Background: Previously, we reported that the prophylactic use of nesiritide did not reduce the incidence of dialysis or death following cardiovascular (CV) surgery despite reducing the incidence of acute kidney injury (AKI) in the immediate postoperative period. Therefore, we investigated whether the observed renal benefits of nesiritide had any long-term impact on cumulative patient survival and renal outcomes. Methods: Participants of the Nesiritide Study, a previously reported prospective, double-blind, placebocontrolled, randomized clinical trial investigating the effect of nesiritide on the incidence of dialysis or death at 21 days in adult patients undergoing high-risk CV surgery, were included in the study. Data of the participants' most recent health and renal function status were obtained using institutional review board-approved patient questionnaires, medical records, and the database of the Social Security Administration. Results: Data on all 94 patients from the Nesiritide Study were obtained. The mean follow-up period was 20.8 ± 10.4 months. No differences in cumulative survival between the groups were noted at follow-up (nesiritide 77.7% vs placebo 81.6%, P = 0.798). Patients with in-hospital incidence of AKI had a higher rate of mortality than those with no AKI (AKI 41.4% vs no AKI 10.7%, P = 0.002). However, differences in survival time were not significant between the groups when the analysis was restricted to patients with AKI (nesiritide 16.8 ± 4 months vs placebo 18.5 ± 2.3 months, P = 0.729). Conclusions: Renoprotection provided by nesiritide in the immediate postoperative period was not associated with improved long-term survival in patients undergoing high-risk CV surgery.
IntroductionEvidence for the renoprotective effect of natriuretic peptides in clinical settings remains controversial. 1 -4 Previously, we reported in a retrospective study that the use of the B-type natriuretic peptide (BNP) nesiritide (Natrecor) in patients with impaired renal function (serum creatinine [SCr]>1 mg/dL) who were undergoing cardiovascular (CV) surgery was associated with a dramatic reduction in 21-day dialysis-free survival (odds ratio [OR]: 0.35, 95% confidence interval [CI]: 0.14-0.87, P = 0.024). 5 However, in a follow-up prospective, randomized clinical trial (the Nesiritide Study), we could not demonstrate a benefit for prophylactic use of nesiritide as related to the incidence of 21-day dialysis and/or death in patients undergoing high-risk CV surgery (nesiritide 6.6% vs control 6.1%; P = 0.914). 6 The study did demonstrate that the prophylactic use of nesiritide was associated with reduced incidence