Ischaemic events and bleeding in patients undergoing percutaneous coronary intervention with concomitant bivalirudin treatment.

Aims: The European ImproveR registry aimed to characterise the patient population undergoing percutaneous coronary intervention (PCI) with bivalirudin treatment in a routine clinical setting and to evaluate associated ischaemic and bleeding events. Methods and results: A total of 3,799 evaluable patients, aged ≥18 years, were enrolled in 102 centres across 12 European countries from January 2005 to June 2006. The population was elderly (median age, 67.2 years; 24% > 75 years) and comprised 27.1% female patients, 27.9% with diabetes and 14.9% with renal impairment. Forty-nine percent of patients presented with acute coronary syndromes (ACS), 22% of these with ST-segment elevation myocardial infarction (STEMI). In-hospital and 30-day rates of major adverse cardiac events (death, myocardial infarction or urgent revascularisation) were 2.3% and 5.6%, respectively. In-hospital ischaemic complications were associated with a STEMI diagnosis and age ≥65 years. In-hospital significant bleeding occurred in 1.7% of patients and was associated with renal impairment, female gender and glycoprotein llb/llla inhibitor use. Conclusion: The ImproveR registry population is characterised by a high proportion of elderly patients and patients with diabetes, renal impairment and ACS. In clinical practice, bivalirudin effectively suppresses ischaemic complications while maintaining a low rate of haemorrhagic consequences, as expected from randomised trials.