Stent or PTCA for Occluded Coronary Arteries in Patients With Acute MI - STOP-AMI 4

Dec 01, 2004
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Date Published:
01/01/2004
Date Updated:
12/01/2004
Original Posted Date:
12/01/2004
References

Description:

The goal of the trial was to evaluate the use of balloon angioplasty versus stenting in patients with acute myocardial infarction (MI) with failed thrombolysis.

Study Design

Study Design:

Patients Enrolled: 181
Mean Follow Up: One year
Mean Patient Age: Median age 62 years
Female: 25
Mean Ejection Fraction: Median 53%

Patient Populations:

Diagnosis of acute MI based on ≥1 episode of chest pain lasting ≥20 minutes within 12 hours from start of thrombolysis and accompanied by ST-segment elevation or left bundle branch block of new onset on surface electrocardiogram; thrombolysis performed within the previous 24 hours; and TIMI flow grade ≤2 during coronary angiography of the infarct-related artery

Primary Endpoints:

Salvage index, defined as the proportion of initial perfusion defect salvaged by rescue intervention on SPECT

Drug/Procedures Used:

Patients treated with thrombolytic therapy in the prior 24 hours were randomized open-label to balloon angioplasty (n=91) or stenting (n=90). Scintigraphic studies were performed prior to randomization and at 7-10 days.

Concomitant Medications:

• Aspirin (500 mg intravenous), heparin (up 5000 U if activated clotting time <200 seconds), and abciximab (0.25 mg/kg bolus plus 0.125 µg/kg/min infusion for 12 hours).
• Postintervention aspirin (200 mg) indefinitely and thienopyridines (ticlopidine or clopidogrel) for at least four weeks.

Principal Findings:

Baseline characteristics were well-balanced between treatment groups. Median time from thrombolytic therapy administration to randomization was 9.6 hours in the stent group and 10.5 hours in the balloon angioplasty group. Reteplase was used in 63% of patients and streptokinase in 34%. Crossover to stent use was performed in 22% of patients in the angioplasty group.

Infarct size trended smaller in the stent group (18.6% vs. 21.6%, p=0.29). Salvage index, the primary endpoint, was greater in the stent group compared with the angioplasty group (0.35 vs. 0.25, p=0.005). When analyzed as treated, there was a trend for larger salvage index in the stent group (0.35 vs. 0.25, p=0.08).

Major bleeding through 30 days occurred in four patients in each group. At one year, there was no difference in death (8% for stent group vs. 12% for balloon angioplasty group, p=0.35), reinfarction (3% for stent vs. 1% for angioplasty, p=0.31), or target vessel revascularization (13% vs. 20%, p=0.18).

Interpretation:

Among patients with acute MI with failed thrombolysis, treatment with stenting was associated with a greater salvage index compared with balloon angioplasty.

Randomized data on treatment of patients with failed thrombolysis are limited. The REACT trial reported a reduction in the composite endpoint of death, MI, cerebrovascular accident, or severe heart failure at six months in patients treated with angioplasty compared with repeat thrombolysis or conservative management. However, use of stenting or balloon angioplasty in the angiography arm was at the discretion of the investigator.

The present study did not show a benefit in clinical outcomes for stenting compared with balloon angioplasty, but the trial was not powered to detect such a difference. A larger trial would be needed to evaluate clinical outcomes.

References:

Schomig A, Ndrepepa G, Mehilli J, et al. A randomized trial of coronary stenting versus balloon angioplasty as a rescue intervention after failed thrombolysis in patients with acute myocardial infarction. J Am Coll Cardiol 2004;44:2073-9.

Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Electrocardiography, Angioplasty, Balloon, Coronary, Stents, Streptokinase, Coronary Angiography, Chest Pain, Research Personnel, Heart Failure, Bundle-Branch Block, Tissue Plasminogen Activator


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