A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST).

Califf RM, Adams KF, McKenna WJ, Gheorghiade M, Uretsky BF, McNulty SE, Darius H, Schulman K, Zannad F, Handberg-Thurmond E, Harrell FE, Wheeler W, Soler-Soler J, Swedberg K
Am Heart J. 1997 134 (1): 44-54

PMID: 9266782 · DOI:10.1016/s0002-8703(97)70105-4

This trial evaluated the effects of epoprostenol on patients with severe left ventricular failure. Patients with class IIIB/IV congestive heart failure and decreased left ventricular ejection fraction were eligible for enrollment if angiography documented severely compromised hemodynamics while the patient was receiving a regimen of digoxin, diuretics, and an angiotensin-converting enzyme inhibitor. We randomly assigned 471 patients to epoprostenol infusion or standard care. The primary end point was survival; secondary end points were clinical events, congestive heart failure symptoms, distance walked in 6 minutes, and quality-of-life measures. The median dose of epoprostenol was 4.0 ng/kg/min, resulting in a significant increase in cardiac index (1.81 to 2.61 L/min/m2), a decrease in pulmonary capillary wedge pressure (24.5 to 20.0 mm Hg), and a decrease in systemic vascular resistance (20.76 to 12.33 units). The trial was terminated early because of a strong trend toward decreased survival in the patients treated with epoprostenol. Chronic intravenous epoprostenol therapy is not associated with improvement in distance walked, quality of life, or morbid events and is associated with an increased risk of death.

MeSH Terms (26)

Aged Angiography Angiotensin-Converting Enzyme Inhibitors Antihypertensive Agents Cardiac Output Cardiotonic Agents Cause of Death Digoxin Diuretics Epoprostenol Exercise Tolerance Female Heart Failure Humans Infusions, Intravenous Male Middle Aged Proportional Hazards Models Pulmonary Wedge Pressure Quality of Life Risk Factors Stroke Volume Survival Rate Vascular Resistance Ventricular Dysfunction, Left Walking

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