Analysis of bleeding complications associated with glycoprotein IIb/IIIa receptors blockade in patients with high-risk acute coronary syndromes: insights from the PRISM-PLUS study.

We aim to characterize the hemorrhagic complications and predictors of increased bleeding risk in a population of patients with high-risk acute coronary syndromes (ACS), enrolled in the PRISM-PLUS study. Patients treated with heparin plus tirofiban had more bleeding events compared to patients treated with heparin alone. No significant increase in major bleeding, thrombocytopenia, blood loss and blood products transfusions was observed among the patients who received the combination therapy. Several clinical variables were independently associated with increased risk of bleeding for both treatment groups: advanced age, lower body weight, female gender, decreased creatinine clearance (<30 ml/min). Females, patients with impaired renal function, patients requiring percutaneous coronary intervention (PCI), especially prolonged PCI (>100 min duration) or coronary artery bypass surgery (CABG) were at risk for increased major bleeding complications. Increased blood loss was also found in females, patients with elevated diastolic blood pressure, PCI, duration of PCI>100 min or CABG. No incremental risk was detected with the addition of tirofiban to heparin in patients at risk for major bleeding or increased blood loss. We concluded that identification of patients with high-risk ACS, at risk for bleeding complications and blood loss can be done with specific clinical variables. Tirofiban added to heparin increased minor hemorrhagic complications. Although there was no significant increase in major bleeding, thrombocytopenia and blood transfusions with the combination of tirofiban plus heparin, the power to detect a statistically significant difference in these endpoints was limited by the small number of events.