Background: Target lesion revascularization (TLR) continues to occur beyond 4 years after bare metal stent (BMS) implantation. However, long-term outcomes after balloon angioplasty (BA) compared with BMS are currently unknown.
Methods and results: From 1989 to 1990, 659 patients (748 lesions) underwent successful BA with final balloon ≥3.0 mm excluding patients with acute myocardial infarction and were compared with 405 patients (424 lesions) with BMS implantation from June 1990 to 1993. Cumulative incidences of death and target lesion thrombosis (>1 year) were similar between the BA group and the BMS group (44.4% versus 45.4%, P=0.60; and 1.5% versus 0.7%, P=0.99; respectively). Cumulative incidence of TLR during overall follow-up was significantly higher after BA than after BMS implantation (44.6% versus 36.0%, P<0.001), whereas cumulative incidence of late TLR (>4 years) tended to be lower in the BA group than in the BMS group (16.3% versus 21.4%, P=0.16). Cumulative incidence of late TLR after BA was significantly lower in patients with small percent diameter stenosis (%DS) at early follow-up angiography compared with large %DS (14.5% versus 28.0%, P=0.02). In lesions with serial angiography, late lumen loss from early (6 to 14 months) to long-term (4 to 10 years) follow-up angiography was significantly smaller in the BA group (n=42) than in the BMS group (n=55) (-0.08±0.45 mm versus 0.11±0.46 mm, P=0.047).
Conclusions: Compared with BMS implantation, BA was associated with a trend for less late TLR beyond 4 years and with significantly smaller late lumen loss from early to long-term follow-up angiography.
Keywords: bare metal stent; coronary artery disease; late restenosis; percutaneous transluminal coronary angioplasty; prognosis.