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Updated: Jun 21, 2026

Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Ischaemic events and bleeding in patients undergoing percutaneous coronary intervention with concomitant bivalirudin
Jan Kyst Madsen1, Bernard Chevalier, Harald Darius
1Gentofte University Hospital, University of Copenhagen, Hellerup, Denmark.
Insights
The ImproveR registry shows bivalirudin effectively reduces ischemic events in high-risk patients undergoing percutaneous coronary intervention (PCI), with low bleeding rates observed in real-world practice.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Percutaneous coronary intervention (PCI) is a common procedure for coronary artery disease.
- Bivalirudin is an anticoagulant used during PCI.
- Real-world data on bivalirudin use in diverse patient populations is valuable.
Purpose of the Study:
- To characterize the patient population undergoing PCI with bivalirudin in a routine clinical setting.
- To evaluate the ischemic and bleeding events associated with bivalirudin treatment.
Main Methods:
- The European ImproveR registry enrolled 3,799 patients across 102 centers in 12 European countries.
- Data was collected from January 2005 to June 2006.
- Patient characteristics, procedural details, and clinical outcomes were analyzed.
Main Results:
- The study population was elderly (median age 67.2 years) with significant comorbidities including diabetes (27.9%) and renal impairment (14.9%).
- Acute coronary syndromes (ACS) were prevalent (49%), including ST-segment elevation myocardial infarction (STEMI) (22%).
- In-hospital major adverse cardiac events were 2.3%, and 30-day events were 5.6%. In-hospital bleeding occurred in 1.7% of patients.
Conclusions:
- The ImproveR registry highlights a patient profile with high prevalence of elderly individuals, diabetes, renal impairment, and ACS undergoing PCI.
- Bivalirudin demonstrated effectiveness in suppressing ischemic complications.
- The observed low rate of hemorrhagic consequences aligns with findings from randomized trials.
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 IIb/IIIa 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.
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