Abstract
The NIR stent is an expandable cellular coronary prosthesis with high flexibility
and excellent trackability. the very low crossing profile, associated to the high
flexibility, makes this stent suitable for complex and distal lesions. The aim of
this study was to evaluate the feasibility, safety, and long-term (clinical follow-up)
efficacy of elective and/or urgent deployment of the NIR stent in a broad patient
group with coronary artery disease. Between June 1996 and May 1997, 986 NIR stents
were implanted in 781 vessels (de novo or restenotic lesions in native vessels, saphenous
vein grafts and internal mammary conduits) of 709 consecutive patients (498 men, 211
women) undergoing coronary angioplasty in two Villa Maria Group Catheterization Laboratories.
Procedural angiographic success was achieved in 98.4% of all the lesions treated,
ranging from 100% success rate in type A lesion to 97.6% in type C lesions (overall
procedural success, 98.4%). Major adverse cardiac events (MACE) were considered from
PTCA/stenting time to the patient discharge. The in-hospital MACE were limited and
occurred in 15 patients: urgent surgical revascularization 0.8%, death 0.7%, sub-acute
stent thrombosis 0.5% (overall in-hospital MACE rate 2.1%). Clinical follow-up data
were obtained at 8.6±2.8 months following the stenting procedure. The event-free survival
rate was 87.9%. The late MACE rate evaluation showed death, target lesion revascularization
9.9% (over-all late MACE rate 12.1%). The NIR stent performances in this broad patient
population were excellent, showing very high procedural success rate both in normal
and complex coronary anatomy. On the basis of the previous data, we can define NIR
stent a safe multifunctional device suitable both for easy and complex situations.
The clinical late results are very promising in term of event-free survivals and late
MACE.
