Stent Restenosis Study II - STRESS II

Jan 31, 2002
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Date Published:
01/01/1998
Date Updated:
01/31/2002
Original Posted Date:
01/31/2002
References

Description:

Stenting vs. PTCA for angiographic restenosis in small-vessel CAD.

Hypothesis:

To compare the efficacy of elective stent implantation and balloon angioplasty for new lesions in small coronary arteries.

Study Design

Study Design:

Patients Screened: 598
Patients Enrolled: 331
Mean Patient Age: 60
Female: 28

Patient Populations:

Symptomatic coronary artery disease
De novo > 70% stenosis in native coronary vessel
Lesion length < 15mm
Reference vessel diameter < 3.0mm

Primary Endpoints:

Angiographic restenosis at 6 months
Clinical outcomes at 1 year

Secondary Endpoints:

Minimal luminal diameter at 6 months

Drug/Procedures Used:

Palmaz-Schatz stent

Principal Findings:

By quantitative coronary angiography, 331 patients in the Stent Restenosis Study (STRESS) I-II were determined to have a reference vessel < 3.0 mm in diameter. Of these, 163 patients were randomly assigned to stenting and 168 to angioplasty.

Reference vessel diameter was similar between the two groups (2.69 +/- 0.21mm stent vs.2.64 +/- 0.24mm angioplasty)

At 30 days, abrupt closure occurred in 3.6% of patients in both groups.

Compared with angioplasty, stenting conferred a significantly larger postprocedural lumen diameter (2.26 vs. 1.80mm, p < 0.001) and a larger lumen at 6 months (1.54 vs. 1.27mm, p < 0.001).

At 6 months, restenosis occurred in 34% of patients assigned to stenting and in 55% of patients assigned to angioplasty (p < 0.001).

At 1 year, event-free (death, MI, or revascularization) survival was achieved in 78% of the stent group and in 67% of the angioplasty group (p = 0.019). Repeat target lesion revascularization was significantly less frequent in the stent group (16.1% vs 26.6%, p = 0.015).

Interpretation:

The STRESS I study noted a higher rate of restenosis after percutaneous intervention in vessels < 3mm. Palmaz-Schatz stents have been designed and approved by the Food and Drug Administration for use in coronary arteries with diameters ≥3.0mm. These findings suggest that elective stent placement provides superior angiographic and clinical outcomes than balloon angioplasty in vessels slightly smaller than 3mm.

References:

1. JACC 1998;31:307-11. Final results

Keywords: Coronary Artery Disease, Coronary Angiography, United States Food and Drug Administration, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents


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