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Bivalirudin versus heparin in patients treated with percutaneous coronary intervention: a meta-analysis of randomised
Salvatore Cassese1, Robert A Byrne, Karl-Ludwig Laugwitz
1Deutsches Herzzentrum, Technische Universität München, Munich, Germany.
Insights
Bivalirudin reduces major bleeding during percutaneous coronary intervention (PCI) compared to heparin alone. However, bivalirudin increases the risk of acute stent thrombosis (ST) despite similar mortality rates.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Current guidelines for bivalirudin use in percutaneous coronary intervention (PCI) primarily stem from comparisons with heparin plus glycoprotein IIb/IIIa inhibitors.
- The comparative efficacy and safety of bivalirudin versus heparin alone in PCI patients without planned glycoprotein IIb/IIIa inhibitors remain less established.
Purpose of the Study:
- To investigate the efficacy and safety of bivalirudin compared to heparin in patients undergoing PCI without the planned use of glycoprotein IIb/IIIa inhibitors.
- To evaluate outcomes including death, major bleeding, myocardial infarction, stent thrombosis, and target vessel revascularization.
Main Methods:
- A meta-analysis of randomized controlled trials was conducted.
- Data from 10 trials involving 18,065 patients were analyzed.
- Primary outcomes were 30-day death and major bleeding; secondary outcomes included myocardial infarction, stent thrombosis, and urgent target vessel revascularization.
Main Results:
- Bivalirudin showed a comparable risk of death and myocardial infarction to heparin.
- A trend towards a higher risk of urgent target vessel revascularization was observed with bivalirudin.
- Bivalirudin significantly reduced the risk of major bleeding, particularly when compared to high-dose heparin.
- A significantly increased risk of definite and acute stent thrombosis was associated with bivalirudin use.
Conclusions:
- Bivalirudin and heparin demonstrate similar mortality rates in patients undergoing PCI.
- Bivalirudin use is associated with a reduced risk of major bleeding.
- The benefit of reduced bleeding with bivalirudin comes at the cost of an increased risk of acute stent thrombosis.
Aims:
Current recommendations on the use of bivalirudin in patients treated with percutaneous coronary intervention (PCI) are mostly based on trials comparing bivalirudin versus heparin plus planned glycoprotein IIb/IIIa inhibitor (GPI). Whether bivalirudin is also superior to heparin alone is still not well established. This meta-analysis investigates the efficacy and safety of bivalirudin versus heparin in patients treated with PCI without planned use of GPI.
Methods And Results:
Scientific databases and websites were searched for randomised controlled trials. The primary efficacy and safety outcomes were the 30-day incidence of death and major bleeding, respectively. The secondary outcomes were the 30-day incidence of myocardial infarction (MI), definite stent thrombosis (ST), urgent target vessel revascularisation (TVR), and overall death at the longest available follow-up. Odds ratio (OR) and 95% confidence interval (95% CI) served as summary statistics. Ten trials were identified including a total of 18,065 PCI patients randomised to bivalirudin (n=9,033) versus heparin (n=9,032). At 30 days, bivalirudin versus heparin showed a comparable risk of death (1.09 [0.83-1.41], p=0.54), and MI (1.10 [0.83-1.46], p=0.50) with a trend towards a higher risk of urgent TVR (1.37 [0.96-1.96], p=0.08). The risk of major bleeding was lower with bivalirudin (0.57 [0.40-0.80], p=0.001) and the bleeding reduction was more evident when high doses of heparin were used as comparator (p for interaction <0.001). The risk of definite ST (2.09 [1.26-3.47], p=0.005) and, in particular, the risk of acute ST (3.48 [1.66-7.28], p<0.001) was increased by bivalirudin.
Conclusions:
Patients undergoing PCI randomised to therapy with either bivalirudin or heparin display a similar mortality. Bivalirudin as compared to heparin appears to reduce the risk of major bleeding at the expense of a higher risk of acute ST.
