September 10, 2008European Heart Journal
Profile of bleeding and ischaemic complications with bivalirudin and unfractionated heparin after percutaneous coronary intervention
Why the study?
The study aimed to identify patients at high risk of bleeding or myocardial infarction after PCI and determine whether these subsets derive preferential benefit from heparin or bivalirudin.
Does bivalirudin reduce major bleeding or myocardial infarction compared to unfractionated heparin in patients with coronary artery disease undergoing percutaneous coronary intervention?
Key Points
- This study aims to identify high-risk patients for bleeding or myocardial infarction post-percutaneous coronary intervention and assess the benefit of bivalirudin versus heparin.
- 4570 patients with coronary artery disease were randomized to receive either bivalirudin or heparin.
- The study tracked in-hospital major bleeding and 30-day myocardial infarction incidence as primary outcomes.
- Bivalirudin reduced major bleeding to 3.1% compared to 4.6% with heparin (P = 0.008), especially in low-risk patients.
- 140 major bleeding, 204 myocardial infarction, and 34 combined events were recorded across the cohort.
- Bivalirudin showed an inverse correlation between reduced bleeding risk and increased myocardial infarction risk (R = -0.61).
Structured PICO
Does bivalirudin reduce major bleeding or myocardial infarction compared to unfractionated heparin in patients with coronary artery disease undergoing percutaneous coronary intervention?
P
Population
4570 patients with coronary artery disease undergoing percutaneous coronary intervention (enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment trial)
I
Intervention
Bivalirudin
C
Comparator
Unfractionated heparin
O
Outcome
In-hospital incidence of major bleeding and 30-day incidence of myocardial infarctionhard clinical
Bivalirudin reduces major bleeding compared to unfractionated heparin during PCI, primarily in low-risk patients, but this benefit is inversely correlated with an increased risk of myocardial infarction.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“unfractionated heparin may be a better choice [because of its lower] cost, but in certain patient subgroups one drug may be better than the other”
HWHarvey WhiteProfessor of cardiology, University of New Zealand Auckland
“The composite end point was numerically in favor of bivalirudin, there was no [significant] increase in ischemic events [with bivalirudin], and major bleeds were reduced. The results show that bivalirudin is the antithrombotic of choice”
Implication
Challenges assumption of greater bivalirudin benefit in high-bleeding-risk PCI; leaves open personalized strategies balancing bleeding and ischaemic trade-offs.
Abstract
AIMS: The aim of this study was to identify a subset of patients at high risk of bleeding or myocardial infarction from a percutaneous coronary intervention and to investigate whether such high-risk subsets derive preferential benefit from heparin or bivalirudin. METHODS AND RESULTS: This study included 4570 patients with coronary artery disease enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment trial and randomized to receive bivalirudin or heparin. Primary outcomes were in-hospital incidence of major bleeding and 30-day incidence of myocardial infarction. Major bleeding, myocardial infarction, and bleeding plus myocardial infarction occurred in 140, 204, and 34 patients, respectively. Older age, female sex, lower body weight, low cholesterol, multi-lesion intervention, complex lesions, and heparin therapy were independent correlates of increased risk of bleeding. Multi-lesion intervention, unstable angina, and lower body weight correlated independently with increased risks of myocardial infarction. Compared with heparin, bivalirudin was associated with a reduction in major bleeding (3.1 vs. 4.6%, P = 0.008), but mostly in low-risk patients. A reduction in the bleeding risk inversely correlated with an increase in the risk of myocardial infarction with bivalirudin (R = -0.61). CONCLUSION: Bivalirudin and unfractionated heparin have a differential effect on risk of bleeding and myocardial infarction across various subsets of patients.
Discussion
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Cite This Study
Iijima et al. (2008) studied this question.