Berlin Stent Study in Acute Myocardial Infarction - BESSAMI

Description:

IVUS-controlled heparinized stent vs. IVUS-guided PTCA in acute MI.

Hypothesis:

To compare IVUS-controlled heparinized stent implantation with IVUS-guided optimal balloon PTCA in the setting of acute MI.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 42 (ongoing)

Patient Populations:

Diagnosis of acute myocardial infarction, confirmed by angiography
Minimum vessel dimension of the smallest reference segment of at least 2.5mm.

Primary Endpoints:

Angiographic outcome

Drug/Procedures Used:

IVUS-guided stent implantation vs IVUS-guided optimal PTCA.

Principal Findings:

The treatment groups for the study are established after successful PTCA. If no dissection is diagnosed by IVUS and angiography, and the IVUS-indicated TIMI flow is 3, patients are assigned to the control group. Optimal results without stenting are assumed to be obtained, and no further intervention is undertaken. If a dissection is diagnosed by IVUS or angiography, or if the TIMI flow is less than 3, patients are randomized into the stent group or the non-stent group.

During the first 3 1/2 months of the study, 42 patients have been enrolled.

No major events occurred in these patients during the acute intervention phase.

In 16% of the patients, IVUS detected a dissection that was missed by angiography.

Interpretation:

Based on the preliminary results of the study, IVUS-guided primary stenting appears to be safe. IVUS may provide more accurate measurements of vessel size than QCA, which may underestimate vessel size.

References:

Presented at the XXth Congress of the European Society of Cardiology, Vienna, 1998

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

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


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