• Heart Failure Clinical Trials

Outpatient infusions of nesiritide did not prolong survival or prevent future hospitalizations in patients with advanced chronic heart failure and a history of acute decompensation, according to the results of FUSION II, the first large, randomized, controlled study to test the efficacy of this regimen as reported by Clyde W. Yancy, MD, of Baylor University Medical Center, Dallas.

The Follow-Up Serial Infusions of Nesiritide in Advanced Heart Failure (FUSION II) trial randomly assigned 911 patients to receive nesiritide as a 2-μg/kg bolus followed by a 0.01-μg/kg/min infusion for 4 to 6 hours or a matching placebo regimen, once or twice a week for 12 weeks. Patients had NYHA class 3 or 4 heart failure and an LVEF <40%, plus a history of at least two prior hospitalizations for heart failure within the past year, the most recent being within the past 2 months.

At the study's end, there were no significant differences in the rates of the primary endpoint of all-cause mortality or cardiovascular or cardiorenal hospitalization, or in rates of the individual component events (Table 1). No particular subgroup derived special benefit from the nesiritide regimen, Dr. Yancy reported.

Event rates were 48% lower than those observed in the FUSION I pilot study. The current study, therefore, was underpowered to find differences, Dr. Yancy suggested. “The most important clinical message from FUSION II is that adherence to guideline-driven therapy and meticulous follow-up defines the benchmark of care for patients with chronic decompensated, or stage D, heart failure,” Dr. Yancy concluded.

• © 2007 MD Conference Express