The safety of bivalirudin during elective percutaneous coronary interventions in heart transplant patients
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Insights
Bivalirudin is safe for heart transplant patients undergoing percutaneous coronary intervention (PCI). This study found no deaths or heart attacks in patients receiving bivalirudin, suggesting it is a safe antithrombotic option.
Area of Science:
- Cardiology
- Transplantation Medicine
- Pharmacology
Background:
- Bivalirudin is a proven safe and effective anticoagulant for percutaneous coronary interventions (PCI) in native coronary arteries.
- The safety profile of bivalirudin in heart transplant recipients undergoing PCI remains unestablished.
Purpose of the Study:
- To evaluate the safety and efficacy of bivalirudin in heart transplant patients undergoing PCI.
- To compare outcomes of bivalirudin use in heart transplant recipients with historical data and a control group.
Main Methods:
- Retrospective review of medical records for heart transplant patients who received bivalirudin during PCI for de novo lesions.
- Data collected included adverse events such as death, myocardial infarction, target vessel revascularization, and major bleeding within 30 days post-discharge.
- Outcomes were compared to the REPLACE 2 trial and a control group of heart transplant recipients who received heparin.
Main Results:
- The study included 30 patients (51 PCIs), with a mean age of 56 years (20% female).
- No deaths, myocardial infarctions, or target vessel revascularizations were observed in the bivalirudin group during follow-up.
- The combined endpoint of adverse events occurred in 3.9% of the bivalirudin group, compared to 9.2% in the REPLACE 2 trial and 14.3% in the heparin control group.
Conclusions:
- Bivalirudin demonstrates a favorable safety profile in heart transplant patients undergoing elective PCI.
- The findings suggest bivalirudin is a suitable antithrombotic agent for heart transplant recipients, particularly those with cardiac allograft vasculopathy.
Background:
Bivalirudin has been shown to be safe and effective during percutaneous coronary interventions (PCI) of native coronary arteries in the REPLACE 2 trial. The safety of bivalirudin during PCIs in heart transplant patients is not known.
Methods:
Heart transplant patients who had undergone PCI of de novo lesions and received bivalirudin during the procedure were included in the study. Medical records were reviewed for the occurrence of death, myocardial infarction, target vessel revascularization or major bleeding up to 30 days after discharge. The results were compared with the REPLACE 2 trial and with a control group of heart transplant recipients who received heparin during their procedures.
Results:
There were 51 separate PCIs performed in 30 patients in the study group. The mean age was 56 +/- 12 years and 6 (20%) were women. The control group consisted of 24 patients who had undergone 35 PCIs. There were no deaths, myocardial infarctions or target vessel revascularization during the follow-up period in the study group. The combined endpoint of death, myocardial infarctions, target vessel revascularization and major bleeding requiring two or more units of packed red blood cells occurred in 2 (3.9%) patients compared to 275 (9.2%) patients in the REPLACE 2 trial (p = 0.195) and 5 (14.3%) in the control group (p = 0.115).
Conclusion:
Bivalirudin is a safe antithrombotic medication to use during elective PCI in heart transplant patients with cardiac allograft vasculopathy. (Cardiol J 2007; 14: 458-462).
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