Randomised placebo-controlled and balloon-angioplasty controlled trial to assess safety of coronary stenting with use of platelet glycoprotein IIb/III - EPISTENT

Description:

Abciximab and stenting for death, MI and revascularization in percutaneous intervention.

Hypothesis:

To assess the role of platelet glycoprotein IIb/IIIa blockade in coronary stenting.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 2,399
Mean Follow Up: 6 months, extended follow-up ongoing
Mean Patient Age: 59
Female: 25

Patient Populations:

Scheduled to undergo elective or urgent percutaneous coronary intervention.
Stenosis of at least 60% amenable to angioplasty or stenting.

Exclusions:

Unprotected left main target lesion
Bleeding diathesis
Intracranial neoplasm
Stroke within past 2 years
Uncontrolled hypertension (systolic BP > 180 or diastolic BP > 100 mmHg)
Recent surgery or percutaneous intervention within previous 3 months
Concurrent warfarin therapy with INR > 1.5 control

Primary Endpoints:

Death, myocardial infarction, or urgent revascularization within 30 days

Drug/Procedures Used:

Stenting with abciximab, stenting with placebo, or balloon angioplasty with abciximab. Abciximab: 0.25 mg/kg bolus, followed by infusion of 0.125 mcg/kg/min for 12 hours (maximum 10 mcg/min)

Concomitant Medications:

Heparin, aspirin, standard pharmacological therapy

Principal Findings:

EPISTENT randomized patients to receive stents with placebo (SP, n=809), stents with adjunctive abciximab therapy (SA, n=794), or angioplasty with abciximab therapy (AA, n=796). The two stent arms were double-blinded.

For the combined outcome of death, MI, and urgent revascularization at 30 days, the event rates were 10.8%, 5.3%, and 6.9% for the SP, SA, and AA arms, respectively. The 51% relative reduction between the two stent arms was highly significant (p < 0.001), as was the 36% relative reduction between stent with placebo and balloon angioplasty with abciximab (p < 0.007).

At 6 months, the rate of death, nonfatal MI, or target vessel revascularization was 18.3% for the SP arm compared to 13% for SA (p=0.003) and 20.5% for AA. The incidence of death or myocardial infarction was 11.4% for SP compared to 5.6% for SA and 7.8% for AA. The 51% relative reduction (p < 0.001) between the two stent arms paralleled the highly significant reductions seen at 30 days. For death and large myocardial infarctions, the rates were 9.4%, 4.1%, and 6.9% for the SP, SA, and AA arms, respectively. This represents a further divergence in outcome for the two stent arms compared to the results at 30 days.

Among 491 patients with diabetes mellitus, there was a 6-month reduction of death, myocardial infarction, and target vessel revascularization from 25.2% in the stent with placebo arm to 13.0% (p=0.005) in the stent with abciximab arm. The event rate was 23% for patients receiving balloon angioplasty with abciximab. The incidence of target vessel revascularization was 18.4% in the angioplasty with abciximab group, compared to 16.6% in the stent with placebo group and 8.1% in the stent with abciximab group.

For women, the angioplasty with abciximab arm had the lowest primary event rate at 30 days (5.1% compared to 11.7% for SP and 8.7% for SA). At 6 months, the rates of death, myocardial infarction, and target vessel revascularization had equilibrated (22.5% SP, 20.4% AA, 19.6% SA).

Interpretation:

The 6-month EPISTENT results extend the findings of death and MI reduction observed at 30 days to 6 months.

References:

1. Lancet 1998;352:87-92. Final results

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Coronary Disease, Constriction, Pathologic, Immunoglobulin Fab Fragments, Platelet Membrane Glycoproteins, Diabetes Mellitus, Stents, Percutaneous Coronary Intervention


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