Effectiveness and Efficiency of Drug Eluting Stents

Coronary artery disease (CAD), also known as ischemic heart disease (IHD) and coronary heart disease (CHD), is caused by the narrowing (stenosis) of one or more coronary arteries, due to atherosclerosis, restricting blood flow and reducing the supply of oxygen to the heart muscle. Transient shortages in blood flow and oxygen lead to angina pectoris and chest pain, which may radiate to the left shoulder, arms, neck, back or jaw. Stable angina symptoms do not tend to progress in intensity over time. More seriously, the rupturing of an atherosclerotic plaque (causing a thrombotic occlusion) and stenosis of the vessel can result in acute myocardial infarction (AMI) due to a critical reduction in the blood supply to the heart muscle (myocardial ischemia). High levels of morbidity and mortality associated with this infarction are a consequence of ischemia. It is vital to promptly re-establish coronary blood flow after an infarction, because sustained ischemic damages and injuries to the heart muscle may lead to sudden death or heart failure. In addition to infarction, acute symptomatic manifestations of ischemic heart disease include unstable angina, and less common conditions such as cardiogenic shock and sudden death (Thygesen, 2007)..

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods: Prospective, multicenter, 'real-world' registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure.

Left atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus. This multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively. IAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102). In the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up

Tratamiento antitrombótico tras revascularización percutánea en pacientes con indicación crónica de anticoagulación oral

The antithrombotic treatment after percutaneous revascularization in patients with chronic indication for oral anticoagulation has always been a matter of great interest and complexity, basically because of the high ischemic and thromboembolic risk of this population and high hemorrhagic risk associated with combination therapy with antiplatelet and anticoagulant drugs. The actual invasive management of ischemic cardiomyopathy has made this population of patients grow and raised concerns on which the optimal drugs and therapeutic strategies really are. Yet despite the scarce scientific evidence available, different antithrombotic regimens have been studied over the last few years in an attempt to reduce hemorrhagic events without affecting the efficacy of the new combination therapies. The strategies studied have been based on shortening the duration of triple anticoagulation therapy, and even on the use of double anticoagulation therapy (anticoagulation plus one single antiplatelet drug) prioritizing clopidogrel. But it has been the arrival of direct-acting anticoagulants, with important clinical trials conducted on this population, that has provided us with relevant and fundamental information that will undoubtedly contribute to change the actual clinical practice.El tratamiento antitrombótico tras una revascularización percutánea en los pacientes con indicación de anticoagulación oral crónica ha sido siempre un tema de máximo interés y de gran complejidad, debido sobre todo al alto riesgo isquémico y tromboembólico intrínseco de esta población, y al elevado riesgo hemorrágico que comporta la combinación de fármacos antiagregantes y anticoagulantes. El manejo invasivo actual de la cardiopatía isquémica hace que esta población esté en crecimiento, aspecto que incrementa el interés por definir cuáles son los mejores fármacos y estrategias terapéuticas. A pesar de la escasa evidencia científica, a lo largo de los últimos años se han estudiado diferentes regímenes antitrombóticos, buscando fundamentalmente una reducción de los eventos hemorrágicos, sin que esto repercutiera en la eficacia de las nuevas combinaciones. Las estrategias estudiadas se han basado en el acortamiento de la duración del tratamiento triple e incluso en el uso del tratamiento doble (anticoagulación más un único antiagregante) priorizando el clopidogrel. Sin embargo, ha sido la llegada de los anticoagulantes de acción directa, con la realización de importantes ensayos clínicos en esta población, lo que está aportando información relevante y trascendente que, sin lugar a dudas, contribuirá a modificar la práctica clínica

Evaluación económica e impacto presupuestario del stent recubierto Endeavor® en España Economic evaluation and budget impact analysis of the Endeavor® drug-eluting stent in Spain

Objetivo: Endeavor® es un stent recubierto de fármaco (DES, drug-eluting stent) con resultados superiores a los stents metálicos (BMS, bare metal stent) y eficacia similar a los otros DES, en revascularización. El objetivo del estudio fue comparar los costes y beneficios de Endeavor®, otros DES, BMS y bypass coronario en España. Métodos: Se construyó un modelo de Markov a cinco años que refleja el tratamiento de los pacientes con lesiones coronarias de novo. Las probabilidades se derivaron de revisiones sistemáticas y de los ensayos clínicos con Endeavor®. El uso de recursos y los costes se obtuvieron de datos locales y validados por expertos. Los resultados se expresaron como revascularizaciones evitadas, coste por acontecimientos adversos cardíacos mayores (MACE, major adverse coronary event) evitados y años de vida ajustados por calidad (AVAC) ganados. Resultados: Endeavor® tuvo unos costes superiores al BMS; un coste por revascularización evitada con Endeavor® de 6851 € (1 año) y 10.831 € (5 años); un coste por MACE evitado de 7003 € y 11.322 €, respectivamente, y un coste por AVAC ganado de 132.877 €, 34.229 € y 10.505 € a 1, 2 y 5 años, respectivamente. El impacto presupuestario de la introducción progresiva de Endeavor® será prácticamente nulo, representando un 0,4% sobre el coste de las intervenciones coronarias percutáneas a los 5 años. Conclusiones: En comparación con BMS y bypass coronario, el empleo de Endeavor® representa un uso eficiente de los recursos en pacientes coronarios, con razones de coste-efectividad por debajo del umbral de eficiencia definido para el Sistema Nacional de Salud español.Objectives: Endeavor® is a drug-eluting stent (DES) with superior results to the bare metal stent (BMS) and similar efficacy to other DES in terms of revascularization. The aim of this study was to assess the costs and benefits of Endeavor®, other DES, BMS and coronary artery bypass grafts (CABG) in Spain. Methods: A Markov model with a 5-year time was used to reflect the management of patients with de novo coronary artery lesions in Spain. Model probabilities were derived from systematic reviews and randomized controlled trials of Endeavor®. Health resources and costs were obtained from local data and were validated by experts. Effectiveness was measured as the number of revascularizations avoided, the major adverse coronary events (MACE) avoided and the quality adjusted life-years (QALYs) gained. Results: Endeavor® had higher total costs than the BMS. The cost per revascularization avoided with Endeavor® was 6,851 € (at 1 year) and 10,831 € (at 5 years). In terms of cost per MACE avoided with Endeavor®, the results were 7,003 € and 11,322 €, respectively, and in terms of costs of QALY gained were 132,877 €, 34,229 € and 10,505 € at 1, 2, and 5 years, respectively. The budget impact of the progressive introduction of Endeavor® would be practically null, representing 0.4% of the total cost of percutaneous coronary interventions at 5 years. Conclusions: The use of the Endeavor® stent compared with BMS and CABG represents efficient resource use in patients with coronary artery disease, with cost-effectiveness results below the threshold of efficiency defined in Spain