A randomized comparison of elective high-pressure stenting with balloon angioplasty: six-month angiographic and two-year clinical follow-up. On behalf of AS (Angioplasty or Stent) trial investigators

Am Heart J. 2000 Aug;140(2):264-71. doi: 10.1067/mhj.2000.107555.

Abstract

Background: Previous randomized trials have shown beneficial effects of coronary stenting on restenosis and event-free survival rates. However, it has not yet been fully established if routine high-pressure stenting with an antiplatelet regimen can show similar results.

Methods: We compared the 6-month angiographic restenosis rate and 2-year event-free survival rate in 400 patients randomly assigned to stent or angioplasty. Aspirin and ticlopidine were prescribed in both groups.

Results: The procedural success rate did not significantly differ between the stent and angioplasty groups (97.92% vs 97.45%, P = not significant). No stent thrombosis was found. The 6-month restenosis rate was lower in the stent group (18. 18% vs 24.87%, P =.055). At 2 years target lesion revascularization rate was 17.19% in the stent group and 25.51% in the angioplasty group (P =.02, 33% reduction). No significant differences with regard to death and myocardial infarction were observed. Event-free survival rate at 6, 12, and 24 months was 86.77% vs 78.84%, 84.13% vs 76.70%, and 83.07% vs 73.54% for stent and angioplasty groups, respectively (P =.0172).

Conclusions: The 6-month angiographic and 2-year clinical outcomes were better in patients who received stent than in those after balloon angioplasty. The difference in 2-year event-free survival rate was explained by a reduction in target lesion revascularization rate in the stent group.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angioplasty, Balloon, Coronary / instrumentation*
  • Aspirin / administration & dosage
  • Combined Modality Therapy
  • Coronary Angiography*
  • Coronary Disease / diagnostic imaging
  • Coronary Disease / mortality
  • Coronary Disease / therapy*
  • Follow-Up Studies
  • Humans
  • Poland
  • Recurrence
  • Single-Blind Method
  • Stents*
  • Survival Rate
  • Ticlopidine / administration & dosage
  • Treatment Outcome

Substances

  • Ticlopidine
  • Aspirin