Facilitation of Early Percutaneous Coronary Intervention After Rateplase With or Without Abciximab in Acute Myocardial Infarction. Results From the SPEED (GUSTO-4 Pilot) Trial - SPEED (GUSTO-4 Pilot) Trial PCI Substudy

Description:

Facilitation of Early Percutaneous Coronary Intervention After Rateplase With or Without Abciximab in Acute Myocardial Infarction. Results From the SPEED (GUSTO-4 Pilot) Trial

Hypothesis:

Prior studies have shown no benefit from early PCI performed after thrombolysis alone. However, the results of these studies might not be applicable to contemporary practice, which is characterized by new technology and new pharmacological interventions.

Study Design

Study Design:

Patients Enrolled: 485

Drug/Procedures Used:

The utility of early PCI was analyzed in 485 patients enrolled in the SPEED (GUSTO-4 pilot) trial that encouraged the use of early PCI after thrombolysis and glycoprotein IIb/IIIa inhibition for acute myocardial infarction. Planned initial angiography was performed at a median of 63 minutes from beginning of reperfusion therapy. Clinical outcomes were compared between early PCI patients (n = 323) and non-early PCI patients (n = 162), between patients with TIMI flow grade 0 or 1 before early PCI and patients with TIMI flow grade 2 or 3, and among three treatment regimens. The three treatment regimens included full-dose rateplase (10+10 U), abciximab alone (0.25 μg/kg bolus and 12-hour infusion at 0.125 μg/kg/min) and the combination abciximab/reduced-dose rateplase (5+5 U).

Principal Findings:

Early PCI was used more often in patients with initial TIMI flow grade 0 or 1 vs. flow grade 2 or 3 (83% vs. 60%, p < 0.0001). In the early PCI group, the procedural success rate was 88%, with 78% of patients receiving coronary stents. When compared with patients who did not undergo early PCI, the early PCI group had a significantly lower incidence of reinfarction (1.2 vs. 4.9%, p = 0.03), urgent revascularization (1.6% vs. 9.3%, p = 0.001), transfusion requirement (9.0% vs. 16%, p = 0.02) and a significantly higher clinical success rate (85.4% vs. 70.4%, p < 0.001) (combined end point defined as freedom from death, reinfarction, urgent revascularization, major bleeding or transfusion at 30 days).

Interpretation:

The suboptimal outcomes of early PCI after successful or failed thrombolysis alone have been well documented in the era before coronary stenting. The answer to this question may have changed now in the era that includes stenting, glycoprotein 2b3a inhibition and thienopyridines. The paradox of this trial is that most of the patients who underwent urgent adjunctive/rescue PCI were not in the combination therapy arm, but rather were in the rPA monotherapy arm. So paradoxically, the study does not provide much insight into the benefits of PCI following combination therapy.

References:

Herrmann HC, Moliterno DJ, Ohman ME, et al. J Am Coll Cardiol 2000;36:1489-96. Gibson CM. A union in reperfusion: The concept of facilitated PCI. J Am Coll Cardiol 2000; Nov 1;36(5):1497-9.

Clinical Topics: Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Lipid Metabolism

Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Fibrinolytic Agents, Immunoglobulin Fab Fragments, Tissue Plasminogen Activator, Stents, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Thienopyridines


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