O papel dos sinais de microembolia cerebral como marcador de risco e como desfecho em pacientes de ensaio clínico piloto na insuficiência cardíaca de etiologia chagásica

Abstract

Introduction: Chagas disease is an important cause of heart failure (HF) and stroke, affecting over six million people. High intensity transient signals (HITS) are detected on transcranial Doppler (TCD) in patients with Chagas disease, but the effect of antithrombotic treatment on HITS is unknown The aim To evaluate the role of cerebral HITS as a risk marker and as a surrogate outcome in patients with HF of Chagasic etiology Methods: In a prospective, open-label, blinded pilot clinical trial (PROBE), patients underwent TCD recording of the unilateral middle cerebral artery for 60 minutes, seeking HITS. Patients with Chagas disease and HITS were selected 2:1 for use of 300 mg aspirin for seven days and standard HF treatment or standard HF treatment alone (control group). Recruitment took place at the outpatient clinic of Edgar Santos Hospital and Ana Nery Hospital. The primary endpoint was the proportion of HITS after one week, verified using the chi-square test. Results: 373 patients with HF were evaluated, HITS occurred in 22/190 (12%) chagasic patients and in 16/183 (8%) non-chagasic patients (p=0.531). Twelve of the 22 (54%) chagasic patients were randomized to treatment with ASA (n = 8) or without ASA (n = 4). Two patients in the control group (50%) persisted with HITS after 7 days of treatment, compared to none in the ASA group, p=0.028. Median number of HITS decreased from 3.5 to 0 with ASA (p=0.012) and 4.0 to 0.5 in the control group (p=0.095), with no significant between-group difference (p=0.262). No adverse events were reported. Conclusion: In this pilot clinical trial, ASA reduced the proportion of HITS in patients with Chagas disease HF.