The Pirogov Clinic of St Petersburg University has launched an international clinical trial titled SURVIVE. It is devoted to the treatment of one of the most common complications of coronary heart disease.
The trials are organised within the framework of a multi-centre study. They were launched on 1 January 2020 by specialists of the Centre of Cardiac Surgery and Interventional Cardiology of the St Petersburg University Clinic of High Medical Technologies. They initiated a large-scale project, with the Clinic becoming a reference centre. It is here that the data obtained from the other participants will be collected and processed, and the results will be summarised.
At present, eight medical centres around the world have announced their eagerness to join the project. They are located in Italy, Serbia, Bosnia and Herzegovina, Bulgaria and some other countries. The multi-centre study format makes it possible to organise simultaneous monitoring of a large number of patients from different countries, selected by uniform parameters. Such a format helps researchers achieve more reliable results.
The study of ischemic mitral regurgitation is one of the major areas of the Stress Echo 2030 global research system. It is led by: Angela Zagatina, Doctor of Science in Medicine and a cardiologist at the St Petersburg University Pirogov Clinic; and Dmitrii Shmatov, Doctor of Science in Medicine, the Clinic's Deputy Director for Medicine, a cardiac surgeon and St Petersburg University professor. The scientists are planning to complete patient recruitment by 2027, and obtain end results in 2030. The St Petersburg specialists cooperate with their Italian colleagues, coordinators of the Stress Echo 2030 programme.
No previous studies have proven the need for surgical treatment of patients with ischemic mitral regurgitation. 'Previously, when evaluating the condition of the programme participants they relied solely on the echocardiography data,' Angela Zagatina said. 'According to our hypothesis, there are other parameters making it possible to classify patients and define who should undergo surgery and who should not. We are testing it,' she explained. Currently, only about a third of the patients with coronary heart disease undergo surgery at the Clinic. Drug therapy still remains the main method of treatment.
Coronary heart disease (CHD) is one of the most common diseases among the residents of developed countries. It is the number one cause of death among adults.
It is characterised by a build-up of plaque in the arteries of the heart and reduced blood flow to the heart. People with coronary heart disease are in danger of having their mitral valve muscles damaged, because they do not receive sufficient nutrition due to a decrease in the diameter of their blood vessels. Although the leaflets of the valve maintain their normal state, its functions are significantly impaired, Angela Zagatina explained. Poor blood flow to the valve apparatus is one of the main causes of ischemic mitral regurgitation. It is detected in almost 20% of patients with coronary heart disease.
Among all patients with ischemic mitral regurgitation, doctors distinguish a group of 'intermediate' patients, the most difficult ones from the point of view of surveillance. It is still unknown how to treat them most effectively. The right choice remains an open issue. Conservative therapy or surgery combined with drug therapy – which approach should be chosen for each individual patient and what should the doctor rely on? The SURVIVE study participants will be searching for the right answers.
We wish to come to an understanding of what treatment should be chosen for a particular patient with this pathology, either surgery or conservative cardiology, in order to extend his or her life.
Angela Zagatina, Doctor of Science in Medicine and a cardiologist at the St Petersburg University Pirogov Clinic
If coronary heart disease is joined by valve problems, even a seemingly insignificant change in its function doubles the patients' death rate, Angela Zagatina explained. A person may not feel a severe pathology and vice versa: the clinical evidence and the valve damage degree are not directly correlated. 'Heart diseases may affect the general condition and the state of health in different ways,' she said. The cardiologist noted that the group of bad cases often included not only elderly patients, but also people aged 40 to 60.
In the future, the study will involve at least 300 patients with severe ischemic mitral regurgitation. Moderately severe patients will be randomly assigned to groups in accordance with the treatment plan: either a surgical or a medical one. Patients requiring surgery, with a large volume of blood return through the valve, will constitute a control group. The 'intermediate' patients' results will be evaluated in comparison to their results.
Every month, encrypted data will be transferred from all centres to the reference centre, where they will be 'frozen' until the end points are reached. These data include: the presence and functional class of cardiac failure; hospitalisation cases with either cardiac failure or myocardial infarction; assessment of valve performance by quantitative criteria; one-year and three-year patient survival rate; and the need for a heart transplant.
Together with the study of these data, the experts will check, using echocardiography and stress echocardiography, how the valve is functioning over time after the operation or after drug treatment instead of an operation. Each patient will be observed for three years.
According to the expert, the scientists will be able to determine, after processing the results, in which group of patients valve plastic surgery or valve replacement are more effective, and in which group it is more appropriate to choose drug therapy without any surgery.