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 success rate among the first 100 patients treated with the tubular, serpentine design, stainless steel, balloon-expandable stent (beStent(TM)) in Israel. The 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 coronary angioplasty had occurred in 52%, 12% and 26% of the patients, respectively. Diabetes mellitus was present in 30 patients and hypertension in 34 patients. 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 types were A (n = 10), B1 (n = 29), B2 (n = 20), and C (n = 44). All patients were clinically monitored with regular visits at 1, 3, 6, 9 and 12 months. Results. Overall, the 12-month event-free survival rate was 82%. Subacute thrombosis occurred in two patients. There were two non-cardiac deaths, one a-wave myocardial infarction, six elective bypass surgeries and 12 target lesion revascularizations. Event-free survival was significantly higher for those with lesions shorter than 15 mm than for those with lesions longer than 15 mm (90% versus 67%, P = 0.003), and for women compared with men (96% versus 78%, P = 0.02). Conclusions. The initial experience with the beStent shows favorable long-term results with an overall event rate of 18% for this subset of relatively complex lesions; higher event rates were observed for longer lesions.