THURSDAY, NOVEMBER 30TH
TOCQUEVILLE
8:00 - 310:00 am
DNew NIH & NHLBI Policies and Funding Opportunities for Clinical Trialists
NIH is the largest public funder of clinical trials in the United States with NHLBI being the primary Institute responsible for heart, lung, blood, and sleep-related research funding. Over the last couple of years, NIH has embarked in a comprehensive reform process with the overall goal of improving the quality and efficiency of the clinical trials it supports. NHLBI has been at the forefront of this effort, by developing new specific Funding Opportunity Announcement (FOA) for the different types of clinical trials it supports, from early phases to large multisite trials. The workshop will review the different types of FOAs available to clinical investigators and their specific requirements, with special focus on specific opportunities for new or early stage investigators.
 
AUDITORIUM
9:30 am – 3:00 pm
ONGOING AND FUTURE ATHEROSCLEROSIS TRIALS
International Society of Cardiovascular Pharmacotherapy (ISCP) – CVCT Joint Session
présentation Chairpersons: Wolfgang Koenig (Munich, GER); Jean-Claude Tardif (Montreal, CAN)

Residual risk still represents an important issue in patients with manifest cardiovascular disease despite standard of care treatment. Thus, over five years post-ACS still 20% of patients have experienced a recurrent event.

Several additional strategies have been reported this year or are presently being tested in large clinical trials like aggressive lowering of LDL cholesterol by PCSK9 inhibition or an RNA silencing mechanism, lowering of Lp(a) and finally triglycerides (TG) have seen a revival and their lowering is presently being tested in several trials applying different interventions like high-dose omega-3 and 6 or a SPARM (selective PPARα modulator). But novel strategies are at the horizon.

The recently published FOURIER Study has shown a 20% decrease of a combined endpoint consisting of cardiovascular death, MI and stroke in stable patients with manifest atherosclerosis and an index event that had occurred three years before randomization. These results fit very nicely in the cholesterol trialists estimation. However, despite having reached on treatment LDL-C levels of 30 mg/dl there was a significant number of patients with recurrent events, which is in line with 36% of patients showing progression in the previously published GLAGOV IVUS Trial also with evolocumab. Thus, there is room for other pathomechanisms and anti-inflammatory treatment on top of standard of care might represent a further option. During ESC this year results of the CANTOS trial in which 10,000 post MI patients were treated with an interleukin-1β antagonist have been presented, showing a positive outcome with a similar effect size on major cardiovascular endpoints as seen during potent LDL-C lowering with a PCSK9 inhibitor. Thus, this implicates proof of the “inflammation hypothesis” and a paradigm change in the treatment of patients with manifest atherosclerosis. This may enable a personalized approach to treatment identifying those with “residual cholesterol risk” versus those with “residual inflammatory risk”.

PCSK9 Trials
 
  • PCSK9: From discovery to clinical evidence
    Marianne Abi-Fadel (Beirut, LBN)
présentation
  • FOURIER: enough evidence to justify widespread use? Did it fulfill its expectations?
    Marc Sabatine (Boston, USA)
Trials of agents targeting inflammation
présentation
  • CANTOS: Anti-inflammatory treatment in the context of extreme low LDL levels. Is there still room for improvement?
    Paul Ridker (Boston, USA)
présentation
  • Lessons from COLCOT and other ongoing and future anti-inflammatory trials
    Jean-Claude Tardif (Montreal, CAN)
 
Further insights regarding into triglycerides as a target for intervention
 
présentation
  • Ongoing clinical trials: STRENGTH and PROMINENT
    Aruna Pradhan (Boston, USA)
présentation
  • Targeting triglycerides: Is angiopoietin-like 4 (ANGPLT 4) a new target? Insights from genomic studies
    Heribert Schunkert (Munich, GER)
  • Would angiopoietin-like 3 (ANGPLT 3) be the better target?
    Sotirios Tsimikas (Ionis Pharmaceutical, USA)
 
Gaining precision with cardiovascular clinical trials using genomics
Marie-Pierre Dubé (Montreal, CAN)
 
Percutaneous coronary intervention in stable angina (ORBITA Trial)
présentation Darrel Francis (London, GBR)
 
Industry Viewpoint
présentation Don Black (Dalcore, CAN); Jay Edelberg (Sanofi, USA); Tom Thuren (Novartis, CHE)
présentation Narimon Honarpour (Amgen, USA)
présentation David Kallend (The Medicine Company, USA)
 
Regulatory Viewpoint
présentation Pieter de Graeff (EMA, NED); James Smith (FDA, USA)
 
Payers Viewpoint: How much PCSK9 inhibition can the health care system afford?
Jakub P. Hlávka (Rand Corporation, USA)
 
Patient Viewpoint
présentation Annemieke Lenselink (The Hague, NED); Marilyn Mann (Washington, USA)
 
The Forum. Moderated discussion with the audience
Regulatory and reimbursement Challenges

Chairpersons: Wolfgang Koenig (Munich, GER); Jean-Claude Tardif (Montreal, CAN)
 
Panelists: Marianne Abi-Fadel (Beirut, LEB); Don Black (Dalcore, CAN); Eugene Braunwald (Boston, USA); Pieter de Graeff (EMA, NED); Marie-Pierre Dubé (Montreal, CAN); Jay Edelberg (Sanofi, USA); Darrel Francis (London, GBR); Jakub P. Hlávka (Rand Corporation, USA); Narimon Honarpour (Amgen, USA); Larry Husten (CardioBrief, USA); David Kallend (The Medicine Company, USA); Wolfgang Koenig (Munich, GER); Annemieke Lenselink (The Hague, NED); Marilyn Mann (Washington, USA); Aruna Pradhan (Boston, USA); Paul Ridker (Boston, USA); Marc Sabatine (Boston, USA); Heribert Schunkert (Munich, GER); James Smith (FDA, USA); Jean-Claude Tardif (Montreal, CAN); Tom Thuren (Novartis, CHE); Sotirios Tsimikas (Ionis Pharmaceutical, USA)
 
AUDITORIUM

12:30 – 1:00 pm

Key note Lecture
“Can We Abolish Coronary Artery Disease?”

présentation  Eugene Braunwald (Boston, USA)
 
BALLROOM

9:30 am – 12:30 pm

EXPANDING THE INDICATIONS OF NOACs. DISSECTION OF THE COMPASS TRIAL IN
PATIENTS WITH CORONARY AND/OR PERIPHERAL ARTERY DISEASE
 
Further insights regarding into triglycerides as a target for intervention
  • Peripheral artery disease (PAD) is considered to be a clinical manifestation of systemic atherosclerosis. Most patients presenting with peripheral artery disease are at high risk for myocardial infarction, ischemic stroke, and cardiovascular death. Concomitant clinical evidence of coronary disease magnifies this risk.
  • Antiplatelet therapy and statins, are the cornerstone of care for the prevention of atherosclerotic events. However, the level of evidence in favor of aspirin in PAD is modest and is mainly based on a meta-analysis involving approximately 5000 patients. In two large clinical trials, in patients with asymptomatic atherosclerosis (which was defined as an abnormal ABI value) aspirin was not superior to placebo in preventing cardiovascular events.
  • In the CAPRIE trial, in a broadly defined stable population of patients with atherosclerotic disease, including coronary artery disease, peripheral artery disease, and cerebrovascular disease, clopidogrel was superior to aspirin. Benefit was driven mainly by the subgroup of patients with PAD. These results from CAPRIE established clopidogrel as the first therapy for peripheral artery disease to be approved by the Food and Drug Administration.
  • The CHARISMA trial, enrolling similar high-risk population of patients with atherosclerosis found no significant benefit for clopidogrel over aspirin in the risk of cardiovascular events in the overall population. However, there was a non-significant trend in the subgroup of patients with PAD. Dual antiplatelet therapy was associated with an increased risk of bleeding. On the basis of this evidence, clopidogrel monotherapy has been the preferred therapy to manage the atherothrombotic risk in patients with peripheral artery disease.
  • In patients with symptomatic PAD enrolled in the EUCLID trial, ticagrelor was not superior to clopidogrel for the reduction of cardiovascular events, and each drug was associated with similar rates of major bleeding.
  • The COMPASS trial randomized 27,402 patients with coronary artery disease or peripheral artery disease (PAD) to receive the oral anticoagulant rivaroxaban at 2.5 mg twice daily plus aspirin at 100 mg/ day, or rivaroxaban 5 mg twice daily without aspirin, or aspirin 100 mg/day without rivaroxaban. The trial was stopped prematurely more than a year ahead of its planned March 2018 completion because, in an interim analysis, the primary end point of MI, stroke, or cardiovascular death «has reached its pre-specified criteria for superiority.»
 
COMPASS, Design, highlights of major results
présentation Deepak Bhatt (Boston, USA)
 
Target patient population. To what patient do the COMPASS results apply?
Faiez Zannad (Nancy, FRA)
 
Stopping prematurely
 
  • Logistical considerations: Informing investigators, managing data backlog, IRB considerations, transitioning patients to open label
    Jackie Bosch (Hamilton, CAN)
présentation
  • Methodological and interpretation considerations. How should it impact the interpretation, generalization of the results?
    Stuart Pocock (London, GBR)
 
Mechanistic plausibility and potential for a class effect?
présentation Deepak Bhatt (Boston, USA)
 
Patients with coronary artery disease and heart failure. Perspectives for COMMANDER-HF trial
Faiez Zannad (Nancy, FRA)
 
Industry Viewpoint
présentation Nancy Cook Bruns (Bayer, GER)
présentation Peter DiBattiste (Janssen, USA)
Martin Unverdorben (Daiichi Sankyo, USA)
 
Regulatory Viewpoint
présentation Joseph Emmerich (EMA, FRA); Ellis Unger (FDA, USA)
présentation Kaori Shinagawa (PMDA, JPN)
 
The Forum. Moderated discussion with the audience
Revisiting the Aspirin dogma in secondary prevention?

Chairpersons: Deepak Bhatt (Boston, USA); Tabassome Simon (Paris, FRA)
 
Panelists: Deepak Bhatt (Boston, USA); Jackie Bosch (Hamilton, CAN); Nancy Cook Bruns (Bayer, GER); Peter DiBattiste (Janssen, USA); Joseph Emmerich (EMA, FRA); Stuart Pocock (London, GBR); Kaori Shinagawa (PMDA, JPN); Tabassome Simon (Paris, FRA); Ellis Unger (FDA, USA); Martin Unverdorben (Daiichi Sankyo, USA); Faiez Zannad (Nancy, FRA)
 
BALLROOM

2:00 – 7:30 pm

RENAL ENDPOINTS IN CKD, HEART FAILURE AND DIABETES TRIALS.
ASN/Kidney Heath Initiative (KHI) & INI CRCT - CVCT Joint Session
 
Chairpersons: Prabir Roy-Chaudhury (Tucson, USA); Patrick Rossignol (Nancy, FRA)
  • Cardiovascular death is either the leading or one of the main causes of death in patients with chronic kidney disease (CKD).
  • CKD is one of the main features associated with poor outcomes in cardiovascular disease patients, especially those with heart failure and/or diabetes.
  • The most suitable choice of components of the composite endpoint for a cardiovascular outcome trial conducted specifically in the CKD population is obviously key for success and depends on the specific therapy being tested.
  • Renal endpoints are pathophysiologically relevant in a CKD population even if the primary intervention target is cardiovascular disease, and a composite endpoint reflecting both cardiovascular and renal outcomes may be desirable, especially if the intervention is expected to affect both systems.
  • However, a challenging problem is which endpoints to combine and how to interpret the results of the composite endpoint.
  • Moreover the meaning of a worsening renal function may be different depending on the considered setting (acutely decompensated heart failure vs. chronic, renin angiotensin aldosterone system inhibition (RAASi) use and uptitration, biphasic temporal effect of SGLT2 inhibition on kidney function).
  • One may also wonder if changes in estimated glomerular filtration rate and/or microalbuminuria should be considered as relevant biotargets and surrogates of outcomes whilst assessing the cardiovascular benefit of a new compound and if any, which outcome (cardiovascular or renal) should be prioritized for testing if the compound exhibits cardiorenal effects.
  • Finally, should we pay attention to a worsening in renal function under RAASi as long as potassium concentrations are maintained in the normal range with a potassium binder?
 
Understanding and overcoming the challenges to involving patients with kidney disease in cardiovascular trials: KHI Project Overview
présentation Julie Ishida (San Francisco, USA)
 
présentation
  • Involving patients with kidney disease in cardiovascular and diabetes trials: Lessons Learned and Future Directions
    Charles Herzog (Minneapolis, USA)
présentation
  • The Issue with competing risk and composite endpoints
    Janet Wittes (Washington, USA)
  • Changes in GFR: How to assess? Reversible vs. irreversible, short – term vs. long-term, and when are these good news, neutral news, or bad news?
    Michael Felker (Durham, USA)
présentation Claudio Ronco (Vicenza, ITA)
présentation
  • Are surrogate endpoints inevitable?
    George Bakris (Chicago, USA)
 
Definitions of ‘Worsening Renal Function’ in cardiorenal trials. How to balance sensitivity and specificity?
présentation Patrick Rossignol (Nancy, FRA)
 
Should renal function ever be a primary efficacy endpoint or only a safety endpoint in heart failure?
 
présentation
  • Cardiologist Viewpoint
    Faiez Zannad (Nancy, FRA)
présentation
  • Nephrologist Viewpoint
    Prabir Roy-Chaudhury (Tucson, USA)
 
Renal endpoints in the setting of CV prevention trials
 
présentation
  • Hypertension
    George Bakris (Chicago, USA)
  • Diabetes Kidney Disease
présentation
  • FIGARO – FIDELIO
    Bertram Pitt (Ann Arbor, USA)
présentation
  • CREDENCE
    Vlado Perkovic (Sydney, AUS)
présentation
  • Regulatory Viewpoint
    Angeles Alonso Garcia (EMA, GBR); Aliza Thompson (FDA, USA)
présentation
  • Industry and CRO Perspective
    Barbara Gillespie (Covance, USA); Jula Inrig (IQVIA, USA); Richard Nkulikiyinka (Bayer, GER); Alain Romero (Relypsa, USA)
  • Patients’ Perspective
    Cynthia Chauhan (Wichita, USA)
 
THE FORUM
Moderated discussion with the audience

Chairpersons: Prabir Roy-Chaudhury (Tucson, USA); Patrick Rossignol (Nancy, FRA)
 
Panelists: Angeles Alonso Garcia (EMA, GBR); George Bakris (Chicago, USA); Erica Caveney (IQVIA, USA); Cynthia Chauhan (Wichita, USA); Michael Felker (Durham, USA); Barbara Gillespie (Covance, USA); Charles Herzog (Minneapolis, USA); Jula Inrig (IQVIA, USA); Julie Ishida (San Francisco, USA); Richard Nkulikiyinka (Bayer, GER); Vlado Perkovic (Sydney, AUS); Bertram Pitt (Ann Arbor, USA); Alain Romero (Relypsa, USA); Claudio Ronco (Vicenza, ITA); Patrick Rossignol (Nancy, FRA); Prabir Roy-Chaudhury (Tucson, USA); Aliza Thompson (FDA, USA); Janet Wittes (Washington, USA); Faiez Zannad (Nancy, FRA)
 
AUDITORIUM
3:30 – 7:30 pm
TRANSCATHETER HEART VALVE THERAPIES TRIALS
 
Chairpersons: Robert Bonow (Chicago, USA); Ileana Pina (New York, USA)
  • Could THV device approval follow a pathway analogous to that of surgical heart valves by incorporating OPC? Would this be more appropriate only for approval of new-generation THVs in high and extremerisk patient populations?
  • Should approval of THV devices for low- and intermediate-risk patients or for new indications be based on data from randomized, clinical trials?
  • How contemporary registries may be useful as a platform for regulatory reform of cardiovascular devices, for generating data to serve as a comparator arm for future trials and to establish objective performance criteria? To perform comprehensive, reliable, and timely post-marketing safety surveillance
  • Surgical heart valves can be appr oved on the basis of objective performance criteria (OPC). In contrast, stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. FDA has recently approved new-generation THVs based on single-arm studies.
 
Trial design and endpoint definitions for transcatheter valve trials
présentation Pieter Kappetein (Rotterdam, NED)
 
When and how to apply to transcatheter valve trials?
présentation Jeffrey Borer (New York, USA)
 
Industry Perspective
présentation Martyn Thomas (Edwards, USA)
 
Statistical considerations beyond objective performance criteria in transcatheter valve trials?
présentation Mike Boulware (Medtronic, USA)
 
Insights from Transcatheter Valve Replacement (TAVR) Registries
présentation Ileana Pina (New York, USA)
 
Registries as a platform for regulatory approval. Are we there yet? What actions are needed to get there?
présentation Roxana Mehran (New York, USA)
 
Mitral valve replacement trials and repair
présentation Jeffrey Popma (Boston, USA)
 
Upstream TAVI in the less sick: when to replace the valve?
Thierry Folliguet (Nancy, FRA)
 
TAVI and Sutureless aortic valve in intermediate risks patients: pros and cons. The PERSIST Trial
présentation Thierry Folliguet (Nancy, FRA)
 
NHLBI Perspective
présentation Marissa Miller (NHLBI, USA)
 
Industry Perspective
Patrick Verta (Edwards, USA)
 
Regulatory Perspective
présentation Alan Fraser (Cardiff, GBR)
présentation Bernard Vasseur (FDA, USA)
 
Payers Viewpoint: How far upstream will TAVI be reimbursable? Based on which evidence?
présentation Tamara Syrek Jensen (CMS, USA); Harindra Wijeysundera (Canadian Agency for Drugs and Technologies in Health, CAN)
 
Thrombosis trials in TAVR patients
 
  • Thrombus apposition and valve mobility/durability in TAVR. The rationale for OAC.
    Rajendra Makkar (Los Angeles, USA)
présentation
  • Industry Perspective
    Martin Unverdorben (Daiichi Sankyo, USA)
présentation
  • Regulatory Perspective: Which study designs may be accepted to obtain approval of an antithrombotic regimen?
    Karen Hicks (FDA, USA)
 
Patient Viewpoint
Stefan Teunis (Oldenzaal, NED)
 
The Forum: Moderated discussion with the audience
How to tackle the ever-evolving technologies? How to optimize anti-bleeding strategies?

Chairpersons: Robert Bonow (Chicago, USA); Ileana Pina (New York, USA)
 
Panelists: Robert Bonow (Chicago, USA); Jeffrey Borer (New York, USA); Mike Boulware (Medtronic, USA); Thierry Folliguet (Nancy, FRA); Alan Fraser (Cardiff, GBR); Karen Hicks (FDA, USA); Pieter Kappetein (Rotterdam, NED); Rajendra Makkar (Los Angeles, USA); Roxana Mehran (New York, USA); Marissa Miller (NHLBI, USA); Ileana Pina (New York, USA); Jeffrey Popma (Boston, USA); Dan Schaber (Medtronic); Tamara Syrek Jensen (CMS, USA); Stefan Teunis (Oldenzaal, NED); Martyn Thomas (Edwards, USA); Martin Unverdorben (Daiichi Sankyo, USA); Bernard Vasseur (FDA, USA); Patrick Verta (Edwards, USA); Harindra Wijeysundera (Canadian Agency for Drugs and Technologies in Health, CAN)
 
 
THURSDAY, NOVEMBER 30TH
 
BALLROOM
8:00 am – 1:00 pm
eTRIALS: OPPORTUNITIES AND CHALLENGES
 
Further insights regarding into triglycerides as a target for intervention
  • This session aims at discussing the current state of the use of digital technology and mobile health in clinical trials in cardiovascular medicine, what data is available for utilizing digital technology as a supportive tool or an intervention in clinical trials, and how can digital technology be used to streamline clinical trial conduct (reduce visits, enrollment/recruitment, subject retention, safety data collection, “site-less” remote clinical trials).
  • Potential outcomes (ex. PRO, HR/BP, and activity trackers) can be used with digital health. Can these be used for new drug registration trials and/or post-marketing trials?.
  • Experts in large IT data platforms will present case studies and discuss what can be gained in CV clinical trial conduct and what are the barriers/challenges to utilizing digital technology in global CV clinical trials?
 
Key note Lecture
“Integrating Data Science with Evidence Generation”

présentation  Robert Califf (Durham, USA) (Former commissioner, FDA, People Centered Research Foundation, Verily, Durham, USA)
 
Opportunities and challenges with medical informatics use for clinical trials?
présentation Adrian Hernandez (Durham, USA)
 
IBM Watson Health
Irene Dankwa-Mullan (IBM, USA)
 
Health eHeart Study and Health eHeart Alliance
présentation Carol Maguire (San Francisco, USA)
 
Approach to Virtual Trials (eConsent to ePROs)
Anthony Costello (Medidata, USA)
 
The National Patient Centered Clinical Research Network (PCORnet)
présentation Adrian Hernandez (Durham, USA)
 
Sweden heart registry for randomized registry trials
présentation Stefan James (Uppsala, SWE)
 
Issues in the acquisition, analysis, and sharing of data in the field of cardiovascular science
présentation Elliot Antman (Boston, USA)
 
How to move from hospital visit and patient reported outcomes to real-life objective measurements
Pierre-Yves Frouin (Bioserenity, FRA)
 
Utility of geofencing to capture missing hospitalizations in clinical trials
Abhinav Sharma (Stanford, USA and Nancy, FRA)
 
Methodology/Statistical Viewpoint
Nancy Geller (NHLBI, USA)
 
Investigator Viewpoint
présentation Mintu Turakhia (Stanford, USA)
 
Industry Viewpoint
présentation Nancy Dreyer (IQVIA, USA)
Helina Kassahun (Amgen, USA)
présentation Kenneth Stein (Boston Scientific, USA)
 
Patient’s Perspective for Clinical E-Trials
présentation Debbe McCall (Murrieta, USA)
 
Regulatory Viewpoint
Bakul Patel (FDA, USA); Gail Pearson (NHLBI, USA); Krishna Prasad (EMA, GBR); Bram Zuckerman (FDA, USA)
 
Media Viewpoint
Ron Winslow (Freelance Journalist, USA)
 
The Forum. Moderated discussion with the audience
Chairpersons: Robert Califf (Durham, USA); Bram Zuckerman (FDA, USA)
 
Panelists: Elliot Antman (Boston, USA); Robert Califf (Durham, USA); Anthony Costello (Medidata, USA); Debbe McCall (Murrieta, USA); Irene Dankwa-Mullan (IBM, USA); Nancy Dreyer (IQVIA, USA); Pierre- Yves Frouin (Bioserenity, FRA); Nancy Geller (NHLBI, USA); Adrian Hernandez (Durham, USA); Stefan James (Uppsala, SWE); Helina Kassahun (Amgen, USA); Carol Maguire (San Francisco, USA); Bakul Patel (FDA, USA); Gail Pearson (NHLBI, USA); Krishna Prasad (EMA, GBR) Dan Schaber (Medtronic, USA); Kenneth Stein (Boston Scientific, USA); Mintu Turakhia (Stanford, USA); Ron Winslow (Freelance Journalist, USA); Bram Zuckerman (FDA, USA)
 
AUDITORIUM

8:00 am – 3:00 pm

EVOLVING APPROACH TO THE CONDUCT OF CARDIOVASCULAR AND RENAL OUTCOME
TRIALS IN DIABETES. HOW DO RECENT TRIALS INFORM FUTURE DRUG DEVELOPMENT?


 
Chairpersons: Bruce Neal (Sydney, AUS); Felipe Martinez (Cordoba, ARG)
  • Regulatory agencies state that reduction of glycated haemoglobin (HbA1C) is an appropriate primary endpoint in diabetes drug development, as it reflects glucose control, and is known to be correlated with a reduced risk of micro vascular complications.
  • Until recently, data have not supported a beneficial effect of improving glycemia in diabetes on CV outcomes. Beneficial effects on macro-vascular complications can only be evaluated properly in large scale and long-term controlled clinical trials, which are not considered mandatory for marketing authorisation approval.
  • In case it is considered necessary to perform a more in-depth assessment of the cardiovascular safety profile of a new drug intended for the treatment of diabetes, EMA recommends two approaches: a meta-analytic approach of outcome data generated in the phase II/III studies, or a dedicated cardiovascular outcome study.
  • The FDA guidance recommends a dedicated preapproval CV trial powered to establish safety by establishing an upper bound of the two-sided 95% confidence interval below 1.8 with the requirement for a subsequent trial to establish non-inferiority to rule out an upper bound confidence interval exceeding 1.3 for a new drug intended for the treatment of diabetes.
  • Would a more tailored approach, requiring a CVOT depending on the mechanism of action of a specific drug and based on nonclinical and early phase clinical data be more appropriate?
  • The EMA’s and FDA’s preferred safety endpoint, is a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Heart failure events occur with a similar frequency as myocardial infarction and with a greater frequency than stroke in patients with type 2 diabetes mellitus at high cardiovascular risk. Regulatory agencies should recommend including heart failure events as endpoints in diabetes clinical trials, whether evaluating efficacy or safety. Should only heart failure requiring hospitalization be the CHF endpoint? Should the focus on primary endpoint (3pt MACE vs CHF) be a function of the mechanism of action of the drug under development?
  • Trials set in compliance with this guidance have occasionally been powered for efficacy, or efficacy has been tested as part of the statistical hierarchy after CV safety has been established. If efficacy (superiority over standard of care) has been established in a trial (as for empagliflozin, liraglutide, and semaglutide), does this have the same strength of evidence as a trial designed for superiority? Should criteria for establishing CV efficacy based on a single trial be explicitly described and, if so, what is an appropriate p value for superiority?
  • Some molecules seem to impact atherosclerosis related endpoints, others improve MACE events with mechanisms other than atherosclerosis, and/or heart failure related endpoints.
  • Trials using agents from the same pharmacological classes produced discrepant results (LEADER and SUSTAIN6 vs. ELIXA and EXSCEL; SAVOR vs. other DPPIV trials; EMPA-REG vs. CANVAS raising issues about class effect vs structural/pharmacokinetic differences between molecules of the same class.
  • There are emerging data suggesting an association between severe hypoglycaemia and death, which should be taken into account in differentiating among new drugs intended for the treatment of diabetes.
 
Endpoint related issues
 
présentation
  • Non-inferiority cardiovascular safety endpoints in diabetes trials. Are efficacy endpoint trials preferable
    Steven Nissen (Cleveland, USA)
présentation
  • Cardiologist Viewpoint
    Naveed Sattar (Glasgow, USA)
présentation
  • Diabetologist Viewpoint
    Steven Marso (Kansas City, USA)
  • Should MACE be the primary endpoint in CV diabetes efficacy/safety outcome trials irrespective of the drug’s mechanism of action? “Atherosclerosis” endpoints and/or heart failure endpoints
    Faiez Zannad (Nancy, FRA)
  • Severe hypoglycemia and all-cause mortality in CVOTs: What have we learned?
    Michael Farkouh (Toronto, CAN)
 
Patient population related issues
 
présentation
  • Challenges of primary prevention (CV risk) and limitations of secondary prevention (history of CV events) target populations?
    Bruce Neal (Sydney, AUS)
  • Addressing patients with CKD
    Vlado Perkovic (Sydney, AUS)
présentation
  • Going beyond diabetes. Non-diabetes trials of new drugs initially intended for the treatment of diabetes
    Milton Packer (Dallas, USA)
 
Methodological issues
 
présentation
  • The issue with non-inferiority design and interim analyses. Protecting subsequent trial conduct during/following an interim analysis
    Darren McGuire (Dallas, USA)
présentation
  • Methodological refinements may help streamline future diabetes trials.
    Cyrus Mehta (Boston, USA)
 
Industry Viewpoint
présentation Elisabeth Björk (AstraZeneca, SWE)
présentation Jyothis George (Boehringer Ingelheim, GER)
Stephen Gough (NovoNordisk, DEN)
présentation Kirk Ways (Janssen, USA)
 
Regulatory Viewpoint
Robert Temple (FDA, USA)
 
NIH Viewpoint
présentation Yves Rosenberg (NHLBI, USA)
 
Payers’ Viewpoint: How to value a diabetes drug with CV mortality benefit?
Lorenzo Mantovani (CESP, ITA)
 
Patient Viewpoint
Patrick Gee (Chesterfield, USA)
 
The Forum. Moderated discussion with the audience
Refining the current regulatory guidance.

Chairpersons: Bruce Neal (Sydney, AUS); Felipe Martinez (Cordoba, ARG)
 
Panelists: Elisabeth Björk (AstraZeneca, SWE); Erica Caveney (IQVIA, USA); Michael Farkouh (Toronto, CAN); Patrick Gee (Chesterfield, USA); Jyothis George (Boehringer Ingelheim, GER); Stephen Gough (NovoNordisk, DEN); Larry Husten (CardioBrief, USA); Darren McGuire (Dallas, USA); Lorenzo Mantovani (CESP, ITA); Felipe Martinez (Cordoba, ARG); Cyrus Mehta (Boston, USA); Bruce Neal (Sydney, AUS); Steven Marso (Kansas City, USA); Steven Nissen (Cleveland, USA); Milton Packer (Dallas, USA); Vlado Perkovic (Sydney, AUS); Stuart Pocock (London, GBR); Susan Quella (Rochester, USA); Yves Rosenberg (NHLBI, USA); Naveed Sattar (Glasgow, GBR); Robert Temple (FDA, USA); Kirk Ways (Janssen, USA); Faiez Zannad (Nancy, FRA)
 
AUDITORIUM


3:30 – 7:30 pm

THE FUTURE OF CARDIOVASCULAR BIOMARKERS: FROM RISK STRATIFICATION
TO PRECISION MEDICINE
A Critical Mechanisms of Disease (CMOD) – CVCT Joint Session


 
Chairpersons: Nick Mills (Edinburgh, GBR); Jean-Claude Tardif (Montreal, CAN)
  • High sensitivity troponins are useful for diagnosis and prognosis in patients with suspected acute coronary syndrome. Though a large volume of evidence to support their utility in such settings has been generated, there is a lack of consensus on the optimal way in which to apply these assays in clinical practice. Novel, rapid algorithms may hold the key to improved patient care using these biomarkers, but much remains to be discussed.
  • Recent publications have focused the attention of many clinicians on the potential role for biomarkers of cardiac injury in refining the approach to cardiovascular (CV) risk stratification in the general population. Whether this will ultimately change practice remains to be seen.
  • Biomarkers may serve to discriminate various substrates for coronary syndromes and heart failure that could direct individuals to different management strategies. As such, they may stratify patients mechanistically and therapeutically and might help achieve the goal of a more precision management and personalized approach.
  • Whether these concepts have gained power and how much are these pertinent to precision and personalized medicine, and how to incorporate in future CV trials is a matter of intense debate.
  • Lessons learnt from the mixed success of biomarker – guided clinical trials need to be shared with the aim of refining methodology and moving the area forward
 


Key note Lecture
“Circulating and Imaging Biomarkers of Atherosclerosis and Prospects of Precision
Management and Personalized Approach of Cardiovascular Disease”

présentation  Peter Libby (Boston, USA)
 
Is CV risk modified by therapies and can that be monitored using CV biomarkers?
présentation Nick Mills (Edinburgh, GBR)
 
The role of biomarkers in detecting risk of cardiac toxicity in cancer trials.
présentation Jean-Claude Tardif (Montreal, CAN)
 
Can high sensitive troponins improve cardiovascular risk stratification in the general population?
 
  • In EU: Johannes Neumann (Hamburg, GER)
  • In US: Christie Ballantyne (Houston, USA)
 
Risk stratification of suspected ACS patients: Optimal algorithm?
Agim Beshiri (Abbott, USA)
 
Health Economics and Outcomes impact of risk stratification with novel CV biomarkers
présentation Amy Durtschi (Abbott, USA)
 
Imaging to guide HF therapy
Faiez Zannad (Nancy, FRA)
 
Biomarker guided therapy trials failed so far. Methodological lessons
Kirkwood Adams (Chapel Hill, USA)
 
Advancing Precision Medicine:
Current and future proteogenomic strategies for biomarker discovery and development
présentation Ida Grundberg (Olink, USA)
 
Industry Viewpoint
Gillian Murtagh (Abbott, USA)
André Ziegler (Roche, CHE)
 
Media Viewpoint
Ron Winslow (Freelance Journalist, USA)
 
The Forum. Moderated discussion with the audience
Are we ready for precision CV medicine?

Chairpersons: Nick Mills (Edinburgh, GBR), Jean Claude Tardif (Montreal, CAN)
 
Panelists: Kirkwood Adams (Chapel Hill, USA); Christie Ballantyne (Houston, USA); Agim Beshiri (Abbott, USA); Ida Grundberg (Olink, USA); Peter Libby (Boston, USA); Amy Durtschi (Abbott, USA); Nick Mills (Edinburgh, GBR); Gillian Murtagh (Abbott, USA); Johannes Neumann (Hamburg, GER); Jean-Claude Provost (GE Healthcare, GBR); Jean-Claude Tardif (Montreal, CAN); Ron Winslow (Freelance Journalist, USA); Faiez Zannad (Nancy, FRA); André Ziegler (Roche, CHE)
 
BALLROOM

2:00 – 7:30 pm

ATRIAL FIBRILLATION TRIALS
HRS – CVCT Joint Session
 
Chairpersons: George Van Hare (Saint Louis, USA); Healther Ross (Tempe, USA)
 
  • Ablation trials
 
  • Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology.
  • It was recently reported that cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (FIRE AND ICE).
  • It is not known whether successful ablation of AF, regardless of technique, will result in reduced mortality. This is under investigation in the Catheter Ablation versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) and Catheter Ablation versus Standard Conventional Treatment in Patients With LV Dysfunction and AF (CASTLE-AF)
  • However, specifically in persistent atrial fibrillation in patients with heart failure catheter ablation, whether ablation is superior to amiodarone was examined in a randomized study which showed that catheter ablation of atrial fibrillation is superior to amiodarone in achieving freedom from AF at long-term follow-up and
 
  • NOAC trials
  • Trials reporting anticoagulant benefits in AF were done in people with either symptomatic AF or paroxysmal AF long enough to be recorded on multiple ECGs.
  • Diagnosis of short term AF is of uncertain significance. It seems that only longer-lasting AF associates with stroke.
  • How valuable short-duration AF as a surrogate marker is questionable and needs further substantiation.
  • Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes.
  • The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with AF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications.
 
  • Left atrial appendage closure trials
    After the initial trials and within the context of controversial evidence of efficacy of the FDA approved Watchman percutaneous left atrial appendage closure (LAAC), further data are derived from registries. CMS covers FDA approved LAAC for non-valvular atrial fibrillation through Coverage with Evidence Development (CED) in patients enrolled in certain well designed registries and in FDA approved trials. Patients unsuitable for oral anticoagulation are further evaluated within the ASAP-TOO trial.
  • Research on the causes and mechanisms of AF points to the role of fibrosis. Trials of anti-fibrotic agents?
 
Trials of anti-thrombotic therapy in AF Ablation (AXAFA - AFNET 5 trial)
Paulus Kirchhof (Birmingham, GBR)
 
NOACs in patients with atrial fibrillation who undergo percutaneous coronary intervention.
présentation Harry Crijns (Maastricht, NED)
 
Targeted anticoagulation for short-term device detected AF. Is it ripe for a prospective NOAC trial?
présentation Renato Lopes (Durham, USA)
 
The value of trial derived novel biomarker-based bleeding risk score for patients with AF.
présentation Ziad Hijazi (Uppsala, SWE)
 
Left Atrial Appendage Closure. Registry non-randomized evidence and how it aligns with randomized trial evidence
présentation Lucas Boersma (Nieuwegein, NED)
 
Targeting the right patient population. Are trials addressing personalized AFib prevention/ treatment strategies?
présentation Nassir Marrouche (Salt Lake City, USA)
 
Vascular closure device to shorten time to ambulation after AF ablation. The AMBULATE Trial
Mintu Turakhia (Stanford, USA)
 
Industry Perspective
présentation Peter Dibattiste (Janssen, USA)
Kenneth Stein (Boston Scientific, USA)
Martin Unverdorben (Daiichi Sankyo, USA)
Regulatory Perspective
présentation Andrew Farb (FDA, USA); Pieter de Graeff (EMA, NED)
 
Benefit/risk and cost effectiveness considerations of anti-thrombotic strategies in AF
 
  • Payers Perspective
    Joseph Chin (CMS, USA)
  • Patient Viewpoint
    Natascha Van der Post (Nijmegen, NED)
 
TThe Forum. Moderated discussion with the audience
How to progress from evidence generation to change in practice.

Chairpersons: George Van Hare (Saint Louis, USA); Heather Ross (Tempe, USA)
 
Panelists: Lucas Boersma (Nieuwegein, NED); Joseph Chin (CMS, USA); Harry Crijns (Maastricht, NED); Pieter de Graeff (EMA, NED); Peter Dibattiste (Janssen, USA); Andrew Farb (FDA, USA); Ziad Hijazi (Uppsala, SWE); Paulus Kirchhof (Birmingham, GBR); Renato Lopes (Durham, USA); Nassir Marrouche (Salt Lake City, USA); Heather Ross (Tempe, USA); Kenneth Stein (Boston Scientific, USA); Mintu Turakhia (Stanford, USA); Martin Unverdorben (Daiichi Sankyo, USA); Natascha Van der Post (Nijmegen, NED); George Van Hare (Saint Louis, USA)
 
 
SATURDAY, DECEMBER 2ND
 
AUDITORIUM

8:00 – 1:00 pm

POSITIVE SIGNALS FROM RECENT NEUTRAL HEART FAILURE TRIALS:
TIME FOR AN AUTOPSY
HFSA – CVCT Joint Session


 
Chairpersons: Christopher O’Connor (Washington, USA); Mona Fiuzat (Durham, USA)
  • So-called “neutral” or “negative” trials contribute to the body of evidence with a drug, device, or procedure. Such trials often provide relevant knowledge to the field and often inform planning of subsequent randomized trials.
  • When a trial fails to show statistically significant evidence of benefit of an experimental intervention, the cardiovascular community should ask whether the intervention worked, but the trial was flawed in some way, or the trial was valid but the intervention was ineffective.
  • The appropriate next steps after completion of an inconclusive trial are influenced by 1) whether a strong mechanistic or biologic rationale supports use of the treatment and 2) the overall assessment of potential reasons why the trial did not meet its primary objective.
  • It is crucial, but often difficult, to determine if a clinical outcomes trial did not show a treatment effect because of errors in trial design or execution or if the treatment was truly ineffective.
  • “Autopsy is performed by anatomists with the principal aim of an autopsy is to determine the cause of death, the state of health of the person before he or she died, and whether any medical diagnosis and treatment before death was appropriate.”
  • The objective of this session is to have trial specialists examine failed trials with the aim of determining causes of failure, the robustness of the trials before they failed, and whether any appropriate early examination or corrective action could have prevented negative/neutral results.
  • The aim is ultimately to draw lessons that may inform the design and the conduct of future trials. Future trials may be designed addressing lessons learned from informative but inconclusive trials, applying different patient populations, alternate treatment regimens, or different outcomes. Alternatively, trials should be viewed in the broader context of how the results can inform the field.
 
Introduction
présentation Christopher O’Connor (Washington, USA)
 
One main reason I believe my trial didn’t meet its primary endpoint:
  • RELAX-AHF-2: JJohn Teerlink (San Francisco, USA)
présentation
  • TRUE AHF: Milton Packer (Dallas, USA)
présentation
  • TOPCAT: Bertram Pitt (Ann Arbor, USA)
  • GUIDE IT: Michael Felker (Durham, USA)
présentation
  • BLAST: Peter Pang (Chicago, USA)
présentation
  • Vericiguat in HFpef: Javed Butler (New York, USA)
  • HF ACTION: Dave Whellan (Durham, USA)
  • BEST: Mike Bristow (Aurora, USA))
  • SERVE-HF: Faiez Zannad (Nancy, FRA)
 
Advanced analytics in clinical trials:
présentation Tariq Ahmad (New Haven, USA)
 
Statistical Viewpoint
Nancy Geller (NHLBI, USA)
présentation Cyrus Mehta (Boston, USA)
 
Investigator Viewpoint
présentation Karl Swedberg (Goteborg, SWE)
 
Industry Viewpoint
présentation Jim Carr (Stealth Biotherapeutics, USA)
Lothar Roessig (Bayer, GER)
James Strait (Merck, USA)
présentation Claudio Gimpelewicz (Novartis, CHE)
 
NHLBI Viewpoint
George Sopko (NHLBI, USA)
 
CRO Viewpoint
présentation Monica Shah (IQVIA, USA); Allen Kindman (IQVIA, USA)
 
Patient Viewpoint
Natascha Van der Post (Nijmegen, NED)
 
Investigator Viewpoint
Karl Swedberg (Goteborg, SWE)
 
The Forum. Moderated discussion with the audience
What lessons have we learned? How is success secured in ongoing trials?

Chairpersons: Christopher O’Connor (Washington, USA); Mona Fiuzat (Durham, USA)
 
Panelists: Mike Bristow (Aurora, USA); Javed Butler (New York, USA); Jim Carr (Stealth Biotherapeutics, USA); Michael Felker (Durham, USA); Mona Fiuzat (Durham, USA); Nancy Geller (NHLBI, USA); Claudio Gimpelewicz (Novartis, CHE); Allen Kindman (IQVIA, USA); Cyrus Mehta (Boston, USA); Christopher O’Connor (Washington, USA); Milton Packer (Dallas, USA); Peter Pang (Chicago, USA); Bertram Pitt (Ann Arbor, USA); Lothar Roessig (Bayer, GER); Monica Shah (IQVIA, USA); James Strait (Merck, USA); George Sopko (NHLBI, USA); Karl Swedberg (Goteborg, SWE); John Teerlink (San Francisco, USA); Natascha Van der Post (Nijmegen, NED); Dave Whellan (Durham, USA); Faiez Zannad (Nancy, FRA)
 
BALLROOM

8:00 am – 1:00 pm

EVALUATION OF NEW TECHNOLOGIES IN CARDIOVASCULAR CARE.
BRIDGING EVIDENCE-BASED WITH VALUE-BASED HEALTH CARE
MedTech Europe & Advamed – CVCT Joint Session
 
Chairpersons: Jeffrey Borer (New York, USA); Nadim Yared (CVRx, USA)
  • Regulators and payers sometimes differ in their perspectives on medical advances and the weight they place on components of the evidence base. These contrasting priorities can lead to divergence between regulatory and payer decisions and delays or barriers in patients’ access to new therapies.
  • Those involved in coverage decisions have not routinely been integrated in the drug development process pre-approval, specifically with respect to clinical trial design. Inclusion of payer representatives sooner in the development process would provide opportunities to detect discordance among stakeholders in terms of data priorities, facilitate cooperation to align objectives, agree on the evidence required for approval and reimbursement, improve transparency and accountability of payer decision making, and ideally minimize delays in patient access to new therapies.
  • Research on the benefits and performance of devices differs between ‘therapeutic’ devices (e.g. pacemakers, nerve stimulators, prostheses) and ‘non-therapeutic’ devices (e.g. diagnostic, monitoring, screening or prognostic tests).
  • “Value-based healthcare”, focuses on outcomes that are relevant to patients, including, but not limited to, clinical outcomes
  • Therefore a linked or network of evidence approach may be better suited to device evaluations than a ‘hierarchy of evidence’ approach.
  • Health ministers in EU recently mandated that the OECD develop an instrument to collect information (Paris) to be able to compare the performance of health systems, as well as the performance of clinicians and technology.
  • MedTech companies and organizations in Europe and the USA currently has programs in place to drive “value-based healthcare”.
  • Device evaluations are enhanced when device developers, manufacturers, trialists, regulators, payers, health professionals and patients collaborate to agree on the “Burden of proof” and describe at an early stage the potential mechanisms/pathways through which achieve “value-based healthcare”, ultimately improving timely patient access to new treatments that reduce the burden of disease or prolong life.
 
Panel on Evaluation Systems for New Technology:
Overview & comparison of evaluation systems. Discussion on whether certain evaluation systems are better suited for certain types of devices/ disease states/ healthcare system. Identification of one evaluation system that is preferred over others.
 
  • Evidence based evaluations of Medical Technology and Biomarkers: what does it actually mean and what do we want?
 
présentation
  • The EU Perspective
    Carl Moons (Utrecht, NED)
présentation
  • Medicare Evaluation: What is the process & what evidence is required for coverage today?
    Joseph Chin (CMS, USA)
présentation
  • Willingness-to-pay: Europe’s Most Economically Advantageous Tender pilot (MEAT)
    Yves Verboven (MedTech Europe, BEL)
 
Panel on Streamlining Clinical Trial Data Collection with Evaluation System Requirements:
Overview & comparison of relevant types of clinical data, with a focus on how each serves (or does not serve) one of the respective evaluation systems. Discussion on why and how evaluation systems must evolve to take such critical data into account.
 
présentation
  • Patient-Reported Outcomes: How should they be valued?
    Michael Nassif (Kansas City, USA)
présentation
  • Real-world data collection: What is the value of this for device therapy?
    Dalal Nirav (Abbott, USA)
 
Industry Viewpoint
présentation Philip Adamson (St Jude, USA); Robin Bostic (Abbott, USA); Julia Stubben (CVRx, CHE); Nadim Yared (CVRx, USA)
 
Regulatory Viewpoint
John Whyte (FDA, USA); Bram Zuckerman (FDA, USA)
 
Payers’ Perspective
Joseph Chin (CMS, USA); Leeza Osipenko (NICE, GBR)
 
The Forum. Moderated discussion with the audience. The Role of Payers in Cardiovascular
Clinical Research: Addressing the Misalignment between Approval and Reimbursement.

Chairpersons: Jeffrey Borer (New York, USA); Nadim Yared (CVRx, USA)
 
Panelists: Philip Adamson (St Jude, USA); Jeffrey Borer (New York, USA); Robin Bostic (Abbott, USA); Joseph Chin (CMS, USA); Carl Moons (Utrecht, NED); Michael Nassif (Kansas City, USA); Dalal Nirav (Abbott, USA); Leeza Osipenko (NICE, GBR); Julia Stubben (CVRx, CHE); Yves Verboven (MedTech Europe, BEL); John Whyte (FDA, USA); Nadim Yared (CVRx, USA); Bram Zuckerman (FDA, USA)
 
AUDITORIUM

2:00 – 6:30 pm

WHY SOME CLINICAL TRIALS DO NOT WORK OR HAVE AN IMPACT.
ARE THERE WAYS TO DO A BETTER JOB?
An International Society of Cardiovascular Pharmacology (ISCP) – CVCT Joint Session


 
présentation Chairpersons: Angeles Alonso Garcia (London, GBR); Milton Packer (Dallas, USA)
  • The structure of a large international clinical trial is complex. It typically involves a sponsor, a leadership committee, numerous geographically-dispersed investigators, and a group responsible for operational functions.
  • A pharmaceutical executive or academic leader must decide whether to propose a very large expensive clinical trial to upper management. The data supporting the drug is marginal. He/ she advocate strongly for investment, emphasizing data that are hopeful but minimizing risks.
  • The leadership committee defines the trial hypotheses and the methods by which the hypotheses can be tested in an unbiased manner. Members focus on the big picture, but do they really know how the trial is being executed?
  • Most sponsors lack internal resources to execute the trial and thus seek help from an outside vendor, a CRO. Their procurement office provides the contract to the lowest bidder.
  • The CRO is itself a business enterprise, which has a responsibility to carry out the trial in a manner financially advantageous to its owners or shareholders. They identify investigators who can recruit quickly and inexpensively.
  • The investigators are paid to recruit patients. Some are very creative in enrolling patients very quickly. When the trial is over, they will receive little academic credit, but will rapidly move on to the next trial.
  • The operations group is charged with ensuring that patients are recruited into the trial on schedule and that the data quality can be made to appear to be reasonable.
  • The data are collected, but the analysis unit understands that certain results will yield predictable benefits. If this is a phase II trial, a trial yielding positive results is likely to be followed by additional substantial investment in more studies.
  • If this is a phase III trial, the results are rarely satisfying; i.e., the trial’s primary hypothesis has proven to be valid, and the supporting data are of very high quality. Much more often than not, both the leadership committee and the sponsor are disappointed by the results. There may be some positive signals, but one can find them only after a very diligent and creative search.
  • The results of the trial are presented, and internet scavengers emerge from their hiding places to feast. If the trial is markedly positive, these vultures seek perceived flaws or hold the trial’s conduct to unrealistic standards. If not, they demand replication (even if it is unethical or not feasible). If the results are disappointing, they rejoice in their claims that they predicted the trial’s failure.
  • The results of the trial are published. How should a new study be interpreted? Many physicians do not even make an attempt to read and understand the primary publication; often they wait for the chatter on the internet or official guidelines to tell them what to do. Physicians have insufficient knowledge, time or motivation to perform a proper evaluation.
 
An overview of the problem seen from the US
présentation Milton Packer (Dallas, USA)
 
How do sponsors make a decision to support a trial?
présentation David Kallend (The Medicine Company, USA)
Kenneth Stein (Boston Scientific, USA)
 
Can academic leaders oversell an idea?
présentation Paul Armstrong (Edmonton, CAN)
présentation Karl Swedberg (Goteborg, SWE)
 
Who should be minding the store?
Janet Wittes (Statistics Collaborative, USA)
 
Why do I sometimes have trouble sleeping at night?
présentation Scott Solomon (Boston, USA)
 
Are academic investigator becoming extinct?
présentation Bertram Pitt (Ann Arbor, USA)
 
Which types of investigative sites do regulators worry about?
présentation Norman Stockbridge (FDA, USA)
 
Are practitioners paying any attention to the results of trials?
Antoni Martínez-Rubio (Barcelona, ESP)
 
What do journal editors think of professional cynics?
présentation Robert M. Golub (JAMA Cardiology, USA); Stuart Spencer (The Lancet, GBR)
présentation John Jarcho (NEJM, USA)
présentation Joseph Hill (Circulation, USA)
 
Are payers happy when a trial shows a benefit of an expensive drug?
Leeza Osipenko (NICE, GBR)
 
Media Viewpoint
Ron Winslow (Freelance Journalist, USA)
 
THE FORUM
Moderated discussion with the audience

Chairpersons: Angeles Alonso Garcia (London, GBR); Milton Packer (Dallas, USA)
 
Panelists: Angeles Alonso Garcia (London, GBR); Paul Armstrong (Edmonton, CAN); Robert M. Golub (JAMA Cardiology, USA); Joseph Hill (Circulation, USA); Larry Husten (CardioBrief, USA); John Jarcho (NEJM, USA); David Kallend (The Medicine Company, USA); Antoni Martínez-Rubio (Barcelona, ESP); Leeza Osipenko (NICE, GBR); Milton Packer (Dallas, USA); Bertram Pitt (Ann Arbor, USA); Scott Solomon (Boston, USA); Stuart Spencer (The Lancet, GBR); Kenneth Stein (Boston Scientific, USA); Norman Stockbridge (FDA, USA); Karl Swedberg (Goteborg, SWE); Ron Winslow (Freelance Journalist, USA); Janet Wittes (Statistics Collaborative, USA)
 
BALLROOM

2:00 – 6:30 pm

TIME IS MUSCLE. ACUTE INTERVENTION TRIALS IN CORONARY ARTERY DISEASE
AND IN HEART FAILURE
 
Chairpersons: Roxana Mehran (New York, USA); Alexandre Mebazaa (Paris, FRA)
 
1. Advances and remaining gaps in the early management of acute coronary syndromes
  • How early is early? Chest pain characteristics and opportunities for very early management from contemporary databases
présentation
  • Speaker: Patrick Badertscher (Basel, CHE)
présentation
  • Discussant: Justin Ezekowitz (Edmonton, CAN)
  • Pre hospital, pre PCI intervention. Review of the evidence: Did ATLANTIC and ACCOAST really fail?
    Roxana Mehran (New York, USA)
présentation
  • How different is a STEMI from a NSTEMI in their infancy?
    Roxana Mehran (New York, USA)
présentation
  • 10-year trends in time to reperfusion of STEMI patients in France
    Tabassome Simon (Paris, FRA)
présentation
  • Home based detection of cardiac ischemia
    Olivier Chételat (Neuchâtel, CHE)
présentation
  • Industry Viewpoint
    Sébastien Roux (Idorsia, CHE)
  • Regulatory Viewpoint
    Ellis Unger (FDA, USA)
 
1. Advances and remaining gaps in the early management of acute coronary syndromes
 
présentation
  • Early pre-admission diagnosis and management of HF congestion related dyspnea.
    Nicolas Girerd (Nancy, FRA)
présentation
  • Early therapy in AHF. Rearview and ways forward. How to progress from proof of concept to outcome trials
    Alexandre Mebazaa (Paris, FRA)
présentation
  • Diuretic – decongesting strategies trials
    Eric J. Velazquez (Durham, USA)
  • Industry Viewpoint
    Shalabh Singhal (BMS, USA)
  • Regulatory Viewpoint
    Robert Temple (FDA, USA)
 
présentation
  • Patient education: Community intervention (campaign) vs targeted education of patients
    Holli DeVon (Chicago, USA)
  • Patient Viewpoint
    Annemieke Lenselink (The Hague, NED); Natascha Van der Post (Nijmegen, NED)
 
THE FORUM
Moderated discussion with the audience

Chairpersons: Roxana Mehran (New York, USA); Alexandre Mebazaa (Paris, FRA)
 
Panelists: Patrick Badertscher (Basel, CHE); Olivier Chételat (Neuchâtel, CHE); Holli DeVon (Chicago, USA); Justin Ezekowitz (Edmonton, CAN); Nicolas Girerd (Nancy, FRA); Annemieke Lenselink (The Hague, NED); Alexandre Mebazaa (Paris, FRA); Roxana Mehran (New York, USA); Sébastien Roux (Idorsia, CHE); Tabassome Simon (Paris, FRA); Shalabh Singhal (BMS, USA); Robert Temple (FDA, USA); Ellis Unger (FDA, USA); Natascha Van der Post (Nijmegen, NED); Eric J. Velazquez (Durham, USA)