Author + information
- Received August 1, 2006
- Revision received September 26, 2006
- Accepted October 12, 2006
- Published online February 13, 2007.
- Robert M. Mentzer Jr, MD, FACC⁎,⁎ (, )
- Mehmet C. Oz, MD, FACC†,
- Robert N. Sladen, MD, FCCM‡,
- Allen H. Graeve, MD, FACS§,
- Robert F. Hebeler Jr, MD∥,
- John M. Luber Jr, MD, FACS¶,
- Nicholas G. Smedira, MD, FACC#,
- NAPA Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Robert M. Mentzer, Jr., Wayne State University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery, 1241 Scott Hall, 540 E. Canfield, Detroit, Michigan 48201.
Objectives The purpose of this study was to determine the role nesiritide might play in patients with left ventricular dysfunction undergoing coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).
Background Given the hemodynamic, neurohormonal, and renal effects of natriuretic peptides, nesiritide might be useful in the management of patients undergoing cardiac surgery.
Methods This prospective, double-blind, exploratory evaluation randomly assigned patients with ejection fraction ≤40% who were undergoing CABG with anticipated use of CPB to receive either nesiritide or placebo, in addition to usual care, for 24 to 96 h after induction of anesthesia. Postoperative renal function, hemodynamics, and drug use (primary end points) were assessed in patients who underwent CABG using CPB; mortality and safety (secondary end points) were assessed in all patients who received the study drug.
Results Of 303 randomized patients, 279 received the study drug and 272 underwent CABG using CPB. Compared with placebo, nesiritide was associated with a significantly attenuated peak increase in serum creatinine (0.15 ± 0.29 mg/dl vs. 0.34 ± 0.48 mg/dl; p < 0.001) and a smaller fall in glomerular filtration rate (−10.8 ± 19.3 ml/min/1.73 m2 vs. −17.2 ± 21.9 ml/min/1.73 m2; p = 0.001) during hospital stay or by study day 14, and a greater urine output (2,926 ± 1,179 ml vs. 2,350 ± 1,066 ml; p < 0.001) during the initial 24 h after surgery. In addition, nesiritide-treated patients had a shorter hospital stay (p = 0.043) and lower 180-day mortality (p = 0.046).
The NAPA trial was sponsored by Scios Inc. (Fremont, California). Drs. Mentzer and Sladen have received honoraria from Scios Inc. Drs. Mentzer, Oz, and Smedira have been consultant/advisory board members for Scios Inc. Drs. Sladen, Luber, and Hebeler have received grant/research support from Scios Inc. Dr. Hebeler was on the speakers’ bureau for Scios Inc. Please see the Appendix for a list of NAPA Investigators.
- Received August 1, 2006.
- Revision received September 26, 2006.
- Accepted October 12, 2006.
- American College of Cardiology Foundation