This year's ESC congress will take place in the Excel Exhibition Centre in London, United Kingdom. The spotlight this year is environment and the heart, highlighting the many different kinds of interactions between the environment and cardiovascular diseases.
This year's congress will feature five Hot Line sessions focusing on: acute myocardial infarction, atrial fibrillation/pacing, diabetes mellitus/pharmacology, hypertension, heart failure, and coronary artery disease. While last year's hot line sessions featured the much-anticipated results from Entresto's (Novartis's LCZ-696) PARADIGM-HF trial as well as updates from several of Praluent's (Sanofi/Regeneron's alirocumab) Odyssey trials, this year's line-up appears quite tame by comparison (further details on each session can be found below).
One trial of interest to this analyst is finerenone's (Bayer) ARTS-HF Phase IIb trial, which compared finerenone with eplerenone (Pfizer's Inspra, generics) in a high-risk population of patients who have worsening chronic heart failure with type 2 diabetes mellitus and/or chronic kidney disease. Thought leaders interviewed by Decision Resources Group are excited about the prospect of a mineralocorticoid receptor antagonist that is theoretically more specific than spironolactone (thus avoiding side effects like gynecomastia) and more potent than eplerenone. The results of this trial should establish the basis for a Phase III trial expected in late 2015.
Full details of Mydicar's (Celladon) Phase IIb CUPID trial in heart failure patients will also be reported during the congress. Following reports in April 2015 that this trial had missed its primary and secondary end points versus placebo, development of this gene therapy was suspended in late June. While thought leaders interviewed by Decision Resources Group have always remained cautious about the prospects of this gene therapy, many had expressed enthusiasm following the positive Phase IIa results reported in 2010. While the latest results will no doubt dampen enthusiasm for gene therapies in this indication, there remains a significant appetite for gene and stem cell therapies in the treatment of heart failure; however, many thought leaders believe that narrowing the treatment focus to specific subpopulations could be key for future success.
Further details on each of the Hot Line sessions:
Hot Line I - Acute myocardial infarction
- Accurate and rapid diagnosis of myocardial infarction using a high sensitivity Troponin I 1-hour algorithm
- Determining Optimal non-invasive Parameters for the Prediction of Left vEntricular morphologic and functional Remodeling in Chronic Ischemic Patients (DOPPLER-CIP)
- Early aldosterone blockade in acute myocardial infarction: the randomized ALBATROSS Trial
- Peri-infarct zone pacing to prevent adverse left ventricular remodeling in patients with very large myocardial infarction
- Does cyclosporine improve clinical outcomes in STEMI patients. The CIRCUS trial
Hot Line II - Atrial fibrillation/Pacing
- Efficacy of Antiarrhythmic drugs Short-Term use after catheter ablation for Atrial Fibrillation (EAST-AF) Trial
- Efficacy of adenosine triphosphate guided ablation for atrial fibrillation (EAST-AF): UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) Trial
- Effect of empirical left atrial appendage isolation on long-term procedure outcome in patients with long-standing persistent atrial fibrillation undergoing catheter ablation: results from the BELIEF
- Assessment of an education and guidance program for apixaban adherence in non-valvular atrial fibrillation: the randomized AEGEAN study
- Safety and efficacy of a Leadless pacemaker: results from the LEADLESS II clinical trial
Hot Line III - Diabetes mellitus/Pharmacology
- Trial Evaluating Cardiovascular Outcomes with Sitagliptin in patients with type-2 Diabetes: TECOS
- Finerenone versus eplerenone in patients with worsening chronic heart failure with type 2 diabetes mellitus and/or chronic kidney disease: main results of the ARTS-HF trial
- The evaluation of Lixisenatide in acute coronary syndromes (ELIXA).
- The Standard care versus Celecoxib Outcome Trial (SCOT); a randomized, trial comparing the cardiovascular safety of celecoxib versus traditional non-steroidal anti-inflammatory drugs.
- The OPTIDUAL trial: 12 vs 48 months of clopidogrel after drug-eluting stent placement
Hot Line IV - Hypertension
- A trial of Telmisartan prevention of cardiovascular diseases (ATTEMPT-CVD) : the large biomarkers study with 1228 patients.
- The principal results of the Prevention And Treatment of Hypertension With Algorithm based therapY (PATHWAY) - Optimal treatment of drug resistant hypertension - PATHWAY 2
- Principal results from Prevention And Treatment of Hypertension With Algorithm based therapY (PATHWAY): comparison of single and combination diuretics in essential hypertension - PATHWAY-3
- Principal results of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly - PARAMETER study
Hot Line V- Heart failure
- Effect of implanted device-based impedance monitoring with telemedicine alerts on mortality and morbidity in heart failure: results from the OptiLink HF study
- CUPID 2: a phase 2b trial investigating the efficacy and safety of the intracoronary administration of AAV1/SERCA2a in patients with advanced heart failure
- Treatment of sleep-disordered breathing with predominant central sleep apnoea with adaptive servo-ventilation in patients with chronic heart failure: SERVE-HF study results
- The BENznidazole Evaluation For Interrupting Trypanosomiasis trial
Hot Line VI - Coronary artery disease
- Outcomes of an FFRCT diagnostic strategy versus usual care in suspected coronary artery disease: results from the PLATFORM (Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts) study
- Everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents in patients with acute myocardial infarction. Results of the ABSORB STEMI TROFI II trial
- ABSORB Japan: 12-month clinical and 13-month angiographic outcomes from a randomized trial evaluating the Absorb Bioresorbable Vascular Scaffold vs. metallic drug-eluting stent.
- Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX Antithrombin)
- PRESERVATION I: bioabsorbable cardiac matrix for the prevention of remodeling of the ventricle after large ST-segment elevation myocardial infarction