Thursday December 2nd, 2010
     
09:00-13:30   SALON ORSAY SUD ROOM
    1ST INTERNATIONAL MEETING OF THE FRENCH SOCIETY OF CARDIOLOGY WORKING GROUP
ON CARDIOVASCULAR PHARMACOLOGY AND DRUG THERAPY - French speaking session
Nucleus Business Meeting
    Présidents: Pierre GIBELIN, Nice - Atul PATHAK, Toulouse, FRA
     
     
     
09:00-10:00   Diabetes medication: what the cardiologist should know
Anti-diabétiques oraux et pathologie cardiovasculaire: ce que le cardiologue doit savoir
    Chairman: Laurent MONASSIER, Strasbourg, FRA
   
    Oldies but goldies: benefit/risk of standard diabetes medication
Les «anciens» anti-diabétiques oraux: Bénéfices / risques cardiovasculaires
    Paul VALENSI, Paris, FRA - [Presentation]
     
    GLP1, DPP IV and others… new target and indication of newcomers
Les «nouveaux» hypoglycemiants oraux (GLP1, DPPIV, autres): nouvelles cibles, effets cardiovasculaires
    François DIEVARTI , Lille, FRA [Presentation]
     
10:00-11:00   Keep your heart in mind / Médicaments neurologiques / psychiatriques et maladies cardiovasculaires
    Chairman: Pierre AMBROSI, Marseille, FRA
     
    Cardiovascular effects of anticholinesterase drugs
Effets cardiovasculaires des inhibiteurs des anticholinesterases
    Laurent MONASSIER , Strasbourg, FRA [Presentation]
Michèle Escande ORTHLIEB, Allauch, FRA
     
    - Introduction et rappels pharmacologiques Laurent Monassier , Strasbourg, FRA [Presentation]
- Effets délétères Michèle Escande ORTHLIEB, Allauch, FRA[Presentation]
- Effets bénéfiques et conclusions Laurent MONASSIER , Strasbourg, FRA
     
     
    Cardiac effects of antipsychotic medications / Effets cardiovasculaires des traitements anti-psycotiques
    Milou DRICI, Nice, FRA [Presentation]
     
11:30-12:30   When cancer drugs affect the heart / Traitements oncologiques et coeur
    Chairman: Gérard ROUL, Strasbourg
     
    Cardiotoxicity of chemotherapy medications / Chimiothérapie et cardiotoxicité
    Pierre GIBELIN, Nice, FRA [Presentation]
     
    Antiangiogenic therapy and hypertension / Médicaments anti-angiogéniques et HTA
    Atul PATHAK, Toulouse, FRA
     
    TNF alpha: the cardiologist’s point of view / Le cardiologue et les immunosuppresseurs
    Pierre AMBROSI, Marseille, FRA [Presentation]
     
12:30-13:30   Vasodilating / Traitements urologiques / sexuel et coeur
    Chairman: François DIEVARTI, Lille, FRA
     
    Alpha Blocker and the Heart / Alpha-bloquants chez le cardiaque
    Pascal PONCELET, Henin Beaumont, FRA [Presentation]
     
    Clinical use of Phosphodiesterase-5 inhibitors in chronic heart failure
Inhibition de la phosphodiéstérase 5 chez l’insuffisant cardiaque chronique
    Gérard ROUL, Strasbourg, FRA [Presentation]
     
     
12:30-14:00   FOYER ORSAY NORD ROOM
    ESC WORKING GROUP ON PHARMACOLOGY AND DRUG THERAPY NUCLEUS BUSINESS MEETING
     
     
14:00-16:00   SALON ORSAY SUD ROOM
    PLENARY SESSION
OPTIMIZING THE RISK TO BENEFIT RATIO WITH NEW REVERSIBLE ANTIPLATELET THERAPIES IN ACUTE
CORONARY SYNDROMES
    Chairmen: Dan ATAR, Oslo, NOR - Lars WALLENTIN, Uppsala, SWE
     
     
    Current guidelines and unmet needs in the management of thrombotic events in acute coronary syndromes
    Nicolas DANCHIN, Paris, FRA
     
    New reversible antiplatelet drugs. Pharmacology and potential advantages
    Steen HUSTED, Arhus, DEN
     
    The mechanisms of the mortality benefit of ticagrelor therapy. Adenosine mediated mechanisms beyond antiplatelet effects.
    Victor SEREBRUANY, Towson, USA [Presentation]
     
    PLATelet inhibition and patient outcomes with ticagrelor or Clopidogrel (PLATO). Practical consideration
    Lars WALLENTIN, Uppsala, SWE [Presentation]
     
14:00-16:00   SALON ORSAY NORD ROOM
    EXPERT WORKSHOP
BIOMARKERS TO GUIDE THERAPY IN HEART FAILURE PATIENTS - IS THE CONCEPT PROVEN?
    Chairmen: Lawrence FINE, Bethesda, USA - Alain COHEN SOLAL, Paris, FRA
     
    Why do we need biomarkers in the heart failure patient?
    Stephan VON HAEHLING, Berlin, GER
     
    What to monitor? Defining the right biomarker to prompt action
    James JANUZZI, Boston, USA [Presentation]
     
    What is the evidence that biomarker guided therapy is useful?
    Hans Peter BRUNNER LA ROCCA, Maastricht, NED [Presentation]
     
    Debate: The challenge of designing biomarker guided therapy trials. Optimization algorithms, endpoint and blinding issues, safety concerns.
    Panellists: Kirkwood ADAMS, Chapel HILL, USA - Hans Peter BRUNNER LA ROCCA, Maastricht, NED - Jay COHN,
Minneapolis, USA - John CLELAND, Hull, GBR - Robert CODY, Merck, USA - Alain COHEN SOLAL, Paris, FRA
Kenneth DICKSTEIN, Stavanger, NOR - Daniela DOBRE, Nancy, FRA - Lawrence FINE, Bethesda, USA
Mona FIUZAT, Durham, USA - James JANUZZI, Boston, USA - Mihai GHEORGHIADE, Chicago, USA
Patrick JOURDAIN, Pontoise, FRA - Ursula-Henrike WIENHUES-Thelen , Roche Diagnostics, GER
Keld KJELDSEN, Copenhagen, DEN - Damien LOGEART, Paris, FRA - Aldo MAGGIONI, Firenze, ITA
Alice MASCETTE, Bethesda, USA - Christian MÜELLER, Basel, SUI - Ileana PIÑA, Cleveland, USA
Bernard SWYNGHEDAUW, Paris, FRA - Patrick ROSSIGNOL, Nancy, FRA - Hani SABBAH, Detroit, USA
Luigi TAVAZZI, Cotignola, ITA - Harald SCHMIDT, Maastricht, NED - Stephan VON HAEHLING, Berlin, GER
David WHEL LAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA - Christian ZAUGG, Roche Diagnostics, SUI
     
16:30-19:00   SALON ORSAY NORD ROOM
    EXPERT WORKSHOP
MYOCARDIAL INNERVATION IMAGING. FROM PROGNOSTICATION TO GUIDING THERAPY
    Chairmen: Denis AGOSTINI, Caen, FRA - Ileana PIÑA, Cleveland, USA
     
     
    Myocardial imaging for assessment of cardiovascular risk in heart failure patients. From retrospective
observations to prospective validation (ADMIRE-HF)
    Paolo G. CAMICI , London, GBR [Presentation]
     
    MIBG myocardial imaging to predict ventricular arrhythmias and cardiac outcome
    Arnold JACOBSON, GE Healthcare, USA
     
    Cardiac MIBG imaging guided therapy in heart failure patients. Time for a trial?
    Ileana PIÑA, Cleveland, USA [Presentation]
     
    EXPERT WORKSHOP
How to turn a prognostic factor into a therapeutic decision and monitoring tool? Design and methodological issues.
   
  • Where are the unmet needs? What is the target population?
    Discussant: John CLELAND, Hull, GBR
  • Mechanistic plausibility: What medication for poor sympathetic neuronal integrity?
    Discussant: Bertram PITT, Ann ARBOR, USA
  • Clinically meaningful endpoints. What will convince the doctor?
    Discussant: James JANUZZI, Boston, USA [Presentation]
    Panellists: Stefan AGEWALL, Stockholm, SWE - Denis AGOSTINI, Caen, FRA - Paolo G. CAMICI, London, GBR
John CLELAND, Hull, GBR - Kenneth DICKSTEIN, Stavanger, NOR - Daniela DOBRE, Nancy, FRA
Lawrence FINE, Bethesda, USA - Mihai GHEORGHIADE, Chicago, USA - Arnold JACOBSON, GE Healthcare, USA
James JANUZZI, Boston, USA - Henry KRUM, Melbourne, AUS - Keld KJELDSEN, Copenhagen, DEN,- Alice MASCETTE,
Bethesda, USA - John McMURRAY, Glasgow, GBR - Marc PFEFFER, Boston, USA - Ileana PIÑA, Cleveland, USA - Bertram PITT ,
Ann ARBOR, USA - Frank RUSCHITZKA, Zurich, SUI - Aldo MAGGIONI, Florence, ITA - Atul PATHAK, Toulouse, FRA - Luigi TAVAZZI, Cotignola, ITA - Patrick ROSSIGNOL, Nancy, FRA - David WHELLAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA
     
16:30-18:30   SALON ORSAY SUD ROOM
    PLENARY SESSION
RISK GUIDED CARDIOVASCULAR PREVENTIVE DRUG THERAPY - FROM INDIVIDUAL RISK FACTORS TO
RISK SCORING
    Chairmen: Luis RUILOPE, Madrid, ESP - Faiez ZANNAB, Nancy, FRA
     
     
    Cardiovascular preventive drug therapy, advantages and limitations of the current paradigm
    Heribert SCHUNKERT, Lübeck, GER [Presentation]
     
    The impact of recent clinical trials on the future of CVD assessment and risk management
Transition to “risk score guided” strategies
    Wolfgang KOENING, Ulm, GER [Presentation]
     
    Clinical utility of biomarkers and bioimaging as tools to identify patients who need drug therapy
    Matthias LORENZ, Frankfurt, GER
     
    Combined lipid lowering and blood pressure lowering in high risk patients. Rationale and design of the HOPE-3 trial
    Eva LONN, Hamilton, CAN [Presentation]
     
    Risk scoring. Beyond Framingham
    Jay COHN, Minneapolis, USA
     
18:30-19:15   FOYER ORSAY NORD ROOM
    ESC WORKING GROUP ON PHARMACOLOGY AND DRUG THERAPY NUCLEUS BUSINESS MEETING
     
Friday December 3rd, 2010
08:30-10:30   SALON ORSAY SUD ROOM
    EXPERT WORKSHOP
DEVICE THERAPY FOR MILD TO MODERATE HEART FAILURE
    Chairmen: John CLELAND, Hull, GBR - Jean Yves LE HEUZEY, Paris, FRA
     
     
    MADIT-CRT, RAFT and heart failure device trials. Accumulating evidence
    Jean ROULEAU, Montreal, CAN - [Presentation]
     
    CRT and ICD therapy: How early in the disease process?
    Johannes HOLZMEISTER, Zurich, SUI
     
    Debate: From trial to approval to guidelines and adoption. How device trials will stand the journey?
     
   
  • Weighing the level of evidence. Consistency, validity and mechanistic plausibility of trial results
    Discussant HF : Kenneth DICKSTEIN, Stavanger, NOR - [Presentation]
    Discussant EP : Jean-Yves LE HEUZEY, Paris, FRA - [Presentation]
  • Updating the guidelines. Have we hit the Ia target?
    Discussant EP : Malcolm ARNOLD, London, CAN - [Presentation]
    Discussant HF : John CLELAND, Hull, GBR - [Presentation]
  • How to identify/refer patients eligible for device therapy?
    Can a “Get With The Guidelines” (GWTG) type initiative help?
    Discussant HF : Faiez ZANNAD, Nancy, FRA - [Presentation]
     
    Panellists: William ABRAHAM, Columbus, USA - John CLELAND, Hull, GBR - Jay COHN, Minneapolis, USA
Martin COWIE, London, GBR - Kenneth DICKSTEIN, Stavanger, NOR - Mihai GHEORGHIADE, Chicago, USA
Johannes HOLZMEISTER, Zurich, SUI - Henry KRUM, Melbourne, AUS - Jean-Yves LE HEUZEY, Paris, FRA
Marc PFEFFER, Boston, USA - Frank RUSCHITZKA, Zurich, SUI - Aldo MAGGIONI, Firenze, ITA
Franco NACCARELLA, Bologna, ITA - Willem REMME, Rhoon, NED - Bernd SCHUBERT, Boston Scientific, BEL
Jean ROULEAU, Montreal, CAN - Luigi TAVAZZI, Cotignola, ITA - Alphons VINCENT, Medtronic, NED
Malcolm ARNOLD, London, CAN - David WHELLAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA
     
08:30-10h30   SALON ORSAY NORD ROOM
11:00-12h30   PLENARY SESSION
    TRIALS OF NEW ANTI-DIABETIC DRUGS A SHIFT IN PARADIGM
    Chairmen: Angeles ALONSO, Madrid, ESP - William C. CUSHMAN, Memphis, USA
     
    The value of the surrogate glycemic control and HbA1 C, the usual endpoint on which approval of diabetes
drugs is based is being strongly challenged. Mega and long duration trials are currently undertaken
in type 2 diabetes. They may be required to obtain significant improvements in macrovascular outcomes.
However, to date, no benefits on macrovascular outcomes have been demonstrated. Ultimately, as at least 50%
of the complications associated with type 2 diabetes are microvascular in nature, it may be more appropriate
to focus on microvascular outcomes. Also, targeting disease progression rather than events may be appropriate.
Because of recently published CV safety issues with the new anti-diabetic agents, the FDA produced
proscriptive industry guidelines requesting the evaluation of CV risk in all new anti-diabetic therapies.
Such measures create ethical and economic challenges.

What to expect from a new anti-diabetic drug? Endpoint related issues

  • HbA1 C, a failed surrogate?
    William C. CUSHMAN, Memphis, USA

  • Micro vs. macrovascular disease progression endpoints
    Peter SLEIGHT, Oxford, GBR - [Presentation]

  • Hard endpoints: MACE and Mortality
    John McMURRAY, Glasgow, GBR

    The metabolic memory of HbA1c, how useful as a surrogate ?
    Hens WEDEL, Gothenburg, SWE

    Debate: Are the current megatrials addressing the unmet needs?
     
    Panellists: Eric ABADIE, Paris, FRA - Stefan AGEWALL [Presentation], Oslo, NOR - Angeles ALONSO, Madrid, ESP
John CLELAND, Hull, GBR - Robert CODY, Merck, USA - William C. CUSHMAN, Memphis, USA
Jeffrey FRIEDMAN, Boehringer INGELHEIM, GER - Nancy GELLER, Bethesda, USA
David GORDON, Bethesda, USA - Yasser KHDER, Boehringer INGELHEIM, FRA - Wolfgang KOENIG, Ulm, GER
Basil LEWIS, Haïfa, ISR - Giuseppe MANCIA, Monza, ITA - John McMURRAY, Glasgow, GBR - Eva LONN, Hamilton,
CAN - Prem PAIS , Bangalore, IND - Alfonso PEREZ, Takeda, USA - Bertram PITT, Ann ARBOR, USA - Stuart POCOCK [Presentation],
London, GBR - James REVKIN, Boehringer INGELHEIM, USA - Eberhardt RITZ, Heidelberg, GER - Yves ROSENBERG ,
Bethesda, USA - Luis RUILOPE, Madrid, ESP - Heribert SCHUNKERT, Lübeck, GER - Daryl SLEEP, Takeda, USA - Peter
SLEIGHT, Oxford, GBR - Christian TORP - Pedersen , Copenhagen, DEN - Hans-Jürgen WOERLE, Boehringer INGELHEIM, GER
Hens WEDEL, Gothenburg, SWE - Faiez ZANNAD, Nancy, FRA
     
11:00-12:30   SALON ORSAY SUD ROOM
    EXPERT WORKSHOP
MANAGEMENT OF HEART FAILURE PATIENTS GUIDED BY REMOTE HEMODYNAMIC MONITORING
IS THE CONCEPT PROVEN?
    Chairmen: Martin COWIE, London, GBR - William ABRAHAM, Columbus, USA
     
     
    Why do we need telemonitoring solutions for the heart failure patient?
    Martin COWIE, London, GBR - [Presentation]
     
    What to monitor? Defining the right signals which would prompt action. A review of the existing monitoring devices.
    Haran BURRI, Geneva, SUI
     
    Who should deal with the telemonitoring information? Practical issues
    Carlos MORAIS, Amadora, POR - [Presentation]
     
    Criteria for trial validation of telemedicine devices for heart failure patients? Critical appraisal of recent
and ongoing trials (COMPASS; DOT-HF; DECODE; PARTNERS-HF; PRECEDE-HF; SENSE-HF; TELE-HF)
    David WHELLAN, Philadelphia, USA
     
    Debate: How to generate evidence? Designing telemonitoring trials
     
    Panellists: William ABRAHAM, Columbus, USA - Haran BURRI, Geneva, SUI - Martin COWIE, London, GBR
Kenneth DICKSTEIN, Stavanger, NOR - Jay COHN, Minneapolis, USA - Lawrence FINE, Bethesda, USA
Mihai GHEORGHIADE, Chicago, USA - Gerasimos FILIPATTOS, Athens, GRE - Henry KRUM, Melbourne, AUS
Alice MASCETTE, Bethesda, USA - Aldo MAGGIONI, Firenze , ITA - Sandrine MASSET, Boston Scientific, BEL
Carlos MORAIS, Amadora, POR - Marc PFEFFER, Boston, USA - Ileana PIÑA, Cleveland, USA - Bertram PITT, Ann
ARBOR, USA - Willem REMME, Rhoon, NED - Frank RUSCHITZKA, Zurich, SUI - Bernd SCHUBERT, Boston Scientific, BEL
Jean ROULEAU, Montreal, CAN - Luigi TAVAZZI, Cotignola, ITA - Alphons VINCENT, Medtronic, GER
David WHELLAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA
     
12:30-13:45   FOYER ORSAY NORD ROOM
    Meet and Eat with the Expert session
SAFETY ISSUES RELATED TO SERUM POTASSIUM IN CARDIOVASCULAR TRIALS - FALLING FROM CHARY
BDE TO SCYLLA?
    Chairmen: Keld KJELDSEN, Copenhagen, DEN - Luis MIGUEL Ruilope , Madrid, ESP
     
     
    The pathophysiology of serum potassium in cardio-renal disease
    Eberhardt RITZ, Heidelberg, GER - [Presentation]
     
    Targets for serum potassium in hypertension and heart failure; Preventing and managing hyperkalemia
    Luis Miguel RUILOPE, Madrid, ESP [Presentation]
     
    Serum potassium and cardiorenal outcomes in cardiovascular clinical trials of RAAS therapy
    Faiez ZANNAD, Nancy, FRA - [Presentation]
     
    Opportunities to prevent/treat hyperkalemia with potassium-binders. Objectives and design of the PEARL-HF trial
    Bertram PITT, Ann ARBOR, USA
     
12:30-13:45   SALON ORSAY SUD ROOM
    MEET AND EAT WITH THE EXPERTS SESSION
CV PREVENTION: ONE DRUG, MULTIDRUGS OR POLYPILL?
    Chairman: Eva LONN, Hamilton, CAN - Marc PFEFFER, Boston, USA
     
     
    Polypill and primary CV prevention. Indian Polycap Study (TIPS)
    Prem PAIS, Bangalore, IND - [Presentation]
     
    Polypill and secondary prevention: the FOCUS trial
    Felipe MARTINEZ, Cordoba, ARG - [Presentation]
     
    The Red Heart multidrug pill Indo European UMPIRE trial
    Simon THOM, London, GBR
     
    The Regulatory approach. Approvability issues of the polypill
    Angeles ALONSO, Madrid, ESP - [Presentation]
     
14:00-16:00   SALON ORSAY SUD ROOM
    EXPERT STATISTICIANS AND TRIALISTS
DISCUSS THE MAJOR TRIALS OF THE YEAR
    Chairmen: Bertram PITT, Ann ARBOR, USA - Mohamed SOBHY, Alexandria, EGY
     
    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 - [Presentation]
Discussant: Roxana MEHRAN, New York, USA
     
    Panellists: Corine BERNAUD, AstraZeneca, BEL - Robert CODY, Merck, USA - Lawrence FINE, Bethesda, USA
Nancy GELLER, Bethesda, USA - David GORDON, Bethesda, USA - Steen HUSTED, Arhus, DEN
Yasser KHDER, Boehringer INGELHEIM, FRA - Eva LONN, Hamilton, CAN - Gerasimos FILIPATTOS, Athens, GRE
Damien LOGEART, Paris, FRA - Josep MASIP, Barcelona, ESP - Marco METRA, Brescia, ITA
Christian MÜELLER, Basel, SUI - Semir NOUIRA, Mahdia, TUN - Hani SABBAH, Detroit, USA - Alice MASCETTE,
Bethesda, USA - Giuseppe MANCIA, Monza, ITA - Roxana MEHRAN, New York, USA - Atul PATHAK, Toulouse,
FRA Marc PFEFFER, Boston, USA - Bertram PITT, Ann ARBOR, USA - Stuart POCOCK, London, GBR - Yves ROSENBERG, Bethesda, USA - Patrick ROSSIGNOL, Nancy, FRA - Victor SEREBRUANY, Towson, USA - Harry SHI,
Pfizer, USA
Mohamed SOBHY, Alexandria, EGY - Christian TORP PEDERSEN, Copenhagen, DEN - Hans WEDEL, Gothenburg,
SWE - Andrew ZALEWSKI, Novartis, USA - Faiez ZANNAD, Nancy, FRA.
     
14:00-16:00   SALON ORSAY NORD ROOM
    PLENARY SESSION
HEART RATE REDUCTION WITH IVABRADINE: FROM CLINICAL TRIALS TO CLINICAL PRACTICE
    Chairmen: Michael BÖHM, Homburg, GER - Faiez ZANNAD, Nancy, FRA
     
    Body of evidence of the importance of heart rate reduction
    Martin COWIE, London, GBR - [Presentation]
     
    Management of heart rate in CAD: lessons from the BEAUTIFUL study
    Jeffrey S. BORER, New York, USA [Presentation]
     
    Management of heart rate in HF: lessons from the SHIFT study
    Michael BÖHM, Homburg, GER [Presentation]
     
    Heart rate management in clinical practice with ivabradine
    Giuseppe ROSANO, Roma, ITA - [Presentation]
     
    Debate: The challenge of optimization of heart failure therapy. Is there a limit to polypharmacy?
     
    Panellists: Stefan AGEWALL, Oslo, NOR - Michael BÖHM, Homburg, GER - Jeffrey S. BORER , New York, USA
Martin COWIE, London, GBR - Jay COHN, Minneapolis, USA - Mihai GHEORGHIADE, Chicago, USA
Mona FIUZAT, Durham, USA - Wolfgang KOENIG, Ulm, GER - Henry KRUM, Melbourne, AUS - Guy LEREBOURS, Servier, FRA
Felipe MARTINEZ, Cordoba, ARG - John McMURRAY, Glasgow, GBR - Willem REMME, Rhoon, NED
Giuseppe ROSANO, Roma, ITA - Heribert SCHUNKERT, Lübeck, GER - Kurt STOSCHITZKY, Graz, AUT
Luigi TAVAZZI, Cotignola, ITA - Faiez ZANNAD, Nancy, FRA
     
16:30-19:00   SALON ORSAY SUD ROOM
    EXPERT WORKSHOP
METHODOLOGICAL, PRACTICAL AND REGULATORY FRAMEWORK FOR CONDUCTING
AN ANTI-THROMBOTIC THERAPY OUTCOME TRIAL IN ATRIAL FIBRILLATION
    Chairmen: Sidney GOLDSTEIN, Detroit, USA - Christian TORP-PEDERSEN, Copenhagen, DEN
     
    Rationale:
Several new anti-thrombotic agents and interventional therapies have been subjected to or are being assessed in large mortality and
morbidity atrial fibrillation trials. Several challenges and issues are related to designing, conducting and interpreting the results of an
anti-thrombotic trial. Understanding these issues is critical for an optimal implementation of the results of these trials into daily clinical
practice.
     
    Objectives:
  • Discussing the strengths and limitations of the recent and ongoing mortality-morbidity trials with anti-thrombotic therapy in atrial fibrillation.
  • Understanding the methodological, practical (environment) and regulatory framework for conducting an anti-thrombotic therapy outcome trial.
  • Discussion among experts with the aim of improving future anti-thrombotic therapy in atrial fibrillation.
    Lectures:
Limitations of warfarin anticoagulation and unmet needs in atrial fibrillation stroke prevention.
    Gregory LIP, Birmingham, GBR - [Presentation]
    New anti-thrombotic agents versus Warfarin in Patients with Atrial Fibrillation. An update on recent and ongoing trials.
    Freek VERHEUGT, AMS, NED
    Debate: Defining the target population and reshaping the guidelines
     
    Dosing issues in thrombosis trials. e.g. Progression from Phase 2 to Phase 3 trials with new oral anti-thrombotic agents
    Discussant: Yasser KHDER, Boehringer Ingelheim, FRA - [Presentation]
     
    PROBE vs. Double Blind study designs in thrombosis trials
    Discussant: Gregory LIP, Birmingham, GBR - [Presentation]
     
    What is a clinically meaningful benefit? All cause vs cause specific events
    Discussant: Freek VERHEUGT, Amsterdam, NED - [Presentation]
     
    Panellists: Corine BERNAUD, AstraZeneca, BEL - Alain GAY, Bayer, FRA - Sidney GOLDSTEIN - Detroit, USA - Yasser
KHDER, Boehringer INGELHEIM, FRA - Stuart KUPFER, Takeda, USA - Andrea LASLOP, Innsbruck, AUT- Gregory LIP,
Birmingham, GBR - Basil LEWIS, Haïfa, ISR - Franco NACCARELLA, Bologna, ITA - Yves ROSENBERG, Bethesda, USA
Ogun SAZOVA, AstraZeneca, BEL- Luigi TAVAZZI, Cotignola, ITA - Christian TORP-PEDERSEN, Copenhagen, DEN
Freek VERGHEUGT, Amsterdam, NED - Lars WALLETIN, Uppsala, SWE - Hans-Jürgen WOERLE, Boehringer INGELHEIM,
GER - Faiez ZANNAD, Nancy, FRA
     
16:30-18:30   SALON ORSAY NORD ROOM
    ALDOSTERONE RECEPTOR BLOCKERS ACROSS THE HEART FAILURE SPECTRUM
    Chairmen: John McMURRAY, Glasgow, GBR - Kenneth DICKSTEIN, Stavanger, NOR
     
    A historical perspective of evidence based therapy in heart failure
    Jay COHN, Minneapolis, USA
     
    EMPHASIS-HF : Extending the indication of eplerenone to mild heart failure
    Faiez ZANNAB, Nancy, FRA - [Presentation]
     
    Aldosterone receptor blockers across the heart failure spectrum. Practical issues and updating the guidelines - [Presentation]
    Henry KRUM, Melbourne, AUS
     
    Anti-aldosterone therapy. New drugs and new trials
    Bertram PITT, Ann Arbor, USA
     
18:30-19:30   Meeting with the steering committee
Saturday December 4th, 2010
     
08:00-10:30   SALON ORSAY NORD ROOM
11:00-12:30   «How to» Workshop
    HOW TO STOP A TRIAL PREMATURELY FOR EXCESS OF BENEFIT
    Chairmen: John McMURRAY, Glasgow, GBR - Stuart POCOCK, London, GBR
     
   

Rationale:
There are obvious ethical reasons for stopping a trial prematurely when protecting the study patients against excess of
harm when a premature evidence of excess adverese events is detected by the data safety and monitoring committee.
It may be also ethically important not to keep the study going when patients in the control group appear to be at highr
risk of events than the active study group. However stopping a trial prematurely exposes to possible bias and several
other interpretation issues. In addition, because they are usually unplanned, the logistical challenges after the decision
to stop and until study close out and beyond may be very important. There is no magic solution, but lessons on how to
optimize stopping rules and the close out of a study that is stopped prematurely may be learnt from recent experiences.
This session is of interest to all investigators, regulators, ethicists, and industry scientists and project managers involved
in steering clinical trials and/or in Data Safety and Monitoring Committees.

Objective:
Discussion among experts on stopping rules, interpretation issues and how to optimize the close out of a study that is
stopped prematurely.
Format:
Short 10 min presentations followed respectively by 20 min discussion among experts and interaction with an open
audience.

Introduction:
Case study. My experience with stopping trials prematurely (RALES, CIBIS 2, EMPHASIS-HF and other trials)
Faiez ZANNAD, Nancy, FRA - [Presentation]

Why to stop – what endpoint?
Bertram PITT, Ann Arbor, USA

When to stop – what level of statistical certainty?
Stuart POCOCK, London, GBR - [Presentation]

How to stop – how quickly? Collecting further events? Open label treatment if stopping for efficacy?
John McMURRAY, Glasgow, GBR

How did I handle expedited event adjudication? Critical event committee issues
Willem REMME, Rhoon, NED

Panellists: Jeffrey S. BORER, New York, USA - Jay COHN, Minneapolis, USA - Henry DARGIE, Glasgow, GBR
Lawrence FINE, Bethesda, USA - Gerasimos FILIPATTOS, Athens GRE - Nancy GELLER, Bethesda, USA
Mihai GHEORGHIADE, Chicago, USA - David GORDON, Bethesda, USA - Yasser KHDER, Boehringer INGELHEIM,
FRA Wolfgang KOENIG, Ulm, GER - Aldo MAGGIONI, Florence, ITA - Alice MASCETTE, Bethesda, USA
Roxana MEHRAN, New York, USA - John McMURRAY, Glasgow, GBR - Marco METRA, Brescia, ITA
Marc PFEFFER, Boston, USA - Bertram PITT, Ann ARBOR, USA - Stuart POCOCK, London, GBR
Willem REMME, Rhoon, NED - Yves ROSENBERG, Bethesda, USA - Harry SHI, Pfizer, USA
Maarten SIMOONS, Rotterdam, NED - Christian TORP-PEDERSEN, Copenhagen, DEN - John VINCENT - [Presentation] , Pfizer, USA
Hans WEDEL, Gothenburg, SWE - David WHELLAN, Philadelphia, USA - Andrew ZALEWSKI, Novartis, USA
Faiez ZANNAD, Nancy, FRA

     
08:30-10:30   SALON ORSAY SUD ROOM
11:00-12:30   EXPERT WORKSHOP
    CARDIAC RESYNCHRONIZATION THERAPY BEYOND LBBB AND WIDE QRS
    Chairmen: Johannes HOLZMEISTER, Zurich, SUI - William ABRAHAM, Columbus, USA
     
    Rationale and design of the Echo-CRT trial
    Frank RUSCHITZKA, Zurich, SUI - [Presentation]
    Debate: From proof of concept to a large scale morbidity and mortality trial. Design challenges.
Bearing results implementation in mind.
  • Where are the unmet needs? What is the target population? Trial population vs. real life patients
    Discussant HF: William ABRAHAM, Columbus, USA - [Presentation]
  • Clinically meaningful endpoints. Composite/cause-specific or all-cause? What will convince the doctors?
    Discussant EP: Johannes HOLZMEISTER, Zurich, SUI
    Discussant HF: Henry KRUM, Melbourne, AUS - [Presentation]
  • What is adequate statistical power?
    Discussant Statisticiant: Stuart POCOCK London, GBR
    Discussant HF: Faiez ZANNAD, Nancy, FRA
    Panellists: William ABRAHAM, Columbus, USA - Malcolm ARNOLD, London, GBR - John CLELAND, Hull, GBR
Kenneth DICKSTEIN, Stavanger, NOR - Johannes HOLZMEISTER, Zurich, SUI - Henry KRUM, Melbourne, AUS
Stuart POCOCK, London, GBR - Alphons VINCENT, Medtronic, GER - Frank RUSCHITZKA, Zurich, SUI
Faiez ZANNAD, Nancy, FRA
     
09:00-10:30   FOYER ORSAY NORD ROOM
11:00-12:30   EXPERT WORKSHOP
    MAXIMIZING THE BENEFITS FROM ANGIOTENSIN RECEPTOR ANTAGONISTS - ENHANCED POTENCY
AND COMBINATION THERAPY
    Chairmen: Angeles ALONSO, Madrid, ESP - Giuseppe MANCIA, Monza, ITA
     
    Are all angiotensin receptor blockers alike? Are maximized potency and ancillary effects clinically relevant?
    Luis RUILOPE, Madrid, ESP - [Presentation]
     
    How to cook a good combo recipe? What is the ideal diuretic to combine?
    Stuart KUPFER, Takeda, USA - [Presentation]
     
    Is combination therapy to become the rule? Insight from hypertension outcome trials and recent guidelines
    Giuseppe MANCIA, Monza, ITA - [Presentation]
     
    How to prove/claim added value conferred by ancillary properties?
    Angeles ALONSO, Madrid, ESP - [Presentation]
     
    How to prove/claim superiority of a new combo drug?
    William C. CUSHMAN, Memphis, USA - [Presentation]
     
    Debate: Approvability of new anti-hypertensive agents.
     
    Panellists: Angeles ALONSO, Madrid, SPA - William C. CUSHMAN, Memphis, USA - Stuart KUPFER, Takeda, USA Eva
LONN, Hamilton, CAN - Giuseppe MANCIA, Monza, ITA - Alfonso PEREZ, Takeda, USA - Bertram PITT, Ann Arbor, USA
Patrick ROSSIGNOL, Nancy, FRA - Vladimir POPOV, Moscow, RUS - Luis RUILOPE, Madrid, SPA - Darryl SLEEP, Takeda,
USA - Faiez ZANNAD, Nancy, FRA
     
12:30-13:45   SALON ORSAY NORD ROOM
    PLENARY GUEST LECTURE
CHALLENGING HYPOTHESES TO BE TESTED IN FUTURE TRIALS
The CV Trialists «FORUM»
   
     
    «fo•rum (fôrm, fr-) n. pl. fo•rums also fo•ra (fôr, fr)
  • The public square or marketplace of an ancient Roman city that was the assembly place for judicial activity and public business.
  • A public meeting place for open discussion.
  • A medium for open discussion or voicing of ideas, such as a newspaper, a radio or television program, or a website.
  • A public meeting or presentation involving a discussion usually among experts and often including audience participation.
  • A court of law; a tribunal.»
    Clinical trials are humbling experiences. Drug discovery is not a linear process. Many drugs have failed
to demonstrate the benefits that were expected from their pharmacological profile. Interestingly, many others have
“apparently unexpected” benefits which were not originally predicted from their pharmacodynamic effects. Pleiotropic
effects and off target effects have been sometime used to explain these non-linear findings.
In this CVCT “Forum” session a tribune is given to an experienced trialist to present new “out of the box”
challenging ideas that could be subjected to new trials. He should stand the criticisms of plebeian trialists,
sceptical scientists and hard to convince sponsors.
     
    Carte blanche to:
Marc PFEFFER, Boston, USA - [Presentation]
     
    Panellists: Kirkwood ADAMS, Chapel Hill, USA - Jeffrey S. BORER, New York, USA - Jay COHN, Minneapolis, USA
Peter CLEMMENSEN, Copenhagen, DEN - John CLELAND, Hull, GBR - Kenneth DICKSTEIN, Stavanger, NOR
Nancy GELLER, Bethesda, USA - Sidney GOLDSTEIN, Detroit, USA - Mihai GHEORGHIADE, Chicago, USA
David GORDON, Bethesda, USA - Lawrence FINE, Bethesda, USA - Yasser KHDER, Boehringer INGELHEIM, FRA
Wolfgang KOEING, Ulm, GER - Henry KRUM, Melbourne, AUS - Stuart KUPFER, Takeda, Chicago, USA
Andrea LASLOP, Innsbruck, AUT - Eva LONN, Hamilton, CAN - Felipe MARTINEZ, Cordoba, ARG
Alice MASCETTE, Bethesda, USA - Alexandre MEBAZAA, Paris, FRA - Roxana MEHRAN, New York, USA
John McMURRAY, Glasgow, GBR - Marc PFEFFER , Boston, USA - Ileana PIÑA, Cleveland, USA - Betram PITT, Ann
Arbor, USA - Stuart POCOCK, London, GBR - Vladimir POPOV, Moscow, RUS - Willem REMME, Rhoon, NED - James
REVKIN, Boehringer INGELHEIM, USA - Yves ROSENBERG , Bethesda, USA - Harry SHI, Pfizer, USA
Maarten SIMOONS , Rotterdam, NED - Bernard SWYNGHEDAUW, Paris, FRA - Christian TORP - PEDERSEN, Copenhagen, DEN
John VINCENT, Pfizer, USA - Hans WEDEL, Gothenburg, SWE - David WHELLAN, Philadelphia, USA
Faiez ZANNAD, Nancy, FRA
     
14:00-16:00   SALON ORSAY SUD ROOM
16:30-18:00   CVCT WORKSHOP
STUDY DESIGN ISSUES IN THROMBOSIS TRIALS
    Chairmen: Peter CLEMMENSEN, Copenhagen, DEN - Roxana MEHRAN, New York, USA
     
    There is no clear relationship between anti-coagulant or anti-platelet activity and clinical endpoint event rates. 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 anti-thrombotic drugs would
be welcomed. ‘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.
Combining safety and efficacy endpoints can make interpretation of study outcomes problematic.
     
    Areas for experts’ discussion:
    Risk benefit issues in progressing to Phase III.
Speaker: Sidney GOLDSTEIN, Detroit, USA - [Presentation]
     
    Do surrogates and/or adaptive design help?
Speaker: Roxana MEHRAN, New York, USA - [Presentation]
Discussant: Sidney GOLDSTEIN, Detroit, USA
     
    Combining efficacy and safety in composite endpoints
Speaker: Andrea LASLOP, Innsbruck, AUT
     
    PROBE vs Double Blind study design in antithrombotic trials
Speaker: Hans WEDEL, Gothenburg, SWE
Discussant: Christian TORP - PEDERSEN, Copenhagen, DEN - [Presentation]
     
    Bleeding outcomes: Definitions and adjudication issues
Speaker: Maarten SIMOONS, Rotterdam, NED - [Presentation]
Discussant: Peter CLEMMENSEN, Copenhagen, DEN
     
    Faculty: Peter CLEMMENSEN, Copenhagen, DEN - Alain GAY, Bayer, FRA - Sidney GOLDSTEIN, Detroit, USA
Yasser KHDER, Boehringer INGELHEIM, FRA - Stuart KUPFER, Takeda, USA - Andrea LASLOP, Innsbruck, AUT
John McMURRAY, Glasgow, GBR - Roxana MEHRAN, New York, USA - Prem PAIS, Bangalore, IND - James REVKIN, Boehringer INGELHEIM, USA - Yves ROSENBERG, Bethesda, USA - Maarten SIMOONS, Rotterdam, NED
Daryl SLEEP, Takeda, USA - Mohamed SOBHY, Alexandria, EGY - Christian TORP - PEDERSEN, Copenhagen, DEN, Hans
WEDEL, Gothenburg, SWE - Faiez ZANNAD, Nancy, FRA.
     
14:00-16:00   SALON ORSAY NORD ROOM
16:30-18:00   CVCT WORKSHOP
ACUTE HEART FAILURE TRIALS. HOW TO OVERCOME ENROLLMENT CHALLENGES
    Chairmen: Mihai GHEORGHIADE, Chicago, USA - Faiez ZANNAD, Nancy, FRA
     
     
    Rationale:
    A fundamental problem in performing heart failure (HF) trials relates to multiple issues including:
  • The heterogeneous nature of the patients presenting with HF
  • The large variability of patients presenting to teaching, academic and tertiary centres versus those presenting to community hospitals and private clinics
  • Lack of cooperation between cardiology, heart failure, medicine and emergency room care providers
  • Lack of infrastructure geared specifically at the site level towards HF research combined with lack of expertise of coordinators in HF
  • Long start up periods related to difficulties in negotiating the complex regulatory environment and long/convoluted contracting process
  • Sponsors as well as CROs and AROs need to work jointly in developing a network of trained acute heart failure trial investigators based on the diversity of the trial settings. The fundamentals of such a network should include:
  • Representation from academics, private, teaching and community centres
  • Common scientific goal to better define “real life” HF – concentrating on acute HF, systolic HF and diastolic HF
  • A global outreach – looking at HF in different continents, countries and regions
  • Create an infrastructure at the site level that would provide the coordinators and scientific platform on which clinical research can be built later
  • Create a common legal and regulatory platform which would enable fast and seamless start up towards clinical studies
  • Clear delineation at each site level which type of HF patients can be assessed by the site – acute, chronic systolic, chronic diastolic, etc.
  • Create a long term training program that would ensure the ethics and quality of HF research at the sites
    Objectives:
   
  • Identify barriers to conducting HF studies that would represent “real life” patients
  • Identify barriers to rapid patient enrollment in AHF trials
  • Define the scientific goals of the network
  • Discuss opportunities for sponsors, CROs and AROs to work jointly in training and setting a durable network of AHF trials investigators.
     
    Programme (each topic will be followed by a 30 min discussion):
Introduction:
    Experience with recent trials in acute and chronic HF. Enrollment challenges and regional differences
    Mihai GHEORGHIADE, Chicago, USA - [Presentation]
     
    Lessons from the largest Acute Heart Failure Trials: ASCEND HF
    Chris O’CONNOR, Durham, USA
     
    How to set up a HF research centre that can enroll “real life” patients in all HF research areas
     
    Experience from Central Europe
    Alexandre MEBAZAA, Paris, FRA - [Presentation]
     
    Experience from Western Europe
    Marco METRA, Brescia, ITA
     
    Experience from the USA
    Mihai GHEORGHIADE, Chicago, USA
     
    Experience from South America
    Felipe MARTINEZ, Cordoba, ARG
     
    Experience from Africa
    Semir NOUIRA, Mahdia, TUN - [Presentation]
     
    Experience in Asia
    Prem PAIS, Bangalore, IND - [Presentation]
     
    Organizational aspects of better HF studies: what should the common mechanism be? The «nuts and bolts»
of regulatory packages and contracts
    Gad COTTER, Durham, USA - [Presentation]
     
    Understanding the heterogeneity of the syndrome: The need for a global registry of HF patients
    Faiez ZANNAD, Nancy, FRA
     
    How can we do better studies?
    Lothar ROESSIG, Bayer, GER
    Faiez ZANNAD, Nancy, FRA
     
    Panel discussion: Opportunities for training and setting a durable network of HF trials investigators.
    Lothar ROESSIG, Bayer, GER
     
    Panellists: William ABRAHAM, Columbus, USA - Kirkwood ADAMS, Chapel Hill, USA
Alain COHEN SOLAL, Paris, FRA - Jay COHN, Minneapolis, USA - Gad COTTER, Durham, USA
Martin COWIE, London, GBR - Kenneth DICKSTEIN, Stavanger, NOR - Gerasimos FILIPPATOS, Athens, GRE
Mihai GHEORGHIADE, Chicago, USA - Mona FIUZAT, Durham, USA - Ewa JANKOWSKA, Wroclaw, POL
Aldo MAGGIONI, Firenze, ITA - Josep MASIP, Barcelona, ESP - Felipe MARTINEZ, Cordoba, ARG
Alexandre MEBAZAA [Presentation] , Paris, FRA - Marco METRA, Brescia, ITA - Christian MÜELLER, Basel, SUI
Semir NOUIRA, Mahdia, TUN - Chris O’CONNOR, Durham, USA - Prem PAIS, Bangalore, IND
Marc PFEFFER, Boston, USA - Ileana PIÑA, Cleveland, USA - Bertram PITT, Ann ARBOR, USA
Willem REMME, Rhoon, NED - Lothar ROESSIG, Bayer, GER - Frank RUSCHITZKA, Zurich, SUI
Hani SABBAH, Detroit, USA - Norman STOCKBRIDGE, Rockville, USA - Luigi TAVAZZI, Cotignola, ITA
Andrew ZALEWSKI, Novartis, USA - Faiez ZANNAD, Nancy, FRA.