Impact of Intravascular Ultrasound Guidance in Stent Deployment on 6-month Restenosis Rate: A Multicenter, Randomized Study Comparing Two Strategies--With and Without Intravascular Ultrasound Guidance - RESIST

Jul 25, 2005
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Date Published:
01/01/1998
Date Updated:
07/25/2005
Original Posted Date:
07/25/2005
References

Description:

RESIST is a randomized study comparing IVUS (intravascular ultrasound) guided coronary stent deployment with standard stent deployment on 6-month restenosis rate.

Hypothesis:

IVUS-guided stent deployment may improve the 6-month rate of coronary restenosis.

Study Design

Study Design:

Patients Enrolled: 155
Mean Follow Up: 6 months
Mean Patient Age: Mean of 56 in non-IVUS group and 57 in IVUS group
Female: 10
Mean Ejection Fraction: Mean of 51% and 53% in the non-IVUS and IVUS group, respectively

Patient Populations:

  • Symptomatic Coronary Artery Disease and Single-Vessel or Native Multivessel disease with >70% stenosis of the target lesion
  • Single <20 mm stent deployment
  • Balloon/Artery Ratio of 1.0-1.2
  • Ballon inflation pressure >12 atm for Palmaz-Schatz or NIR stent and >9 atm for premounted AVE or Freedom stent
  • Optimal angiographic result after stent implantation without dissection or residual stenosis

Exclusions:

  • Vessel diameter <3.0 mm
  • Coronary lesion >15mm in length
  • Previous bypass surgery
  • Contraindication to antiplatelet therapy
  • Treatment of acute or chronic total occlusion
  • Saphenous vein graft stenosis
  • Recent (<7 days) acute coronary syndrome

Primary Endpoints:

6-month restenosis rate (>50% narrowing at the stent site) or restenosis 5 mm from either end of the stent

Secondary Endpoints:

6-month angiographic mean luminal diameter and 6-month lumen cross-sectional area by IVUS.

Drug/Procedures Used:

Patients were randomized to stent deployment without intravascular ultrasound compared with stent deployment with additional balloon dilation until achievement of IVUS criterion for stent expansion.

Concomitant Medications:

  • Heparin (discontinued within 24 hours of angioplasty)
  • Aspirin 250 mg
  • Ticlid 500 mg
    • for 1 month

Principal Findings:

  • The use of IVUS guided stent dilation was not associated with a difference in mean luminal diameter or average percent stenosis at 6-month follow-up
  • 6-month cross-sectional area was 5.36±2.81 in the IVUS group and 4.47± 2.59 in the non-IVUS group (p=0.03)
    • Restenosis rate did not differ by treatment group (22.5% in the IVUS group and 28.8% in the non-IVUS group (p=0.25), nor did minimum lumen diameter (1.70 mm vs 1.60 mm, p=0.20)

Interpretation:

Among patients with symptomatic coronary artery disease without recent acute coronary syndrome IVUS-guided stent deployment was not associated with significant differences in 6-month mean luminal diameter but was associated with a significant increase in lumen cross-sectional area.

References:

Schiele F, et al. Impact of Intravascular Ultrasound Guidance in Stent Deployment on 6-month Restenosis Rate: A Multicenter, Randomized Study Comparing Two Strategies--With and Without Intravascular Ultrasound Guidance. JACC 1998; 32:320-8.

Keywords: Coronary Artery Disease, Acute Coronary Syndrome, Follow-Up Studies, Coronary Restenosis, Cross-Sectional Studies, Constriction, Pathologic, Stents


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