Reparación mitral transcatéter mediante dispositivo PASCAL: experiencia inicial / Transcatheter mitral valve repair with the PASCAL system: initial experience

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Reabsorción completa tras implante de múltiples armazones solapados / Complete resorption after implantation of multiple overlapped scaffolds

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Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial.

OBJECTIVES: The REAC-TAVI (Assessment of platelet REACtivity after Transcatheter Aortic Valve Implantation) trial enrolled patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) pre-treated with aspirin + clopidogrel, aimed to compare the efficacy of clopidogrel and ticagrelor in suppressing high platelet reactivity (HPR) after TAVI. BACKGROUND: Current recommendations support short-term use of aspirin + clopidogrel for patients with severe AS undergoing TAVR despite the lack of compelling evidence. METHODS: This was a prospective, randomized, multicenter investigation. Platelet reactivity was measured at 6 different time points with the VerifyNow assay (Accriva Diagnostics, San Diego, California). HPR was defined as (P2Y12 reaction units (PRU) ≥208. Patients with HPR before TAVR were randomized to either aspirin + ticagrelor or aspirin + clopidogrel for 3 months. Patients without HPR continued with aspirin + clopidogrel (registry cohort). The primary endpoint was non-HPR status (PRU <208) in ≥70% of patients treated with ticagrelor at 90 days post-TAVR. RESULTS: A total of 68 patients were included. Of these, 48 (71%) had HPR (PRU 273 ± 09) and were randomized to aspirin + ticagrelor (n = 24, PRU 277 ± 08) or continued with aspirin + clopidogrel (n = 24, PRU 269 ± 49). The remaining 20 patients (29%) without HPR (PRU 133 ± 12) were included in the registry. Overall, platelet reactivity across all the study time points after TAVR was lower in patients randomized to ticagrelor compared with those treated with clopidogrel, including those enrolled in the registry (p < 0.001). The primary endpoint was achieved in 100% of patients with ticagrelor compared with 21% with clopidogrel (p < 0.001). Interestingly, 33% of clopidogrel responder patients at baseline developed HPR status during the first month after TAVR. CONCLUSIONS: HPR to clopidogrel is present in a considerable number of patients with AS undergoing TAVR. Ticagrelor achieves a better and faster effect, providing sustained suppression of HPR to these patients. (Platelet Reactivity After TAVI: A Multicenter Pilot Study [REAC-TAVI]; NCT02224066).

Radial Versus Femoral Approach for Percutaneous Coronary Intervention: MACE Outcomes at Long-Term Follow-up.

OBJECTIVE: To compare the main outcomes of radial versus femoral access at long-term follow-up. BACKGROUND: Little is known about the long-term major cardiovascular events and bleeding complications of patients undergoing percutaneous coronary intervention (PCI) with radial vs femoral approach. METHODS: A total of 1107 patients from the CENTURY II trial were included. To minimize baseline differences between radial and femoral groups, we applied propensity-score matching for this comparison. RESULTS: In this multicenter study, the radial approach was used in 73.4% of patients. After propensity-score matching, baseline and procedural characteristics were comparable between both groups. Procedural success was high and similar in radial and femoral approaches (98.2% vs 97.5%; P=.47) while radial access was associated with a shorter hospital stay (1.69 ± 1.92 days vs 2.08 ± 1.98 days; P<.01). The short-term bleeding and vascular complication rates were significantly lower in the radial group (1.7% vs 6.2% [P<.001 in-hospital] and 2.7% vs 9.6% [P<.001 at 1-month follow-up]). At 3-year follow-up, radial access was associated with lower rates of all-cause mortality (3.9 vs 6.9%; P=.04) and cardiovascular death (2.1 vs 4.9%; P=.02). The composite of all-cause mortality, myocardial infarction, and revascularization showed no differences between groups (18.2 vs 21.1%; P=.29). CONCLUSIONS: Compared to the femoral approach, the radial approach is associated with significantly lower long-term all-cause mortality rate as well as lower in-hospital and short-term bleeding rates. These results suggest additional long-term benefits of radial access for PCI, but should be interpreted within the context of the current study and further verified in future studies.

Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

BACKGROUND: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation. METHODS: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis]. RESULTS: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 µm and 73.9 ± 54.3 µm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization. CONCLUSIONS: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.

Novedades en stents farmacoactivos. Actualización y futuros desarrollos / News in drug-eluting stents. update and future developments

Con el objetivo de mejorar las limitaciones de la primera generación de stents farmacoactivos, las nuevas generaciones se han desarrollado para mejorar su seguridad y su biocompatibilidad optimizando sus tres principales componentes: la plataforma, el polímero y el fármaco. Además de estas, otras líneas de investigación se centran en desarrollar nuevos dispositivos con polímeros biodegradables, sin polímero, entre los que se incluyen los llamados stents bioactivos, que introducen mejoras en la superficie del stent para optimizar la reendotelización arterial, y finalmente prototipos completamente biodegradables. Es impresionante el esfuerzo en investigación básica, estudios de anatomía patológica e ingeniería de diseño que se ha realizado en los últimos años en este campo. Por lo tanto, la información que ha surgido en poco tiempo también es increíble. En esta revisión se hace un análisis de las novedades y los estudios aparecidos en los últimos 3 años en relación con los stents farmacoactivos. Se analizan las mejoras en la segunda generación y se describe la llamada tercera o siguiente generación de stents farmacoactivos (AU)

With the aim of overcoming the limitations of firstgeneration drug-eluting stents, a new generation of stents has been developed to improve safety and biocompatibility by optimizing their three main components: the stent platform, coating and drug. In addition, other lines of research have focused on developing new devices either with biodegradable polymers or without polymers, including so-called bio-active stents, in which the stent surface is modified to optimize arterial endothelialization. Finally, prototypes of fully biodegradable stents are also being developed. The effort put into basic research, studies of anatomy and pathology, and engineering design in recent years in this field has been impressive. As a result, the amount of data that has been produced in a short time has also been remarkable. This review provides an analysis of developments in and studies on drugeluting stents that have taken place in the last 3 years. Improvements in second-generation stents are discussed and the nature of the so-called third or next generation of drug-eluting stents is described (AU)

Tratamiento de reperfusión en el infarto agudo de miocardio con elevación del segmento ST / Reperfusion therapy in ST elevation acute myocardial infarction

Se revisan los avances más relevantes relacionados con el tratamiento de reperfusión en pacientes con infarto agudo de miocardio. En primer lugar, se revisa el papel que tuvo la fibrinolisis intravenosa, pero sobre todo se actualiza el papel de las terapias coadyuvantes antitrombóticas y antiplaquetarias, la evidencia del uso de stents convencionales frente a stents farmacoactivos en el infarto, de los dispositivos de aspiración trombótica y en especial el gran cambio que ha supuesto la introducción de la angioplastia coronaria percutánea primaria como estrategia más eficiente de reperfusión en el infarto agudo de miocardio; se resalta el papel de los modelos de organización en red de la asistencia a pacientes con infarto agudo de miocardio basados en realizar angioplastia primaria en el menor tiempo posible, sobre el principio de llevar al paciente desde el sitio del primer contacto con el sistema sanitario directamente al laboratorio de hemodinámica, para conseguir el menor tiempo de isquemia-reperfusión (AU)

This paper contains a review of the most significant developments in reperfusion therapy for patients with acute myocardial infarction. Firstly, the role of intravenous fibrinolysis is considered. However, the main focus is on recent developments in the use of adjuvant antithrombotic and antiplatelet therapy; comparisons of bare metal and drug-eluting stent use in infarctions; the role of thrombus aspiration devices; and, in particular, the significant progress brought about by the introduction of primary percutaneous coronary angioplasty, which is most effective reperfusion strategy for acute myocardial infarction. In addition, the article also highlights the role of organizational models for health-care networks for patients with acute myocardial infarction, which operate on the basis of carrying out primary angioplasty as quickly as possible. The guiding principle is that the patient should be transferred directly from the site of first contact with the health-care system to the catheterization laboratory in order to achieve the shortest ischemia-reperfusion time (AU)

Nuevas evidencias y directrices en antiagregación y anticoagulación en síndrome coronario agudo e intervencionismo coronario percutáneo / New findings and directions in antiaggregation and anticoagulation therapy in acute coronary syndrome and percutaneous coronary intervention

Se revisan los avances más relevantes relacionados con el tratamiento antiagregante y anticoagulante en el campo del síndrome coronario agudo y el intervencionismo coronario percutáneo. En primer lugar, se revisan los últimos estudios sobre la seguridad y la efectividad de la bivalirudina en el intervencionismo coronario. Se describen también los nuevos datos del abciximab en pacientes con síndrome coronario agudo sometidos a intervencionismo coronario. Además, se realiza una actualización sobre los antiplaquetarios de tercera generación, en concreto la nueva tienopiridina prasugrel. En cuanto a los fármacos anti-factor X, se comentan los resultados de los ensayos clínicos más recientes en cardiología intervencionista y síndrome coronario agudo. Por último, se revisan los avances en la utilización de heparinas de bajo peso molecular, sobre todo en el intervencionismo coronario (AU)

This article contains a review of the most significant developments in antiaggregation and anticoagulation therapy in acute coronary syndrome and percutaneous coronary intervention. Firstly, the latest studies on the safety and efficacy of bivalirudin in percutaneous coronary interventions are considered. Thereafter, new data on the use of abciximab in patients with acute coronary syndrome undergoing percutaneous coronary intervention are discussed. The article also provides an update on third-generation antiplatelet drugs, specifically the thienopyridine prasugrel. With regard to anti-factorXa drugs, the findings of the most recent clinical trials in interventional cardiology and acute coronary syndromes are discussed. Finally, progress in the use of lowmolecular-weight heparin, primarily in percutaneous coronary interventions, is also reviewed (AU)

Implantación transcatéter de prótesis valvular aórtica (situación actual, novedades tecnológicas y perspectivas clínicas). Resultados del Registro Edwards de implantación transfemoral en España / Transcatheter implantation of aortic valve prostheses (current status, new techniques and clinical prospects). Findings of the Edwards transfemoral valve implantation Study in Spain

La estenosis valvular aórtica severa degenerativa tiene mal pronóstico con tratamiento médico. Se ha demostrado que la cirugía de sustitución valvular es un tratamiento muy eficaz y seguro en los pacientes sometidos a él. Sin embargo, son muchos los pacientes que, por diferentes razones (edad, comorbilidades graves, riesgo quirúrgico excesivo, etc.), nunca llegan a ser operados. En estos pacientes se ha propuesto una terapia alternativa mediante la implantación transcatéter de prótesis valvular aórtica. Están disponibles dos modelos de prótesis transcatéter (Edwards y Medtronic CoreValve). El modelo Edwards se implanta por vía transfemoral y transapical; la Medtronic CoreValve ha tenido como vía de acceso la transfemoral con alguna experiencia por vía transapical. Con ambos modelos se han observado buenos resultados, progresivamente mejores, en registros individuales y multicéntricos. Los resultados pendientes del estudio aleatorizado PARTNER determinarán el verdadero papel de la prótesis transcatéter en diferentes contextos. Nuevos modelos (Direct Flow, Sadra Lotus, HLT) están en diferentes estadios de evaluación clínica, dispuestos a incrementar el arsenal de esta nueva tecnología que, sin duda, tendrá un impacto muy importante en el tratamiento de la estenosis valvular aórtica severa degenerativa (AU)

Patients with severe degenerative aortic stenosis who receive medical treatment have a poor prognosis. Surgical valve replacement has been shown to be very safe and effective in patients who receive such treatment. Nevertheless, a significant number do not undergo surgery for various reasons (e.g. age, serious comorbid conditions and excessive surgical risk). For this group, the alternative therapeutic approach of transcatheter aortic valve prosthesis implantation has been proposed. Two different types of transcatheter aortic valve prosthesis are available: the Edwards and Medtronic CoreValve prostheses. The Edwards aortic valve can be implanted using either transfemoral or transapical access, while transfemoral access is usually used with the Medtronic CoreValve, though some experience has been gained with transapical access. Both types of valve have demonstrated increasingly good clinical results in both single-center and multicenter studies. The findings of the randomized PARTNER study, which are still awaited, will be decisive in defining the true role of transcatheter valve implantation in various clinical settings. New types of valve (e.g. the Direct Flow, Sadra Lotus and HLT valves) are in different stages of clinical evaluation and are set to increase the armamentarium of this new technology, which will, without doubt, have a substantial impact on the treatment of severe degenerative aortic valve stenosis (AU)

Análisis y características de los stents farmacoactivos disponibles en la actualidad. Futuros desarrollos / Characteristics of currently available drug-eluting stents. Future developments

Los stents metálicos se desarrollaron para combatir el retroceso elástico, las complicaciones agudas y la reestenosis de la angioplastia con balón, pero crearon una nueva entidad, la restenosis intra-stent, ligada a múltiples factores. Entre ellos, las características clínicas del paciente y el tipo de lesión son inmodificables. Sin embargo, la técnica de implante y, muy particularmente, el diseño del stent han experimentado una gran transformación que ha desembocado en la nueva era de los stents recubiertos, stents liberadores de fármacos o el término que mejor los define, stents farmacoactivos. Estos nuevos stents son dispositivos muy complejos que involucran tecnología y diseño de la plataforma o stent, investigación y desarrollo en el terreno de los polímeros que actuan como transportadores y liberadores de los fármacos, y el propio fármaco que debe inhibir la proliferación neointimal. Si bien los primeros diseños, con 5 años de seguimiento clínico a sus espaldas, han mostrado una reducción significativa y sostenida de la reestenosis y las nuevas revascularizaciones frente a los stents metálicos convencionales, también han mostrado debilidades y sombras, que deben irse corrrigiendo en las próximas generaciones de stents farmacoactivos. En esta revisión se lleva a cabo un análisis detallado de la importancia del diseño del stent, se hace una incursión breve en el mundo de los polímeros, sus tipos y su funcionamiento, y se describen los fármacos empleados en los stents farmacoactivos. Se analizan las características y los resultados clínicos y angiográficos de los stents actualmente disponibles o en fase de estudio, y se abre una ventana hacia los futuros desarrollos (AU)

Metallic stents were developed to minimize the elastic recoil, acute complications, and restenosis that occur with balloon angioplasty. However, they also led to the new problem of in-stent restenosis, which is associated with a number of factors, including some that can not be modified, such as the patient’s clinical characteristics and the type of lesion. Nevertheless, stent implantation techniques and, most importantly, stent design have undergone an enormous transformation, which has led to the new era of coated stents and drug-eluting stents, or, in the terminology that best defines them, active stents. These new stents are very sophisticated devices, which involve innovative stent technology and design, and research and development into polymer coatings for drug storage and release and into the drugs for inhibiting intimal thickening themselves. Although first-generation drug-eluting stents, which have already been followed up clinically for 5 years, have resulted in significant and sustained improvements in the rates of restenosis and revascularization compared with bare metal stents, they have also been found to have weaknesses and disadvantages that will have to be corrected in future generations of drug-eluting stents. This review contains a detailed description of the importance of stent design, involves a brief exploration of the world of polymers and how they function, and surveys the different drugs used in drugeluting stents. It also summarizes the characteristics of and clinical and angiographic data on the drug-eluting stents that are either currently available or being investigated in clinical trails, and provides a glimpse of future developments (AU)