Clinical Investigations
Nesiritide in congestive heart failure associated with acute coronary syndromes: a pilot study of safety and efficacy☆

https://doi.org/10.1016/j.cardfail.2003.08.012Get rights and content

Abstract

Background

To compare the safety and efficacy of nesiritide versus intravenous nitroglycerin (NTG) in patients with acute coronary syndromes enrolled in the Vasodilation in the Management of Acute Congestive heart failure trial.

Methods and results

Retrospective review of Vasodilation in the Management of Acute Congestive heart failure trial data for heart failure associated with prospectively diagnosed acute coronary syndromes. Sixty-one patients were included; 34 received nesiritide and 27 received NTG. Pulmonary capillary wedge pressure was measured in right heart–catheterized patients (11 nesiritide, 9 NTG). Death at 6 months occurred in 2 nesiritide and 5 NTG patients (P > .2). Hypotension occurred in 4 nesiritide and 3 NTG patients (P > .6). At 24 hours, pulmonary capillary wedge pressure improvements persisted (P = .001) in the nesiritide group, whereas the NTG group had returned to baseline (P > .1). In non–right heart–catheterized patients, 24-hour dyspnea scores were at least moderately improved in all nesiritide and 71% of NTG (P = .031). At least minimal dyspnea improvement was seen in 100% of nesiritide versus 71% of NTG patients (P > .3), and 6-hour global clinical scores were at least moderately better in 75% of nesiritide versus 32% of NTG (P = .031). In non–right heart–catheterized patients, there were no 30-day readmissions with nesiritide versus 17% with NTG (P > .2).

Conclusions

Nesiritide is as safe as NTG in heart failure patients with acute coronary syndromes.

Section snippets

Methods

This study retrospectively analyzed the subset of patients in the VMAC trial who reported an ACS within 7 days before enrollment. The diagnosis of ACS was made by the investigator based on electrocardiographic, serum ischemia markers, and clinical evidence. For this analysis we used the diagnosis of acute myocardial infarction or unstable angina contained in the original VMAC case report forms, as noted in the Coding Symbols for “Thesaurus of Adverse Reaction Terms” dictionary.4 The

Results

Sixty-one patients were defined as having an ACS within 7 days of enrollment. Among these patients, during the initial 3-hour placebo controlled arm, 21 received standard therapy, 20 received NTG, and 20 received nesiritide. After the initial 3-hour period, placebo patients were rerandomized so that there were a total of 34 patients in the NTG group and 27 patients in the nesiritide group. Four patients in the nesiritide group were randomized to adjustable dose nesiritide. Because these 4

Discussion

Because both ACS and HF share similar risk factors, patients with these concurrent conditions will present for medical care. As many as 14% of acutely decompensated HF patients presenting to an emergency department have an underlying acute coronary syndrome.2 Because HF treatment is commonly initiated before serum cardiac marker results are available, it is important that nesiritide is safe for use both in HF and ACS.

Though a small cohort, this analysis suggests nesiritide is safe for the

Conclusion

This analysis suggests that nesiritide is safe for the management of decompensated HF when there is an accompanying ACS. A larger study is warranted to further evaluate the role of nesiritide in patients with acute coronary syndromes.

Acknowledgements

The authors would like to thank Mei Cheng, PhD, Scios Inc., and Gerri Smoluk. PhD, Scios Inc.; thanks also to Charlotte Melton for secretarial support.

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