Darbepoetin Plus Iron Fails to Reduce Transfusion Rates After TAVR in Anemia Patients
Among patients with anemia undergoing transcatheter aortic valve replacement (TAVR), use of darbepoetin alfa plus iron results in only a small increase in hemoglobin levels and fails to reduce the rate of red-cell transfusions or the number of red-cell units used after the procedure, according to a study presented at TCT 2015. The treatment has no impact on 30-day clinical outcomes.
In EPICURE, a double-blind, placebo-controlled, single-center study, Marina Urena, MD, of the Quebec Heart and Lung Institute, Quebec, Canada, and colleagues randomized 104 anemic patients (mean age 81 years) undergoing TAVR to darbepoetin 0.75 µg/kg (Aranesp, Amgen) plus IV iron sucrose 200 mg or placebo. Injections were administered with a first dose 6 to 14 days before TAVR and a second dose either the day before or the day of the procedure.
Hemoglobin concentration was higher in the placebo group at baseline (11.3 vs. 10.7 g/dL; P = .018) but did not differ between study arms before TAVR or at hospital discharge. The rate of red-cell transfusion in the first 30 days after the procedure (primary endpoint) was similar in the treatment and placebo groups, with no differences observed for any of the secondary endpoints either (Figure). The rate of the primary endpoint was lower than expected, Urena noted.
“Despite randomization, there were differences in hemoglobin concentration at baseline between groups,” said Urena, who noted, too, “that this study was not powered to detect differences in clinical events.”
Urena speculated that higher doses of darbepoetin might have changed the results of the study, although there would be a potentially higher risk for thrombotic events.
She also noted that the darbepoetin alfa response may differ in a younger and lower-risk population, although a subgroup analysis did not detect a differential effect based on age > 81 years vs. ≤ 81 years (P = .81 for interaction).
- Urena reports no relevant conflicts of interest.