Elective Intracoronary Micro-Stent II™ Implantation Without Quantitative Coronary Angiography or Intravascular Ultrasound Guidance and Without Subsequent Anticoagulation: Short- and Long-Term Results

Abstract

Intracoronary stenting has been shown to reduce acute closure and restenosis rate in patients treated with coronary angioplasty. The use of high inflation pressures and intravascular ultrasound guidance allowed the substitution of anticoagulants with antiplatelet agents but increased the cost. The aim of this study was to investigate the effectiveness, safety, and long-term outcome of the elective implantation of a relatively new type of stent (Micro-Stent II™), without the use of quantitative coronary angiog raphy or intravascular ultrasound guidance and without subsequent anticoagulation.

The study included 361 patients who underwent elective microstent implantation. Stent expansion was performed at 8 atm followed by higher inflation pressure at 14-20 atm. Heparin was given intraarterially only once immediately after the arterial sheath insertion. Ticlopidine was started at least 48 hours before the procedure and continued for 1 month while aspirin was continued indefinitely. All patients were followed up for 12.9 ±3.6 months. Short term outcome (first month): Stent implantation was successfully achieved 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 total, 423 stents were implanted. There was no subacute thrombosis, but acute vessel closure occurred in one patient (0.3%). Non-Q wave myocardial infarction occurred in six patients (1.7%), Q wave myocardial infarction occurred in one patient (0.3%), and only one death (0.3%) of nonischemic origin was reported. No major peripheral vascular complications were observed. Late results: Q or non-Q wave infarction occurred in 13 patients (3.6%), 26 patients (7.2%) underwent a repeat angioplasty, eight patients (2.2%) underwent 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™ implantation without quantitative coronary angiog raphy or intravascular ultrasound guidance and without anticoagulation was found to be effective, safe, and with good long-term outcome.