Immediate Coronary Angioplasty with Elective Wiktor Stent Implantation Compared with Conventional Balloon Angioplasty in Acute Myocardial Infarction - STENTIM-2

Description:

Stenting vs. PTCA for restenosis in CAD.

Hypothesis:

To compare primary stenting to primary balloon angioplasty in acute myocardial infarction.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 211

Patient Populations:

Randomization performed prior to wire recanalization

Exclusions:

Bifurcation lesions
Extensive calcification
Left main coronary disease

Primary Endpoints:

Combined angiographic restenosis and reocclusion at 6 months

Secondary Endpoints:

In-hospital death, reinfarction, repeat procedures

Drug/Procedures Used:

Wiktor stent versus conventional balloon angioplasty.

Principal Findings:

Computerized randomization divided patients into two groups: a stent group (101 patients) and a balloon group (110 patients). Thirty-five percent of patients assigned to the balloon group required rescue stenting for dissection or residual stenosis > 50%.

The following data were obtained from 90 patients in the balloon group before PTCA: reference diameter 2.90 ± 0.48, MLD 0.13 ± 0.32, and % stenosis 95.38 ± 11.24. Data from 77 patients in the stent group before PTCA showed reference diameter 2.67 ± 0.54, MLD 0.10 ± 0.28, and % stenosis 96.35 ± 10.26.

After PTCA, the values for the balloon group were as follows: reference diameter 2.95 ± 0.47, MLD 2.12 ± 0.50, and % stenosis 28.22 ± 10.63. For the stent group, the values were reference diameter 2.98 ± 0.41, MLD 2.42 ± 0.36, and % stenosis 18.43 ± 6.68.

At the six-month follow-up, the values for the balloon group were reference diameter 2.82 ± 0.53, MLD 1.60 ± 0.50, and % stenosis 43.25 ± 14.50. The values for the stent group were reference diameter 2.88 ± 0.54, MLD 1.79 ± 0.58, and % stenosis 37.96 ± 15.03.

The clinical follow-up at 6 months showed a higher incidence of re-PTCA for the balloon group (25.5% versus 15.8%). The balloon group also had more ischemic events (15.5% versus 11.9%). The 6-month event-free survival rate was 81.2% for the stent group and 75.5% for the balloon group.

Interpretation:

The STENTIM-2 investigators concluded that primary stenting in acute myocardial infarction improves angiographic outcomes compared to primary balloon angioplasty. There was no significant difference in event-free survival at 6 months, although there were fewer ischemic events and revascularization procedures in the stented group.

References:

1. Eur Heart J 1998;19(Abstr Suppl):59.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Research Personnel, Disease-Free Survival, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents


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