February 12 15, 2014 Vienna, Austria. Final Programme.

Transkript

1 58 t h ANNUAL MEETING SOCIETY OF THROMBOSIS AND HAEMOSTASIS RESEARCH Translational medicine on the road to tailored therapies February 12 15, 2014 Vienna, Austria Final Programme U1

2 Ein NEUER rekombinanter Faktor VIII zur Behandlung der Hämophilie A 1 NovoEight geschaffen für eine Welt voller Möglichkeiten Julian studiert Sozialpädagogik und engagiert sich als Betreuer in Kinder- und Jugendfreizeiten. Julian lebt mit Hämophilie A. Das erste neue rfviii-molekül seit über einem Jahrzehnt 1 7 VERLÄSSLICHKEIT PTPs *, die in Zulassungsstudien auf NovoEight umgestellt wurden, entwickelten 1, ** 0HEMMKÖRPER Gleichbleibende Aktivität: Charge für Charge 8, 9 Nachgewiesene Wirksamkeit 1 im bislang größten Zulassungsstudien- Programm eines FVIII (n = 213) REINHEIT UND SICHERHEIT Erster rfviii unter Verwendung von 9, 10 20NM-FILTERN Fünfstufiger Aufreinigungsprozess inklusive selektiver Immunaffinitäts- 9, 10 Chromatographie und Nanofiltration Gute Verträglichkeit in klinischen 1, 11, 12, *** Studien MOBILITÄT Erster rfviii mit einer Lagerungstemperatur bis 30 **** 1, CELSIUS Verbesserte Temperaturstabilität 1 * PTP: Previously Treated Patients, vorbehandelte Menschen mit Hämophilie A. ** Patienten mit anamnestisch bekannter Hemmkörperentwicklung wurden von diesen Studien ausgeschlossen. Menschen mit Hämophilie A können Hemmkörper gegen FVIII entwickeln. Patienten, die NovoEight erhalten, 1, 16 sollten daher hinsichtlich der Entwicklung von Hemmkörpern überwacht werden. *** Während aller klinischen Studien mit NovoEight wurden insgesamt 30 Nebenwirkungen bei 19 von 214 Patienten, denen NovoEight verabreicht wurde, gemeldet. Die am häufigsten gemeldeten Nebenwirkungen waren Reaktionen an der Injektionsstelle und erhöhte Leberenzymwerte. Von den 30 Nebenwirkungen wurden 2 bei 1 von 31 Patienten unter 6 Jahren, keine bei Patienten im Alter von 6 bis 18 Jahren und 28 bei 18 von 127 Erwachsenen gemeldet. **** Innerhalb der Haltbarkeitsdauer kann NovoEight einmalig bis 6 Monate bei Raumtemperatur 30 C gelagert werden. Nach Entnahme aus dem Kühlschrank darf es nicht wieder in den Kühlschrank zurückgestellt werden. Aus mikrobiologischer Sicht sollte NovoEight nach der Rekonstitution sofort verwendet werden. Literatur: 1. NovoEight Fachinformation. 2. Thim L. Haemophilia 2010;16(2): Baxter. History. Baxter website. Accessed 19 March McCormack PL, Plosker GL. Drugs 2005;65(18): European Medicines Agency. European public assessments. Kogenate. EMA website: medicines/000275/human_med_ jsp&mid=wc0b01ac058001d124. Accessed 24 July European Medicines Agency. European public assessments. Advate. EMA website: jsp?curl=pages/medicines/human/medicines/000520/human_med_ jsp&mid=wc0b01ac058001d124. Accessed 24 July European Medicines Agency. European public assessments. ReFacto. EMA website: Accessed 24 July Christiansen MLS. Haemophilia 2010;16(6): Lentz et al. Turoctocog alpha and drug development for hemophilia A (zur Veröffentlichung eingereicht). 10. NovoEight US prescribing information. 11. Lentz SR. Haemophilia 2013;19(5): Kulkarni R. Haemophilia 2013;19(5): Kogenate Fachinformation. 14. Advate Fachinformation. 15. ReFacto Fachinformation. 16. Data on file. Novo Nordisk NovoEight 250 I.E. / 500 I.E. / 1000 I.E. /1500 I.E. / 2000 I.E. / 3000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung. Wirkstoff: Turoctocog alfa. Zusammensetzung: Arzneilich wirksamer Bestandteil: Turoctocog alfa (humaner Blutgerinnungsfaktor VIII (rdns)). 250/500/1.000/1.500/2.000/3.000 I.E. pro Durchstechflasche. Sonstige Bestandteile des Pulvers: Natriumchlorid, L-Histidin, Sucrose, Polysorbat 80, L-Methionin, Calciumchlorid-Dihydrat, Natriumhydroxid, Salzsäure. Sonstige Bestandteile des Lösungsmittels: Natriumchlorid, Wasser für Injektionszwecke. Anwendungsgebiete: Behandlung u. Prophylaxe von Blutungen bei Pat. mit Hämophilie A (angeborener Mangel an Faktor VIII). NovoEight kann bei allen Altersgruppen angewendet werden. Gegenanzeigen: Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile. Bekannte allergische Reaktion gegen Hamsterprotein. Nebenwirkungen: Selten: Überempfindlichkeitsreaktionen od. allergische Reaktionen (wie Angioödem, brennendes od. stechendes Gefühl an der Injektionsstelle, Schüttelfrost, Hitzegefühl, generalisierte Urtikaria, Kopfschmerzen, Nesselsucht, Hypotonie, Lethargie, Übelkeit, Ruhelosigkeit, Tachykardie, Engegefühl im Brustbereich, Kribbeln, Erbrechen, pfeifendes Atmen), die sich in einigen Fällen zu einer schweren Anaphylaxie (einschließlich Schock) entwickeln können. Sehr selten: Entwicklung von Antikörpern gegen Hamsterproteine mit damit verbundenen Überempfindlichkeitsreaktionen. Pat. mit Hämophilie A können neutralisierende Antikörper (Hemmkörper) gegen Faktor VIII entwickeln. Wenn derartige Hemmkörper auftreten, stellt sich dieser Zustand als unzureichendes klinisches Ansprechen dar. In diesen Fällen wird empfohlen, ein spezialisiertes Hämophiliezentrum zu kontaktieren. Verschreibungspflichtig. Novo Nordisk A/S, 2880 Bagsvaerd, Dänemark. Stand: November NovoEight ist ein eingetragenes Warenzeichen der Novo Nordisk Health Care AG und der Apis-Stier ist eine eingetragene Marke von Novo Nordisk A/S Novo Nordisk Healthcare AG, Zurich, Switzerland.

3 Contents Floor Plans Lecture Hall Overview Sponsors Welcome Address Congress Organization Registration Area Official Networking Evening General Congress Information Media (Preview) Center Guidelines for Speakers Guidelines for Chairpersons Guidelines for Poster Presenters Awards Best Abstract Prizes Exhibition Programme at a Glance Scientific Programme Wednesday, February Scientific Programme Thursday, February Scientific Programme Friday, February Scientific Programme Saturday, February Poster Sessions Thursday, February Poster Sessions Friday, February Exhibition Floor Plans Exhibitor Lists General Information Vienna Travel to Vienna City Map Vienna Underground Map Vienna List of Chairs, Speakers and Authors Printed in Austria by: ROBIDRUCK, A-1200 Vienna 1

4 Floor Plans Lecture Hall Overview GROUND FLOOR SCHWEIZERHOF (FRANZENSPLATZ) SCHWEIZERTOR BOTSCHAFERTSTIEGE FOYER- SCHATZ- KAMMER- SAAL SCHATZKAMMERSAAL SCHLOSSERGANG LICHTHOF BURGPASSAGE WC VERBINDUNGSGANG WC LIFT INTERNET POINT FORUM GARDEHALLE I LIFT VORRAUM VERANSTALTER- BÜRO MEDIA CENTER FESTSTIEGE WC WC ARZTZIMMER BIBLIOTHEKSHOF GARDEHALLE II PRINZ EUGEN SAAL SEITENHALLE HOFBURG FOYER GARTENSAAL ERZHERZOG KARL SAAL HELDENPLATZ + + LIFT P ENTRANCE HELDENPLATZ LEGEND = LECTURES = EXHIBITION = SCIENTIFIC POSTER = MEDIA (PREVIEW) CENTER, INTERNET POINT = REGISTRATION = CLOAKROOM = HOSPITALITY SUITE = CASH BAR 2

5 E-Verteiler E-Verteiler LIFT E-Verteiler Floor Plans Lecture Hall Overview MEZZANINE (1 st FLOOR) NINE RADETZKY- ÜBERGANG REDOUTENSÄLE KLEINER REDOUTENSAAL MARIA THERESIEN (FRANZENSPLATZ) RADETZKY- APP. II RADETZKY- APP. I THEATERGANG SCHWEIZERHOF KAPELLENGANG MARIA THERESIEN MARIA THERESIEN KAPELLENHOF KÜNSTLER- ZIMMER HOSPITALITY SUITE BAYER HEALTHCARE BOTSCHAFTERSTIEGE ENTREE- ZIMMER HOFBURGKAPELLE GEHEIME RATSTUBE MARMORSAAL ANTEKAMMER RITTERSAAL TRABANTEN- STUBE WC WC HOFBURG GALERIE CASH BAR LIFT LIFT ZEREMONIEN- SAAL SEITENGALERIE PLATZL HELDENPLATZ WINTERGARTEN ORCHESTERGANG FESTSAAL CASH BAR HELDENPLATZ LIFT 3

6 Sponsors The organizers of the 58 th Annual Meeting of the GTH gratefully acknowledge the support of the following companies Platinum Sponsors Gold Sponsors Silver Sponsors (as per December 2013) 4

7 Welcome Address Dear Ladies and Gentlemen, Dear Colleagues! We are delighted to welcome you at the 58 th Annual Meeting of the GTH here in Vienna. The translational medicine approach of this meeting is demonstrated by the combination of basic research with clinical applications and vice versa in all areas covered. A strong focus is put on the work of young researchers who will be able to present their results in oral sessions as well as in interactive moderated poster sessions. Although not well accepted by everyone but based on the fact that the GTH decided to go international every second year, the meeting will be held mainly in English. This applies to the official symposia and abstract presentations and moderations. However, this not a pre- requisite for industry-sponsored satellite symposia, which may be held in German. Moreover, we would ask to prepare English slides to give the non-german speaking audience the opportunity to follow the presentations in those satellite symposia that are held in German. We made huge efforts to invite international societies, working groups and experts for the 58 th Annual Meeting of the GTH 2014 in order to create joint sessions with the GTH. These sessions, the state-of-the-art symposia and the plenary sessions are the educational highlights of this meeting. Finally, it should also be emphasized that Vienna, like few other big cities in Europe, offers a wide range of cultural highlights and leisure activities to be enjoyed after a demanding day at the meeting. We are convinced that the 58 th Annual Meeting of the Society of Thrombosis and Haemostasis Research will exceed your expectations. With best regards, Johann Wojta Vice President Kurt Huber Congress President Vienna, January

8 Congress Organization Organizer Gesellschaft für Thrombose- und Hämostaseforschung (GTH) Feodor-Lynen-Strasse Hannover, Germany Tel.: Fax: mail@gth-online.org Congress President Kurt HUBER, MD, FACC, FESC, FAHA Director 3 rd Department of Medicine, Cardiology Wilhelminenhospital Montleartstrasse Vienna, Austria Congress Vice President Johann WOJTA, PhD Department of Internal Medicine II Division of Cardiology Medical University Vienna Währinger Gürtel Vienna, Austria National Scientific Committee Christoph BINDER Marianne BRODMANN Sabine EICHINGER-HASENAUER Margarethe GEIGER Christoph KOPP Paul A. KYRLE Irene LANG Elisabeth MAHLA Christoph MALE Christine MANNHALTER Ingrid PABINGER Heinz REDL Jolanta SILLER-MATULA Oswald WAGNER Günter WEIGEL Ansgar WELTERMANN Executive Board Members GTH Christoph BODE, Freiburg (Chair) Ulrich WALTER, Mainz (Assistant Chair) Andreas TIEDE, Hannover (Secretary) Edelgard LINDHOFF-LAST, Frankfurt (Treasurer) Johanna A. KREMER HOVINGA, Berne (Assessor) Christoph MALE, Vienna (Assessor) Andreas GREINACHER, Greifswald (Assessor) Congress Secretariat Basic Research Stefan KASTL, MD Department of Internal Medicine II Division of Cardiology Medical University Vienna Währinger Gürtel Vienna, Austria Clinical Research Thomas WEISS, MD, PhD 3 rd Department of Medicine, Cardiology Wilhelminenhospital Montleartstrasse Vienna, Austria International Scientific Committee Marie-Christine ALESSI (FR) Lina BADIMON (ES) Anne-Marie BLOCH MÜNSTER (DK) Christoph BODE (DE) Armando D ANGELO (IT) Tilman HACKENG (NL) Sigrun HALVORSEN (NO) Robert Gabor KISS (HU) Wolfgang KORTE (CH) Gregory LIP (UK) Nico MARX (DE) Klaus T. PREISSNER (DE) Frits R. ROSENDAAL (NL) Karsten SCHRÖR (DE) Ingebjorg SELJEFLOT (NO) Agneta SIEGBAHN (SE) Michael SPANNAGL (DE) Ulrich WALTER (DE) Christian WEBER (DE) 6

9 Congress Organization Congress Office Exhibition/Sponsoring Office Mondial Congress & Events Barbara OBRITZHAUSER, Liesa WESSELY, Denise LEMBÄCKER Operngasse 20B 1040 Vienna, Austria Tel.: , 224, 158 Fax: gth2014@mondial-congress.com Speaker Management CSC Congress and Study Concept GesmbH Franziska BECKMANN Widerhoferplatz 4/3/ Vienna, Austria Tel.: csconcept@chello.at Medizinische Ausstellungs- und Werbegesellschaft International Exhibitions & Advertising Sonja CHMELLA, Andrea ETZ, Simone BIACH Freyung 6/ Vienna, Austria Tel.: , 42, 37 Fax: gth2014@media.co.at Congress Venue Hofburg Congress Center Heldenplatz 1010 Vienna, Austria 7

10 Registration Area The Registration Area is located on the ground level at the entrance of the congress center. The Mondial Congress & Events team as well as the congress hostesses will be pleased to help you with all inquiries regarding registration, congress materials, hotel accommodation, the networking programme as well as tours and city guidance. Please do not hesitate to approach the team members if there is anything they can do to make your stay more enjoyable. Opening Hours Registration Counters Wednesday, February 12, :00 19:30 Thursday, February 13, :00 19:00 Friday, February 14, :00 19:00 Saturday, February 15, :30 12:30 The registration counter can be reached onsite through the following telephone number: Tel: Pre-Registration Counter For participants who are already registered. Please have the confirmation letters sent by Mondial Congress & Events close at hand. If you still have an outstanding payment you may settle your account in cash or by credit card (Visa, MasterCard, American Express, and Diners Club will be accepted). EURO ( ) only. Onsite Registration Counter For participants registering and paying their registration fees onsite. You will need to fill out an onsite registration form. Payments will be accepted in cash or by credit card (Visa, MasterCard, American Express and Diners Club will be accepted). EURO ( ) only. Tour & Concert Counter For bookings of sightseeing tours, concert and opera tickets. 72 hour public transportation tickets can also be purchased at this counter. Onsite Registration Fees All prices are given in EUR ( ). Full Congress Registration Onsite Fee Member 280. Non-Member 330. Medical Technical Assistant* 110. Nursing Staff* 110. PhD Student* 110. Physician in Training* 110. Retired member 110. Student* 25. Day Tickets** Onsite Fee Member 110. Non-Member 140. Medical Technical Assistant* 60. PhD Student* 60. Physician in Training* 60. Retired member 60. * Proof of current status needs to be provided, otherwise regular delegate fees (member/non-member) will apply. ** Only one day ticket may be purchased. 8

11 Registration Area Registration Fee Includes Admission to all scientific sessions Admission to scientific poster area Admission to the commercial exhibition Congress materials (congress bag, final programme, badge, Abstract CD) Certificate of Attendance Admission to the Opening Ceremony & Welcome Reception Day ticket registration: Entrance to the Opening Ceremony and Welcome Reception is only included for day tickets valid on the day the events take place. Congress Material Upon registration, you will receive your registration documents including the vouchers for your congress bag and your Abstract CD. Name Badges Participants will receive their name badges when collecting their congress materials. You are kindly requested to wear your name badge during all congress events, including the Opening Ceremony and the Welcome Reception. Please note that admission to scientific sessions is strictly restricted to participants wearing their badges. The following badge colours are used at the Congress: Delegate Day Ticket Invited Faculty Organizing Committee GTH Executive Board Staff nn nn nn nn nn nn Payment Please note that all onsite payments should be made in cash or by credit card (Visa, MasterCard, American Express and Diners Club will be accepted). EURO ( ) only. Unfortunately, we cannot accept traveller s cheques, other credit cards, Euro cheques or other currencies. Official Networking Evening The official networking evening takes place on Friday, February 14 at own expense. A limited number of tickets for 50. each is still available. For further information please visit the registration counter. 9

12 General Congress Information Congress Language The official language of the congress is English. No simultaneous translation will be provided. Satellite Symposia, Workshops and Working Group Meetings may be held in German. Language information can be found in the detailed programme section. DFP Accreditation The scientific programme of the 58 th Annual Meeting of the Society of Thrombosis and Haemostasis Research (ID ) is accredited by the Austrian Medical Chamber with 30 DFP credit points. DFP credit points can be converted to the German equivalent at your local medical chamber in Germany. Media (Preview) Center The Media (Preview) Center will be located on the left side of the Feststiege please follow the signs. Staff and equipment will be available for you to arrange and preview your PowerPoint presentation. Please find more detailed information on page 12. Scientific Poster Area The Scientific Poster Area is located on the ground level throughout the Prinz Eugen Saal and the Erzherzog Karl Saal please follow the signs. Posters will be on display on Thursday, February 13 and Friday, February 14, On both days in the afternoon, the presenting authors will be available to explain and discuss their contributions with the interested audience. Please find more detailed information on page 13. Final Programme & Abstract CD The Final Programme will be published on the Internet at A printed version is included in your congress bag. All abstracts are published in digital form on the Abstract CD which is sponsored by Grifols. Your personal copy can be picked up at the Grifols booth 210 upon presentation of the voucher which you will receive with your congress materials. Certificate of Attendance Your Certificate of Attendance will be included in your congress materials available at the registration counter. GTH Booth For matters regarding GTH membership and other GTH activities, participants are cordially invited to visit the GTH booth on the ground floor, booth 100. Congress Staff The Mondial Congress & Events team members will be at your service at the registration counters. The congress hostesses are present in all lecture rooms as well as at the preview center. Do not hesitate to approach them with queries they will gladly assist you. Hostesses are easily recognisable in turquoise GTH Polos. 10

13 General Congress Information Internet Point The Internet Point is located on the ground level in the exhibition area. In addition, free WiFi is available throughout the congress venue. Network: HofburgSecured Password: vienna2014 After entering the password, please open your browser and click the accept button on the bottom left corner (in case you are using a smart-phone you may not see the button immediately please navigate to the bottom left corner manually). Cloakroom A cloakroom and luggage storage facilities are available on the ground level on the far left. Please follow the signs. Smoking We have a strict non-smoking policy at the GTH Smoking inside the congress venue is prohibited. Smoking areas are available outside the main entrance. First Aid In case of need, please contact the staff at the registration counter. Car Parking It is highly recommended to use public transportation as there are only a very limited number of parking spots available at the congress center. Within the city center of Vienna, parking charges apply. The following car parks are nearby the congress venue: Parkgarage Oper (open 24/7) 39. per 24 hours Kärntnerstrasse 51 Parkgarage Freyung (open 24/7) 40. per 24 hours Herrengasse Parkgarage Rathaus (open 24/7) 40. per 24 hours Universitätsring 1 Parkgarage Museumsquartier (open 24/7) 22. per 24 hours Museumsplatz 1 Parkgarage Robert Stolz Platz (open 24/7) 38. per 24 hours Robert Stolz Platz Changes to the Congress Programme In the event of cancellations by speakers or other changes in the main congress programme, no full or partial refund of the registration fee can be made. Insurance and Liability The organisers cannot be held responsible for any personal injury, loss, damage or accident to private property, or for additional expenses incurred as a result of delays or changes in air, rail, road or other services, strikes, sickness, weather and other causes. All participants are encouraged to make their own arrangements for health and travel insurance. Further Information Please visit the congress website: 11

14 Media (Preview) Center The Media (Preview) Center is located on the left side of the Feststiege please follow the signs. Opening Hours Media (Preview) Center Wednesday, February 12, :00 19:30 Thursday, February 13, :00 19:00 Friday, February 14, :00 19:00 Saturday, February 15, :30 12:00 Guidelines for Speakers Presentation slides are to be prepared in English language only. Only PowerPoint presentations format 4:3 are accepted. Speakers should deliver and view/check their PowerPoint presentations at the Media (Preview) Center at least 2 hours prior to the start of the respective session. For sessions starting at 09:00, PowerPoint presentations should be delivered on the previous day. In order to avoid any delays, speakers are kindly requested to hand in their PowerPoint presentations on CD- ROM or USB. Your PowerPoint presentation will be transferred to the congress server in the Media (Preview) Center and will be available for you to present in the session room. For case presentations and videos: Please bring your own laptop. It is crucial however to announce this in the Media Center at least 2 hours prior to your session for organisational reasons!!! Your laptop must be connected to the technical equipment during the break prior to your session by the technician in your session room. At the Media (Preview) Center, work stations are available to make final changes or additions to presentations. Technical staff is present to assist you if necessary. All PCs in the lecture rooms are installed with the operating system Windows 7 (or younger) and are equipped with Microsoft Office 2010 (including PowerPoint 2010). The presentations will be projected from a projector to the screen. Double projections are not possible. Please locate your session room in due time. Please be in your session room at least 15 minutes prior to the start of the session. 12

15 Guidelines for Chairpersons Please locate your session room in due time. Please be at your session room at least 15 minutes prior to the start of the session. We may remind you that speakers need to strictly adhere to the time schedule. Panellists should not speak before they are recognised by the chair and must first clearly state their name, institution and country of origin. Chairmen guidelines will be handed to you prior to the session. Guidelines for Poster Presenters The Scientific Poster Area is located on the ground level throughout the Prinz Eugen Saal and the Erzherzog Karl Saal please follow the signs. A poster info desk is located at the entrance to the Prinz Eugen Saal. Moderated Poster Presentations: 3 minutes of presentation, 3 minutes of discussion each Poster Mounting Times Posters need to be mounted during the following times for the moderated poster presentations on Thursday, February 13 and Friday, February 14, 2014: Poster Sessions 1 14: February 13, 2014, 14:30 15:45 Poster authors of Poster Sessions 1 14 are kindly asked to mount their posters between Wednesday (February 12, 2014) 12:00 and Thursday (February 13, 2014) 10:00 at the latest. Posters need to be removed on Thursday (February 13, 2014) between 19:00 19:30. Poster Sessions 15 28: February 14, 2014, 14:30 15:45 Poster authors of Poster Sessions are kindly asked to mount their posters after the removal time of Poster Sessions 1 14, however at the latest on Friday (February 14, 2014) between 08:00 10:00. Posters need to be removed on Friday (February 14, 2014) between 19:00 19:30. Posters that have not been removed according to the schedule will be disposed of by congress staff. Poster Dimensions & Mounting Material Posters should be prepared in portrait style, with maximum dimensions of 130 cm length and 90 cm width. Please attach the poster to the board with the corresponding poster placement number. Material for mounting the posters will be available in the Poster Area. If you have any questions regarding your poster(s), please do not hesitate to contact the staff at the poster info desk and/or the registration counter. 13

16 Eine Substanz oral von Anfang an bei Tiefer Venen-Thrombose und Lungenembolie * nders Vertrauen in Fortschritt. * Nicht empfohlen bei Patienten mit einer LE, die hämodynamisch instabil sind od. eine Thrombolyse od. pulmonale Embolektomie benötigen. Xarelto 15 mg / 20 mg Filmtabletten Wirkstoff: Rivaroxaban. Vor Verschreibung Fachinformation beachten. Zusammensetzung: Wirkstoff: 15 mg / 20 mg Rivaroxaban. Sonstige Bestandteile: Mikrokristalline Cellulose, Croscarmellose-Natrium, Lactose-Monohydrat, Hypromellose, Natriumdodecylsulfat, Magnesiumstearat, Macrogol (3350), Titanoxid (E171), Eisen(III)oxid (E172). Anwendungsgebiete: Prophylaxe von Schlaganfällen und systemischen Embolien bei erwachsenen Patienten mit nicht-valvulärem Vorhofflimmern und einem oder mehreren Risikofaktoren, wie kongestiver Herzinsuffizienz, Hypertonie, Alter ab 75 Jahren, Diabetes mellitus, Schlaganfall oder transitorischer ischämischer Attacke in der Anamnese. Behandlung von tiefen Venenthrombosen (TVT) und Lungenembolien (LE) sowie Prophylaxe von rezidivierenden TVT und LE bei Erwachsenen. Gegenanzeigen: Überempfindlichkeit gegen Rivaroxaban oder einen d. sonst. Bestandteile; klinisch relevante akute Blutungen; Läsionen oder Situationen mit einem signifikanten Risiko einer schweren Blutung; gleichzeitige Anwendung von anderen Antikoagulanzien, außer bei der Umstellung der Antikoagulationstherapie auf oder von Rivaroxaban oder wenn unfrakt. Heparin in Dosen gegeben wird, die notwendig sind, um die Durchgängigkeit eines zentralvenösen oder arteriellen Katheters zu erhalten; Lebererkrankungen, die mit einer Koagulopathie u. einem klinisch relevanten Blutungsrisiko, einschließlich zirrhotischer Patienten mit Child Pugh B und C, verbunden sind; Schwangerschaft u. Stillzeit. Vorsichtsmaßnahmen und Warnhinweise: Eine klinische Überwachung in Übereinstimmung mit der antikoagulatorischen Praxis wird während der gesamten Behandlungsdauer empfohlen. Die Gabe von Xarelto sollte bei Auftreten einer schweren Blutung unterbrochen werden. Die Anwendung von Rivaroxaban wird nicht empfohlen bei Patienten: - mit einer schweren Nierenfunktionseinschränkung (Kreatinin-Clearance < 15 ml/min), - die zeitgleich eine systemische Behandlung mit Wirkstoffen, die gleichzeitig stark CYP3A4 und P-gp inhibieren, z. B. Azol-Antimykotika oder HIV-Proteaseinhibitoren, erhalten, - mit einem erhöhten Blutungsrisiko und, da keine Daten vorliegen, bei Patienten: - unter 18 Jahren, - mit künstlichen Herzklappen, - mit einer LE, die hämodynamisch instabil sind oder eine Thrombolyse oder pulmonale Embolektomie benötigen, - die zeitgleich mit Dronedaron behandelt werden. Die Anwendung sollte mit Vorsicht erfolgen bei Patienten: - mit erhöhtem Blutungsrisiko, - mit einer schweren Nierenfunktionsstörung (Kreatinin-Clearance ml/min), - mit einer Nierenfunktionsstörung, wenn gleichzeitig andere Arzneimittel eingenommen werden, die zu erhöhten Rivaroxaban Plasmaspiegeln führen, - die gleichzeitig auf die Gerinnung wirkende Arzneimittel erhalten, - die gleichzeitig starke CYP3A4 Induktoren erhalten. Bei Patienten mit dem Risiko einer ulzerativen gastrointestinalen Erkrankung kann eine prophylaktische Behandlung erwogen werden. Obwohl die Behandlung mit Rivaroxaban keine Routineüberwachung der Exposition erfordert, können die mit einem kalibrierten quantitativen Anti-Faktor Xa-Test bestimmten Rivaroxaban-Spiegel in Ausnahmesituationen hilfreich sein. Für Patienten mit einer mittelschweren oder schweren Nierenfunktionsstörung sowie für Patienten mit einer TVT/LE, deren abgeschätztes Blutungsrisiko überwiegt, gelten spezielle Dosisempfehlungen. Xarelto enthält Lactose. Nebenwirkungen: Häufig: Anämie, Schwindel, Kopfschmerzen, Augeneinblutungen, Hypotonie, Hämatome, Epistaxis, Hämoptyse, Zahnfleischbluten, gastrointestinale Blutungen, gastrointestinale u. abdominale Schmerzen, Dyspepsie, Übelkeit, Verstopfung, Durchfall, Erbrechen, Pruritus, Hautrötung, Ekchymose, kutane und subkutane Blutung, Schmerzen in den Extremitäten, Blutungen im Urogenitaltrakt, Nierenfunktionseinschränkung, Fieber, periphere Ödeme, verminderte Leistungsfähigkeit, Transaminasenanstieg, postoperative Blutungen, Bluterguss, Wundsekretion. Gelegentlich: Thrombozythämie, allergische Reaktion, allergische Dermatitis, zerebrale und intrakranielle Blutungen, Synkope, Tachykardie, trockener Mund, Leberfunktionsstörung, Urtikaria, Hämarthros, Unwohlsein, Anstieg von: Bilirubin, alkalischer Phosphatase im Blut, LDH, Lipase, Amylase, GGT. Selten: Gelbsucht, Blutung in einen Muskel, lokale Ödeme, Anstieg von konjugiertem Bilirubin, vaskuläres Pseudoaneurysma (gelegentlich beobachtet bei der Präventionstherapie nach einem ACS nach perkutaner Intervention). Häufigkeit nicht bekannt: Kompartmentsyndrom oder (akutes) Nierenversagen als Folge einer Blutung. Verschreibungspflichtig. Stand: DE/3; 11/2013 Bayer Pharma AG, Berlin, Deutschland L.DE.GM