MO201: Effects of Aspirin in Primary Prevention of Cardiovascular (CV) Disease in People with Chronic Kidney Disease (CKD): Results of the TIPS3 Trial

Abstract

Abstract BACKGROUND AND AIMS Subjects with CKD carry a high (CV) risk. Whether this risk is blunted by aspirin is controversial. We examined CV outcomes of CKD participants of the TIPS3 trial. METHOD The International Polycap Study3 (TIPS3) randomized people (N = 5713) with and without CKD, but without previous CV disease, to aspirin, aspirin plus polypill, polypill or respective placebo in a factorial design. In 983 participants that were randomized to aspirin or placebo, eGFR was below 60 mL/min/1.73 m2 at baseline (CKD). The primary outcome for this comparison was non-fatal myocardial infarction (MI), non-fatal stroke or CV death. The mean follow-up was 4.6 years. RESULTS In all participants, there were 250 primary MACE outcomes, 116 on aspirin and 134 on placebo (HR 0.86; 95% CI 0.67–1.10). In those with CKD, there were 65 primary MACE outcomes, 26 in the 502 participants on aspirin, 39 in the 481 participants on placebo, HR 0.57 (95% CI 0.34–0.94). Directionally similar results were found for aspirin versus placebo for the secondary outcome all-cause death with 312 events in all participants (HR 0.87; 0.70–1.07) and 82 events in CKD patients (HR 0.64; 0.41–0.99). There was no significant interaction of eGFR <60 mL/min with the treatment effects of aspirin versus placebo. Major and minor bleedings were rare and not different between groups. When aspirin was combined with a polypill (containing atenolol, ramipril, hydrochlorothiazide and simvastatin) and compared to double placebo, in all participants the HR for the MACE outcome was 0.69, 0.50–0.97 and for all-cause death 0.80, 0.59–1.08; in CKD patients the HR was 0.37, 0.18–0.75 for MACE and HR 0.49, 0.29–0.97 for death. CONCLUSION Results suggest that the CV risk in people with CKD may be substantially alleviated with aspirin alone and in combination with a polypill.