Effects of perioperative nesiritide in patients with left ventricular dysfunction undergoing cardiac surgery:the NAPA Trial.

Abstract

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 m(2) vs. -17.2 +/- 21.9 ml/min/1.73 m(2); 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).

CONCLUSIONS:

Nesiritide in the setting of CABG with CPB is associated with improved postoperative renal function and possibly enhanced survival. (The NAPA Trial; ; ).

• Authors: Robert M Mentzer Jr, Mehmet C Oz, Robert N Sladen, Allen H Graeve, Robert F Hebeler Jr, John M Luber Jr, Nicholas G Smedira, NAPA Investigators
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 49 Issue 6 Pg. 716-26 (Feb 13 2007) ISSN: 1558-3597 [Electronic] United States
• PMID: 17291938 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Natriuretic Agents
• Natriuretic Peptide, Brain

Topics

• Adult
• Cardiac Surgical Procedures
• Cardiopulmonary Bypass
• Coronary Artery Bypass
• Double-Blind Method
• Female
• Heart Diseases (physiopathology, surgery)
• Humans
• Male
• Middle Aged
• Natriuretic Agents (therapeutic use)
• Natriuretic Peptide, Brain (therapeutic use)
• Perioperative Care
• Prospective Studies
• Ventricular Dysfunction, Left (drug therapy, physiopathology)