RESUMEN
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.
Asunto(s)
Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Anciano , Proliferación Celular , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Reestenosis Coronaria/etiología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neointima , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral/terapia , Cateterismo Cardíaco , Angiografía Coronaria , Ecocardiografía , Femenino , Humanos , Persona de Mediana Edad , Insuficiencia de la Válvula Mitral/diagnóstico por imagenRESUMEN
The aim of this study was to evaluate th effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia.Conventional paclitaxel-eluting stents use a durable polymer coating as vehicle for drug delivery.The Conor stent (Conor Medsystem, Menlo Park, Califórnia) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmakocinetics.Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent(n=53) or one of six different release formulations that varied in dose (10 or 30yg) and elution release kinetics (first order, zero oder), direction (abluminal, luminal), and duration (5, 10, and 30 days)...
Asunto(s)
Hiperplasia/fisiopatología , Hiperplasia/prevención & control , Hiperplasia/tratamiento farmacológico , Paclitaxel/administración & dosificación , Paclitaxel/farmacocinética , Paclitaxel/uso terapéutico , Stents/normas , Stents/tendenciasRESUMEN
The one year clinical benefit of various doses and release durations of paclitaxel eluted from an erodablepolymer has not been evaluated so far.Methods and results: Conor paclitaxel-eluting stents have intra-stent wells in which drug and polymer aredeposited. Stents with six different release formulations (dose: 10 μg or 30 μg, duration: 5, 10 or 30 days,direction: mural or bidirectional) were implanted in 6 patient cohorts. Clinical follow-up was conducted at4 and 12 months. Quantitative angiography and IVUS were performed at 4 months, and additional angiographicand IVUS follow-up were performed for groups D5 (10μg/30days/mural) and D6(30μg/30days/mural), as they had shown the most favorable results at 4 months. At one year, the lowestmajor adverse cardiac event rates were observed in the slow release (30 day) group (5.1% in D5 and 6.9%in D6). One-year in-stent late loss was 0.52±0.34 mm in D5 and 0.36±0.50mm in D6 (p=0.20) whileneointimal area was 0.99±0.54 mm2 in D5 and 0.77±0.92 mm2 in D6 (p=0.42). Corresponding in-stentbinary restenosis at one year was 0% and 5.6% respectively (p=0.36).Conclusions: Patients who received the slow release formulation stent had better clinical outcome at oneyear than those who received the fast release formulation. However, the effect on neointimal suppressionrequires investigation in a larger population to determine whether the high dose formulation confers anadditional clinical benefit.
Asunto(s)
Angiografía , Paclitaxel , StentsRESUMEN
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.
Asunto(s)
Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Insuficiencia de la Válvula Mitral/terapia , Válvula Mitral/cirugía , Enfermedad Aguda , Cateterismo Cardíaco/tendencias , Enfermedad Crónica , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Humanos , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/cirugía , Isquemia Miocárdica/complicaciones , Isquemia Miocárdica/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Disfunción Ventricular Izquierda/complicaciones , Disfunción Ventricular Izquierda/cirugía , Disfunción Ventricular Izquierda/terapiaRESUMEN
Evaluar los efectos clínicos y angiográficos a largo plazo de la radiación gamma intracoronaria, en un grupo de pacientes sometidos a angioplastia transluminal percutánea. Hospital "Dr. Miguel Pérez Carreño" y Centro Médico de Caracas. Entre julio de 1994 y enero de 1995 se trataron con radioterapia intracoronaria 22 lesiones en 21 pacientes después de angioplastia transluminal percutánea con una fuente de irido 192 no centrada. Los pacientes fueron seguidos por 3 años. El diámetro promedio de referencia del vaso fue 2,97 ± 0,49 mm (rango 1,8 a 4,0 mm), y el diámetro luminal mínimo antes y después de la angioplastia fue 0,98 ± 0,53 mm y 1,98 ± 0,5 mm respectivamente; el porcentaje de estenosis residual por diámetro después del procedimiento fue de 35 ± 13 por ciento. En el control a las 24 horas todas arterias estaban permiables excepto una, que presentó trombosis subaguda en un lugar de bifurcación. La pérdida tardía calculada es de 0,19 ± 0,78 mm y el índice de pérdida tardía fue 0,19 ± 0,4. El diámetro luminal mínimo mostró una pérdida tardía negativa en 10 de las 22 arterias. se observó una reestenosis angiográfica binaria (mayor a 50 por ciento del diámetro de la estenosis) en 27,3 por ciento de las arterias. El procedimiento angiográfico a los 2 años fue realizado en 19 sitios de tratamiento. El diámetro luminal mínimo fue 1,90 ± 0,69 y el diámetro promedio de reestenosis residual fue de 35 ± 19 por ciento. La reestenosis angiográfica binaria estuvo presente en 6 arterias (27,2 por ciento). Hubo pequeños cambios en el seguimiento angiográficos a los 3 años. Todas las arterias continuaban permeables y no hubo pérdida adicional tardía. No se observó ningún efecto adverso en los segmentos adyacentes y hubo un pequeño crecimiento de los segmentos aneurismáticos. Ninguno de los pacientes o personal médico desarrolló complicaciones o enfermedades relacionadas con la radiación. La radioterapia intracoronaria podría constituir una estrategia alternativa a la colocación rutinaria de stent después de una adecuada angioplastia con balón para la prevención de la reestenosis
Asunto(s)
Humanos , Masculino , Femenino , Angioplastia de Balón , Rayos gamma , Oclusión de Injerto Vascular/radioterapia , Radioterapia , Medicina , VenezuelaRESUMEN
BACKGROUND: Ionizing gamma radiation has been shown to reduce neointimal formation and the incidence of restenosis after balloon angioplasty and stenting in clinical trials. However, the long-term effects of this therapy are unknown. The first cohort of patients to receive intracoronary gamma radiation after balloon angioplasty for the prevention of restenosis have completed a 5-year angiographic and clinical follow-up. The outcome of these patients is presented and discussed. METHODS: Twenty-one patients with unstable angina (22 arteries) underwent standard balloon angioplasty. Intracoronary radiation therapy was performed immediately after the intervention using an Iridium-192 source wire hand-delivered to the angioplasty site. All patients were followed clinically and Quantitative Coronary Analysis (QCA) was performed at 6, 24, 36 and 60 months. RESULTS: Target lesion revascularization occurred in six lesions, three of which were total occlusions (two early within 30 days and one occurred at 2 years), and one patient had a myocardial infarction attributable to a nontarget vessel. Serial QCA detected a binary restenosis rate of 28.6% (n=6) at 6 months. The late loss (0.29 mm) and loss index (0.25) remained low at 2, 3 and 5 years. Angiographic complications included four aneurysms (two procedure related and two occurring within 3 months). At 2 years, only one aneurysm increased in size (46 vs. 27 mm(2)); and at 3 and 5 years, all aneurysms remained unchanged. No other angiographic complications were observed. CONCLUSION: The early clinical and angiographic effects of intracoronary gamma radiation were maintained at 5 years without further increase in the aneurysm formation or apparent new adverse effects related to the radiation therapy between 2 and 5 years.