746 DAL COMPASS AI DATI DI REAL LIFE: UNO STUDIO CASO-CONTROLLO

Abstract

Abstract Background The COMPASS trial showed that rivaroxaban plus aspirin was associated with fewer adverse cardiovascular events, but more major bleeding events, as compared with aspirin alone in patients with chronic vascular disease. The clinical benefit was particularly favorable in high-risk subgroups, who are frequently undertreated because of the fear of severe bleeding events. Purpose Our aim is to evaluate objective effects of anticoagulation strategies with rivaroxaban among patients with stable cardiovascular disease. Methods We considered a population of patients with stable cardiovascular disease (coronary and/or peripheral artery disease) which has had dual antiplatelet therapy (DAPT) for 1 year. Between them we selected 65 patients (52 males and 13 females, mean age 59±7 years) with high risk of ischemic events and low bleeding risk. We used DAPT Score and HAS BLED Score to enroll patients. We stopped them DAPT and starting a dual therapy combining rivaroxaban 2,5 mg twice daily plus aspirin 100 mg. We excluded patients with high bleeding risk and heart failure with less than 35% ejection fraction. At baseline they underwent blood tests, transthoracic echocardiography, six minutes walking test (6MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ) Score, evaluation of carotid– femoral pulse wave velocity (cf-PWV) and ankle brachial index (ABI). We established 3, 6 and 12 months follow-up. Results At 3 months follow-up we evaluated 41 patients (the study is going on) repeating those exams and comparing them with the baseline ones. We observed that 35% of population had reduction of cf-PWV values and in 40% of population ABI increased. 15% of patients had also improvement of more than 100 meters in 6MWT. Particularly, reduction of cf-PWV and improvement of ABI values suggest that rivaroxaban 2,5 mg twice daily may have effects on vascular protection and arterial stiffness through different mechanisms such as improvement of endothelial functionality and fibrinolytic activity at endothelium, anti-inflammatory properties and platelet-dependent thrombin generation. Nevertheless none of the patients experienced subjective clinical improvement and the KCCQ Score was unmodified. This element indicates that patients at 3 months follow-up have imperceptible changes that can be documented only by diagnostic imaging evaluation and not by anamnestic data. Finally, an important evidence was that none of the patients at 3 months follow-up reported major bleeding events. Conclusion Preliminary data suggest that the addiction of rivaroxaban 2,5 mg to aspirin exerts vascular protection and its effects can be primarly documented by evaluation of cf-PWV and ABI. The 6MWT seems to play a minor role at 3 months assessment. The KCCQ may not be useful to fill in at 3 months follow-up because patients seem not to perceive subjective clinical improvement in this phase. If confirmed on a large cohort these results may give rivaroxaban a higher relevance not only for the power but also for the immediacy of its effects. Anyway, we are continuing our check to give our data more statistical significance and to test any role of the other parameters at 6 and 12 months follow-up.