RESUMEN
BACKGROUND: Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy. AIMS: The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate. METHODS: BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up. RESULTS: Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration. CONCLUSIONS: The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.
Asunto(s)
Enfermedad de la Arteria Coronaria , Reestenosis Coronaria , Intervención Coronaria Percutánea , Adulto , Anciano , Anciano de 80 o más Años , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Persona de Mediana Edad , Polímeros , Estudios Prospectivos , Stents , Resultado del TratamientoAsunto(s)
Enfermedad de la Arteria Coronaria , Trombosis Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Placa Aterosclerótica , Trombosis , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Trombosis Coronaria/diagnóstico por imagen , Trombosis Coronaria/etiología , Stents Liberadores de Fármacos/efectos adversos , Humanos , Lípidos , Intervención Coronaria Percutánea/efectos adversos , Placa Aterosclerótica/diagnóstico por imagen , Factores de Riesgo , Resultado del TratamientoRESUMEN
AIMS: Left atrial appendage closure (LAAC) with AMPLATZER occluders is used for stroke prevention in atrial fibrillation (AF). Net clinical benefit compared to medical therapy has not been tested. The aim of this study was to test whether long-term clinical outcome after LAAC with AMPLATZER occluders may be similar to medical therapy. METHODS AND RESULTS: Five hundred consecutive patients who underwent LAAC with AMPLATZER occluders were compared to 500 patients with medical therapy by propensity score matching. The primary efficacy endpoint was a composite of stroke, systemic embolism and cardiovascular/unexplained death. The primary safety endpoint consisted of major procedural adverse events and major bleedings. For assessment of net clinical benefit, all of the above-mentioned hazards were combined. After 2,645 patient-years at a mean follow-up of 2.7±1.5 years, the primary efficacy endpoint was reached by 75/1,342, 5.6% in the LAAC group versus 102/1,303, 7.8% per 100 patient-years (hazard ratio [HR] 0.70, 95% confidence interval [CI]: 0.53-0.95, p=0.026). The primary safety endpoint occurred in 48/1,342, 3.6% versus 60/1,303, 4.6% per 100 patient-years (HR 0.80, 95% CI: 0.55-1.18, p=0.21), and the combined hazard endpoint in 109/1,342, 8.1% versus 142/1,303, 10.9% per 100 patient-years (HR 0.76, 95% CI: 0.60-0.97, p=0.018). Patients receiving LAAC demonstrated lower rates of both all-cause and cardiovascular mortality (111/1,342, 8.3% vs 151/1,303, 11.6% per 100 patient-years [HR 0.72, 95% CI: 0.56-0.92, p=0.005] and 54/1,342, 4.0% vs 84/1,303, 6.5% per 100 patient-years [HR 0.64, 95% CI: 0.46-0.89, p=0.007]). CONCLUSIONS: LAAC with AMPLATZER devices showed a net clinical benefit over medical therapy by superior efficacy, similar safety and a benefit in all-cause and cardiovascular mortality.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Procedimientos Quirúrgicos Cardíacos , Dispositivo Oclusor Septal , Accidente Cerebrovascular , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Humanos , Dispositivo Oclusor Septal/efectos adversos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Resultado del TratamientoAsunto(s)
Estenosis Coronaria/diagnóstico por imagen , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Ultrasonografía Intervencional , Anciano , Angioplastia Coronaria con Balón/instrumentación , Angiografía por Tomografía Computarizada , Medios de Contraste/administración & dosificación , Angiografía Coronaria , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Gelatina/administración & dosificación , Humanos , Masculino , Imagen Multimodal , Valor Predictivo de las Pruebas , Tomografía de Coherencia Óptica , Resultado del TratamientoAsunto(s)
Stents Liberadores de Fármacos , Implantes Absorbibles , Angioplastia , Polímeros , Sistema de Registros , SueciaRESUMEN
Simultaneous appearance of a pacemaker-lead associated thrombus and a left atrial appendage closure device related thrombus in a patient with urothelial carcinoma shown in a transesophageal echocardiography.