Golden Jubilee National Hospital

Glasgow, United Kingdom

Golden Jubilee National Hospital

Glasgow, United Kingdom
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Functional intracoronary measurements with pressure guidewires assess how much a stenosis limits blood flow. They are currently used mainly in patients with coronary stenosis of intermediate severity. However, there is limited evidence on the safety of deferring revascularisation based on functional measurements in this subset of patients. Two recent large randomised clinical trials, DEFINE FLAIR and iFR SWEDEHEART, showed good outcomes in patients with intermediate stenosis undergoing physiology-guided revascularisation but did not report on patients where procedures were deferred. The new analysis pooled patient-level data for the 4,529 patients enrolled in these two studies and looked at the impact of deferring procedures. Results showed that significantly fewer patients underwent interventions when iFR was used for decision making compared to FFR (50% vs. 45%, p=0.01). The rate of major adverse cardiovascular events (MACE) was low in the 2,130 patients where myocardial revascularisation was deferred (4.12% with iFR and 4.05% with FFR at one year). "The findings support the safety of deferring revascularisation based on iFR or FFR," said lead author Javier Escaned, Consultant Interventional Cardiologist at Hospital Clinico San Carlos, Madrid, Spain. The event rate was higher in deferred patients who had acute coronary syndromes (ACS) than in those with stable coronary disease (SCD) (5.9% vs. 3.6%, p=0.04). Outcomes between ACS and SCD were significantly different when FFR was used for assessment (6.4% in ACS vs. 3.4% in SCD, p=0.049) but the difference was less marked when iFR was used (5.4% in ACS vs. 3.8% in SCD, p=0.37). "Deferral of myocardial revascularisation was associated with a higher rate of MACE in patients with acute coronary syndromes than in those with stable coronary disease," said Escaned. He added, "The findings support the importance of further research into the physiological evaluation of patients with ACS." Commenting on the study, Colin Berry, Professor of Cardiology and Imaging, University of Glasgow and Golden Jubilee National Hospital, UK, said, "Congratulations to the investigators! In ACS patients, invasive management reduces the risk of recurrent spontaneous MI and cardiac death, but these data are not reported in this meta-analysis, nor is the use of evidence-based medicines. This information would be helpful to better understand the results for translation to practice." EuroPCR 2017 session: Tuesday 16 May 11:30-12:50, Hot Line/Late-breaking trials, Coronary interventions, interventions for valvular disease, left main and multivessel disease, NSTEMI, STEMI, Stents and scaffolds, TAVI; Main Arena For any press-related inquiries, please contact: Press registration for EuroPCR is open to accredited journalists, free of charge. Journalists must hold a valid press card and/or provide a letter of assignment from a recognised publication. To register as press go to https:/ EuroPCR press releases can be found at https:/ Abstracts are available online at https:/ EuroPCR, the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions (EAPCI), a registered branch of the European Society of Cardiology, is the world-leading course in interventional cardiovascular medicine. PCR has established a distinctive format for educational activities in the field of cardiovascular interventions. Beyond its flagship course in Paris that gathers more than 11,500 participants every year, PCR organises annual courses in Singapore, London UK, Dubai EAU, Johannesburg RSA, Milan Italy, Chengdu China and Tokyo Japan. For further information on EuroPCR, PCR London Valves, PCR Peripheral, PCR-CIT China Chengdu Valves, GulfPCR-GIM, AsiaPCR, AfricaPCR, PCR Tokyo Valves, and all PCR activities, please contact: Célia Vilà: For more information, please visit: https:/ and follow us on Twitter https:/ using the hashtag #EuroPCR

Biosensors International Group, Ltd. ("Biosensors" or the "Company"), a developer, manufacturer and marketer of innovative medical devices, announced today the enrollment of the first patient in LEADERS FREE II, its new BioFreedom Pivotal Study, conducted under an Investigational Device Exemption (IDE), which will include sites in the United States, Canada, Denmark, France Germany, Italy, and the United Kingdom. The BioFreedom drug-coated stent (DCS) has been implanted to date in over 150,000 patients in more than 40 countries outside the United States. The initiation of LEADERS FREE II marks a key milestone on the path towards obtaining FDA approval for the BioFreedom DCS. Similar to LEADERS FREE, the therapeutic focus of this new US pivotal IDE trial is on patients at high bleeding risk (HBR) who receive an ultra-short dual anti-platelet drug regimen of only 1 month. Professor Keith Oldroyd performed the first LEADERS FREE II implant earlier this week at the Golden Jubilee National Hospital in Glasgow, Scotland and stated: "We are excited to participate in the European arm of the BioFreedom DCS US Pivotal IDE study and further contribute to building the HBR patient experience for potential expansion of the availability of BioFreedom to American patients." The study is conducted under the leadership of Dr. Mitchell W. Krucoff from Duke University, NC, USA, as Principal Investigator and Dr. Philip Urban from La Tour hospital in Geneva, Switzerland, who is the co-Principal Investigator in Europe. The chairman of the Executive Physician Committee is Dr. Marty Leon, Columbia University, New York. Dr. Urban commented: "The results of the LEADERS FREE trial underscore the need to improve treatment of patients at high bleeding risk throughout the world. With the development of the BioFreedom stent, Biosensors has successfully addressed an unmet need for a patient population that had been very largely overlooked." BioFreedom™ represents the latest development in Biosensors' stent technology, featuring a unique micro-structured abluminal surface which permits the controlled release of BA9™ using neither a polymer nor a carrier. BA9™ is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents and is the world's first polymer-free active stent releasing BA9. For more information, please visit

Biosensors International Group, Ltd. ("Biosensors" oder das "Unternehmen"), ein Entwickler, Hersteller und Vermarkter innovativer medizinischer Geräte gab heute die Aufnahme des ersten Patienten in die neue Schlüsselstudie BioFreedom LEADERS FREE II bekannt, die unter einem IDE-Antrag (Investigational Device Exemption) und an Standorten in den Vereinigten Staaten, Kanada, Dänemark, Frankreich, Deutschland, Italien und im Vereinigten Königreich durchgeführt wird. Der medikamentenbeschichteten Stent BioFreedom (DCS - Drug-Coated Stent) wurde außerhalb der Vereinigten Staaten bisher in über 150.000 Patienten in mehr als 40 Ländern implementiert. Der Beginn der Studie LEADERS FREE II markiert einen wichtigen Meilenstein auf dem Weg zur FDA-Genehmigung für den medizinbeschichteten Stent BioFreedom. Wie schon bei LEADERS FREE liegt der therapeutische Fokus dieser neuen US-Schlüsselstudie unter IDE-Antrag auf Patienten mit hohem Blutungsrisiko, die eine sehr kurze duale blutplättchenhemmende Therapie von nur einen Monat erhalten. Professor Keith Oldroyd führte die erste LEADERS FREE II-Implantierung anfang dieser Woche im Golden Jubilee National Hospital in Glasgow (Schottland) durch und merkte an: "Wir freuen uns, am europäischen Zweig der Schlüsselstudie zum medikamentenbeschichteten Stent BioFreedom unter IDE-Antrag teilzunehmen und weiter dazu beizutragen, die Erfahrung von Patienten mit hohem Blutdruck bei der potenziellen Verbreitung von BioFreedom unter amerikanischen Patienten zu gestalten." Die Studie wird unter der Leitung von Dr. Mitchell W. Krucoff von der Duke University, (NC, USA) als Prüfarzt und Dr. Philip Urban vom Krankenhaus La Tour in Genf (Schweiz), der der Ko-Prüfarzt in Europa ist, durchgeführt. Der Vorsitzende des Executive Physician Committee ist Dr. Marty Leon, Columbia University, New York. Dr. Urban kommentierte: "Die Ergebnisse der Studie LEADERS FREE heben hervor, wie wichtig es ist, die Behandlung von Patienten mit hohem Blutungsrisiko weltweit zu verbessern. Mit der Entwicklung des Stents BioFreedom hat sich Biosensors erfolgreich einem ungedeckten Bedarf für eine Patientenpopulation angenommen, die bisher weithin übersehen wurde. BioFreedom™ stellt die neueste Entwicklung in der Stentechnologie von Biosensors dar, eine einzigartige mikrostrukturierte abluminale Oberfläche, die die kontrollierte Freigabe von BA9™ ohne Polymer oder Carrier ermöglicht. BA9™ ist ein hochlipophiles, der Verengung entgegenwirkendes Medikament, dass von Biosensors spezifisch für die Nutzung mit Stents entwickelt wurde und ist das weltweit erste polymerfreie Stent, dass BA9 freisetzt.

Biosensors International Group, Ltd. (« Biosensors » ou la « Société »), un développeur, fabricant et distributeur de dispositifs médicaux innovants, a annoncé aujourd'hui le recrutement du premier patient dans LEADERS FREE II, sa nouvelle étude pivot sur BioFreedom, effectuée dans le cadre d'une autorisation IDE (exemption des dispositifs expérimentaux), qui inclura des sites aux États-Unis, au Canada, au Danemark, en France, en Allemagne, en Italie et au Royaume-Uni. Le stent enduit de médicament (DCS - drug-coated stent) BioFreedom a, à ce jour, été implanté chez plus de 150 000 patients dans plus de 40 pays en-dehors des États-Unis. Le démarrage de LEADERS FREE II marque une étape clé vers l'obtention d'une homologation de la FDA pour le DCS BioFreedom. Similaire à LEADERS FREE, le domaine thérapeutique de ce nouvel essai pivot américain entrant dans le cadre d'une autorisation IDE concerne des patients présentant un risque élevé de saignement ayant reçu un double traitement antiplaquettaire ultra-court de seulement 1 mois. Le professeur Keith Oldroyd a effectué cette semaine le premier implant dans le cadre de LEADERS FREE II au Golden Jubilee National Hospital de Glasgow, en Écosse, et a déclaré : « Nous sommes enthousiasmés de participer à la branche européenne de l'étude pivot américaine d'un IDE portant sur le DCS BioFreedom, et de contribuer davantage à améliorer l'expérience des patients présentant un risque élevé de saignement pour une expansion potentielle de la disponibilité de BioFreedom pour les patients américains. » L'étude est réalisée sous la direction du Dr Mitchell W. Krucoff de l'Université Duke, en Caroline du Nord, aux États-Unis, en qualité d'enquêteur principal, et du Dr Philip Urban de l'hôpital La Tour à Genève, en Suisse, qui est le co-enquêteur principal en Europe. Le président du comité exécutif de médecins est le Dr Marty Leon de l'Université de Columbia, à New York. Le Dr Urban a déclaré : « Les résultats de l'essai LEADERS FREE soulignent le besoin d'améliorer le traitement des patients présentant un risque élevé de saignement à travers le monde. Avec la mise au point du stent BioFreedom, Biosensors a réussi à répondre à un besoin non satisfait d'une population de patients en grande partie ignorée. » BioFreedom™ représente le dernier développement de la technologie de stent de Biosensors, offrant une surface abluminale micro-structurée unique permettant la libération contrôlée de BA9™ sans utiliser de polymère ni de vecteur. BA9™ est un médicament anti-resténotique hautement lipophile mis au point par Biosensors spécialement pour une utilisation avec des stents, et il s'agit du premier stent actif sans polymère au monde libérant du BA9.

Biosensors International Group, Ltd. ("Biosensors" o la "Compañía"), un desarrollador, fabricante y comercializador de innovadores dispositivos médicos, anunció hoy el reclutamiento del primer paciente en LEADERS FREE II, su nuevo estudio central BioFreedom, realizado bajo una Investigational Device Exemption (IDE), que incluirá sitios en Estados Unidos, Canadá, Dinamarca, Francia, Alemania, Italia y Reino Unido. El stent recubierto de fármaco BioFreedom (DCS) ha sido implantado hasta la fecha a más de 150.000 pacientes en más de 40 países fuera de los Estados Unidos. La iniciación de LEADERS FREE II marca un hito clave en el camino hacia la obtención de la aprobación de la FDA para BioFreedom DCS. Similar a LEADERS FREE, el enfoque terapéutico de esta nueva prueba IDE central de EE.UU. es en pacientes con alto riesgo de sangrado (HBR) que reciben un regimen de fármacos anti-plaquetas doble ultra-corto de sólo 1 mes. El profesor Keith Oldroyd realizó el primer implante LEADERS FREE II a comienzos de semana en el Golden Jubilee National Hospital de Glasgow, Escocia y declaró: "Estamos encantados de participar en el brazo europeo del estudio BioFreedom DCS US Pivotal IDE y seguir contribuyendo a la construcción de la experiencia del paciente HBR para la posible expansión de la disponibilidad de BioFreedom a los pacientes americanos." El estudio se realizó bajo la dirección del Dr. Mitchell W. Krucoff de Duke University, Carolina del Norte, EE.UU., como investigador principal y el Dr. Philip Urban de La Tour Hospital en Ginebra, Suiza, quien es el co-investigador principal en Europa. El presidente del Comité Médico Ejecutivo es el Dr. Marty Leon, Columbia University, Nueva York. El Dr. Urban comentó: "Los resultados de la prueba LEADERS FREE subrayan la necesidad de mejorar el tratamiento de pacientes con alto riesgo de sangrado en todo el mundo. Con el desarrollo del stent BioFreedom, Biosensors ha abordado con éxito una necesidad no cubierta de una población de pacientes que habían sido ignorados en gran medida." BioFreedom™ representa el último avance en tecnología de stent de Biosensors, que ofrece una superficie abluminal exclusiva micro-estructurada que permite la liberación controlada de BA9™ sin usar ni un polímero ni un portador. BA9™ es un fármaco anti-restenótico altamente lipofílico desarrollado por Biosensors específicamente para su uso con stents y es el primer stent en el mundo activo libre de polímero liberando BA9.

Castagno D.,University of Turin | Petrie M.C.,Golden Jubilee National Hospital | Claggett B.,Harvard University | McMurray J.,University of Glasgow
European Heart Journal | Year: 2012

Aims The importance of heart rate in the pathophysiology of heart failure with reduced LVEF has recently attracted attention. In particular, the findings of the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT) have put special emphasis on heart rate reduction with ivabradine for improvement in clinical outcomes. Of course, there is a much older drug that reduces heart rate, i.e. digoxin. Methods and resultsIn this short commentary, we retrospectively analyse the Digitalis Investigation Group (DIG) Trial looking at the primary composite endpoint used in SHIFT (i.e. cardiovascular death or hospital admission for worsening heart failure) and compare the effect of digoxin on this endpoint with that of ivabradine. A remarkably similar risk reduction in the composite outcome and in its components appears evident among patients receiving the active treatment in both studies (although ivabradine was added to a beta-blocker, whereas digoxin was not). ConclusionsThis raises the question of whether the Cardiological community dismissed digoxin too readily and if we should reappraise its potential role in the treatment of heart failure. Published on behalf of the European Society of Cardiology. © The Author 2012.

Wald D.S.,Queen Mary, University of London | Wald D.S.,London Chest Hospital | Morris J.K.,Queen Mary, University of London | Wald N.J.,Queen Mary, University of London | And 5 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: In acute ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to treat the artery responsible for the infarct (infarct, or culprit, artery) improves prognosis. The value of PCI in noninfarct coronary arteries with major stenoses (preventive PCI) is unknown. METHODS: From 2008 through 2013, at five centers in the United Kingdom, we enrolled 465 patients with acute STEMI (including 3 patients with left bundle-branch block) who were undergoing infarct-artery PCI and randomly assigned them to either preventive PCI (234 patients) or no preventive PCI (231 patients). Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia. The primary outcome was a composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. An intention-to-treat analysis was used. RESULTS: By January 2013, the results were considered conclusive by the data and safety monitoring committee, which recommended that the trial be stopped early. During a mean follow-up of 23 months, the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI (infarct-artery- only PCI), which translated into rates of 9 events per 100 patients and 23 per 100, respectively (hazard ratio in the preventive-PCI group, 0.35; 95% confidence interval [CI], 0.21 to 0.58; P<0.001). Hazard ratios for the three components of the primary outcome were 0.34 (95% CI, 0.11 to 1.08) for death from cardiac causes, 0.32 (95% CI, 0.13 to 0.75) for nonfatal myocardial infarction, and 0.35 (95% CI, 0.18 to 0.69) for refractory angina. CONCLUSIONS: In patients with STEMI and multivessel coronary artery disease undergoing infarctartery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery. Copyright © 2013 Massachusetts Medical Society.

Scott N.B.,Golden Jubilee National Hospital
Anaesthesia | Year: 2010

Wound infiltration with local anaesthetics is a simple, effective and inexpensive means of providing good analgesia for a variety of surgical procedures without any major side-effects. In particular, local anaesthetic toxicity, wound infection and healing do not appear to be major considerations. The purpose of this review is to outline the existing literature on a procedure-specific basis and to encourage a more widespread acceptance of the technique, ensuring that all layers are infiltrated in a controlled and meticulous manner.

Peacock A.,Golden Jubilee National Hospital | Ross K.,Golden Jubilee National Hospital
Thorax | Year: 2010

Supraventricular tachycardia (SVT) is a rare but important complication of pulmonary arterial hypertension. β-Adrenoceptor blocking agents are commonly used to treat SVT, but they are potentially dangerous in the context of pulmonary arterial hypertension. Their negative inotropic and chronotropic effects are poorly tolerated in this condition, where cardiac reserve is compromised by a reduced and fixed stroke volume, and their administration can result in significant cardiorespiratory compromise. This is not a new discovery, but it is nonetheless poorly recognised in day-to-day clinical practice.

Peacock A.,Golden Jubilee National Hospital
European Respiratory Review | Year: 2013

2011 to 2012 has seen an explosion in published research in the field of pulmonary vascular disease, especially pulmonary hypertension. In conjunction with this research has been an explosion in clinical interest in treating pulmonary hypertension. This is possible because we now have three different generic classes of drug therapy: endothelin receptor antagonists, phosphodiesterase-5 inhibitors and prostacyclins. Clearly, however, we need to be careful that we are treating the correct disease with the correct drug and measuring the correct response. Herein, I will review the papers published over the last year that offer the most insight into the pathobiology, but also those that give us the clinical information we need in epidemiology, treatment and end-points so that we can treat this devastating group of disease. © ERS 2013.

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