Efficacy and safety of various regimens of multiagent antithrombotic therapy in patients with multifocal atherosclerosis (data from real-world practice)

Aim . To compare the efficacy and safety of two variants of long-term multiagent antithrombotic therapy in patients with multifocal atherosclerosis as follows: a combination of acetylsalicylic acid (ASA) with rivaroxaban 2,5 mg 2 times a day or with clopidogrel 75 mg 1 time per day. Material and methods . The study is based on the prospective REGATA-1 registry, ClinicalTrials NCT04347200 (1500 patients with stable coronary artery disease (CAD)). A total of 311 patients (241 men, median age 66 years [60; 72]) with multivessel CAD in combination with peripheral artery disease were selected. Depending on the decision of clinicians, the patients were distributed into two groups for following open-label administration in addition to ASA: rivaroxaban at a dose of 2,5 mg 2 times a day (n=109) or clopidogrel 75 mg/day (n=202). Thrombotic events (TEs) (major ischemic events and unscheduled revascularization of any vascular system, as well as major bleeding (BARC 3-5)) were analyzed. In addition, clinically significant bleeding (BARC 2) was taken into account. Results. The median follow-up period was 13 months [interquartile range 11; 21]. During the 24-month follow-up period, TEs were registered in 26 (8,4%) patients. TEs were registered significantly more often in the clopidogrel group — 11,4 vs 2,8% (p=0,009). According to the regression analysis, prior myocardial infarction and the use of clopidogrel rather than rivaroxaban as part of multiagent therapy increase the risk of thromboembolism by 3 and 4 times, respectively. All major bleedings (BARC 3) with the frequency of 2,8% were registered in the rivaroxaban group. There were no fatal bleedings. Clinically significant BARC 2 bleedings were more often registered in the rivaroxaban group — 13,8 vs, 4,5% (p=0,006). Bleeding of this type did not affect the prognosis and was not a reason for refusing to take antithrombotic therapy. Conclusion. In patients with multifocal atherosclerosis, the use of rivaroxaban as the second agent of antithrombotic therapy compared with clopidogrel may be associated with a better clinical benefit, determined by the sum of thromboembolism and major bleedings.