PROCEDURAL AND FOLLOW-UP RESULTS WITH A NEW BALLOON-EXPANDABLE STENT IN UNSELECTED LESIONS

Objective-To assess the clinical and angiographic results of the first clinical application of a new balloon expandable stent, the NIR stent , characterised by high longitudinal flexibility and low profile befor e expansion, and by high radial support and minimal recoil and shorten ing after expansion. Design-Single centre survey of unselected lesions in consecutive patients. Setting-Tertiary referral centre. Patients a nd lesions-93 stents of various length (9, 16, and 32 mm) were implant ed in 64 lesions in 41 patients. Twenty lesions (31%) were longer than 15 mm, and 17 lesions (27%) were located in vessels with a diameter s maller than 2.5 mm. Extreme tortuosity of the proximal vessel was pres ent in 15 lesions (23%). All patients were treated with aspirin and ti clopidine. All lesions were evaluated before and after treatment by qu antitative angiography, and in 47 lesions (75%) the stent expansion wa s also controlled by intracoronary ultrasound. Clinical follow up was available in all patients and angiographic follow up was performed in 53 lesions (84%), at a mean (SD) interval of 5.4 (1.7) months.Results- Deployment of the stent failed in two lesions (3%). Minimum lumen diam eter, increased from 1.01 (0.54) mm to 2.94 (0.49)mm, and diameter ste nosis decreased from 66(15)% to 7(11)%. There was one in-hospital non- Q wave myocardial infarction, one sudden death after 40 days, and 17 t arget lesion revascularisations (27%). Angiographic restenosis (greate r than or equal to 50% diameter stenosis) was documented in 19 lesions (36% of all lesions with angiographic follow up), with an average res idual diameter stenosis of 43(21)% and minimum lumen diameter of 1.63 (0.74)mm. Restenosis was more common in vessels with a reference diame ter <2.5 mm (45%) and for lesions longer than 15 mm (46%). Conclusions -The NIR stent could be used successfully in most lesions, achieving o ptimal angiographic results with very few in-hospital or subacute card iac events. The angiographic restenosis rate and need for target lesio n revascularisation remained high in this unfavourable lesion subset, especially in small vessels and long lesions.