Top 10 Hot Liners at the European Society of Cardiology Annual Congress 2024

The global cardiovascular community will soon descend upon London for what is the world's largest cardiovascular medicine conference. It is a time to meet friends and colleagues old and new, but of course it is the clinical research, learning and education that take centre stage. To that end the Hot Line sessions represent the pinnacle of scientific endeavour the congress has to offer. There will be 12 sessions this year taking place across all four days of the congress, all held in the Main Auditorium. Top line results from 38 major studies will be presented, often to a packed audience where seats are at a premium and standing room only is often the norm.

I have been given the unenviable task of selecting my top 10 clinical trials to look out for this year. These trials have been selected based on the clinical conundrum they have been designed to potentially unravel, novelty factor, personal interests (as an interventional cardiologist with a penchant for structural heart disease), and let's be honest a catchy acronym always goes a long way.

I cast no aspersions on the trials that were not selected. Working for a mid-sized full-service contract research organisation like Medpace, I witness first-hand, on a daily basis, the sheer volume of people, grit and determination it takes to conduct large international multi-centre clinical trials. To that end, I salute and congratulate all those individuals who have participated in all 38 studies being presented in London, most importantly of all the patients who have so kindly volunteered their time, effort and commitment to improve the lives of others with cardiovascular disease.

1. HELIOS-B: Primary results from phase 3 study of vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy

Speaker: Marianna Fontana (University College London - London, United Kingdom of Great Britain & Northern Ireland)
Date/Time: Friday 30th August 2024 | 11:00

There have been significant advancements in the contemporary management of transthyretin amyloidosis cardiomyopathy (ATTR-CM) in the past few years. The HELIOS-B trial will look to add to that burgeoning precision medicine evidence base. Vutrisiran is a subcutaneously administered transthyretin-directed small interfering RNA (siRNA), that has already received FDA approval back in June 2022 for the treatment of the polyneuropathy of hereditary ATTR amyloidosis.

2. Beta blocker interruption in patients with prior myocardial infarction: results of the ABYSS trial and effect on blood pressure and heart rate control

Speaker: Johanne Silvain (Sorbonne University - Paris, France)
Date/Time: Friday 30th August 2024 | 11:22

Following hot on the heels of the REDUCE-AMI trial presented as a late-breaker at the American College of Cardiology scientific sessions earlier this year, the ABYSS trial has been designed to determine whether it is safe to interrupt long-term beta blocker therapy a year after a heart attack in those patients stabilised on medical therapy and that have preserved left ventricular systolic function. REDUCE-AMI was an equivocal trial. Let's hope ABYSS can be more definitive.

3. GMRx2: Efficacy and safety of a novel triple single pill combination

Speaker: Anthony Rodgers (The George Institute for Global Health - Sydney, Australia)
Date/Time: Saturday 31st August 2024 | 08:54

The polypill concept has long been the focus of cardiovascular research. Theoretical advantages include improved adherence to therapy, attacking multiple pathways simultaneously to reduce cardiovascular risk, and simplified treatment protocols that are quicker to initiate. However, traction into clinical practice has been impeded by the lack of personalisation, side effects, drug-drug interactions and regulatory challenges. GMRx2 (Geroge Medicines, London, UK) is a single pill combining telmisartan, amlodipine and indapamide in novel and proprietary dosage strengths. Multiple mechanisms of action to treat hypertension, without the intolerance often seen with higher doses of each individual component, make for an intriguing re-exploration of the polypill concept.

4. MATTERHORN: Transcatheter versus surgical mitral valve repair in patients with heart failure and secondary mitral regurgitation

Speaker: Volker Rudolph (Heart and Diabetes Center NRW - Bad Oeynhausen, Germany)
Date/Time: Saturday 31st August 2024 | 11:22

The gladiatorial arena that was the percutaneous versus surgical management of severe calcific aortic stenosis now shifts across to symptomatic functional mitral valve incompetence. Swords at the ready.

5. NOTION-3: Percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation

Speaker: Jacob Thomsen Loenborg (Copenhagen University Hospital - Copenhagen, Denmark)
Date/Time: Saturday 31st August 2024 | 17:35

Those treated by transcatheter aortic valve implantation (TAVI) for severe degenerative aortic stenosis will often have concomitant coronary artery disease (CAD). How to manage this and the timing of coronary revascularisation remains unresolved.

The ACTIVATION trial (doi/10.1016/j.jcin.2021.06.041) is the only randomised trial to have previously addressed the issue of whether revascularization of coronary arteries before TAVI improves outcomes. However, the trial was underpowered, had a relatively short follow-up period, and the decision to perform PCI was largely left to the discretion of the treating physicians, which introduced variability in the management of CAD.

NOTION-3 aims to be more definitive, by randomising TAVI patients to physiologically guided percutaneous coronary intervention of significant CAD versus medical management. The results will be highly provocative.

6. RHEIA: Transcatheter versus surgical aortic valve replacement in women with severe aortic stenosis

Speaker: Helene Eltchaninoff (University Hospital of Rouen - Rouen, France)
Date/Time: Saturday 31st August 2024 | 18:19

Women have been consistently under-represented in trials of cardiovascular disease management, especially device studies. The situation is getting better, but we are nowhere near where we need to be. In the meantime, trials like RHEIA are absolutely essential to ensure women receive the most evidence-based intervention for their structural heart disease. RHEIA is a prospective, randomized controlled study that will enrol women with severe symptomatic aortic stenosis and randomize them to undergo aortic valve intervention with either TAVI or surgical aortic valve replacement. Follow-up is for 1 year, which may be too short a timeframe to elicit a definitive outcome but we would expect a long-term follow-up report to assess for prosthetic valve durability and accrual of further hard endpoints.

7. EPIC-CAD: Edoxaban monotherapy vs. dual antithrombotic therapy for atrial fibrillation and stable coronary artery disease

Speaker: Gi-Byoung Nam (Asan Medical Center - Seoul, Korea (Republic of))
Date/Time: Sunday 1st September 2024 | 09:16

Atrial fibrillation (AF) and CAD have a propensity to co-exist and how best to protect against the risk of recurrent major adverse cardiovascular events from either or both pathologies remains unknown. EPIC-CAD will randomize patients with high-risk AF (CHA2DS2-VASc score ≥2 points) and stable CAD (≥6 months after revascularization for stable angina or ≥12 months for acute coronary syndrome; or medical therapy alone) to monotherapy with edoxaban or combination therapy with edoxaban plus a single antiplatelet agent. The open-label study design may encourage significant crossovers, and a preponderance to clinician bias with respect to preferred strategy but we shall wait and see.

8. FINEARTS-HF: Finerenone in heart failure with mildly reduced and preserved ejection fraction

Speaker: Scott Solomon (Brigham and Women's Hospital, Harvard Medical School - Boston, United States of America)
Date/Time: Sunday 1st September 2024 | 11:00

Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA) whereas spironolactone and eplerenone are steroidal MRAs. Topline results already announced by Bayer (Leverkusen, Germany) show that finerenone does reduce the composite primary endpoint of cardiovascular death and total heart failure events in patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). The devil, as they say, is in the detail and these will be presented in London.

9. SENIOR RITA: Invasive versus Conservative Strategy for Older Patients with Myocardial Infarction

Speaker: Vijay Kunadian (Newcastle University - Newcastle-Upon-Tyne, United Kingdom of Great Britain & Northern Ireland)
Date/Time: Sunday 1st September 2024 | 16:15

This is the trial the interventional cardiology community has been waiting for. Much like women and ethnic minorities, the elderly are also poorly represented in trials of CAD management. In this British Heart Foundation supported study, patients aged ≥75 years old presenting with non-ST-elevation myocardial infarction (NSTEMI) will be randomised to invasive treatment (plus optimal medical therapy) versus optimal medical therapy alone. The composite primary endpoint is time to cardiovascular death or non-fatal MI. Will this trial definitively answer the erstwhile question many cardiologists face - should elderly patients receive a routine early invasive strategy to treat their NSTEMI or should conservative management be the default option for this patient cohort? We wait with bated breath.

10. RAPIDxAI: Re-engineering the clinical approach to suspected cardiac chest pain assessment in the emergency department by expediting evidence to practice using artificial intelligence

Speaker: Derek Chew (Victorian Heart Hospital - Melbourne, Australia)
Date/Time: Monday 2nd September 2024 | 15:37

You ignore the proliferation of machine learning and artificial intelligence (AI) in healthcare at your peril. AI, however, should not intend to replace the clinician but be there to support healthcare professionals in streamlining workflows, maximising efficiencies, and/or enhancing diagnostic accuracy of established investigational pathways.

The assessment of suspected cardiac chest pain in the emergency room is a case in point, especially with the advent of high-sensitivity Troponin assays. That is why RAPIDxAI could be a game-changer and absolutely one to watch out for.

Your Cardiovascular Breakthrough Starts Here

At Medpace, our team of cardiovascular specialists are highly skilled in the scientific methodology, standard of care, evolving regulatory requirements, and operational considerations to drive successful drug and device development for heart disease treatment. With tailored approaches and strong KOL relationships, we adapt to each trial's unique requirements, ensuring precision and innovation throughout.

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