with de novo lesions < or = 14 mm in length, located in native coronaries of diameter from 3.0 to 3.5 mm were consecutively enrolled in this First-in-Man study (FIM). By protocol, angiography and IVUS would be done at baseline and repeated at four and eight months. Dual anti-platelet therapy was maintained for a minimum of 12 months. The primary endpoint was QCA lumen loss at 4-month follow-up. Secondary endpoints included MACE, in-stent neointimal obstruction by IVUS and device success. A total of 15 patients were included with 67% female patients and diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15 +/- 0.29 mm) by QCA and % volume obstruction (2.6 +/- 2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31 +/- 0.25 mm and % volume obstruction by IVUS was 6.0 +/- 4.4%. Late incomplete stent apposition (ISA) were not observed among these patients and no MACE was evidenced through nine month clinical follow-up. CONCLUSIONS: In this FIM study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation. Additional large clinical trials should be considered to confirm these promising results.
Assuntos
Angioplastia Coronária com Balão , Antibióticos Antineoplásicos/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Macrolídeos/administração & dosagem , Sirolimo/análogos & derivados , Idoso , Antibióticos Antineoplásicos/efeitos adversos , Ligas de Cromo , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Stents Farmacológicos/efeitos adversos , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Macrolídeos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
First degeration DES have markdly reduced restenosis. However , there is a major interest in developing a new DES with greater flexibility , radiopacity and safety profile. The elixir medical drug eluting stents is a novel DES combines a chromium-cobalt platform with novolimus (an atiproliferative sirolimos-analogue drug) and a polimer from the metacrylate family. As potential advantages , it provides a lower drug dose as compared to Cypher (85hg of novolimus vs 140 hg of sirolimus) and therefore has a lower polymer load. We sought to evaluated the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS...