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Direct thrombin inhibition appears to be a safe and effective anticoagulant for percutaneous bypass graft
John Kao1, A Michael Lincoff, Eric J Topol
1Division of Cardiology, University of Illinois at Chicago, Chicago, IL, USA.
Insights
Bivalirudin with provisional glycoprotein IIb/IIIa inhibition is safe and effective for coronary artery bypass graft percutaneous coronary interventions (CABG PCI). This direct thrombin inhibitor showed similar outcomes to heparin, with reduced minor bleeding events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Percutaneous coronary interventions (PCI) on coronary artery bypass grafts (CABG) have poorer outcomes than native coronary PCI.
- Limited data exists on direct thrombin inhibitors during CABG PCI.
- Investigating bivalirudin with glycoprotein IIb/IIIa (GPIIb/IIIa) blockade in CABG PCI is crucial.
Purpose of the Study:
- To evaluate the safety and efficacy of bivalirudin with GPIIb/IIIa blockade in patients undergoing CABG PCI.
- To compare bivalirudin-based strategies with heparin-based strategies in this patient population.
Main Methods:
- Post hoc analysis of patients from the REPLACE-1 and REPLACE-2 trials undergoing CABG PCI.
- Patients were randomized to heparin or bivalirudin, with GPIIb/IIIa inhibitor use varying (discretionary in REPLACE-1, provisional in REPLACE-2).
- Outcomes assessed included death, myocardial infarction, urgent revascularization, major and minor bleeding, and 12-month mortality.
Main Results:
- No significant differences in combined endpoints (death, MI, urgent revascularization, major bleeding) between bivalirudin and heparin groups.
- Minor bleeding was significantly reduced with bivalirudin (14.8% vs. 22.7%, P=0.037).
- At 12 months, similar efficacy was observed, with a trend towards decreased mortality in the bivalirudin group (4.2% vs. 7.8%, P=0.16).
Conclusions:
- Bivalirudin with provisional GPIIb/IIIa inhibition demonstrates comparable safety and efficacy to heparin with GPIIb/IIIa inhibition in CABG PCI.
- Bivalirudin offers a potential benefit of reduced minor bleeding in this setting.
- These findings support the use of bivalirudin in CABG PCI procedures.
Background:
Percutaneous coronary interventions (PCI) of coronary artery bypass grafts (CABG) are associated with worse outcomes compared with those of native coronary PCI. Little is known concerning the use of direct thrombin inhibition during CABG intervention. The objective of this report is to examine the safety and efficacy of bivalirudin with GPIIb/IIIa blockade inhibition in patients undergoing CABG PCI. GP IIb/IIIa use was provisional in REPLACE-2 and planned in REPLACE-1.
Methods And Results:
A post hoc analysis of patients undergoing CABG PCI in the REPLACE-1 and -2 trials was performed. In REPLACE-1, patients were randomized to either heparin or bivalirudin, with GP IIb/IIIa inhibitor use at the operator's discretion. In REPLACE-2, patients were randomized to heparin plus GP IIb/IIIa inhibition versus bivalirudin with provisional GP IIb/IIIa blockade. In both studies, randomized treatment groups were well matched. In unadjusted and logistic regression analysis, there were no significant differences in the combined endpoint of death, myocardial infarction, urgent revascularization, or major bleeding when patients were treated with either heparin or bivalirudin. Individual safety and efficacy endpoints were also similar. Minor bleeding was significantly reduced in patients treated with bivalirudin (14.8% vs. 22.7%, P = 0.037). Follow-up data available from the REPLACE-2 trial at 12 months found similar efficacy between groups with a trend towards decreased 12 month mortality in the bivalirudin vs. heparin groups (4.2% vs. 7.8%, P = 0.16).
Conclusion:
CABG PCI using bivalirudin with provisional GPIIb/IIIa inhibition appears to provide similar safety and efficacy to heparin with GPIIb/IIIa inhibition.
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