Nieves Gonzalocardiologist at San Carlos Clinical Hospital of Madridleads in Europe the first clinical trial in the world that is carried out exclusively about women with illness coronary. The main researcher for Europe, highlights the importance of this study, in addition to confirming the safety and effectiveness of an innovative technology for the treatment and removal of calcium plaques in clogged arteries in women who participate, is in information about coronary heart disease in women and their behavior, which is underdiagnosed.
In addition to the San Carlos Clinical Hospital, other Spanish centers also participate in this international study such as the Reina Sofía Hospital, in Córdoba; the Hospital del Mar, in Barcelona; and the Clinical Hospital of Santiago de Compostela, as well as German, British and American health centers. The trial will examine the safety and effectiveness of using an innovative technology such as intravascular lithotripsy for the treatment of calcium plaques in women with lesions in calcified coronary arteries.
The health center has already carried out the first cases of the Empower Cad trial, in which 400 women from Spain, Germany, the United Kingdom and the United States participate.
This public health center in the Community of Madrid has already carried out the first cases of the trial Empower Cadin which 400 women from Spain, Germany, United Kingdom and United Statesand its main purpose is to assess the safety and effectiveness of a special system such as intravascular lithotripsy.
Intravascular lithotripsy “consists of the application of pressure waves to treat calcium plaques in arteries with calcified lesions, with the aim of allowing the implantation of a stent coronary artery to unblock them and restore blood flow,” explains the interventional cardiologist at the San Carlos Clinic.
Historically, women with coronary heart disease have a worse prognosis than men in relation to multiple factors, warns the cardiologist
Historically, women with coronary heart disease have a worse prognosis than men in relation to multiple factors, such as presentation with more atypical symptoms that make diagnosis difficult, later access to treatments and, in the case of calcified lesions, a higher rate of complications with traditional systems of calcium treatment.
Most effective therapy
Therefore, this system – which has been used for a short time in both men and women with coronary heart disease -, It is presented as an alternative given that the good results it is offering “they lead us to think that it may be a more effective and safer therapy to treat calcified lesions in women’s arteries, which tend to be smaller and tortuous, making access difficult and increasing the possibility of complications with other treatment systems” , adds Nieves Gonzalo.
This calcification causes the artery to harden. and it is more complicated to reopen or unclog it, even with traditional therapies such as atherectomy, which has been used for many years, but whose use is “relatively limited” due to to its complexity and the possibility of complications, especially in women, explains the specialist. Intravascular lithotripsy allows calcification to be modified by sound pressure waves so that the stent can expand within the artery, reestablishing the flow of blood.
Furthermore, specialists remember that women is usually underrepresented in clinical trials, as well as in research groups. In the study Empower Cad, around 70% of the research staff are women, reversing the proportion with respect to the majority of clinical trials to date, with a majority of males among the researchers.
This underrepresentation of women in these clinical trials has resulted in the provision of a smaller amount of information and data, even though the female sex seems to be an adverse prognostic factor, given that they are more likely to suffer complications after the application of some of the conventional treatments. Therefore, concludes the cardiologist at the San Carlos Clinical Hospital, “it is very stimulating to define a possible ideal strategy for women who suffer from the most advanced form of coronary artery disease.”