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.

内容摘要

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. 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. 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. 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. XATOA registry (NCT03746275). Many people have coronary artery disease (CAD), a disease where the arteries supplying the heart are narrowed, or peripheral artery disease (PAD), a disease where blood flow to the legs is reduced. These patients are at high risk of heart attacks, strokes or serious leg problems.Doctors often use a ‘dual pathway inhibition’ (DPI) approach to treat these patients. This involves combining a low dose of a blood thinner called rivaroxaban (2.5 mg twice daily) with aspirin.While we know this treatment works from large clinical trials, an international study (called the XATOA registry) wanted to see how it performs in everyday medical practice. Here, we report the results obtained specifically for patients in Latin America. The researchers followed 311 adults from Latin America who were prescribed the DPI treatment by their doctors. Most patients had CAD (74.3%), some had PAD (40.5%), and about 15% had both. The researchers monitored their health for over a year to see if they experienced any major health events or side effects. The study showed that, even though these patients were at high risk for vascular problems, the rates of serious events were low:Heart-related events: only a small number of patients experienced serious heart or brain problems, including heart attack, stroke or death caused by heart disease.Leg-related events: very few patients had serious leg problems caused by severe loss of blood flow to the limbs or needed amputations.Safety: the treatment was generally well tolerated. Only 0.3% of patients experienced serious side effects related to the medication. These results are important because they confirm that the combination of low-dose rivaroxaban and aspirin is both safe and effective for patients at high risk in Latin America. It provides ‘real-world’ evidence, beyond the controlled environment of a clinical trial, that this treatment helps protect patients from life-threatening heart and limb complications without causing significant safety concerns.