A randomized comparison of elective high-pressure stenting with balloon angioplasty: Six-month angiographic and two-year clinical follow-up ☆ ☆☆ ★

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. (Am Heart J 2000;140:264-71.)