One-year clinical follow-up with the serpentine balloon expandable stent: report of the first 100 patients

Background We recently reported a high technical and 30-day clinical succes s rate among the first 100 patients treated with the tubular, serpentine de sign, stainless steel, balloon-expandable stent (beStent (TM)) in Israel. T he present study examined the clinical results in these patients after the first year. Methods Seventy-eight men and 22 women were included in the study. Previous myocardial infarction, bypass surgery and percutaneous transluminal corona ry angioplasty had occurred in 52%, 12% and 26% of the patients. respective ly. Diabetes mellitus was present in 30 patients and hypertension in 34 pat ients. One hundred and forty-eight stents of 15, 25, and 35 mm lengths were used. The indications for stenting were suboptimal results (n=85), bailout conditions (n=10) or for the prevention of restenosis (n=8), and lesion ty pes were A (n=10), B1 (n=29), B2 (n=20), and C (n=44). All patients were cl inically monitored with regular visits at 1, 3, 6, 9 and 12 months. Results Overall, the 12-month event-free survival rate was 82%, Subacute th rombosis occurred in two patients. There were two non-cardiac deaths, one Q -wave myocardial infarction, six elective bypass surgeries and 12 target le sion revascularizations. Event-free survival was significantly higher for t hose with lesions shorter than 15 mm than for those with lesions longer tha n 15 mm (90% versus 67%, P=0.003), and for women compared with men (96% ver sus 78%, P=0.02). Conclusions The initial experience with the beStent shows favorable long-te rm results with an overall event rate of 18% for this subset of relatively complex lesions; higher event rates were observed for longer lesions. Coron ary Artery Dis 10:421-425 (C) 1999 Lippincott Williams & Wilkins.