Lugano perspectives: final considerations

Twenty years after a first meeting, a group of Investigators and friends convened in Lugano at the Cardiocentro Ticino to discuss their past experience of research, the current situation and the possibility to start innovative epidemiological or controlled research in the field of cardiovascular diseases.

The great majority of participants planned and conducted the most important trials of the last 35 years substantially modifying the way to treat several, relevant cardiovascular illnesses, starting from the use of thrombolysis and aspirin in the patients with acute myocardial infarction, going to the introduction of blockers of the renin-angiotensin system in heart failure, of statins in primary or secondary prevention and of dual antiplatelet treatment in acute coronary syndromes. These great achievements entered as strong recommendations in International guidelines and modified the management of patients with the most frequent cardiovascular diseases, substantially improving their outcomes and quality of life. An important by-product of these successful projects of research was also the creation of a network of International researchers able to friendly collaborate at the global level to address the unmet need of clinical practice.

As Gianni Tognoni stated in his article, the meeting was convened to try to answer the question: ‘Does and how a collective exercise of memory of roots, help to look more clearly into the future?’.

And this was precisely the motivation, based on the past experiences and faced to the future challenges, that joined in this round table also colleagues with relevant roles in International Scientific Societies, such as Roberto Ferrari, former President of the European Society of Cardiology or Barbara Casadei, current President elected of the same Society or Salim Yusuf, immediate past President of World Heart Federation, with the aim to face new challenges trying to overcome differences and inequalities in the management of cardiac diseases between high- and low-income countries, large metropolitan and rural areas, highly scholarized subjects vs. illiterates.

Marc Pfeffer stressed the concept on how the efforts to identify preventive strategies focused on the treatment of hypertension, hypercholesterolaemia, and diabetes have led to great success but also to some failures, e.g. ‘the disappointing results of HDL raising therapies such as Niacin and some CETP inhibitors serves to underscore of differentiating attractive hypothesis from definitive proof from randomized controlled clinical outcome trials’.

But looking at the future, there are simple but essential questions such as that raised by Roberto Ferrari: ‘how long do we aim to improve (cardiovascular) life?’.

From different perspectives, Luigi Tavazzi and Barbara Casadei report the relevance of future, methodologically solid programs of observational research conducted by the European Society of Cardiology and the growing role of the universal electronic health records, with the collection of clinical data of million subjects, who also agreed to be genotyped.

Rory Collins, on the basis of the results of the large scale simple clinical trials conducted in the past and in front of the growing complexity of the rules, which are creating huge obstacles in the conduction of current and future clinical trials, stated: ‘We need to go back to the future and reinvent RCT for the 21st century’. The proposal is to establish strategies to facilitate recruitment into trials, as use of pre-screening, widen inclusion criteria (and minimal exclusion criteria), and revaluate how to conduct safety monitoring, as implementation of innovative monitoring methods, more efficient in improving the quality of clinical trials. But above all it raises a severe criticism, shared by the majority of Investigators: ‘The over-regulation and bureaucracy related to clinical trials that has been introduced over the past 20–30 years has caused increased obstacles, delays and inacceptable cost for trials’.

A global vision of controlled trials has been discussed also by Salim Yusuf who believes it is right to develop an ‘effective and efficient health system tackling the inadequacy distribution of the health care work force and overcome the gaps in the availability of affordable and effective medical products’. This is a challenge that also Alejandro Macchia considered important to improve the situation in the Latin American countries.

Finally, if the mission of the European Society of Cardiology, as Barbara Casadei stated, is to reduce ‘the burden of CV disease in Europe’, Salim Yusuf proposed to make all together the maximal efforts to reduce cardiovascular deaths by 50% within a generation in the world.