Stent Restenosis Study III - STRESS III

Description:

Stenting vs. PTCA for angiographic restenosis in CAD.

Hypothesis:

To assess the incidence of restenosis in patients undergoing stent implantation with high pressure (> 16 atm) post-dilatation.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 250
Mean Follow Up: 1 year
Female: 0

Patient Populations:

De novo native coronary artery lesions
Vessel size 3.0-4.0mm
Lesion length < 15mm

Primary Endpoints:

Binary restenosis at 6 months

Secondary Endpoints:

Acute and subacute vessel closure

Drug/Procedures Used:

Palmaz-Schatz stents

Concomitant Medications:

Ticlopidine, aspirin

Principal Findings:

The greater acute procedural gain observed with high pressure stent deployment was offset by significantly greater late loss, resulting in no benefit on 6-month luminal diameter or restenosis.

High-pressure deployment and antiplatelet therapy was associated with a 37% reduction in major adverse cardiac events (death, MI, CABG, or target lesion revascularization) at one year compared to the stent arm of the STRESS I trial (12.9% vs 20.5%, p=0.03).

Interpretation:

Although high pressure deployment did not result in improved angiographic outcomes compared to the stent arm of STRESS I, refinements in devices, technique, and pharmacotherapy have significantly improved clinical outcomes.

References:

1. Circulation 98(Suppl I):I-823. Preliminary results

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Dilatation, Stents


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