Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcomes (ISAR-STEREO) Trial - ISAR-STEREO

Description:

Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcomes (ISAR-STEREO) Trial.

Hypothesis:

Do stents with different strut thickness result in similar restenosis rates and clinical outcomes?

Study Design

Study Design:

Patients Enrolled: 651

Primary Endpoints:

The incidence of angiographic restenosis, defined as a diameter stenosis >50% at 6 months follow-up angiography.

Secondary Endpoints:

Repeat target vessel revascularization (TVR) due to restenosis-induced symptoms and myocardial infarction (MI).

Drug/Procedures Used:

Patients were randomized to receive either a thin-strut stent (n=326, ACS MultiLink stent) or a thick-strut stent (n=325, ACS MultiLink Duett stent). Procedure success was defined by stent placement with a procedural stenosis of <30% and TIMI flow >/=2. The primary end point was the incidence of angiographic restenosis, defined as a diameter stenosis >50% at 6 months follow-up angiography. Secondary end points included repeat target vessel revascularization (TVR) due to restenosis-induced symptoms and myocardial infarction (MI).

Principal Findings:

Baseline demographic and clinical data were similar between the two groups. At 30 days, the mortality rate was 1.5% in the thin-strut group and 2.5% in the thick-strut group (p=0.40). Myocardial infarction was observed in 0.9% and 1.2% of patients, respectively. At 30 days, urgent TVR was the same in the two groups (1.5%). At 6-month follow-up, angiography was obtained in 79.1% of eligible patients in the thin-strut group and 82.1% of patients in the thick-strut group. Late lumen loss was significantly lower in the thin-strut group when compared to the thick-strut group (0.94±0.74 mm vs. 1.17±0 .78 mm, p=0.001). The lower late lumen loss in the thin-strut group was associated with a lower restenosis rate (15% vs. 25.8%, p=0.003). After adjustment for length of the stented segment and for final post-procedure diameter stenosis, the thin-strut stent was associated with a lower incidence of restenosis (adjusted OR 0.42, 95% CI 0.26–0.68). At 1-year follow-up, 8.6% of the thin-strut stent patients and 13.8% of the thick-strut stent patients required TVR because of restenosis-related ischemia (p=0.03).

When compared with thick-strut stents, thin-strut stents result in a lower restenosis rates and better clinical outcome.

Interpretation:

This study supports the hypothesis that even minor changes in design may be associated with significantly different clinical outcomes.

References:

1. Kastrati A, Mehili J, Dirschinger J et al. Circulation 2001;103:2816-21.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Constriction, Pathologic, Stents


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