High-Dose, Bolus-Only, Glycop rotein IIb/IIIa Inhibitors for Elective Coronary Intervention: Logical, Safe, Cost-Effective, an
- Volume 20 - Issue 2 - February, 2008
- Posted on: 8/1/08
- 0 Comments
- 2131 reads
An important recent randomized clinical study has demonstrated the safety and efficacy of bolus-only abciximab with outpatient PCI compared to overnight stay after PCI with conventional bolus plus infusion of abciximab.14 This randomized clinical trial adds further support for the use of a bolus-only IIb/IIIa inhibitor for elective PCI.
Cost savings using high-dose bolus IIb/IIIa inhibitors. The hospital-discounted price of an eptifibatide regimen in the PURSUIT study was $1,014.20 The median cost of an eptifibatide regimen in the ESPRIT study was $502.21 The costs of anticoagulant in the bivalirudin and eptifibatide arms of the REPLACE-2 study were $530 and $930, respectively.7 In contrast, a single vial of eptifibatide used in our study13 was only $59. The cost of a dose of 25 μg/kg of tirofiban (1.75 mg bolus dose for a 70 kg male), as was used in the current study by Marmur et al,15 would cost $52.80 at our medical center. When combined with the small cost for weight-adjusted heparin, the total cost for procedural anticoagulation using a high-dose single bolus eptifibatide or tirofiban would be ~$70 per patient. This represents a substantial cost savings for centers currently using either conventional IIb/IIIa inhibitors (bolus + drip) or bivalirudin. Additional cost savings may also be realized with the elimination of prolonged intravenous dosing after the procedure, as well as the costs associated with incremental bleeding, which may be associated with conventional (prolonged) dosing of IIb/IIIa inhibitors.
Limitations of current data on high-dose bolus IIb/IIIa inhibitors. There are some limitations in the interpretation of the high-dose, bolus-only IIb/IIIa inhibitor studies. The majority of the data, including the current study, are prospective, observational studies, without a defined (conventional IIb/IIIa inhibitor) control group. Despite this limitation, comparison to previously published studies such as ESPRIT and REPLACE-2 provide contemporary historical control data from a similar cohort of patients undergoing elective intervention. There is only one randomized clinical trial using bolus IIb/IIIa inhibition versus conventional dosing, which demonstrated equivalency of a high-dose bolus compared to bolus plus infusion.14 However, this study utilized only a transradial approach and may not be directly translatable to transfemoral PCI.
Conclusions. Despite the limitations of the studies of high-dose bolus IIb/IIIa inhibitor use, the current study by Marmur et al adds to the growing body of evidence suggesting that a high-dose bolus administration of potent IIb/IIIa inhibitors may provide a safe, clinically effective and highly cost-effective strategy for elective PCI.11–15
Ultimately, it will be important to perform a large-scale randomized clinical trial examining the relative safety, efficacy and cost-effectiveness of high-dose bolus IIb/IIIa inhibition compared to conventional IIb/IIIa inhibitor dosing (bolus plus drip) and to conventional dosing with the direct thrombin inhibitor, bivalirudin. Since it is unlikely that the pharmaceutical industry would sponsor such a trial, it is incumbent upon the interventional cardiology community to organize and find alternative funding for this important study.