RESUMO
BACKGROUND: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. METHODS: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 µg/18mm, n=30) or group B (8 µg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. RESULTS: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773). CONCLUSIONS: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.
Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Idoso , Proliferação de Células , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Reestenose Coronária/etiologia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Fatores de Tempo , Resultado do TratamentoRESUMO
We report the first-in-human mitral valve repair using percutaneous technology that creates a "surgical-like" edge-to-edge repair. A catheter-delivered clip was introduced transseptally from the femoral vein, advanced through the mitral orifice, retracted to grasp the leaflets, and detached to create a functional double-orifice valve. The patient had an uncomplicated post-procedural course. Echocardiography at 1- and 2-years post procedure showed mild mitral regurgitation and positive ventricular remodeling. The success of this case suggests that percutaneous mitral valve repair may be a feasible therapy for certain patients suffering from mitral regurgitation.
Assuntos
Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/terapia , Cateterismo Cardíaco , Angiografia Coronária , Ecocardiografia , Feminino , Humanos , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/diagnóstico por imagemRESUMO
Mitral Regurgitation (MR) is a common medical problem. MR is also a prognostic factor; patients with severe symptomatic MR have a poor prognosis with an annual mortality rate of 5% without surgical intervention. An anatomic understanding of the normal and regurgitant mitral valve is essential in order to evaluate appropriately the severity and impact of MR. We briefly discuss mitral complex anatomy, MR evaluation, and treatment options (surgical and catheter-based alternatives) according to the type of lesion found. In particular, our group has shown temporal percutaneous annuloplasty and definitive percutaneous edge-to-edge mitral valve repair to be a feasible technique. Recently a study evaluating endovascular mitral valve edge-to-edge repair was successfully initiated by our group. Acute and chronic ischemic mitral regurgitation and special situations, such as paravalvular leaks, hypertrophic obstructive cardiomyopathy, and mixed lesions are also discussed. Future directions may include the percutaneous transcatheter implantation of a bioprosthetic valve in mitral position.