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

Background Precious randomized trials have shown beneficial effects of coro nary stenting an restenosis and event-free survival rates. However, it has not yet been fully established if routine high-pressure stenting with an an tiplatelet regimen can show similar results. Methods We compared the 6-month angiographic restenosis rate and 2-year eve nt-free survival rate in 400 patients randomly assigned to stent or angiopl asty. Aspirin and ticlopidine were prescribed in both groups. Results The procedural success rate did not significantly differ between th e 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 st ent group (18.18% vs 24.87%, P =.055). At 2 years target lesion revasculari zation rate was 17.19% in the stent group and 25.51% in the angioplasty gro up (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 bett er in patients who received stent than in those after balloon angioplasty. The difference in 2-year event-free survival rate was explained by a reduct ion in target lesion revascularization rate in the stent group.