ESC Rene Laennec Lecture on Clinical Cardiology: Prof. Aldo Maggioni
Why do we need large-scale clinical networks?
28 Aug 2021
The presenter of this year’s ESC Rene Laennec Lecture on Clinical Cardiology is Professor Aldo Pietro Maggioni, Director of the Research Center of the Italian Association of Hospital Cardiologists, Florence, Italy. As a member of the coordinating centre of the Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico (GISSI) studies, the Scientific Coordinator of the ESC EURObservational Research programme (EORP), and an executive committee member of the ESC’s European Unified Registries for Heart care Evaluation And Randomised Trials (EuroHeart) initiative, Prof. Maggioni sees large-scale clinical networks as being essential to furthering clinical knowledge.
What first got you interested in cardiology?
I trained in the mid-1970s at a time when coronary care units had been opened just a few years before, when coronary intervention procedures were just starting and when a lot of interesting new technologies, such as echocardiography and Holter monitoring, had begun to emerge. When the time came for me to specialise, these novel technologies, along with the possibility to improve the clinical course of patients with cardiovascular disease quite rapidly, drew me to the field of cardiology.
Tell us something about your lecture topic
The key message is that if you want to make progress in the management of patients with cardiovascular disease, you need an extensive network of investigators who are doing research during routine clinical activities.
My interest in this area started in the early 1980s when I became intrigued by a novel approach to research from a group in Oxford, involving large-scale trials with relevant endpoints as a part of clinical practice. A huge unmet need at that time was the lack of active treatments for acute myocardial infarction (MI). I was lucky enough to be a part of the GISSI-1 trial of nearly 12,000 patients from a large number of hospitals across Italy, which was the first to demonstrate that an active treatment of MI can reduce mortality.1 Results from our continued networks’ research in Italy have since contributed to reductions in in-hospital MI mortality from 13% to 5%. Next, in 1995, we turned our attention to studying heart failure (HF), and since then, we have seen one-year HF mortality rates reduce from 10% to 5%.
The success of networks’ research lies in the inclusion of real-life hospital settings, not just centres of excellence, and the use of methodology that is easily achievable in a clinical setting, such as simple record forms and just one or two relevant endpoints.
What do you see as the challenges in conducting clinical research in cardiology?
We can learn lessons from the challenges encountered in the search for treatments for COVID-19. We saw thousands of small trials on potential COVID-19 therapies, but I think we need to go back to the concept of large-scale trials and networks if we are to find reliable treatment solutions. The highly successful RECOVERY trial of treatments for COVID-19 used methodologies that are similar to those of our old GISSI studies – we must aim for simplicity and reduced bureaucracy, and also explore the integration of new technologies into trial designs, where possible, to improve efficiencies and reduce costs.
What do you think is the future of large-scale clinical networks?
We currently have a variety of effective treatments for cardiovascular diseases. While there is a need to continue to investigate new drugs and devices, a pressing problem is how we ensure best implementation of existing treatments and guideline recommendations within clinical practice. EORP has helped us in this regard, but now we are ready to take further steps.
Part of the work of the EuroHeart initiative, in addition to providing an IT platform to collect continuous patient data, is to develop standardised variables and definitions in order to harmonise the way we describe common cardiovascular diseases.2 With EuroHeart, we may also have the possibility for post-marketing surveillance of new devices and therapies.
Registry-based randomised trials can overcome some of the limitations of current clinical trials, particularly the applicability of results to the real-life clinical setting. With EuroHeart, continuous registration of high-quality, harmonised patient data will allow for pragmatic randomised trials in general patient populations, while substantially reducing the cost burden. A well-designed, collaborative infrastructure for observational and randomised research will be a very powerful tool indeed!
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1. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Lancet. 1986;327:397–402.
2. Wallentin L, et al. Eur Heart J. 2019;40:2745–2749.