RESUMEN
BACKGROUND AND PURPOSE: The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix(2) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death. MATERIALS AND METHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix(2) and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months. RESULTS: At 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix(2) (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size. CONCLUSIONS: Tested Matrix(2) coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.
Asunto(s)
Materiales Biocompatibles Revestidos/química , Embolización Terapéutica/instrumentación , Matriz Extracelular/química , Aneurisma Intracraneal/cirugía , Platino (Metal)/química , Stents/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Embolización Terapéutica/mortalidad , Análisis de Falla de Equipo , Femenino , Humanos , Incidencia , Internacionalidad , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/mortalidad , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Radiografía , Recurrencia , Factores de Riesgo , Método Simple Ciego , Tasa de Supervivencia , Resultado del Tratamiento , Adulto JovenRESUMEN
In a double-blind randomized clinical trial the efficacy and safety of oral high-dose torasemide (1-isopropyl-3- ([4-(3-methyl-phenylamino)pyridine]-3-sulfonyl)urea, T) therapy was compared with that of furosemide (F) in 10 patients with advanced chronic renal failure. The efficacy on edema, fluid and electrolyte balance including the influence on renin-angiotensin-aldosterone system and cochlear function was evaluated. Patients were randomly allocated to either 500 mg F/d (group 1) or 200 mg T/d (group 2). After 14 days of treatment doses were doubled in each group for further 14 days. With respect to the 2.5 times lower dose of T the clinical effect of both drugs on edema, fluid and sodium excretion was equipotent. Significant differences were noted on calciuresis. Serum calcium levels were reduced with F, while T had no influence on calcium balance. A significant increase in plasma renin activity (PRA) was observed after F, whereas T had no raising effect on PRA. No significant alteration of plasma aldosterone concentration occurred with T or F. No adverse effects were noted in both groups. Serial audiometries showed no significant impairment of cochlear function with both drugs. In conclusion, these results indicate that high-dose T is efficient and safe in the treatment of advanced chronic renal failure. The lack of a calciuric effect with T can be regarded as an advantage in patients with hypocalcemia in chronic renal failure.
Asunto(s)
Diuréticos/uso terapéutico , Fallo Renal Crónico/tratamiento farmacológico , Sulfonamidas/uso terapéutico , Adulto , Calcio/orina , Ensayos Clínicos como Asunto , Cóclea/efectos de los fármacos , Diuresis/efectos de los fármacos , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Natriuresis/efectos de los fármacos , Distribución Aleatoria , Sistema Renina-Angiotensina/efectos de los fármacos , TorasemidaRESUMEN
A method is proposed for comparing the orifice size and the morphology of stenotic mitral valves, removed intact at the time of replacement, with the preoperative two dimensional echocardiographic cross-sections. The excised mitral valve apparatus is suspended on a specially constructed mounting. To avoid shrinkage the orifice is stabilised with an airfilled balloon. A radiography is taken directing the x-ray beam perpendicular to the valve orifice. In 40 of 51 patients this method provided the means of relating the echocardiographic cross-sections to the morphology of the valve. Planimetry of the valve area compared favourably with the postoperatively determined orifice size. Agreement was found in 34 of 40 patients in orifice shape between preoperative echocardiograms and x-rays of th excised valve. The relation between intraoperative estimation of size of the valve, using dilators with known diameters, and the postoperative results was less favourable. Areas of calcification were identified on echocardiography as dense conglomerate echoes. In 30 patients (75%) the localisation of calcium deposits and in 67% the degree of calcification was in agreement with the x-rays of the valve taken after operation. In addition to determination of the area, two dimensional echocardiography allows detailed studies of the stenotic valves, and is of particular importance for planning operative treatment.