Friday 2 December 2011
       
09.00 - 13.30 Baccarat room Workshop session
Atherosclerosis and lipid lowering trialists workshop
       
  Chairpersons: John CHAPMAN, Paris, FRA - Wolfgang KOENIG, Ulm, GER
  Webex co-chairperson: Giuseppe Rosano, Rome, IT
     
  The territories of statin therapy are being extended to patients with “normal” LDL-C, based on risk scoring and
CRP levels. This creates new implementation challenges. Even after LDL-C is aggressively controlled to very
low levels with statin therapy, low HDL-C still remains a significant cardiovascular risk factor.

Low serum levels of HDL-C or of apolipoprotein A-1, (ApoA-1), the major protein of HDL particles, are
consistently associated with increased risk for all forms of atherosclerotic disease.

Lipoprotein-associated phospholipase A2, (LpPLA2) is part of a family of lipases involved in the modification of
lipids within the atheroma and may be a complimentary therapeutic target to the reduction of LDL-C.

There is great interest in developing a reliable measure of atherosclerotic disease activity that can serve as an
index of response to anti-atherosclerotic therapies.
     
  Topics for discussion:
       
  Atherosclerosis drugs on the horizon
 
  • Newer CETP inhibitors
    • Bart STAELS, Lille, FRA
 
  • Apolipoprotein mimetics
    • John CHAPMAN, Paris, FRA

 
  • Apolipoprotein upregulators
    • Robert ROSENSON, New York, USA
 
    Wolfgang KOENIG, Ulm, GER
  
       
  How to target the right population?
 
  • Scoring systems and risk-guided therapy
    Speaker: François GUEYFFIER, Lyon, FRA
 
  • Discussant: David WOOD, London, GBR
   
  • Biomarkers and bio-imaging. Where they may help best?
 
  • - Imaging atherosclerosis Ahmed TAWAKOL, New York, USA
 
  • - Is CRP an independent risk predictor in patients receiving statins? Peter SEVER, London, GBR
 
  • Discussant: Wolfgang KOENIG, Ulm, GER
  
       
  Addressing the regulatory challenges
       
  Speaker: Lennart FORSLUND, Uppsala, SWE
  Discussants: David KALLEND, F. Hoffmann-La-Roche, CHE
       
  Can PMS and conditional approval help?
       
  Speaker: Gonzalo CALVO, Madrid, ESP
  Discussants: Angeles ALONSO, Madrid, ESP - Norman STOCKBRIDGE, FDA, Rockville, USA
       
  Drugs: Statins - Anacetrapib - Dalcetrapib - Darapladib - Evacetrapib - Rilapladib - Niacin - Rosuvastatin Varespladib
       
  Trials: AIM-HIGH - DAL OUTCOMES - DEFINE - SOLID TIMI - STABILITY - VISTA-16
       
  Expert Panellists:
       
  ANDRE Stéphane, F. Hoffmann-La Roche, CHE - ALONSO Angeles, Madrid, ESP - CALVO Gonzalo, Madrid, ESP
CHAPMAN John, Paris, FRA - FORSLUND Lennart, Uppsala, SWE - GOEHRS Jean Marie, Versailles, FRA
GORDON David, Bethesda, USA - GUEYFFIER François, Lyon, FRA - HISLOP Colin, Anthera Pharmaceuticals, USA
HORROW Jay, Astra zeneca, USA - KALLEND David, F. Hoffmann-La-Roche, CHE - KOENIG Wolfgang, Ulm, GER
LAUER Michael S, Bethesda, USA - LEWIS Basil, Haïfa, ISR - MENDELSOHN Michael, Merck, USA
PARKS Mary, Rockeville, USA - PLUTZKY Jorge, Boston, USA - POPOV Vladimir, Moscow, RUS
ROSANO Giuseppe, Roma, ITA - ROSENBERG Yves, Bethesda, USA - ROSENSON Robert, New York, USA
SEVER Peter, London, GBR - STAELS Bart, Lille, FRA - STOCKBRIDGE Norman, Rockville, USA
SZAFIR Deborah, F. Hoffmann-La Roche, CHE - TEDGUI Alain, Paris, FRA - TOUBOUL Pierre Jean, Paris, FRA
TAWAKOL Ahmed, New York, USA - WOOD David, London, GBR
     
09.00 - 13.30 Bolero room Workshop session
The RAAS trialists workshop
       
  Chairpersons: Georges BAKRIS, Chicago, USA - Bernard WAEBER, Lausanne, CHE
     
  The use of drugs aimed at inhibiting the RAAS is one of the most remarkable advances in CV medicine.
Combining an ACE-Inhibitor and an Angiotensin receptor blocker did not lead to a significant benefit in patients
with high risk, nor in patients with acute myocardial infarction, although some benefit is achieved with this
combination in patients with chronic heart failure. Combining a mineralocorticoid receptor antagonist, (MRA)
to ACE-Inhibitor or an Angiotensin receptor blocker was proven to be a much better option in heart failure.
Various ways to maximize the benefit of agents targeting the RAAS are being explored. These include
       
   
  • Trials with new drug entities:
    • Direct renin inhibitors
    • New MRA and aldosterone synthase inhibitors
    • Agents with super ARB activity
    • Hybrid ARB and NEP inhibitors
  • Better tackling of renal and potassium safety issues
  • Exploring new indications for old drugs
       
  With generic spironolactone available and being the default option, the challenge with new aldosterone antagonists
is differentiation. Head-to-head comparisons being not on the agenda, creative thinking is needed to explore
new indications in new patient populations.
     
  Topics for discussion:
       
New Renin Angiotensin Aldosterone System antagonists on the horizonJohn MCMURRAY, Glasgow, GBR
The need for new types of morbidity-mortality trials in hypertensionBernard WAEBER, Lausanne, CHE
       
  Development challenges
 
  • Pharmacological differentiation in hypertension
    Speaker: Bernard WAEBER, Lausanne, CHE
    		•   
      Discussants: Georges BAKRIS, Chicago, USA - Stuart KUPFER, Takeda, USA  
     
  • Pharmacological differentiation in Heart Failure
    Speaker: Faiez ZANNAD, Nancy, FRA
    		•   
      Discussants: Mihai GHEORGHIADE, Chicago, USA - Bertram PITT, Ann Arbor, USA  
           
      New indications
           
        Speaker: Domenic SICA, Richmond, USA
      Discussant: Frank MISSELWITZ, Bayer, GER - Luis RUILOPE, Madrid, ESP  
           
      Optimization of RAAS inhibition: Uptitration vs. Combination vs. Guided-therapy? Limits and alternatives
           
        Speaker: Bernard WAEBER, Lausanne, CHE
    Discussant: Georges BAKRIS, Chicago, USA - Stuart KUPFER, Takeda, USA
           
      Approvability of new RAAS
           
      Speaker: Karl SWEDBERG, Gothenburg, SWE
        Discussant:
      Joerg KOGLIN, Merck, USA  
      Ileana L PIÑA, New York, USA  
      Drugs: Aliskiren - Azilsartan - BAY 94-8862 - eplerenone - LCI699 - LCZ 696 - Olmesartan
           
      Trials: ART - ACCELERATE - AQUARIUS - ALBATROSS - APOLLO - ASTRONAUT - ATMOSPHERE - PEARL-HF
    PARADIGM - REMINDER - ROADMAP - TOPCAT
           
      Expert Panellists:
           
      ADAMS Kirkwood, Chapel Hill, USA - ARENS Hans-Juergen, Fresenius, GER - BAKRIS Georges, Chicago, USA
    BRISTOW Michael, Broomfield, USA - BUYSSE Jerry, Relypsa, USA - COHEN SOLAL Alain, Paris, FRA
    FELKER Michael, Durham, USA - GHEORGHIADE Mihai, Chicago, USA - GRIMM Richard, Minneapolis, USA
    KJELDSEN Keld, Copenhagen, DEN - KOGLIN Joerg, Merck, USA - KUPFER Stuart, Takeda, USA
    MAGGIONI Aldo Pietro, Florence, ITA - MCDONALD Kenneth, Dublin, IRE - MCMURRAY John, Glasgow, GBR
    MASCETT E Alice, Bethesda, USA - MASSY Ziad, Amiens, FRA - MISSELWITZ Franck, Bayer, GER
    O’CONNOR Christopher, Durham, USA - PATHAK Atul, Toulouse, FRA - PEREZ Alfonso, Takeda, USA
    PFEFFER Marc, Boston, USA - PIÑA Ileana L., New york, USA - PITT Bertram, Ann Arbor, USA
    ROESSIG Lothar, Bayer, GER - ROQUES Bernard P., Paris, FRA - ROSANO Giuseppe, Roma, ITA
    ROSENBERG Yves, Bethesda, USA - RUILOPE Luis, Madrid, ESP - SABBAH Hani, Detroit, USA
    SWEDBERG Karl, Gothenburg, SWE - TAVAZZI Luigi, Cotignola, ITA - TURGONYI Eva, Pfizer, GBR
    WAEBER Bernard, Lausanne, CHE - ZALEWSKI Andrew, Novartis, USA - ZANNAD Faiez, Nancy, FRA
         
    14.00 - 16.00 Baccarat room Plenary session
    Heart rate: a biomarker and a biotarget in cardiovascular disease
           
      Chairpersons: Jeffrey S. BORER, New York, USA - Faiez ZANNAD, Nancy, FRA
      Webex co-chairpersons: Daniela Dobre, Nancy, FRA - Kurt Stoschitzky, Graz, AUT
           
      Heart rate: a biomarker and a biotarget in health and disease – insight from epidemiology
    and pathophysiology
      Kim FOX, London, GBR
         
      Slowing heart rate in coronary artery disease and in heart failure – the distinct roles of different
    heart rate-lowering agents
    Jeffrey S. BORER, New York, USA
         
      Evidence from recent trials with ivabradine – updating the guidelines and clinical significance
    Karl SWEDBERG, Gothenburg, SWE
           
    Debate: Guidelines and implementation challenges in clinical practice
           
      Expert Panellists:
           
      ADAMS Kirkwood, Chapel Hill, USA - BERDEAUX Alain, Créteil, FRA - BORER Jeffrey S., New York, USA
    BRISTOW Michael, Broomfield, USA - CLELAND John, Hull, GBR - COHEN SOLAL Alain, Paris, FRA
    DARGIE Henry, Glasgow, GBR - FELKER Michael, Durham, USA - FOX Kim, London, GBR
    GHEORGHIADE Mihai, Chicago, USA - GUEYFFIER François, Lyon, FRA - JOUVEN Xavier, Paris, FRA
    LAUER Michael S, Bethesda, USA - MAGGIONI Aldo Pietro, Florence, ITA - MCMURRAY John, Glasgow, GBR
    MCDONALD Kenneth, Dublin, IRE - O’CONNOR Christopher, Durham, USA - PATHAK Atul, Toulouse, FRA
    PFEFFER Marc, Boston, USA - SWEDBERG Karl, Gothenburg, SWE - PITT Bertram, Ann Arbor, USA
    PIÑA Ileana L., New York, USA - ROSANO Giuseppe, Roma, ITA - SABBAH Hani, Detroit, USA
    STOSCHITZKY Kurt, Graz, AUT- TAVAZZI Luigi, Cotignola, ITA - ZANNAD Faiez, Nancy, FRA
         
    14.00 - 16.00 Bolero room Plenary session
    Geographical variation in clinical outcomes in cardiovascular drug trials: fact or artefact?
           
      Joint session :
    CVCT, ESC Working Group on Cardiovascular Pharmacology and Drug Therapy
    International Society of Cardiovascular Pharmacology
           
      Chairpersons: Juan Carlos KASKI, President, ISCP, London, GBR and Angeles ALONSO, ESC Working
    Group on Cardiovascular Pharmacology and Drug Therapy, Madrid, ESP
           
      Hypertension trials
    Luis RUILOPE, Madrid, ESP
           
      Heart Failure trials
      Felipe MARTINEZ, Cordoba, ARG
           
      Atrial fibrillation trials
      Gheorge Andrei DAN, Bucharest, ROM
           
      ACS trials
    Sidney GOLDSTEIN, Ann Arbor, USA
         
    16.30 - 18.00 Baccarat room Plenary session
    Expert statisticians and trialists discuss the major trials of the year
           
      Chairpersons: John MCMURRAY, Glasgow, GBR - Faiez ZANNAD, Nancy, FRA
      Webex co-chairpersons: François Gueyffier, Lyon, FRA - Angeles Alonso, Madrid, ESP
         
      Medicine deals with treatments that work often but not always, so treatment success must be based on
    probability. This unique session is meant to be educational and possibly controversial. Interpreting trial
    results requires a good understanding of statistics and trial methodology. Senior statisticians and clinical
    trialists debate their own views as well as tips and tricks for understanding the most recent trials of the year.
           
      Speaker: Stuart POCOCK, London, GBR
      Discussant: Marc PFEFFER, Boston, USA
           
    Expert Panellists: All CVCT faculty members
           
           
    Saturday 3 December 2011
           
    08.30 - 12.00 Bolero room Workshop session
    Diabetes trialists workshop
           
      Chairpersons: Sverre E KJELDSEN, Olso, NOR - Richard GRIMM, Minneapolis, USA
           
      While a number of new drugs with new pharmacological mechanisms for glucose control have recently
    emerged, long-term benefits and harms of diabetes medications remain unclear.

    The value of the surrogate glycaemia control and HbA1 C, the usual endpoint on which approval of diabetes
    drugs is based is being strongly challenged.

    The debate on whether newer, (and older) oral hypoglycaemic drugs may cause deleterious CV effects has
    been fuelled by the results of recent trials and controversial meta-analyses.

    Contrasting and balancing the accepted benefits of glucose control and micro-vascular prevention vs.
    the potential risks and less proven benefits of macro vascular complications has led the FDA to issue a risk
    evaluation and mitigation strategy (REMS) as well as proscriptive industry guidelines requesting the evaluation
    of CV risk in all new anti-diabetic therapies.

    Implementing the FDA new type of adaptive design non-inferiority trials is challenging.
           
      Topics for discussion:
           
      Are the cardiovascular risks related to new anti-diabetes agents drug specific/class specific?
           
        Speaker: Jorge PLUTZKY, Boston, USA
        Discussants: Jorge PLUTZKY, Boston, USA
           
      Micro vs. macrovascular disease progression endpoints
           
      Speaker: Peter SLEIGHT, Oxford, GBR
      Discussants:Gilles DAGENAIS, Quebec, CAN - David G. WARNOCK, Birmingham, USA
           
      Are the current megatrials addressing the unmet needs?
           
      Speaker: Stuart POCOCK, London, GBR
      Discussant: David GORDON, Bethesda, USA
           
      Time for comparative effectiveness trials?
           
      Speaker: Yves ROSENBERG, NHLBI, Bethesda, USA
      Discussant: Gonzalo CALVO, Madrid, ESP
           
      Methodological, steering, ethical and economic challenges of the new FDA industry guidelines
           
        Speaker: Guntram SCHERNTHANER, Vienna, AUT
      Discussants: Boaz HIRSHBERG, Astrazeneca, USA
           
      Drugs: Albiglutide - Aleglitazar - Alogliptin - Exenitide - Canagliflozin - Glimeperide - Liraglutide - Lixisenatide
    Pioglitazone - Rosiglitazone - Saxagliptin - Sitagliptin - Vildagliptin
           
      Trials: ALECARDIO - CANVAS - CAROLINA - ELIXA - EXAMINE - EXSCEL - LEADER - SAVOR - TECOS
           
      Expert Panellists:
           
      ADAMS Kirkwood, Chapel Hill, USA - CALVO Gonzalo, Madrid, ESP - CLELAND John, Hull, GBR
    DAGENAIS Gilles, Quebec, CAN - Domanski Michael, New York, USA - FORSLUND Lennart, Uppsala, SWE
    GUEYFFIER François, Lyon, FRA - GORDON David, Bethesda, USA - HIRSHBERG Boaz, Astrazeneca, USA
    KHDER Yasser, Boehringer Ingelheim, FRA - KJELDSEN Sverre E, Olso, NOR - KUPFER Stuart, Takeda, USA
    KOENIG Wolfgang, Ulm, GER - PLUTZKY Jorge, Boston, USA - Pocock Stuart, London, GBR
    ROSANO Giuseppe, Roma, ITA - ROSENBERG Yves, Bethesda, USA - SCHERNTHANER Guntram, Vienna, AUT
    SICA Domenic, Farmington, USA - SLEIGHT Peter, Oxford, GBR - STAELS Bart, Lille, FRA
    SWYNGHEDAUW Bernard, Paris FRA - Warnock David G., Birmingham, USA - Wood David, London, GBR
           
    08.30 - 12.00 Baccarat room Workshop session
    Expert opinion consensus workshop
    The use of mineralocorticoid receptor antagonist, MRA in clinical practice
           
      Chairpersons: Luigi TAVAZZI, Cotignola, ITA - Adrian VOORS, Groningen, NDL
      Webex co-chairpersons: Luca Bettari, Brescia, ITA - Atul Pathak, Toulouse, FRA
           
      Recent high level evidence from trials with eplerenone, (EPHESUS and EMPHASIS), consistent with the results
    of the earlier spironolactone RALES trial is likely to establish MRAs as third drugs in addition to ACE inhibitors,
    (or ARBs) and beta-blockers across the complete spectrum of severity of chronic heart failure patients with
    left ventricular systolic dysfunction. Beyond the expected revision in the international guidelines, it is important
    that more extensive and specific practical guidance is provided to clinicians about the practical use of MRAs.
    This session is to deliver an Expert Consensus Statement paper that may complement current international guidelines.
           
      Ideal current indications
           
      Speaker: Bertram PITT, Ann Arbor, USA
      Discussant: Alain COHEN SOLAL, Paris, FRA
           
      Spironolactone or Eplerenone? Class effect, differential effects
           
      Speaker: Alan STRUTHERS, Dundee, GBR
      Discussant: Faiez ZANNAD, Nancy, FRA
           
      Dosing: Dose-related benefit and risk issues
           
      Speaker: Adrian VOORS, Groningen, NDL
      Discussant: Luis RUILOPE, Madrid, ESP
           
      Understanding, predicting, preventing and managing renal and potassium safety issues
           
      Speaker: Patrick ROSSIGNOL, Nancy, FRA
      Discussant: Georges BAKRIS, Chicago, USA
           
      Targeting the right patient: Mechanistic insights
           
      Speaker: Faiez ZANNAD, Nancy, FRA
      Discussant: Johannes BAUERSACHS, Hanover, GER
           
      Guidelines: Overview of the current international guidelines and Implementation issues
           
      Speaker: John MCMURRAY, Glasgow, GBR
      Discussant: Christopher O’CONNOR, Durham, USA
           
    Expert Panellists:
           
      ARENS Hans-Juergen, Fresenius, GER - ALONSO Angeles, EMEA, Madrid, ESP - BAKRIS Georges, Chicago, USA
    BAUERSACHS Johannes, Hanover, GER - BRISTOW Michael, Broomfield, USA - COHEN SOLAL Alain, Paris, FRA
    BEYGUI Farzin, Paris, FRA - FELKER Michael, Durham, USA - FILIPPATOS Gerasimos, Athens, GRE
    GHEORGHIADE Mihai, Chicago, USA - ISNARD Richard, Paris, FRA - MAGGIONI Aldo Pietro, Florence, ITA
    MASSY Ziad, Amiens, FRA - MCMURRAY John, Glasgow, GBR - MENDELSOHN Michael, Merck, USA
    MISSELWITZ Frank, Bayer, GER - O’CONNOR Christopher, Durham, USA - PATHAK Atul, Toulouse, FRA
    PFEFFER Marc, Boston, USA - PITT Bertram, Ann Arbor, USA - PIÑA Ileana, New York, USA
    ROSSIGNOL Patrick, Nancy, FRA - RUILOPE Luis Miguel, Madrid, ESP - SABBAH Hani, Detroit, USA
    SICA Domenic, Richmond, USA - STRUTHERS Alan, Dundee, GBR - SWEDBERG Karl, Gothenburg, SWE
    TAVAZZI Luigi, Cotignola, ITA - VOORS Adrian, Groningen, NDL - ZANNAD Faiez, Nancy, FRA
           
    12.00 - 13.30 Baccarat room meet and eat with the experts
    Serum potassium in cardiorenal trials
           
      Chairpersons: Ziad MASSY, Amiens, FRA - Bertram PITT Ann Arbor, USA
      Webex co-chairpersons: Keld Kjeldsen, Copenhague, DEN - Patrick Rossignol, Nancy, FRA
           
    The pathophysiology of serum potassium in cardiorenal disease George BAKRIS, Chicago, USA
           
    Serum potassium and cardio(renal) outcomes in cardiovascular clinical trials of RAAS therapy
    Bertram PITT, Ann Arbor, USA
           
    Hyperkalemia: Physiology, Control and Potassium Binder Mechanism of Action Jerry BUYSSE, Relypsa, USA
           
      Expert Panellists:
           
      ARENS Hans-Juergen, Fresenius, GER - BAKRIS George, Chicago, USA - BAUERSACHS Johannes, Hanover, GER
    BUYSSE Jerry, Relypsa, USA - CLELAND John, Hull, GBR - DARGIE Henry, Glasgow, GBR - FELKER Michael, Durham, USA
    KJELDSEN Keld, Copenhagen, DEN - LAVILLE Maurice, Lyon, FRA - MASSY Ziad, Amiens, FRA
    MISSELWITZ Frank, Bayer, GER - PITT Bertram, Ann Arbor, USA - ROSANO Giuseppe, Rome, ITA
    ROSSIGNOL Patrick, Nancy, FRA - SICA Domenic, Richmond, USA - WARNOCK David G., Birmingham, USA
           
    12.00 - 13.30 BOLERO room meet and eat with the experts
    Is Heart Failure a thrombotic disease? Time for a trial?
           
    Chairpersons: Mihai GHEORGHIADE, Chicago, USA - Faiez ZANNAD, Nancy, FRA
           
      In spite of major progress in the management of chronic heart failure, the post discharge event rate
    (hospitalization and mortality) in patients admitted with heart failure is around 35 to 50% at six months.
    Sudden death is the mode of death in 30% of patients and is frequently due to new coronary (thrombotic)
    occlusion and not only to lethal arrhythmias.

    There is increasing evidence that heart failure is associated with a hypercoagulable state, platelet activation
    and endothelial dysfunction. It is possible that thromboembolic events contribute to the high mortality and
    re-hospitalization rate in this patient population.

    Decompensated heart failure is a recognized risk factor for venous thromboembolism.
    The role of antithrombotic therapy in patients with heart failure is still unclear and data, coming mostly from
    poorly designed studies were restricted to patients with chronic stable (not acute) heart failure.

    The conclusions drawn from post hoc analyses do not support definitive beneficial effect for antithrombotic
    therapy in heart failure. A safe and effective “Antithrombotic agent” may help indirectly to understand how
    much thrombotic events contribute to the high post discharge event rate in acute heart failure.

    On another hand, thrombin and factor Xa act on specific protease-activated receptors (PARs), which are
    present on cardiomyocytes and are involved in vascular development and a variety of other biological processes
    including apoptosis and remodeling.

    In most ACS trials, patients with low EF tend to benefit most from anti-thrombotic therapy.

    Further trials are needed, especially concerning the effect of thrombin inhibitors and other anticoagulant drugs on
    cardiomyocyte function and cardiac remodeling in acute coronary syndromes.
    Thromboembolism and antithrombotic therapy in patients with heart failure in sinus rhythm
    Current Status and Future Directions
     Christopher O’CONNOR, Durham, USA
           
    Thrombin inhibition in the ischemic and failing myocardium. Pleiotropic protection beyond anticoagulation?
    Efthymios DELIARGYRIS, The Medicines Company, GER
           
      New trial opportunities with the new anti-thrombotic agents in heart failure syndromes.
    Faiez ZANNAD, Nancy, FRA
           
      Debate: Time for a new trial?
           
      Expert Panellists:
           
      AGEWALL Stefan, Oslo, NOR - ALONSO Angeles, EMEA, Madrid, ESP - BERKOWITZ Scott, Bayer, USA
    BEYGUI Farzin, Paris, FRA - BONNEFOY Eric, Lyon, FRA - BORER Jeffrey S., New York, USA
    BURTON Paul, J&J, USA - CALVO Gonzalo, Madrid, ESP - COHEN SOLAL Alain, Paris, FRA
    COOK-BRUNS Nancy, Bayer, GER - DELIARGYRIS Efthymios, The Medicines Company, GER
    FILIPPATOS Gerasimos, Athens, GRE - FORSLUND Lennart, Uppsala, SWE - GHEORGHIADE Mihai, Chicago, USA
    GOLDSTEIN Sidney, Ann Arbor, USA - ISNARD Richard, Paris, FRA - KHDER Yasser, Boehringer Ingelheim, FRA
    KOGLIN Joerg, Merck, USA - LEWIS Basil, Haïfa, ISR - MAGGIONI Aldo Pietro, Florence, ITA
    O’CONNOR Christopher, Durham, USA - PFEFFER Marc, Boston, USA - ROSENBERG Yves, Bethesda, USA
    ROSSIGNOL Patrick, Nancy, FRA - SIMON Tabassome, Paris, FRA - STOCKBRIDGE Norman, Rockville, USA
    SWEDBERG Karl, Gothenburg, SWE - UNGER Ellis, Rockville, USA - VERHEUGT Freek, Amsterdam, NDL
    ZANNAD Faiez, Nancy, FRA
         
    14.00 - 18.00 Baccarat room Workshop session
    Thrombosis trialists expert workshop
           
      Chairpersons: Sidney GOLDSTEIN, Ann Arbor, USA - Freek VERHEUGT, Amsterdam, NDL
      Webex co-chairpersons: Stefan Agewall, Oslo, NOR - Basil Lewis, Haïfa, ISR
           
      A host of novel oral anticoagulants nearing or already on the market, aim at replacing warfarin for a variety of
    indications, including prevention and treatment of VTE and prophylaxis of stroke in patients with AF.

    Three of the new anticoagulants, the factor Xa inhibitor, rivaroxaban and apixaban and the direct thrombin
    inhibitor dabigatran, (Pradaxa, Boehringer Ingelheim), are available for VTE prevention and dabigatran has also
    recently been approved for stroke prevention in atrial fibrillation.

    Some agents are also in trials for acute coronary syndrome, but development here is more challenging because
    of the declining event rate and the question arises if the risk is so low, can you gain anything more by adding
    more effective antithrombotic therapy?

    There is no clear relationship between anticoagulant or anti-platelet activity and clinical endpoint event rates.
    Therefore, the single dose that is taken into phase III studies provides inadequate evidence of the optimal use
    of the drug. The FDA preferred approach is to take multiple doses into phase III and avoid over-valuing bleeding.
    Different definitions of bleeding across trials and variations in the way that bleeding data are captured make
    comparisons between studies difficult. Harmonization of collection and reporting of bleeding data in trials of
    antithrombotic drugs would be welcome. Balancing risk and benefit is essential and new endpoints for predicting
    and assessing the bleeding risk may help in comparative studies.

    Combining safety and efficacy endpoints can make interpretation of study outcomes problematic. ‘Net clinical
    benefit’ is not a substitute for benefit-risk. Time has an effect. One component can drive the results. Using more
    endpoints is not always better and results vary depending on the combination of endpoints.
      Topics for discussion:
           
      Defining/approving the “right” dose. The FDA – Trialists dilemma
           
      Speaker: Jeffrey S. BORER, New York, USA
      Discussants: Yasser KHDER, Boehringer Ingelheim, FRA - Ellis UNGER, Rockville, USA
           
      Endpoints combining benefit and bleeding risk
           
      Speaker: Roxana MEHRAN, New York, USA
      Discussant: Paul BURTON, J&J, USA
           
      Regional differences and globalization issues
           
      Speaker: Sidney GOLDSTEIN, Ann Arbor, USA
      Discussant: Efthymios DELIARGYRIS, The Medicines Company, GER
      Debate
           
      Atrial fibrillation: Unmet needs. Targeting gaps with warfarin therapy
      Speaker: John MCMURRAY, Glasgow, GBR
      ACS: add-on and antithrombotic background therapy issues
           
      Speaker: John MCMURRAY, Glasgow, GBR
      Discussants: Freek W.A VERHEUGT, Amsterdam, NDL
      Scott BERKOWITZ, Bayer, USA  
           
      Drugs: Apixaban - atopaxar - Betrixiban, Bivaluridin - Cangrelor - Cilostazol - Dabigatran - Edoxaban - Elinogrel Fondaparinux - Prasugrel - Rivaroxaban - Ticagrelor - Tecarfarin - Varopaxar
           
      Trials:
           
      Atrial Fibrillation: ARISTOTLE - AVERROES, BOREALIS - CHAMPION - Engage AF TIMI48 - EMBRACE AC
    PEGASUS - RELY - RELY-ABLE - ROCKET AF
      Acute Coronary Syndromes: ACCOAST - ATLAS ACS 2-TIMI 51 - CHAMPION - CHAMPION-PHENIX
    CHAMPION PLATFORM - EUROMAX - LANCELOT-CAD - RIVAROXACS - TRACER ACS - TRAP2P - TRANSLATE ACS
           
      Expert Panellists:
           
      AGEWALL Stefan, Oslo, NOR - BERKOWITZ Scott, Bayer, USA - BONNEFOY Eric, Lyon, FRA
    BORER Jeffrey S., New York, USA - BURTON Paul, J&J, USA - CALVO Gonzalo, Madrid, ESP - CLELAND John, Hull,
    GBR COOK-BRUNS Nancy, Bayer, GER - DELIARGYRIS Efthymios, The Medicines Company, GER
    FERGUSON Terry J, Astra zeneca, USA - FORSLUND Lennart, Uppsala, SWE - GOLDSTEIN Sidney, Ann Arbor, USA
    KHDER Yasser, Boehringer Ingelheim, FRA - LEWIS Basil, Haïfa, ISR - MEHRAN Roxana, New York, USA
    MISSELWITZ Frank, Bayer, GER - POPOV Vladimir, Moscow, RUS - ROSENBERG Yves, Bethesda, USA
    SIMON Tabassome, Paris, FRA - UNGER Ellis, Rockville, USA - VERHEUGT Freek, Amsterdam, NDL
         
    14.00 - 18.00 Bolero room Workshop session
    CardioVascular personalized medicine trialists workshop
    Guiding therapy with biomarkers and telemonitoring
           
      Chairpersons: Alexandre MEBAZAA, Paris, FRA - Christopher O’CONNOR, Durham, USA
      The search for biomarkers that can forecast risk is one of the most active research areas in cardiology.

    This has turned up a few promising novel biomarkers. Although the validation process of a new biomarker
    is now well established, establishing the clinical usefulness of biomarkers is still challenging.

    Risk guided therapy trials and biomarker monitored therapy optimization are fast growing areas of
    investigation.
    Introduction: are oncologists doing a better job than cardiologists using biomarkers?
    Ludwig NEYSES, Manchester, GBR
           
      Topics for discussion:
           
      Risk models and their relevance to therapeutic decision-making
           
        Speaker: François GUEYFFIER, Lyon, FRA  
      Discussant: Nancy GELLER, Bethesda, USA
           
      Validation of a therapeutic decision making tools
        For selecting/initiating, indicating a therapy  
           
      Speaker: Michael BRISTOW, Broomfield, USA  
      Discussant: Pieter MUNTENDAM, BG Medicine, USA  
           
        For optimizing therapy  
           
      Speaker: Kirkwood ADAMS, Chapel Hill, USA  
      Discussant: Adrian VOORS, Groningen, NDL  
           
      Biomarker approach to the early identification of events
      Michael FELKER, Durham, USA
           
      The prerequisites for a useful signal
      Ileana L PIÑA., New York, USA
           
      Approvability of a biomarker guided therapy
      Speaker: Norman STOCKBRIDGE, Rockville, USA
           
      Public funding of cardiovascular personalized medicine research
           
      The EU Framework Programme: Virginija DAMBRAUSKAITE, Brussels, BEL
      The NHLBI Perspective: Alice MASCETTE, Bethesda, USA
           
      Drugs/biomarkers: beta-1 receptor genotype, Bucindolol - Copeptin, Tolvaptan - Ferritin, Ferric Carboxymaltose Galectin-3, Aldosterone Antagonists - CRP, Rosuvastatin - MIBG - Procalcitonin - sTREM1
           
      Trials: ACTIVATE - ADREVIEW - ARCA - CHAMPION - FAIR-HF - HOME-BNP - JUPITER
           
      Expert Panellists:
           
      ADAMS Kirkwood, Chapel Hill, USA - ALONSO Angeles, EMEA, Madrid, ESP - BRISTOW Michael, Broomfield, USA DAMBRAUSKAITE Virginija, Brussels, BEL - DARGIE Henry, Glasgow, GBR - FELKER Michael, Durham, USA FILIPPATOS Gerasimos, Athens, GRE - FIUZAT Mona, Durham, USA - GELLER Nancy, Bethesda, USA GORDON David, Bethesda, USA - GUEYFFIER François, Lyon, FRA - ISNARD Richard, Paris, FRA REGNSTROEM Jan, EMEA, London, GBR - MEBAZAA Alexandre, Paris, FRA - MASCETTE Alice, Bethesda, USA MUNTENDAM Pieter, BG Medicine, USA - NEYSES Ludwig, Manchester, GBR O’CONNOR Christopher, Durham, USA - PATHAK Atul, Toulouse, FRA - PIÑA Ileana L., New York, USA POCOCK Stuart, London, GBR - STOCKBRIDGE, Norman, Rockeville, USA - VOORS Adrian, Groningen, NDL ZALEWSKI Andrew, Novartis, USA - ZANNAD Faiez, Nancy, FRA