Investigators in the Florence Randomized Elective Stenting in Acute Coronary Occlusions - FRESCO

Description:

Stenting vs. PTCA for death, reinfarction, or revacularization in acute MI.

Hypothesis:

To compare stenting of the primary infarct-related artery (IRA) with optimal primary angioplasty for patients with an acute myocardial infarction.

Study Design

Study Design:

Patients Screened: 223
Patients Enrolled: 150
Mean Follow Up: 6 months
Mean Patient Age: 62
Female: 29
Mean Ejection Fraction: 51%

Patient Populations:

Chest pain for > 30 min
ST elevation of at least 0.1 mV in two or more contiguous leads
Admission within 6 hours of symptom onset, or admission within 24 hours if there was evidence of continuing ischemia

Exclusions:

Previous administration of fibrinolytic therapy
Stenosis of IRA of < 70%
Inability to identify IRA

Primary Endpoints:

Composite death, reinfarction or repeat target vessel revascularization within 6 months.

Secondary Endpoints:

Angiographic evidence of restenosis or reocclusion at 6 months after randomization.

Drug/Procedures Used:

Intracoronary stents vs. balloon angioplasty.

Concomitant Medications:

IV heparin, aspirin, and ticlopidine.

Principal Findings:

Primary PTCA was attempted in 223 patients. 73 patients were not randomized due to unsuccessful primary PTCA or coronary anatomy. The remaining patients were randomized to stenting (n=75) or no further intervention (n=75).

One-month recurrent ischemia was 3% in the stent group, and 15% in the PTCA group (p=0.009). The restenosis or reocclusion rate was 3% in the stent group and 17% in the PTCA group (p=004).

At 6 months, the incidence of the primary end point was 9% in the stent group and 28% in the PTCA group (p=0.003); the incidence of restenosis or reocclusion was 17% in the stent group and 43% in the PTCA group (p=0.001).

Interpretation:

Primary stenting of the IRA, compared with optimal primary angioplasty, results in a lower rate of major adverse events related to recurrent ischemia and a lower rate of angiographically detected restenosis or reocclusion of the IRA.

References:

1. Journal of the American College of Cardiology 1998;31(6):1234-9. Final results

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Chest Pain, Angioplasty, Balloon, Coronary, Stents


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