Friday 6 december 2013
         
  08.00 12.25 MODIGLIANI CONFERENCE ROOM

THROMBOSIS TRIALISTS WORKSHOP:
COMPETING NEW THERAPIES IN ATRIAL FIBRILLATION AND HEART FAILURE

         
    Moderators: Paulus Kirchhof (Birmingham, GBR); Dan Atar (Oslo, NOR)
     
   
  • A number of new anti-thrombotic agents and a number of new trials have dramatically changed the management of acute coronary syndromes, atrial fi brillation, and venous thrombo-embolism. New oral anticoagulants (NOACS) have shaken the supremacy of warfarin.
   
  • Warfarin in atrial fi brillation is still the reference oral anticoagulant, but it is now challenged by many new anti-thrombosis strategies.
   
  • Results of the NIH-led trial will answer the question whether the use of genotype-guided warfarin therapy leads to an improvement in anticoagulation control above and beyond the use of only clinical information.
   
  • The results of ENGAGE AF-TIMI48 were presented at AHA 2013 shortly before this CVCT 2013 meeting. The results add to the level of evidence and should be discussed within the context of the previous RE-LY, ROCKET AF and ARISTOTLE trials.
   
  • Stroke risk after AF ablation appears to be favorably infl uenced; however, it is largely unknown if the benefi t extends to all stroke CHADS2 risk profi les of AF patients and to patients with heart failure.
   
  • Evidence from clinical trials and registry data is accumulating with left atrial (LAA) appendage closure, now available for use in Europe. Experts will debate on what further evidence is needed for establishing the value of LAA closure in the various AFib clinical situations.
   
  • The combination of AF after ACS, or the other way around, is very common and is associated with severe bleeding. Do the NOACS with their better safety profi le have a role here? Or should we drop aspirin in this specifi c indication?
   
  • Many complications related to heart failure can be related to thrombosis. Epidemiological and pathophysiological data also link HF to an increased risk of thrombosis, leading to the clinical consequences of sudden death, stroke, systemic thromboembolism and/or venous thromboembolism. In HF patients with reduced LV ejection fraction who are in sinus rhythm there is no evidence of an overall benefi t of warfarin on mortality, with risk of major bleeding. New oral anticoagulants that offer a different risk-benefi t profi le compared with warfarin may appear as attractive therapeutic option, but this would need to be confi rmed in clinical trials.
     
    Pharmacogenetics and pharmacoproteomics guided anticoagulation: results of the COAG trial and future perspectives
  présentation Speaker: Yves Rosenberg (NHLBI, USA)
  présentation Discussant: Nancy Geller (NHLBI, USA)
  présentation Discussant: Mark Chan (Singapore, SGP)
     
    New oral anticoagulants in Atrial fi brillation
  présentation Paulus Kirchhof (Birmingham, GBR)
     
    The latest trial results: ENGAGE-AF
  présentation Christian Ruff (Boston, USA)
     
    Reversing the anticoagulant effects of the NOACS
  présentation Discussant: James Costin (Perosphere, USA)
     
    What is the role of catheter ablation and LAA closure? Registries, and ongoing trials (CABANA and RAFT AF, PREDICT, PREVAIL)
  présentation Cecilia Linde (Stockholm, SWE)
     
    Combination of AF and ACS: the potential role of NOACS
  présentation Freek Verheugt (Amsterdam, NED)
     
    NOACS for heart failure with sinus rhythm: rationale and design of the COMMANDER-HF trial
  présentation Faiez Zannad (Nancy, FRA)
     
    Industry perspective:
  présentation Peter DiBattiste (J&J, USA)
  présentation Joerg Koglin (Merck, USA)
  présentation Michele Mercuri (DSI, USA)
    Martin van Eickels (Bayer, GER) cancelled
     
    Regulatory perspective:
  présentation Angeles Alonso (EMA, ESP)
  présentation Krishna Prasad (MHRA, GBR)
  présentation Kaori Shinagawa (PMDA, JAP)
     
Moderated Discussion with Audience Participation
Which therapy for which patient?
Shouldn’t stroke prevention in AFib be personalized medicine?
     
    Panellists: Angeles Alonso (EMA, ESP); Dan Atar (Oslo, NOR); Mark Chan (Singapore, SG); Rob Cody (J&J, USA); James Costin (Perosphere, USA); Peter DiBattiste (J&J, USA); Neal Eigler (St. Jude Medical, USA); Christophe Gaudin (Sanofi , FRA); Nancy Geller (NHLBI, USA); Young-Hoon Jeong (Jinju, KOR); Paulus Kirchhof (Birmingham, GBR); Joerg Koglin (Merck, USA); Tim Laske (Medtronic, USA); Andrea Laslop (EMA, Innsbruck, AUT); Basil Lewis (Haïfa, ISR); Cecilia Linde (Stockholm, SWE); Matthias Lorenz (Frankfurt, GER); Felippe Martinez (Cordoba, ARG); Michele Mercuri (DSI, USA); Gilles Montalescot (Paris, FRA); Kiyoshi Nobori (PMDA, JAP); Krishna Prasad (MHRA, GBR); David Radzik (Sanofi , FRA); Yves Rosenberg (NHLBI, USA); Christian Ruff (Boston, USA); Kaori Shinagawa (PMDA, JAP); Tabassome Simon (Paris, FRA); Solomon Steiner (Perosphere, USA); Juan Tamargo (Madrid, ESP); Ferran Torres (EMA, ESP); Martin van Eickels (Bayer, GER); Freek Verheugt (Amsterdam, NED); Sven Wassmann (Munich, GER); Faiez Zannad (Nancy, FRA)
     
  08.00 12.25 SOUTINE / UTRILLO CONFERENCE ROOM

DEVICES AND BIOMARKERS TO GUIDE CARE IN HEART FAILURE:
TRIAL METHODOLOGY AND REGULATORY ISSUES

     
    Moderators: William Abraham (Columbus, USA); James Januzzi (Boston, USA)
     
   
  • Technologies and biomarkers can detect pathophysiologic deteriorations in HF patients weeks before symptom onset.
   
  • Many devices are currently under investigation for heart failure, including cardiac contractility modulation, ventricular partitioning devices, intra-atrial shunts, percutaneous valve repair/replacement, transvenous phrenic nerve stimulation, implantable counter-pulsation devices, autonomic nervous system modulation, implantable hemodynamic monitors, and more.
   
  • Progress in the understanding of heart failure biomarker science has led to considerable advances toward application of natriuretic peptides and other biomarkers with a goal to better manage patients and there are increasing numbers of potential candidate biomarkers to chose from for the management of patients with heart failure.
   
  • Some view devices and biomarkers as a way to achieve target drug doses, while others view device/biomarker guided heart failure care as a way to supplement standard management by using an objective tool that refl ects heart failure biology. Therefore, device/biomarker guided therapy includes selecting the appropriate therapy to suit individual patient phenotype, as to maximize response rate and minimize adverse events. However, more research has been devoted to the use of device/biomarkers to help optimize dosage.
   
  • HF detection algorithms using multiple physiologic variables, each with its independent prognostic value, may result in a combined prognostic index of superior predictive and personalized value to an algorithm based on a single variable.
   
  • The sponsor role may be central in investigator education, protocol adherence, ongoing data review and feedback to centres, automated versus nurse-directed alerts.
   
  • Challenges and fundamentals of guided therapy trials from the regulatory perspective, including target population, trial design (e.g., observational versus RCT), control groups, monitoring and therapeutic algorithms, endpoints, and more generally what are regulatory agencies looking for need to be aligned with the clinically unmet needs and also met with the appropriate methodologies.
   
  • Finally approvability, regulatory, implementation, economic model and reimbursement issues with large geographical variances and across various heath care systems are other challenges to be addressed.
   
  • Consistency between the US, EU, and other regulatory bodies is a desirable goal.
     
    The goal of this session is to stimulate collaborative practical discussions and generate consensus around appropriate design and execution of device/biomarker guided heart failure trials and the aspects surrounding their evaluation by regulatory agencies.
     
    Implantable hemodynamic monitors
  présentation Speaker: William Abraham (Columbus, USA)
     
    Multisense technologies and integrated algorithms
  présentation Speaker: Martin Cowie (London, GBR)
  présentation Discussant: Torsten Kayser (Boston Scientifi c, BEL)
     
    Biomarker aspects: which biomarker? How to judge best approach for application?
  présentation Speaker: James Januzzi (Boston, USA)
    Discussant: Jae Kim (Amgen, USA) cancelled
  présentation Discussant: James Snider (Critical Diagnostics, USA)
     
    What have we learned so far? An update of the strength and limitations of the recent guided therapy trials
  présentation Devices: William Abraham (Columbus, USA)
  présentation Discussant: Arthur Mark Richards (Singapore, SGP)
     
    Defining device/biomarker guided therapy: what is the target? Drug doses or the biology of heart failure?
  présentation Speaker: Javed Butler (Atlanta, USA)
  Discussant: Kirkwood Adams (Chapell Hill, USA)
     
  présentation What is the best primary outcome measure? Hans-Peter Brunner-La Rocca (Maastricht, NED)
     
    Biomarkers for mechanistic phenotyping and responder targeted therapy
 
  • The BIOSTAT approach Marco Metra (Brescia, ITA)
  présentation
  • The HOMAGE approach Faiez Zannad (Nancy, FRA)
     
    Statistical cautions regarding the allure of personalized medicine
  présentation Speaker: Stuart Pocock (London, GBR)
     
Moderated Discussion with Audience Participation
The pathway to regulatory approval -
what do the regulatory agencies think of devices and biomarkers to guide heart failure care?
     
    Panellists: William Abraham (Columbus, USA); Kirkwood Adams (Chapel Hill, USA); Hans-Peter Brunner-La Rocca (Maastricht, NED); Javed Butler (Atlanta, USA); Blai Coll (Abbvie, USA); Martin Cowie (London, GBR); Gaetano DeFerrari (Pavia, ITA); Neal Eigler (St. Jude Medical, USA); Mona Fiuzat (Durham, USA); Philip Janiak (Sanofi , FRA); James Januzzi (Boston, USA); Torsten Kayser (Boston Scientifi c, BEL); Jae Kim (Amgen, USA); Damien Logeart (Paris, FRA); Alexandre Mebazaa (Paris, FRA); Marco Metra (Brescia, ITA); Tim Meyer (Boston Scientifi c, USA); Atul Pathak (Toulouse, FRA); Ileana Piña (New York, USA); Thierry Pochet (Boston Scientifi c, BEL); Stuart Pocock (London, GBR); Arthur Mark Richards (Singapore, SGP); Giuseppe Rosano (EMA, ITA); Veronique Semjonow (Philips, NED); James Snider (Critical Diagnostics, USA); Scott Solomon (Boston, USA); Frank van Leeuwen (Medtronic, CHE); Patrick Verta (Sunshine Heart, USA); Alphons Vincent (Medtronic, CHE); Hans Wedel (Gothenburg, SWE); Holger Woehrle (Resmed, GER); Faiez Zannad (Nancy, FRA)
         
  12.35 15.15 MODIGLIANI CONFERENCE ROOM

MANAGEMENT OF CO-MORBIDITIES IN HEART FAILURE

     
    Moderators: Ewa Jankowska (Wroclaw, POL); Christopher O’Connor (Durham, USA)
     
   
  • Anemia and iron defi ciency are common in patients with heart failure, and are associated with worse symptoms and adverse outcomes in this population. Although the two can occur together, anemia in HF is often not caused by iron defi ciency, and iron defi ciency can be present without causing anemia. New data on the importance of iron defi ciency in HF have become available, and a number of studies with intravenous iron have shown promising results (FAIR-HF). Therefore, this treatment approach is likely to become an attractive option for patients with HF and iron defi ciency.
   
  • Sleep disordered breathing (SDB) is very common in patients with HF, with reported prevalence rates of 50-75%. The presence of SDB is associated with decreased survival in HF patients. The only randomized controlled trial investigating mortality in patients with HF treated with CPAP was the CANPAP study. The trial was stopped prematurely after enrolment of 258 of the planned 408 patients, and data analysis did not show a benefi cial effect of CPAP treatment. However, a post-hoc analysis suggested that outcomes might be improved if SDB was well controlled. Studies to date have not been of adequate size or duration to determine whether therapy with CPAP is associated with signifi cant reductions in morbidity and mortality in patients with HF and SDB. The SERVE-HF study was designed to address these issues and has recently completed enrolment.
   
  • In the cardiorenal syndrome, the disappointing fi ndings of the CARRESS-HF trial, coupled with previous similar studies, imply that although early aquapheresis could be advantageous for management of patients with acute heart failure, it might not be the ideal option for salvage therapy after development of diuretic resistance. However, UNLOAD and CARRESS-HF have excluded patients with more severe renal dysfunction. In the UNLOAD study, the 90-day HF re-hospitalization was a pre-specifi ed secondary end-point and was positively infl uenced by aquapheresis.
   
  • The aim of the AVOID-HF study is to confi rm and expand the fi ndings of UNLOAD that fl uid removal by aquapheresis reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. The AVOID-HF study is going beyond studying only the amount of fl uid removal and will explore whether the modality of fl uid removal infl uences HF outcomes.
     
    Is anemia still a valid therapeutic target? Critical appraisal of TREAT and RED-HF
  présentation Aldo Maggioni (Florence, ITA)
     
    Iron deficiency: what can we expect from ongoing trials of iron therapy ferric carboxymaltose (EFFECT-HF, CONFIRM-HF)?
  présentation Speaker: Ewa Jankowska (Wroclaw, POL)
  présentation Discussant: Claudio Mori (Vifor Pharma, CHE)
     
    Sleep disordered breathing: insight from registry data and update on SERVE-HF morbidity-mortality trial
  présentation Speaker: Martin Cowie (London, GBR)
  présentation Discussant: Holger Woehrle (Resmed, GER)
     
    Cardiorenal syndrome: critical appraisal of aquapheresis trials and opportunities with the ongoing AVOID-HF trial
  présentation Speaker: Javed Butler (Atlanta, USA)
  présentation Discussant: Christopher O’Connor (Durham, USA)
     
     
Moderated Discussion with Audience Participation
     
    Panellists: Kirkwood Adams (Chapel Hill, USA); Javed Butler (Atlanta, USA); Jason A Campagna (Medco, USA); Blai Coll (Abbvie, USA); Martin Cowie (London, GBR); Ewa Jankowska (Wroclaw, POL); Keld Kjeldsen (Copenhagen, DEN); Carolyn Lam (Singapore, SGP); Aldo Maggioni (Florence, ITA); Claudio Mori (Vifor Pharma, CHE); Bertram Pitt (Ann Arbor, USA); Stuart Pocock (London, GBR); Gianpaolo Rossi (Padua, ITA); Patrick Rossignol (Nancy, FRA); Luis Ruilope (Madrid, ESP); Lars Christian Rump (Dusseldorf, GER); Adriaan Voors (Groningen, NED); Karen Wai (Quintiles, SGP); Holger Woehrle (Resmed, GER); Faiez Zannad (Nancy, FRA)
     
  12.35 15.15 SOUTINE / UTRILLO CONFERENCE ROOM

VASODILATORS IN ACUTE HEART FAILURE: HOW TO DESIGN SUCCESSFUL TRIALS?

     
    Moderators: Alexandre Mebazaa (Paris, FRA); Naoki Sato (Tokyo, JAP)
     
   
  • Many trials in acute heart failure failed. Despite disappointing results, a large number of trials are ongoing, mostly testing new vasodilators in acute heart failure. RELAX-HF was successful and confi rms that vasodilators can improve short and long-term outcomes in acute heart failure.
   
  • However, one of the major side effects of vasodilators is hypotension that may occur any time during the course of administration. Hypotension, in the context of old patients with many comorbidities might be very harmful. Are all the vasodilators equal to induce hypotension? Can we adjust inclusion and exclusion criteria to avoid side-effects of vasodilators?
   
  • In order to avoid hypotension, many studies have recently increased the threshold of inclusion blood pressure. This might prevent hypotension. However, this will also select patients who are not those seen in our daily practice..
     
    How can vasodilators save lives in acute heart failure?
  présentation Speaker: Dan Longrois (Paris, FRA)
  Discussant: Marco Metra (Brescia, ITA); Johannes Holzmeister (Zurich, CHE)
     
    Which data support benefi cial effects of vasodilators?
  présentation Speaker: Alexandre Mebazaa (Paris, FRA)
  présentation Discussant: Lothar Roessig (Bayer, GER)
     
    Hypotension is a major safety issue when assessing drugs with vasodilator properties
  Mihai Gheorghiade (Chicago, USA)
     
    How did I design my trial to be successful?
  Speaker: Marco Metra (Brescia, ITA)
    Discussant: Alexandre Mebazaa (Paris, FRA)
     
Moderated Discussion with Audience Participation
What is the pathway for a successful acute heart failure trial?
     
    Panellists: Angeles Alonso (EMA, ESP); Rob Cody (J&J, USA); Nancy Cooks Bruns (Bayer, GER); Mihai Gheorghiade (Chicago, USA); Johannes Holzmeister (Zurich, CHE); Jae Kim (Amgen, USA); Dan Longrois (Paris, FRA); Alexandre Mebazaa (Paris, FRA); Marco Metra (Brescia, ITA); Arthur Mark Richards (Singapore, SGP); Lothar Roessig (Bayer, GER); Naoki Sato (Tokyo, JAP); Scott Solomon (Boston, USA); Faiez Zannad (Nancy, FRA)
     
  15.30 19.30 MODIGLIANI CONFERENCE ROOM

THE ATHEROSCLEROSIS TRIALISTS FORUM:
NEW LIPID ASSOCIATED TARGETS AND IMPROVED PATHWAY TO SUCCESSFUL CLINICAL TRIALS

     
  présentation  Moderators: Wolfgang Koenig (Ulm, GER); Bart Staels (Lille, FRA)
     
   
  • Despite widespread early intervention in acute coronary syndromes and complete revascularization of stenotic lesions complemented by aggressive polypharmacy, still a high percentage of patients develop a secondary event. This has been shown in various registries and recent data from the GRACE registry have suggested that we grossly underestimate long-term risk in these patients. Thus, despite all our current efforts there is room for improvement.
   
  • A very active research program is delivering an important number of new potential therapeutic targets that may be ready for trial testing. A fairly large number of lipid-associated new targets or targets refl ecting other pathways of the complex atherosclerotic process are being evaluated in mechanistic imaging studies but also in large outcome trials..
   
  • Yet, phase III clinical endpoint trials evaluating treatments for atherosclerosis typically require very large sample sizes, cost hundreds of millions of dollars and historically have had very low success rates. As a result, few new therapies that attenuate the progression of atherosclerosis have been identifi ed in over 30 years (since the discovery of statins), and actually many recent large trials were disappointingly “negative”.
   
  • Nearly a decade ago, in recognition of the low success of phase III trials, regulatory agencies called for the adoption of new biomarkers or surrogate endpoints to enhance the rate of clinical development. To that end, several cardiovascular imaging technologies have gone through evolutionary cycles of validation over the past decade and several have demonstrated promise as clinical tools and as clinical trial biomarkers.
   
  • With imaging biomarker tools as gatekeepers, only those treatments with proven effi cacy during phase II trials would be promoted to phase III with the expectation of high likelihood of success in the clinical endpoint trials. By enhancing the success rate of phase III
     
    Overview on potential new targets
  présentation Bart Staels (Lille, FRA)
     
    Monoclonal antibody: for lipid lowering or for CV prevention?
  présentation Speaker: Evan Stein (Cincinnatti, USA)
  Discussant: Scott Wasserman (Amgen, USA)
     
    New targets based on antisense technology: ApoB,Lp(a), APO CIII, CRP
  présentation Walter Singleton (ISIS, USA)
     
    What have we learned from recent “failed” trials?
  présentation Wolfgang Koenig (Ulm, GER)
     
    Why are imaging endpoints needed in atherosclerosis clinical trials
  Hector Garcia (Rotterdam, NED)
     
    Established measures of atherosclerosis: IMT as a surrogate of vascular event risk?
  présentation Matthias Lorenz (Francfort, GER)
     
    Tomographic measures of atherosclerosis: CTA and MRI
  présentation Udo Hoffmann (Boston, USA)
     
    New multi-modality measures of atherosclerosis: PET-CT and PET-MRI
  Ahmed Tawakol (Boston, USA)
     
    Industry perspective:
  présentation David Kallend (MedCo, USA); Walter Singleton (ISIS, USA); Scott Wasserman (Amgen, USA)
     
    Regulatory perspective: What kind of data may be needed for a go or no go decision in drug development?
  présentation Kiyoshi Nobori (PMDA, JAP)
  Ferran Torres (EMA, ESP)
     
Moderated Discussion with Audience Participation
Is there a safer trial pathway for a more successful delivery of new atherosclerosis therapies?
     
   
  • Where do we go from here? Do we need new trial designs? The end of one size fi ts all?
   
  • Personalized/individualized approach using adequate markers to identify suitable patients for specifi c treatments: e.g. CRP (CANTOS), Lp-PLA2 activity (STABILITY, SOLID)
   
  • Can Omics technologies help to generate such markers?
   
  • Need for prospective validation of surrogate biomarkers (Some data for IVUS, controversial data on IMT, no data for PET/ MRI)
   
  • What methods can be successfully combined on the way to Phase III trials? (Imaging, biomarkers, mendelian randomization results?).
     
    Panellists: Stefan Agewall (Oslo, NOR); Henry Black (New York, USA); Denise Bonds (NHLBI, USA); Gonzalo Calvo (Barcelona, ESP); Edoardo Camenzind (Geneva, CHE); Gheorghe-Andrei Dan (Bucharest, ROM); Kristina Dunder (EMA, SWE); Hector Garcia (Rotterdam, NED); David Gordon (NHLBI, USA); Udo Hoffmann (Boston, USA); David Kallend (MedCo, USA); Jae Kim (Amgen, USA); Wolfgang Koenig (Ulm, GER); Basil Lewis (Haïfa, ISR); Matthias Lorenz (Frankfurt, GER); Kiyoshi Nobori (PMDA, JAP); Yves Rosenberg (NHLBI, USA); André Scheen (Liège, BEL); Harald Schmidt (Maastricht, NED); Kaori Shinagawa (PMDA, JAP); Tabassome Simon (Paris, FRA); Walter Singleton (ISIS, USA); Moncef Slaoui (GSK, GBR); Bart Staels (Lille, FRA); Evan Stein (Cincinnati, USA); Ahmed Tawakol (Boston, USA); Christian Torp-Pedersen (Copenhagen, DEN); Ferran Torres (EMA, ESP); Gilbert Wagener (Genzyme, GER); Scott Wasserman (Amgen, USA); Hans Wedel (Gothenburg, SWE)
     
  15.30 17.30 SOUTINE / UTRILLO CONFERENCE ROOM

International Society of Cardiovascular Pharmacology (ISCP-CVCT) joint session
CORONARY ARTERIAL DISEASE TRIALS:
CHANGE IN PRACTICE AND CHANGE IN PATHOPHYSIOLOGICAL UNDERSTANDING

     
    Moderators: Gheorghe-Andrei Dan (Bucharest, ROM); Felipe Martinez (Cordoba, ARG)
     
   
  • The results of COURAGE and of other trials suggest that stent therapy will improve symptoms and reduce the likelihood of needing a subsequent interventional procedure, but we still do not know whether this therapy improves survival and the risk of MI. The NIH funded ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) is still to deliver an answer to this question.
   
  • The evidence base to support the recommendation for the use of beta-blockers after MI dates back to the mid-1980s. In the past 25 years, the introduction of coronary reperfusion and of effective non-reperfusion therapies has changed the natural history of MI and there have been substantial changes in the defi nition of MI. Recent analyses have questioned the widespread use of beta-blockers as fi rst-line therapy in patients with stable coronary heart disease and no LV dysfunction.
   
  • New anti-anginal, heart rate slowing non beta-blocker drugs.
     
    Clinical utility of coronary investigations in stable CAD patients
  Gilles Montalescot (Paris, FRA)
     
    Is there still a need to treat angina? Trial population vs. real-life population: lessons from CLARIFY
  présentation Nicolas Danchin (Paris, FRA)
     
    Antianginal vs. anti-ischemic vs. disease modifi er drugs: evidence-based drug therapy in stable CAD patients
  présentation Marco Metra (Brescia, ITA)
     
    Evidence for beta-blocker in post MI patients without LVD, still valid?
  Giuseppe Rosano (EMA, ITA)
     
Moderated Discussion with Audience Participation
Where does drug therapy fi t in the management of coronary artery disease in the age of PCI?
     
    Panellists: Angeles Alonso (EMA, ESP); Farzin Beygui (Caen, FRA); Edoardo Camenzind (Geneva, CHE); Gheorghe-Andrei Dan (Bucharest, ROM); Nicolas Danchin (Paris, FRA); Dayi Hu (Beijing, CHN); Guy Lerebours (Servier, FRA); Felipe Martinez (Cordoba, ARG); Marco Metra (Brescia, ITA); Gilles Montalescot (Paris, FRA); Giuseppe Rosano (EMA, ITA); Juan Tamargo (Madrid, ESP); Stephan Windecker (Bern, CHE)
     
  17.45 19.30 SOUTINE / UTRILLO CONFERENCE ROOM

REFINING CARDIAC RESYNCHRONIZATION AND IMPLANTABLE DEFIBRILLATOR THERAPY

     
    Moderators: Gaetano DeFerrari (Pavia, ITA); Cecilia Linde (Stockholm, SWE)
     
   
  • Inappropriate shock with CRT-D and ICD devices may be a barrier to therapy. Better programming or new algorithms can solve this. MADIT-RIT and ADVANCE III studies have enrolled different kind of patients, which is important to realize and discuss to give it the right interpretation.
   
  • The BLOCK HF study was recently published in the NEJM (CRT-P in AV block with EF below 50%) and the results were incorporated in the new ESC guidelines for Cardiac Pacing and Cardiac Resynchronization Therapy. How important are these data to move from CRT as a therapy for heart failure to CRT to prevent heart failure is a matter for debate.
   
  • The EchoCRT trial was recently halted due to futility. (Although patients and investigators have been informed of the early stopping, no public announcement by the company or the sponsor has been made to date.) The trial had been designed to evaluate the effect of CRT on morbidity and mortality in heart failure patients with a narrow QRS (< 130 ms) and with echo evidence of dyssynchrony. Results of the trial are expected to be presented at a medical meeting in the near future. However, it appears unlikely that they will support an expanded FDA indication for CRT or that another large trial will be performed in this population
   
  • Other trials include the recently initiated MIRACLE EF trial, which is looking at CRT as a primary treatment in heart failure patients with LBBB and mild LV dysfunction, and the ongoing PROMPT trial, which is evaluating LV or biventricular pacing as a treatment to prevent adverse myocardial remodeling early after myocardial infarction.
     
    Evidence based progress in ICD therapy: new algorithms, better programming, subcutaneous ICDs
  présentation Maurizio Gasparini (Rozzano, ITA)
     
    CRT solutions for slowing the progression of LV dysfunction: insight from BLOCK-HF, and expectations from MIRACLE EF and PROMPT trials
  présentation Speaker: Cecilia Linde (Stockholm, SWE)
  présentation Discussant: Claude Daubert (Rennes, FRA)
     
    LBBB, QRS cut offs and echo dyssynchrony any reason to revise the CRT guidelines?
  présentation Speaker: Johannes Holzmeister (Zurich, CHE)
  présentation Discussant: Gaetano DeFerrari (Pavia, ITA)
     
    Industry perspective:
  présentation Thierry Pochet (Boston Scientific, BEL)
  présentation Alphons Vincent (Medtronic, CHE)
     
Moderated Discussion with Audience Participation
Putting evidence into clinical practice
     
    Panellists: Claude Daubert (Rennes, FRA); Gaetano DeFerrari (Pavia, ITA); Maurizio Gasparini (Rozzano, ITA); Edoardo Gronda (Milan, ITA); Johannes Holzmeister (Zurich, CHE); Torsten Kayser (Boston Scientifi c, BEL); Cecilia Linde (Stockholm, SWE); Tim Meyer (Boston Scientifi c, USA); Thierry Pochet (Boston Scientifi c, BEL); Alphons Vincent (Medtronic, CHE)
     
     
 
       
         
SATURDAY 7 DECEMBER 2013
         
  08.00 12.25 MODIGLIANI CONFERENCE ROOM

ACUTE HEART FAILURE AND HEART FAILURE WITH PRESERVED EJECTION FRACTION:
THE NEXT FRONTIER

         
    Moderators: Mihai Gheorghiade (Chicago, USA); Burkert Pieske (Graz, AUT)
     
    Despite the disappointing results of aliskiren in the acute heart failure trial ASTRONAUT, and the intriguing fi nding of benefi t possibly only in the non-diabetes patients, ATMOSPHERE is still ongoing in CHF patients with low EF.
    So many acute heart failure trials failed. Most recently, RELAX-HF was the very fi rst trial to show that a short term IV administration of a drug could have long-term clinical benefi t, in addition to short-term relief of dyspnea.
     
   
  • The hypothesis that acute drug administration might protect against the long-term consequences of acute heart injury is supported by a wealth of biomarker data.
   
  • However, a second confi rmatory trial might be needed in order to understand the long-term mortality benefi t with no signifi cant effect on the rate of HF readmission.
   
  • Other original fi ndings are the equal effect in HFREF and HFPEF.
   
  • Other opportunities are exploring the effi cacy of super early administration.
   
    The very fi rst HFPEF trials were complex to perform, took very long to enroll patients or had neutral results. More recent trials adopted different strategies attempting to better defi ne patient populations enrolled in the trials.
   
   
  • Is it possible to homogenize the heterogeneous HF-PEF population?
   
  • What approaches are most promising? (e.g. biomarkers, hemodynamics, echo parameters, omics, other?)
   
  • How to better target a primary pathophysiology?
   
  • How soon after heart failure admission should patients be ideally enrolled?
   
  • How to deal with the confounding role of concomitant comorbidity?
   
  • What are the implications for industry?
   
    Insight from epidemiology
  Carolyn Lam (Singapore, SGP)
   
    Mechanisms and clinical relevance of insuffi cient sGC/cGMP signaling and oral sGC stimulators compared with other pathways to treat cGMP defi ciency in HF
  Speaker: Dirk L. Brutsaert (Antwerp, BEL)
  présentation Discussant: Javed Butler (Atlanta, USA)
   
    sGC stimulator SOCRATES programme and future trials
  Mihai Gheorghiade (Chicago, USA)
   
    TOPCAT, lessons learned and implications for clinical practice and for the design and conduct of future trials
  Speaker: Bertram Pitt (Ann Arbor, USA)
  présentation Discussant: Faiez Zannad (Nancy, FRA)
   
    Serelaxin in acute heart failure. Equally effective in HFREF and HFPEF?
  présentation Adriaan Voors (Groningen, NED)
   
    LCZ696D: from PARAMOUNT to PARAGON, the ultimate design?
  Speaker: Scott Solomon (Boston, USA)
  présentation Discussant: Martin Lefkowitz (Novartis, USA)
   
    Drugs and trials on the horizon: Soluble Guanylate Cyclase stimulator, and PDE inhibitors
  présentation Speaker: Alexandre Mebazaa (Paris, FRA)
  présentation Discussant: Burkert Pieske (Graz, AUT)
  présentation Discussant: Lothar Roessig (Bayer, GER)
   
Moderated Discussion with Audience Participation
   
    Panellists: Kirkwood Adams (Chapel Hill, USA); Angeles Alonso (EMA, ESP); Dirk L. Brutsaert (Antwerp, BEL); Javed Butler (Atlanta, USA); Jason A Campagna (Medco, USA); Blai Coll (Abbvie, USA); Alan Fraser (Cardiff, GBR); Mihai Gheorghiade (Chicago, USA); Jae Kim (Amgen, USA); Carolyn Lam (Singapore, SGP); Martin Lefkowitz (Novartis, USA); Aldo Maggioni (Florence, ITA); Alexandre Mebazaa (Paris, FRA); Burkert Pieske (Graz, AUT); Bertram Pitt (Ann Arbor, USA); Stuart Pocock (London, GBR); Arthur Mark Richards (Singapore, SGP); Lothar Roessig (Bayer, GER); Naoki Sato (Tokyo, JAP); Scott Solomon (Boston, USA); Adriaan Voors (Groningen, NED); Karen Wai (Quintiles, SGP); Faiez Zannad (Nancy, FRA)
   
  08.00 12.25 SOUTINE / UTRILLO CONFERENCE ROOM

INTERVENTIONAL CARDIOLOGY TRIALISTS WORKSHOP:
DES AND DAPT TRIAL AND IMPLEMENTATION ISSUES

   
    Moderators: Ileana Piña (New York, USA); Patrick Serruys (Rotterdam, NED)
     
   
  • Among the statutory obligations of the US Food and Drug Administration to regulate the marketing of cardiovascular devices based on valid scientifi c evidence, the use of Objective Performance Criteria and Goals (OPC and OPG) for the evaluation of cardiovascular devices has become established as an alternative to randomized, controlled trials (RCTs). These single-armed comparisons may facilitate rapid entry of novel devices to the market. Unlike RCTs, they do not establish superiority or non-inferiority of the examined therapy, and study populations must be carefully inspected to ensure validity of comparisons to historical controls. The OPC model allows rapid entry of innovative devices to the market. How to secure that innovations reaching the market translate into safe and effective therapies based on clinical and cost effectiveness endpoints is a matter of debate.
   
  • Durable polymer coatings on drug-eluting stents have been associated with chronic infl ammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. Optimal duration of dual-antiplatelet after drugeluting stents has become a matter of debate with some defending prolonged duration and others – based on recent studies and analysis – short-term use.
   
  • Results from the PROTECT trial suggest that information about stent thrombosis rate with a given drug-eluting device has to be assessed with caution and always in perspective of the concomitant dual antiplatelet therapy treatment and duration of follow-up.
   
  • Although prasugrel is an effective and relatively safe agent in the invasive management of ACS, will comparative effectiveness and/or registry data better inform on whether we should refrain from giving it upfront before the cathlab, or from giving it late in patients on clopidogrel? Or is ticagrelor the better choice for all options in ACS?
   
  • There are several limitations of available oral antiplatelet drugs when they are used for urgent or periprocedural treatment of patients with cardiovascular disease who may undergo PCI, including a delayed onset of action. Intravenous glycoprotein IIb/IIIa inhibitors, like abciximab can be effective in reducing the incidence of ischemic events, but their effects last long and cannot be quickly reversed. Whether cangrelor, a potent, intravenous, fast acting, and reversible antiplatelet agent could address this unmet clinical need has been addressed by the recently published CHAMPION PHOENIX trial. Where this new therapy may fi t within the current antiplatelet armamentarium is a new matter of debate.
   
    Justifying an objective performance criteria (OPC) model for drug-eluting stents approval: general principles
   
    Clinical perspectives:
  EU: Patrick Serruys (Rotterdam, NED)
  présentation USA: Ileana Piña (New York, USA)
   
    Bioabsorbable Polymer Delivery and Bioabsorbable Scaffolds: from OPC to clinical benefit
  présentation Speaker: Robert Byrne (Munich, GER); Adnan Kastrati (Munich, GER)
     
    Current long-term DAPT studies: does it really matter?
  présentation Gregg Stone (New York, USA)
     
    Targeting DAPT to time dependent risk
  présentation Edoardo Camenzind (Geneva, CHE)
     
    More potent DAPT for more complex PCI: label expansion from ACS to stable disease?
  présentation Stephan Windecker (Bern, CHE)
     
    What does Cilostazol have to offer?
  présentation Young-Hoon Jeong (Jinju, KOR)
     
    Regulatory perspectives:
  présentation Andrea Laslop (EMA, AUT)
  présentation Krishna Prasad (MHRA, GBR)
     
    Industry perspectives:
  Gunnar Olsson (previously Astrazeneca, SWE) cancelled
  présentation David Rutledge (Abbott Vascular, USA)
     
Moderated Discussion with Audience Participation
How to improve OPCs for DES? Dual Antiplatelet therapy after DES
     
    Panellists: Robert Byrne (Munich, GER); Edoardo Camenzind (Geneva, CHE); Mark Chan (Singapore, SGP); Young-Hoon Jeong (Jinju, KOR); Adnan Kastrati (Munich, GER); Torsten Kayser (Boston Scientifi c, BEL); Wolfgang Koenig (Ulm, GER); Tim Laske (Medtronic, USA); Andrea Laslop (EMA, AUT); Gunnar Olsson (previously Astrazeneca, SWE); Ileana Piña (New York, USA); Krishna Prasad (MHRA, GBR); David Rutledge (Abbott Vascular, USA); Patrick Serruys (Rotterdam, NED); Kaori Shinagawa (PMDA, JAP); Gregg Stone (New York, USA); Frank van Leeuwen (Medtronic, CHE); Stephan Windecker (Bern, CHE)
     
  12.35
15.00
MODIGLIANI CONFERENCE ROOM

MINERALOCORTICOID RECEPTOR ANTAGONISTS:
THE KIDNEY, THE HEART AND BEYOND

     
    Moderators: John Funder (Melbourne, AUS); Bertram Pitt (Ann Arbor, USA)
     
   
  • Despite their proven benefi ts in large-scale, prospective, double-blind, randomized trials and recommendations for their use included in international guidelines, adoption of optimal therapy including Mineralocorticoid receptor antagonists (MRAs) is slow and mainly hindered by concerns over the risk of hyperkalemia, especially in the elderly and in patients with concomitant CKD and diabetes
   
  • Hyperkalemia may result from the use of multiple renin-angiotensin-aldosterone inhibitors or blockers, particularly in patients with heart failure and concomitant chronic kidney disease. Interventions to reliably control serum potassium during renin-angiotensin-aldosterone inhibition have not been available to date, and would be of particular value with the use of mineralocorticoid receptor antagonists that have been shown to reduce mortality in patients with heart failure and a reduced left ventricular ejection fraction.
   
  • Whether potassium-binding polymers may lower the incidence of hyperkalemia and allow a higher proportion of heart failure patients to receive life saving multiple renin-angiotensin-aldosterone inhibitors is an attractive solution being currently tested in several clinical trials.
   
  • Prevention of heart failure is high on the agenda. Although there is no low hanging fruits, metabolic syndrome, diabetes, CKD, resistant hypertension and a whole host of potential indications offer important opportunities for novel agents action on the aldosterone pathways.
     
    Beyond spironolactone and eplerenone, there is a need for more selective, better-tolerated MRAs. The next generation of MRAs has entered the clinical trial development phase (ARTS trials with FINERENONE, Mitsubishi agent). How to position them vis-a-vis the available MRAs in heart failure needs creativity in designing novel trials with more focused patient populations.
     
    Sudden cardiac death and other risks related to hypo- and hyperkalemia as triggers. What is the evidence?
  Keld Kjeldsen (Copenhagen, DEN)
     
    Interpreting renal function changes and hyperkalemia under multiple RAAS blockade in heart failure: trial and registry data
  présentation Speaker: Patrick Rossignol (Nancy, FRA)
  Discussant: Scott Solomon (Boston, USA)
     
    How to predict, prevent, and manage hyperkalemia with RAAS inhibitor and MRA therapy: need for and approvability of potassium binding polymers
  Bertram Pitt (Ann Arbor, USA)
     
    Can mineralocorticoid receptor antagonist be kidney friendly? Insight from ARTS trials, and opportunities for expanding MRA therapy
  présentation Speaker: Faiez Zannad (Nancy, FRA)
  présentation Discussant: Frank Eitner (Bayer, GER)
     
    What is in the pipeline? Next generation MRAs and aldosterone synthase inhibitors
  présentation Speaker: John Funder (Melbourne, AUS)
  Discussant: Michel Azizi (Paris, FRA)
  Discussant: Peter Kolkhof (Bayer, GER)
     
Moderated Discussion with Audience Participation
The future of MRA therapy
     
    Panellists: Kirkwood Adams (Chapel Hill, USA); Angeles Alonso (EMA, ESP); Michel Azizi (Paris, FRA); Lance Berman (Relypsa, USA); Javed Butler (Atlanta, USA); Frank Eitner (Bayer, GER); John Funder (Melbourne, AUS); Qifang Huang (Shanghai, CHN); Keld Kjeldsen (Copenhagen, DEN); Peter Kolkhof (Bayer, GER); Stuart Kupfer (Takeda, USA); Felippe Martinez (Cordoba, ARG); Christopher O’Connor (Durham, USA); Bertram Pitt (Ann Arbor, USA); Arthur Mark Richards (Singapore, SGP); Giuseppe Rosano (EMA, ITA); Gianpaolo Rossi (Padua, ITA); Patrick Rossignol (Nancy, FRA); Danni Shi (Novartis, CHN); Scott Solomon (Boston, USA); Faiez Zannad (Nancy, FRA)
     
  12.35 15.00 SOUTINE / UTRILLO CONFERENCE ROOM

NEURAL MODULATION TRIALS:
TIME TO MOVE FROM PROOF OF CONCEPT TO OUTCOME TRIALS?

     
    Moderators: Paul Hauptman (Saint Louis, USA); John Bisognano (Rochester, USA)
     
    Trials: SYMPLICITY-HTN, SYMPLICITYHF; NNEOS, DENER-HTN, NECTAR-HF, INSPiRED, DERENEDIAB; PRAGUE-15, DREAMS; ACHIEVE; RENSYMPIS; EnligHTN II; REACH; SAVE; H-FIB; RSDforAF; RESCUE-VT; ANTHEM-HF; INOVATEHF; STARTSTIM; Defeat-HF, HOPE4HF.
     
    Resistant hypertension: is lowering BP also a valuable surrogate in device trials?
     
    Renal denervation
  présentation Georges Bakris (Chicago, USA)
     
    Barostimulation
  présentation Speaker: John Bisognano (Rochester, USA))
  présentation Discussant: Rolf Wachter (Göttingen, GER)
     
    Heart failure: what is being learnt from POC trials?
     
    Renal denervation
  Atul Pathak (Toulouse, FRA)
     
    Vagal modulation
  présentation Speaker: Paul Hauptman (Saint Louis, USA)
  présentation Discussant: Gaetano DeFerrari (Pavia, ITA)
     
    Barostimulation
  présentation Speaker: Rolf Wachter (Göttingen, GER)
  présentation Discussant: John Bisognano (Rochester, USA)
     
    Angina, arrhythmias, CKD, metabolic syndrome and other potential indications: would neural modulation become a cure-all therapy?
  présentation Speaker: Edoardo Gronda (Milan, ITA)
  présentation Discussant: Stephan Windecker (Bern, CHE)
     
    Industry perspective:
  présentation Scott Meyer (Boston Scientifi c, USA)
  présentation Dan Schaber (Medtronic, USA)
     
Moderated Discussion with Audience Participation
What level of evidence? Effectiveness and Cost-effectiveness issues
     
    Panellists: William Abraham (Columbus, USA); Georges Bakris (Chicago, USA); John Bisognano (Rochester, USA); Gaetano DeFerrari (Pavia, IT); Neal Eigler (St. Jude Medical, USA); Edoardo Gronda (Milan, ITA); Paul Hauptman (Saint Louis, USA); Torsten Kayser (Boston Scientifi c, BEL); Scott Meyer (Boston Scientifi c, USA); Atul Pathak (Toulouse, FRA); Ileana Piña (New York, USA); Dan Schaber (Medtronic, USA); Frank van Leeuwen (Medtronic, CHE); Rolf Wachter (Göttingen, GER); Stephan Windecker (Bern, CHE)
     
  15.20
18.20
MODIGLIANI CONFERENCE ROOM

LESSONS FROM FIRST POST FDA GUIDANCE CASE STUDIES OF DIABETES CV OUTCOMES TRIALS

     
    Moderators: Michel Marre (Paris, FRA); William White (Farmington, USA)
     
   
  • Improved glycemic control has been shown to reduce the risk of many of the microvascular complications of diabetes. However, recent studies have not yet determined a similar impact for glycemic control in reducing macrovascular events in moderate CV risk patients. Rather, there has been concern regarding the association of anti-diabetic agents with negative CV outcomes.
   
  • Consequently, the FDA released a guidance that outlines a new approach to CV safety requirements, designed to gather suffi cient data during a development program to show that new anti-diabetic therapies are not associated with an unacceptable increase in CV risk. A large number of trials have since been initiated, adhering to the new guidance.
   
  • As mandated by the FDA, trials should attempt to rule out a pre-approval level of risk (inferiority margin 1.8) following approximately 1 year of treatment in a portion of the study population but then continuing the study for up to 3 to 4 additional years to continue to collect CV safety data (inferiority margin 1.3). However in a number of trials, while the intent is to fi rst rule out harm of the study drug, there is also the possibility that some new agents may reduce CV harm and, in many trials, testing for superiority of the agent over that of placebo is part of the analysis plan if non-inferiority is proven.
   
  • Fundamental to this study design was the capacity to prevent the release of interim data defi ning the effects of the compound on cardiovascular outcomes in the review process of the data by the regulators when the 1.8 non inferiority margin is achieved, until the 1.3 margin is achieved next, or until study completion if the trial is planned for superiority. The steering committees must struggle with creative ways to prevent signifi cant breach in the integrity of the trial.
   
  • The EXAMINE and SAVOR-TIMI 53 trials represent the fi rst studies completed in adherence with the post-FDA new guidance, reporting the results of DPP-4 inhibitors (Alogliptin, Saxagliptin) in diabetic patients with CV risk. The trials are quite different, while EXAMINE aimed at non inferiority, SAVOR also aimed at superiority, and fi nally both met the non inferiority objective with MACE as the primary endpoint. Debate is to be expected regarding secondary outcomes.
   
  • In the CANVAS trial, yet with another class of drug, the SGLT2 inhibitor Canaglifl ozin, a strategy that would ensure concealment of the hazard ratio for the primary outcome was not implemented, and the sponsor elected to un-blind the data to obtain better insight into the effects of the compound while preparing materials for submission to the regulators. Accordingly, recruitment to the second phase of the study was stopped and a separate large outcome trial is being considered.
   
  • Following another strategy, Sanofi recently announced its decision to withdraw the lixisenatide NDA in the US, which included early interim results from the ongoing ELIXA cardiovascular outcomes study. The company plans to resubmit the NDA after completion of the trial. The decision to withdraw the lixisenatide application follows discussions with the FDA regarding its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data could potentially compromise the integrity of the ongoing study.
   
  • Finally, Novo Nordisk recently announced that it received a Complete Response Letter from the FDA regarding the New Drug Applications for insulin degludec and insulin degludec/insulin aspart requesting post-approval cardiovascular outcomes trial commitment.
   
  • From the kidney protection side, patients with diabetic nephropathy represent a high unmet medical need. Glycemic control in type 2 diabetes is not automatically translated into improved kidney outcomes.. Endothelin receptor antagonists are a promising class of drugs, although the risk of fl uid retention and congestive heart failure has driven some programs to be prematurely stopped. The program with atrasentan (two completed phase 2b studies and an ongoing phase 3 registration trial is specifi cally addressing this risk.
     
    The goal of this session is to use the recently available data as fi rst real case-studies discussing the appropriateness and challenges of FDA Guidance trials to establish the CV safety of diabetes agents, and discuss the likely important consequences on ongoing trials in the area, as well as the area of CV safety of weight loss drug.
     
    Where are the unmet needs? The challenge of CV prevention: blood glucose, blood pressure and blood lipids
  présentation Dayi Hu (Beijing, CHN)
     
    Results of and lessons from the first CV safety trials of oral diabetes drugs, in the new FDA regulation environment
  présentation The EXAMINE trial William White (Farmington, USA)
  The SAVOR TIMI 53 trial Ofri Mosenzon (Jerusalem, ISR)
    Other ongoing diabetes CV safety trials: the various scenarii of interim or no interim results for approval
  présentation Harald Sourij (Oxford, GBR)
     
    Clinical perspective:
  présentation The cardiologist view: Faiez Zannad (Nancy, FRA)
  présentation The diabetologist view: Michel Marre (Paris, FRA)
     
    Operational challenges in conducting FDA guidance diabetes CV safety trial
     
    Industry perspective:
  présentation Christoph Koenen (BMS, FRA)
  présentation Stuart Kupfer (Takeda, USA)
  Christina Stahre (Astrazeneca, SWE) cancelled
    Regulatory perspective:
  présentation Angeles Alonso (EMA, ESP)
  présentation Kristina Dunder (EMA, SWE)
     
    Atrasentan for the treatment of diabetic nephropathy: how to control the risk of heart failure?
  présentation Speaker: Peter McCullough (Novi, USA)
  présentation Discussant: Blai Coll (Abbvie, USA)
     
    Why and how to think about Rule Out trials
  présentation Ray Lipicky (North Potomac, USA)
     
Moderated Discussion with Audience Participation
Updating the guidelines and changing practice
     
    Panellists: Angeles Alonso (EMA, ESP); George Bakris (Chicago, USA); Henry Black (New York, USA); Jeffrey Borer (New York, USA); Gonzalo Calvo (Barcelona, ESP); Blai Coll (Abbvie, USA); Wesley Day (Vivus, USA); Kristina Dunder (EMA, SWE); Mads David Engelmann (Novonordisk, DEN); David Gordon (NHLBI, USA); Samy Hadjadj (Poitiers, FRA); Peter Held (Astrazeneca, SWE); Dayi Hu (Beijing, CHN); Christoph Koenen (BMS, FRA); Wolfgang Koenig (Ulm, GER); Stuart Kupfer (Takeda, USA); Ray Lipicky (North Potomac, USA); Michel Marre (Paris, FRA); Peter McCullough (Novi, USA); Ofri Mosenzon (Jerusalem, ISR); Alfonso Perez (Takeda, USA); Beth Anne Piper (Pfi zer, USA); André Scheen (Liège, BEL); Harald Schmidt (Maastricht, NED); Harald Sourij (Oxford, GBR); Christina Stahre (Astrazeneca, SWE); Juan Tamargo (Madrid, ESP); Bart Van der Schueren (EMA, BEL); William White (Farmington, USA); Faiez Zannad (Nancy, FRA)
     
  15.20 17.30 SOUTINE / UTRILLO CONFERENCE ROOM

CARDIOVASCULAR MEDICAL DEVICE INNOVATION: BARRIERS AND SOLUTIONS

     
    Moderators: Ileana Piña (New York, USA); Patrick Serruys (Rotterdam, NED)
     
   
  • A new regulation to govern the evaluation and approval of medical devices in Europe is as an important step towards improving patient safety. The European Society of Cardiology (ESC) have outlined fi ve suggestions that they feel would make the legislation stronger: a requirement to establish the clinical effi cacy of certain new high-risk devices, greater transparency, a formalized European system for obtaining expert scientifi c and medical advice, specialisation of Notifi ed Bodies evaluating high-risk medical devices, the establishment of independent post-market surveillance.
   
  • The FDA Safety and Innovation Act (FDASIA) includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions. MDUFA includes performance goals. These will change the way the FDA approves clinical trials, provide a new de novo pathway for risk-based classifi cation of devices, expand FDA’s postmarket surveillance capabilities, and change the process for reclassifi cation of devices.
   
  • The FDA has recently published for consultation a guidance document developed to facilitate the initiation of clinical investigations to evaluate medical devices.
     
    The FDA’s Safety and Innovation Act: impact of FDASIA on clinical trials
  présentation Randall Brockman (FDA, USA)
     
    The European Innovation Strategies
  Alan Fraser (Cardiff, GBR)
     
    Challenges from the prospective of a clinician
  Patrick Serruys (Rotterdam, NED)
     
    Challenges from the perspective of a statistician/trialist
  présentation Stuart Pocock (London, GBR)
     
    A view from industry on global harmonization
  présentation David Rutledge (Abbott Vascular, USA)
     
    The importance of post hoc analyses in device approval
  présentation Patrick Verta (Sunshine Heart, USA)
     
Moderated Discussion with Audience Participation
Gobal cross talk - a view to the future
     
    Panellists: William Abraham (Columbus, USA); Randall Brockman (FDA, USA); Edoardo Camenzind (Geneva, CHE); Gaetano DeFerrari (Pavia, ITA); Neal Eigler (St. Jude Medical, USA); Alan Fraser (Cardiff, GBR); Torsten Kayser (Boston Scientifi c, BEL); Tim Laske (Medtronic, USA); Kiyoshi Nobori (PMDA, JAP); Ileana Piña (New York, USA); Stuart Pocock (London, GBR); Luis Rios-Nogales (Gambro, USA); David Rutledge (Abbott Vascular, USA); Patrick Serruys (Rotterdam, NED); Frank van Leeuwen (Medtronic, CHE); Patrick Verta (Sunshine Heart, USA); Alphons Vincent (Medtronic, CHE); Stephan Windecker (Bern, CHE)