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