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An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention
Rahman Shah1, Kelly C Rogers2, Khalid Matin3
1Section of Cardiology, University of Tennessee, School of Medicine, Memphis, TN; Veterans Affairs Medical Center, Memphis, TN.
Insights
Bivalirudin reduces mortality and bleeding in primary percutaneous coronary intervention (PCI) compared to heparin. However, it increases stent thrombosis risk, with bleeding benefits influenced by concurrent P2Y12 inhibitors, radial access, and avoiding routine glycoprotein IIb/IIIa inhibitors.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- The optimal anticoagulant for primary percutaneous coronary intervention (PCI) remains debated despite numerous studies.
- Bivalirudin and heparin are common anticoagulants used in primary PCI.
- Glycoprotein IIb/IIIa inhibitors (GPI) are sometimes used adjunctively.
Purpose of the Study:
- To conduct an updated meta-analysis comparing bivalirudin and heparin in primary PCI.
- To evaluate safety and efficacy outcomes, including mortality, major adverse cardiac events, and bleeding.
- To examine factors modulating outcomes, such as GPI use, access site, and P2Y12 inhibitors.
Main Methods:
- Systematic search of scientific databases for randomized clinical trials.
- Inclusion of 6 trials with 14,095 patients comparing bivalirudin and heparin.
- Random-effects models used for pooled risk ratios; moderator analyses performed.
Main Results:
- Bivalirudin showed similar rates of major adverse cardiac events and net adverse clinical events compared to heparin.
- Bivalirudin significantly reduced all-cause mortality (RR 0.81) and cardiac mortality (RR 0.68).
- Bivalirudin decreased major bleeding by 37% (RR 0.63) but increased acute stent thrombosis (RR 3.31).
Conclusions:
- Bivalirudin offers mortality and bleeding reduction benefits in primary PCI versus heparin, with comparable major adverse cardiac events.
- The bleeding reduction benefit of bivalirudin is influenced by the use of second-generation P2Y12 inhibitors, radial access, and avoidance of routine GPI with heparin.
- Higher rates of acute stent thrombosis necessitate careful consideration in clinical practice.
Background:
Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI.
Methods And Results:
Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95% CI 0.87-1.19, P = .800), myocardial infarction (RR 1.41, 95% CI 0.94-2.11, P = .089), target vessel revascularization (RR 1.37, 95% CI 0.91-2.04, P = .122), and net adverse clinical events (RR 0.81, 95% CI 0.64-1.01, P = .069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95% CI 0.67-0.99, P = .041) and cardiac mortality (RR 0.68, 95% CI 0.51-0.91, P = .009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95% CI 1.79-6.10, P < .001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37% (RR 0.63, 95% CI 0.44-0.90, P = .012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95% CI 0.23-0.81, P = .009) vs bailout (RR 0.73, 95% CI 0.42-1.25, P = .252), predominantly radial access (RR 0.54, 95% CI 0.25-1.15, P = .114) vs non-radial access (RR 0.60, 95% CI 0.36-0.99, P = .049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95% CI 0.40-1.24, P = .226) vs clopidogrel use (RR 0.39, 95% CI 0.18-0.85, P = .018).
Conclusions:
In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin.
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