Aspirin for Primary Prevention of Cardiovascular Disease and Renal Disease Progression in Chronic Kidney Disease Patients: a Multicenter Randomized Clinical Trial (AASER Study)

• Published in: Cardiovascular drugs and therapy Vol. 32; no. 3; pp. 255 - 263
• Main Authors: Goicoechea, Marian, de Vinuesa, Soledad García, Quiroga, Borja, Verde, Eduardo, Bernis, Carmen, Morales, Enrique, Fernández-Juárez, Gema, de Sequera, Patricia, Verdalles, Ursula, Delgado, Ramón, Torres, Alberto, Arroyo, David, Abad, Soraya, Ortiz, Alberto, Luño, José
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.06.2018; Springer Nature B.V
• Subjects: Aged; Angina; Angina pectoris; Aspirin; Aspirin - adverse effects; Aspirin - therapeutic use; Bleeding; Cardiology; Cardiovascular Agents - adverse effects; Cardiovascular Agents - therapeutic use; Cardiovascular diseases; Cardiovascular Diseases - diagnosis; Cardiovascular Diseases - mortality; Cardiovascular Diseases - prevention & control; Clinical trials; Coronary artery disease; Creatinine; Diabetes mellitus; Disease control; Disease Progression; Epidermal growth factor receptors; Female; Glomerular filtration rate; Glomerular Filtration Rate - drug effects; Health risk assessment; Health risks; Heart diseases; Hemorrhage - chemically induced; Humans; Kidney - drug effects; Kidney - physiopathology; Kidney diseases; Kidneys; Male; Medical treatment; Medicine; Medicine & Public Health; Middle Aged; Original Article; Patients; Primary Prevention - methods; Prospective Studies; Renal Insufficiency, Chronic - diagnosis; Renal Insufficiency, Chronic - drug therapy; Renal Insufficiency, Chronic - mortality; Renal Insufficiency, Chronic - physiopathology; Risk; Risk Factors; Spain; Therapy; Time Factors; Treatment Outcome; Spain; Cardiovascular disease; Aspirin; Chronic kidney disease; Dialysis; Primary prevention
• ISSN: 0920-3206; 1573-7241
• DOI: 10.1007/s10557-018-6802-1

Background Patients with chronic kidney disease (CKD) are at high risk for developing cardiovascular events. However, limited evidence is available regarding the use of aspirin in CKD patients to decrease cardiovascular risk and to slow renal disease progression. Study Design Prospective, multicenter, open-label randomized controlled trial. Setting and Participants One hundred eleven patients with estimated glomerular filtration rate (eGFR) 15–60 ml/min/1.73 m 2 without previous cardiovascular events. Intervention Aspirin treatment (100 mg/day) ( n  = 50) or usual therapy ( n  = 61). Mean follow-up time was 64.8 ± 16.4 months. Outcomes The primary endpoint was composed of cardiovascular death, acute coronary syndrome (nonfatal MI, coronary revascularization, or unstable angina pectoris), cerebrovascular disease, heart failure, or nonfatal peripheral arterial disease. Secondary endpoints were fatal and nonfatal coronary events, renal events (defined as doubling of serum creatinine, ≥ 50% decrease in eGFR, or renal replacement therapy), and bleeding episodes. Results During follow-up, 17 and 5 participants suffered from a primary endpoint in the control and aspirin groups, respectively. Aspirin did not significantly reduce primary composite endpoint (HR, 0.396 (0.146–1.076), p  = 0.069. Eight patients suffered from a fatal or nonfatal coronary event in the control group compared to no patients in the aspirin group. Aspirin significantly reduced the risk of coronary events (log-rank, 5.997; p  = 0.014). Seventeen patients in the control group reached the renal outcome in comparison with 3 patients in the aspirin group. Aspirin treatment decreased renal disease progression in a model adjusted for age, baseline kidney function, and diabetes mellitus (HR, 0.272; 95% CI, 0.077–0.955; p  = 0.043) but did not when adjusted for albuminuria. No differences were found in minor bleeding episodes between groups and no major bleeding was registered. Limitations Small sample size and open-label trial. Conclusions Long-term treatment with low-dose aspirin did not reduce the composite primary endpoint; however, there were reductions in secondary endpoints with fewer coronary events and renal outcomes. ClinicalTrials.gov Identifier: NCT01709994.