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

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Abstract

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 m2 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.

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Funding

AASER was supported by Sociedad Española de Nefrologia (SEN) and Sociedad Madrileña de Nefrología (SOMANE). MG, GFJ, DA, AO, and JL are supported by ISCIII RETIC REDINREN RD016/009 and FEDER funds.

Author information

Authors and Affiliations

  1. Nephrology Department, Hospital General Universitario Gregorio Marañón, C/ Dr Esquerdo 46, 28007, Madrid, Spain

    Marian Goicoechea, Soledad García de Vinuesa, Eduardo Verde, Ursula Verdalles, Soraya Abad & José Luño

  2. Spanish Kidney Research Network (REDINREN), FEDER FUND, Madrid, Spain

    Marian Goicoechea, Soledad García de Vinuesa, Eduardo Verde, Enrique Morales, Gema Fernández-Juárez, Ursula Verdalles, Soraya Abad, Alberto Ortiz & José Luño

  3. Nephrology Department, Hospital Universitario La Princesa, Madrid, Spain

    Borja Quiroga & Carmen Bernis

  4. Nephrology Department, Hospital Universitario Doce de Octubre, Madrid, Spain

    Enrique Morales

  5. Nephrology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain

    Gema Fernández-Juárez

  6. Nephrology Department, Hospital Universitario Infanta Leonor, Madrid, Spain

    Patricia de Sequera

  7. Nephrology Department, Clinica Ruber, Madrid, Spain

    Ramón Delgado

  8. Nephrology Department, Hospital Universitario La Paz, Madrid, Spain

    Alberto Torres

  9. Nephrology Department, Hospital Universitario Severo Ochoa, Madrid, Spain

    David Arroyo

  10. Nephrology Department, IIS-Fundación Jimenez Diaz UAM, Madrid, Spain

    Alberto Ortiz

Authors
  1. Marian Goicoechea
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  2. Soledad García de Vinuesa
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  3. Borja Quiroga
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  4. Eduardo Verde
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  5. Carmen Bernis
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  7. Gema Fernández-Juárez
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  8. Patricia de Sequera
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  9. Ursula Verdalles
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  10. Ramón Delgado
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  11. Alberto Torres
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  12. David Arroyo
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  13. Soraya Abad
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  14. Alberto Ortiz
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  15. José Luño
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Corresponding author

Correspondence to Marian Goicoechea.

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Conflict of Interest

The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments.

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Goicoechea, M., de Vinuesa, S.G., Quiroga, B. et al. Aspirin for Primary Prevention of Cardiovascular Disease and Renal Disease Progression in Chronic Kidney Disease Patients: a Multicenter Randomized Clinical Trial (AASER Study). Cardiovasc Drugs Ther 32, 255–263 (2018). https://doi.org/10.1007/s10557-018-6802-1

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  • DOI: https://doi.org/10.1007/s10557-018-6802-1

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