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Published on: January 21, 2018
A Double-Blinded Randomized Controlled Trial Comparing Eptifibatide Bolus Only Versus Bolus Plus Infusion In Patients
Mehdi Mousavi1, Fatemeh Sehati2, Amirhossein Tayebi2
1Nipawin Hospital, Saskatchewan Health Authority, Niapwin, SK, Canada.
Insights
Eptifibatide bolus only during percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is as safe as continuous infusion. This approach reduces costs without increasing bleeding or ischemic complications.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Current guidelines recommend continuous infusion of eptifibatide with heparin during PCI for STEMI.
- Emerging evidence suggests bolus-only eptifibatide may be sufficient and cost-effective.
- Randomized trials are needed to confirm the efficacy and safety of bolus-only eptifibatide.
Purpose of the Study:
- To compare the safety and efficacy of bolus-only eptifibatide versus continuous infusion in patients undergoing PCI for STEMI.
- To evaluate vascular, bleeding, and ischemic complications in both treatment groups.
Main Methods:
- A double-blinded, randomized controlled trial involving 330 patients with STEMI undergoing PCI.
- Patients received either 75 mg IV eptifibatide infusion or a placebo, following an initial bolus.
- Primary outcomes included vascular or bleeding complications; secondary outcomes included ischemic complications.
Main Results:
- No significant differences in major bleeding, hematoma, or ecchymosis between the bolus-only and bolus plus infusion groups.
- Multivariate analysis showed no significant differences in bleeding events.
- In-hospital death and ischemic events, including stent thrombosis, were similar between groups.
Conclusions:
- Eptifibatide bolus only during PCI for STEMI is a safe alternative to continuous infusion.
- This approach does not increase the risk of bleeding or ischemic complications.
- Using eptifibatide bolus only can be a cost-saving strategy for STEMI patients undergoing PCI.
Backgrounds:
The use of eptifibatide combined with heparin during percutaneous coronary intervention (PCI) in patients presenting with ST-elevation myocardial infarction (STEMI) is recommended to be followed by continuous infusion. Recently, there are some suggestions that using bolus only may be sufficient and cost-effective but randomized trials are lacking.
Aims:
The goal of this study was to evaluate these two approaches in a double-blinded randomized control trial.
Methods:
The primary PCI patients who received bolus eptifibatide were randomized to 75 mg IV eptifibatide infusion or placebo blindly. The patients were followed up for the primary outcome of vascular or bleeding complications and secondary outcome of ischemic complications.
Results:
330 patients (165 from each group) completed the study. The mean age was 57.67 ± 11.53 years and 77.3 % were male. Major bleeding was seen in 1 patient in each group. Hematoma occurred in 8.5 %. The relative risk of hematoma and ecchymosis in bolus plus infusion group to bolus only group were 0.988 (95 % CI: 0.486-2.006) and 1.032 (95 % CI: 0.729-1.459). Multivariate analysis confirmed no significant differences in the bleeding event. Furthermore, there was no significant difference in in-hospital death or any ischemic events. (Cath lab death: 1.4 % in bolus only vs zero % in the control group, p = 0.217, stent thrombosis was seen in one patient in each group).
Conclusion:
There were no differences in the risk of access site ecchymosis, hematoma or major bleeding. Ischemic events and stent thrombosis rates were also similar. Our study suggests that using eptifibatide bolus only during PCI of patients with STEMI is safe and can be cost-saving.
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