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Restenosis Stent Trial - REST
Description:
Stenting vs. PTCA for 6-month angiographic outcomes in restenosis.
Hypothesis:
To compare stenting versus balloon angioplasty for restenotic lesions.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: Planned 400
Mean Follow Up: 6 months
Female: 0
Patient Populations:
Native coronary artery lesions
Restenotic lesions
Vessel size > 3mm
Lesion length < 20mm
Primary Endpoints:
6-month angiographic restenosis rate
Major adverse clinical events at 6 months
Drug/Procedures Used:
Palmaz-Schatz stents vs. balloon angioplasty.
Principal Findings:
Preliminary results are available for the first 172 lesions treated; 85 were assigned to stenting and 87 to balloon angioplasty.
Pre-procedure MLD was similar for both groups (1.25 ± 0.44 mm stent, 1.25 ± 0.35 mm balloon). Post-procedure MLD was 3.12 ± 0.43 mm for the stent group, and 2.33 ± 0.57 mm for the angioplasty group. At 6 months, the follow-up MLD remained higher for the stent group (2.14 ± 0.66 mm vs 1.86+±0.56).
Binary restenosis rates were 11.7% for the stent group and 37.0% for the PTCA group.
Bleeding complications were slightly higher for the stent group (12.3%) compared to the angioplasty group (4.6%).
There was an incidence of subacute thrombosis of 3.5% in the stent group.
Interpretation:
These preliminary results suggest that stenting in restenotic lesions improves angiographic outcomes at 6 months.
References:
1. J Am Coll Cardiol 1996; 28:139A. Preliminary results
Keywords: Incidence, Follow-Up Studies, Thrombosis, Coronary Disease, Angioplasty, Balloon, Coronary, Stents
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