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Efficacy and Safety of a Routine Early Invasive Strategy After Fibrinolysis Stratified by Glycoprotein IIb/IIIa Inhibitor Use During Percutaneous Coronary Intervention: A Pre-Specified Subgroup Analysis of the TRANSFER-AMI Randomised Controlled Trial
Study Questions:
What is the efficacy and safety of an early invasive strategy post-fibrinolysis in relation to glycoprotein (GP) IIb/IIIa inhibitor use?
Methods:
The TRANSFER-AMI (Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction) study randomized 1,059 patients with ST-segment elevation myocardial infarction to an early invasive strategy or standard therapy post-fibrinolysis. The primary endpoint was the composite of death, reinfarction, recurrent ischemia, new or worsening heart failure, or cardiogenic shock at 30 days. In this prespecified analysis, the investigators examined efficacy and safety outcomes of an early invasive strategy after stratification by GP IIb/IIIa inhibitor use, which was permitted during percutaneous coronary intervention (PCI) at the discretion of the treating physician.
Results:
A total of 695 patients (65.6%) received GP IIb/IIIa inhibitors. There was significant heterogeneity (p < 0.001) in the efficacy of an early invasive strategy compared to standard therapy, between the strata with GP IIb/IIIa inhibitor use (primary endpoint 9.6% vs. 22.3%, respectively; p < 0.001) and without GP IIb/IIIa inhibitor use (primary endpoint 14.8% vs. 10.4%, respectively; p = 0.21). Patients who received GP IIb/IIIa inhibitors had lower Global Registry of Acute Coronary Events (GRACE) risk scores compared to those without GP IIb/IIIa inhibitor use (median 121 vs. 130, p < 0.001). After adjusting for the interaction between GRACE risk score and treatment assignment, the heterogeneity in the efficacy of an early invasive strategy with respect to GP IIb/IIIa inhibitor use was no longer significant (p interaction = 0.08).
Conclusions:
The authors concluded that the apparent difference in the efficacy of an early invasive strategy between GP IIb/IIIa inhibitor strata likely reflects an association between GP IIb/IIIa inhibitor use and baseline risk.
Perspective:
This analysis of the TRANSFER-AMI trial demonstrated an apparent heterogeneity in the efficacy of an early invasive strategy in relation to GP IIb/IIIa inhibitor use. The use of GP IIb/IIIa inhibitors during PCI did not have a significant modulating effect on the safety or efficacy of an early invasive strategy post-fibrinolysis after adjusting for baseline differences in GRACE risk score. It is possible that experienced clinicians appropriately tailored the use of GP IIb/IIIa inhibitors based on baseline risk, and this may explain the apparent heterogeneity in the treatment effect of an early invasive strategy between the GP IIb/IIIa inhibitor strata. Additional prospective studies are indicated to validate these findings.
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