Odds of major bleeding, mortality lower with fondaparinux than heparin

Patients with non-STEMI who were treated with fondaparinux had better rates of major bleeding and mortality during hospitalization and up to 180 days after discharge compared with patients treated with low–molecular-weight heparin, according to new data.

The prospective, multicenter cohort study included data on 40,616 consecutive patients with non-STEMI enrolled in the SWEDEHEART registry. Patients received treatment with fondaparinux (n = 14,791) or low–molecular-weight heparin (n = 25,825) from September 2006 to June 2010.

The absolute rate of severe in-hospital bleeding was 1.1% in the fondaparinux group vs. 1.8% in the heparin group (adjusted OR = 0.54; 95% CI, 0.42-0.7). Severe bleeding that occurred in the hospital or resulted in readmission also was lower in the fondaparinux group at 30 days (1.4% vs. 2.1%; adjusted OR = 0.56; 95% CI, 0.44-0.7) and 180 days (1.9% vs. 2.8%; adjusted OR = 0.6; 95% CI, 0.5-0.74).

The mortality rate among patients with a severe in-hospital bleeding event was 11.5% in the fondaparinux group vs. 11.7% in the heparin group. Risk for in-hospital mortality was significantly lower in the fondaparinux group (2.7% vs. 4%; adjusted OR = 0.75; 95% CI, 0.63-0.89). Risk for mortality was similarly decreased in the fondaparinux group at 30 days (OR = 0.82; 95% CI, 0.71-0.95) and 180 days (OR = 0.76; 95% CI, 0.68-0.85).

The risk for bleeding or mortality was lower in the fondaparinux group during hospitalization (adjusted OR = 0.68; 95% CI, 0.58-0.79), at 30 days (adjusted OR = 0.74; 95% CI, 0.65-0.84) and 180 days (adjusted OR = 0.72; 95% CI, 0.65-0.8).

Rates of stroke and recurrent MI were not significantly different with fondaparinux or heparin at any time point. However, when MI, stroke and mortality were analyzed as a combined endpoint, risk was significantly lower in the fondaparinux group at 30 days (OR = 0.82; 95% CI, 0.71-0.95) and 180 days (OR = 0.76; 95% CI, 0.68-0.85).

Although the pattern of decreased risk for bleeding with fondaparinux was consistent, “conclusions regarding the degree of treatment effect should be done with caution,” as the number of bleeding events is likely to be underestimated within the registry, the researchers wrote. They also noted that the dose and duration of both treatment options were not recorded.

“However, the study reflects the situation when results from trials and practice guidelines are translated into clinical reality,” the researchers wrote. – by Adam Taliercio

Source: www.healio.com