Drugs in context · 2026
Clinical profile, management and outcomes of patients taking dual pathway inhibition for cardiovascular protection in clinical practice in Latin America. Data from the XATOA registry.
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Cornejo-Avendaño Juan Rene, Novoa Carlos, Peón Gerardo, Rapallo Carlos, Alcocer Alejandro Ricalde, Vita Nestor Alejandro, Virgen-Carrillo Luis Ramón, Barrera-Ramírez Carlos Felipe, Ramacciotti Eduardo
Аннотация
BACKGROUND: The COMPASS trial showed the benefits of dual pathway inhibition (DPI) in patients with atherosclerotic vascular disease. However, the characteristics of patients initiated on DPI have not been previously defined in clinical practice. This study aims to determine the clinical profile, management and outcomes of patients with coronary artery disease (CAD), peripheral artery disease (PAD) or both, initiating DPI using rivaroxaban 2.5 mg twice daily plus aspirin in clinical practice in Latin America.
METHODS: XATOA was an international, multicentre, prospective and single-arm registry that consecutively included adults with CAD, PAD or both, receiving DPI within 4 weeks before enrolment, according to clinical practice. Data from XATOA in Latin America are presented.
RESULTS: A total of 311 patients were included (mean age 67.74±11.63 years, 29.6% women, 74.3% with CAD, 40.5% with PAD and 14.8% with both conditions). The most frequently reported reason for initiating DPI was the presence of existing, worsening or newly diagnosed atherothrombotic risk characteristics (74.9%). Mean follow-up was 445.2±145.7 days. The incidence of major adverse cardiovascular events, cardiovascular death, major adverse limb events, and acute or severe limb ischaemia was 1.72 (95% CI 0.63-3.75), 1.15 (95% CI 0.31-2.94), 1.15 (95% CI 0.31-2.95) and 0.57 (95% CI 0.07-2.07) per 100 patient-years, respectively. Permanent discontinuation of rivaroxaban treatment was observed in 15.8% of patients, and serious adverse events related to rivaroxaban occurred in 0.3% of patients.
CONCLUSION: Although patients with DPI in Latin America presented with a high vascular risk profile, the incidence of major adverse cardiovascular events and major adverse limb events, as well as the risk of major bleeding, remained low during follow-up. These results support the use of rivaroxaban 2.5 mg twice daily combined with aspirin in this population in clinical practice.
TRIAL REGISTRATION NUMBER: XATOA registry (NCT03746275).
METHODS: XATOA was an international, multicentre, prospective and single-arm registry that consecutively included adults with CAD, PAD or both, receiving DPI within 4 weeks before enrolment, according to clinical practice. Data from XATOA in Latin America are presented.
RESULTS: A total of 311 patients were included (mean age 67.74±11.63 years, 29.6% women, 74.3% with CAD, 40.5% with PAD and 14.8% with both conditions). The most frequently reported reason for initiating DPI was the presence of existing, worsening or newly diagnosed atherothrombotic risk characteristics (74.9%). Mean follow-up was 445.2±145.7 days. The incidence of major adverse cardiovascular events, cardiovascular death, major adverse limb events, and acute or severe limb ischaemia was 1.72 (95% CI 0.63-3.75), 1.15 (95% CI 0.31-2.94), 1.15 (95% CI 0.31-2.95) and 0.57 (95% CI 0.07-2.07) per 100 patient-years, respectively. Permanent discontinuation of rivaroxaban treatment was observed in 15.8% of patients, and serious adverse events related to rivaroxaban occurred in 0.3% of patients.
CONCLUSION: Although patients with DPI in Latin America presented with a high vascular risk profile, the incidence of major adverse cardiovascular events and major adverse limb events, as well as the risk of major bleeding, remained low during follow-up. These results support the use of rivaroxaban 2.5 mg twice daily combined with aspirin in this population in clinical practice.
TRIAL REGISTRATION NUMBER: XATOA registry (NCT03746275).