Elective intracoronary Micro-Stent II (TM) implantation without quantitative coronary angiography or intravascular ultrasound guidance and without subsequent anticoagulation: Short- and long-term results

Intracoronary stenting has been shown to reduce acute closure and restenosi s rate in patients treated with coronary angioplasty. The use of high infla tion pressures and intravascular ultrasound guidance allowed the substituti on of anticoagulants with antiplatelet agents but increased the cost. The a im of this study was to investigate the effectiveness, safety, and long-ter m outcome of the elective implantation of a relatively new type of stent (M icro-Stent II(TM)), without the use of quantitative coronary angiography or intravascular ultrasound guidance and without subsequent anticoagulation. The study included 361 patients who underwent elective microstent implantat ion. Stent expansion was performed at 8 atm followed by higher inflation pr essure at 14-20 atm. Heparin was given intraarterially only once immediatel y after the arterial sheath insertion. Ticlopidine was started at least 48 hours before the procedure and continued for 1 month while aspirin was cont inued indefinitely. All patients were followed up for 12.9 +/-3.6 months. S hort term outcome (first month): Stent implantation was successfully achiev ed in 361 of 366 patients (98.6%). Seven patients (1.9%) were excluded from the study and received anticoagulants because of a suboptimal result; In t otal, 423 stents were implanted. There was no subacute thrombosis, but acut e vessel closure occurred in one patient (0.3%). Non-Q wave myocardial infa rction occurred in six patients (1.7%), Q wave myocardial infarction occurr ed in one patient (0.3%), and only one death (0.3%) of nonischemic origin w as reported. No major peripheral vascular complications were observed. Late results: Q or non-Q wave infarction occurred in 13 patients (3.6%), 26 pat ients (7.2%) underwent a repeat angioplasty, eight patients (2.2%) underwen t coronary artery bypass grafting, and four patients (1.1%) died. Overall, 284 patients (78.7%) were free of symptoms, while 77 (21.3%) had recurrent coronary ischemia. In conclusion, Micro-Stent II(TM) implantation without quantitative:coronar y angiography or intravascular ultrasound guidance and without anticoagulat ion was found to be effective, safe, and with good long-term outcome.