ABSTRACT
PURPOSE: To evaluate the effectiveness, adverse reactions, and adherence to treatment of hypolipidemic inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9is) in a context of real clinical practice. METHODS: We present an observational, retrospective, descriptive, multicenter study of patients with hypercholesterolemia who began treatment with PCSK9is between January 2017 and December 2019, with a minimum treatment period of 3 months. The main variable we recorded was the frequency of cardiovascular events (cardiovascular death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina) in patients treated with PCSK9is. We recorded patient demographic characteristics and cardiovascular risk factors at onset of treatment as well as LDL-C levels and their reductions at 3, 6, 12, and 24 months. We calculated adherence to treatment and recorded the adverse reactions during treatment. FINDINGS: A total of 154 patients were studied, 64 (41.6%) of whom were treated with alirocumab and 90 (58.4%) with evolocumab. The initial dose of alirocumab was 75 mg every 14 days in 48 patients (75%) and 150 mg eery 14 days in 16 (25%). All patients who in the evolocumab group received a dose of 140 mg every 14 days. The mean (SD) basal LDL-C level was 159.6 (50.1) mg/dL, the level at 3 months was 87.9 (49.9) mg/dL (mean [SD] decrease, 44.5% [28.2%]), the level at 6 months was 86.7 (49.2) mg/dL (mean [SD] decrease, 46.3% [25.6%]), and the level at 12 months was 80.5 (41.4) (mean [SD] decrease, 48.9% [23.0%]). These values were maintained at 24 months (mean [SD], 80.3 [41.8] mg/dL; mean [SD] decrease, 47.9% [27.8%]). The percentage decrease of LDL-C for both drugs was approximately 50%, which was maintained until 24 months after treatment. Six patients (3.9%) presented with some cardiovascular event: acute myocardial infarction (2 [1.3%]), stroke (1 [0.65%]), coronary revascularization (1 [0.65%]), and hospitalization for unstable angina (2 [1.3%]). We did not see any adverse reactions related to PCSK9i treatment in 76.5% of patients. In the first 6 months, adherence to treatment with PCSK9is, measured as the possession ratio, was a mean (SD) of 99.4% (3.9%). In the rest of the study period (6-24 months), the mean (SD) adherence to treatment was 99.2% (4.7%). IMPLICATIONS: The frequency of cardiovascular events in patients treated with PCSK9is was low and occurred despite adequate adherence to treatment (100% possession ratio) with PCSK9is and concomitant treatment with other hypolipidemics. The effectiveness of PCSK9is is similar to that referred to in other published studies with PCSK9is, and this was maintained in the long term (24 months) with few adverse events, all of which were mild.
Subject(s)
Anticholesteremic Agents , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Hypercholesterolemia , Proprotein Convertase 9 , Antibodies, Monoclonal/adverse effects , Anticholesteremic Agents/adverse effects , Cholesterol, LDL , Humans , Hypercholesterolemia/drug therapy , PCSK9 Inhibitors , Retrospective Studies , Subtilisins , Treatment OutcomeABSTRACT
El objetivo principal en el abordaje del paciente con fibrilación auricular es la reducción del riesgo de ictus mediante el tratamiento antitrombótico adecuado. Sin embargo, a pesar de una adecuada anticoagulación, sigue habiendo un importante riesgo residual de eventos isquémicos, particularmente infarto de miocardio y muerte de origen cardiovascular, que exige una protección más completa. Por lo tanto, en el paciente con fibrilación auricular, el tratamiento anticoagulante debería perseguir este doble objetivo, la reducción tanto del riesgo de ictus como de las complicaciones isquémicas. Diferentes estudios han demostrado que los antagonistas de la vitamina K solo disminuyen el riesgo de ictus y de eventos isquémicos cuando el control de la anticoagulación es óptimo, cosa que ocurre en un pequeño número de pacientes. Con respecto a los anticoagulantes orales de acción directa, aunque en general muestran un perfil de eficacia y seguridad mejor que los antagonistas de la vitamina K, parece que no todos ofrecerían la misma protección en cuanto a la reducción de los eventos isquémicos. Está demostrado que el rivaroxabán reduce de manera significativa (18%) el riesgo de infarto de miocardio. De hecho, los estudios muestran que el rivaroxabán proporciona una protección vascular más completa en diferentes contextos clínicos, no solo en el paciente con fibrilación auricular, sino también en el paciente con enfermedad vascular ateroesclerótica
The main aim of management in patients with atrial fibrillation is to reduce the risk of stroke using appropriate antithrombotic treatment. However, despite adequate anticoagulation, there remains a substantial residual risk of ischemic events, particularly myocardial infarction and cardiovascular death. A more general approach is needed. Consequently, in patients with atrial fibrillation, anticoagulation treatment should seek to achieve the twin targets of reducing the risk of both stroke and ischemic events. Studies have demonstrated that vitamin K antagonists reduce the risk of stroke and ischemic events only when anticoagulation control is optimal, a situation that occurs in only a small number of patients. Direct oral anticoagulants are generally more effective and safer than vitamin K antagonists. However, not all direct oral anticoagulants appear to offer the same protection against ischemic events. It has been shown that rivaroxaban significantly reduces the risk of myocardial infarction (by 18%). In fact, studies demonstrate that rivaroxaban provides comprehensive vascular protection across a range of clinical scenarios, not only in patients with atrial fibrillation, but also in those with atherosclerotic vascular disease
Subject(s)
Humans , Atrial Fibrillation/drug therapy , Myocardial Ischemia/drug therapy , Stroke/prevention & control , Myocardial Infarction/drug therapy , Anticoagulants/administration & dosage , Fibrinolytic Agents/administration & dosage , Vitamin K/administration & dosage , Rivaroxaban/administration & dosageABSTRACT
AIMS: The aim of the study was to validate a novel formula for aortic area, based on the principle of continuity equation (CE), that substitutes Doppler-derived stroke volume (SV) by SV directly measured with real-time three-dimensional (RT3D) echo and semi-automated border detection. RT3D has proved outstanding accuracy for left ventricular volume calculation. So far, however, neither this potential has been applied to haemodynamic assessment, nor RT3D has succeeded in the evaluation of aortic valve disease. METHODS AND RESULTS: Aortic area was measured in 41 patients with aortic stenosis using Gorlin's equation, Hakki's formula, Doppler CE, two-dimensional Simpson's volumetric method, and by the novel RT3D method. RT3D has the best linear association and absolute agreement with Gorlin of all non-invasive methods r = 0.902, intraclass correlation coefficient (ICC) = 0.846, better than CE (r = 0.646, ICC = 0.626) and two-dimensional volumetric method (r = 0.627, ICC = 0.378). Linear and Passing-Bablok regression show that RT3D fits better to Gorlin (r(2) = 0.814) than CE (r(2) = 0.417) and two-dimensional method (r(2) = 0.393). Its accuracy is comparable to Hakki's formula, routinely employed in catheter laboratories. Inter- and intraobserver agreements (ICC) were, respectively, 0.732 and 0.985, better than CE (0.662, 0.857). RT3D also grades most efficiently the severity of aortic stenosis as mild, moderate, or severe (weighted kappa = 0.932). RT3D underestimates aortic area (95% CI 0.084-0.193). ROC curves, however, show that the optimal cutoff point to consider aortic stenosis severity remains close to 1 cm(2) (1.06 cm(2)). CONCLUSIONS: RT3D is more accurate than CE and than two-dimensional volumetric methods to calculate area and to grade the severity of aortic stenosis. Area obtained by three-dimensional echo is slightly underestimated, but its range is clinically negligible.
Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Calcinosis/diagnostic imaging , Echocardiography, Three-Dimensional/methods , Aged , Echocardiography, Three-Dimensional/standards , Female , Humans , Male , Observer Variation , ROC Curve , Sensitivity and SpecificityABSTRACT
An arterial pseudoaneurysm is an uncommon complication of cardiovascular procedures associated with considerable morbidity and increased hospital costs. Percutaneous thrombin injection is one approach to therapy. We describe our initial experience with this technique in 3 patients, with special attention to the utility of sonographic guidance. In all cases complete closure was achieved, although one patient required additional brief extrinsic compression with the ultrasound probe.
Subject(s)
Aneurysm, False/drug therapy , Femoral Artery , Hemostatics/administration & dosage , Thrombin/administration & dosage , Aged , Aneurysm, False/diagnostic imaging , Angiography , Female , Femoral Artery/diagnostic imaging , Humans , Injections, Intra-Arterial , Male , Time Factors , Treatment Outcome , Ultrasonography, Doppler , Ultrasonography, Doppler, ColorABSTRACT
El seudoaneurisma arterial es una complicación poco frecuente de los procedimientos cardiovasculares que conlleva una importante morbilidad e incremento en los costes de hospitalización. Una alternativa terapéutica es la administración percutánea de trombina. Describimos nuestra experiencia preliminar con esta técnica en 3 pacientes, con especial enfoque sobre la utilidad del control ecográfico. Se logró el cierre completo en los 3 casos, aunque en uno de ellos el procedimiento se completó con un breve período de compresión extrínseca con la sonda de ultrasonidos. (AU)
