Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcomes (ISAR-STEREO) Trial - ISAR-STEREO
Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcomes (ISAR-STEREO) Trial.
Do stents with different strut thickness result in similar restenosis rates and clinical outcomes?
Patients Enrolled: 651
The incidence of angiographic restenosis, defined as a diameter stenosis >50% at 6 months follow-up angiography.
Repeat target vessel revascularization (TVR) due to restenosis-induced symptoms and myocardial infarction (MI).
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).
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.
This study supports the hypothesis that even minor changes in design may be associated with significantly different clinical outcomes.
1. Kastrati A, Mehili J, Dirschinger J et al. Circulation 2001;103:2816-21.
Keywords: Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Constriction, Pathologic, Stents
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