di Mario C, Reimers B, Almagor Y, Moussa I, Di Francesco L, Ferraro M, Leon M B, Richter K, Colombo A
Centro Cuore Columbus, Milan, Italy.
Heart. 1998 Mar;79(3):234-41. doi: 10.1136/hrt.79.3.234.
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 before expansion, and by high radial support and minimal recoil and shortening after expansion.
Single centre survey of unselected lesions in consecutive patients.
Tertiary referral centre. PATIENTS AND LESIONS: 93 stents of various length (9, 16, and 32 mm) were implanted 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 smaller than 2.5 mm. Extreme tortuosity of the proximal vessel was present in 15 lesions (23%). All patients were treated with aspirin and ticlopidine. All lesions were evaluated before and after treatment by quantitative angiography, and in 47 lesions (75%) the stent expansion was 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.
Deployment of the stent failed in two lesions (3%). Minimum lumen diameter increased from 1.01 (0.54) mm to 2.94 (0.49) mm, and diameter stenosis 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 target lesion revascularisations (27%). Angiographic restenosis (> or = 50% diameter stenosis) was documented in 19 lesions (36% of all lesions with angiographic follow up), with an average residual diameter stenosis of 43(21)% and minimum lumen diameter of 1.63 (0.74) mm. Restenosis was more common in vessels with a reference diameter < 2.5 mm (45%) and for lesions longer than 15 mm (46%).
The NIR stent could be used successfully in most lesions, achieving optimal angiographic results with very few in-hospital or subacute cardiac events. The angiographic restenosis rate and need for target lesion revascularisation remained high in this unfavourable lesion subset, especially in small vessels and long lesions.
评估一种新型球囊扩张式支架（NIR支架）首次临床应用的临床及血管造影结果。该支架的特点是纵向柔韧性高、扩张前外形纤细，扩张后具有高径向支撑力、最小回缩及缩短。
对连续患者中未经选择的病变进行单中心调查。
三级转诊中心。患者及病变：在41例患者的64处病变中植入了93枚不同长度（9、16和32毫米）的支架。20处病变（31%）长度超过15毫米，17处病变（27%）位于直径小于2.5毫米的血管中。15处病变（23%）近端血管极度迂曲。所有患者均接受阿司匹林和噻氯匹定治疗。所有病变在治疗前后均通过定量血管造影进行评估，47处病变（75%）的支架扩张情况还通过冠状动脉内超声进行了监测。所有患者均有临床随访资料，53处病变（84%）进行了血管造影随访，平均（标准差）随访间隔为5.4（1.7）个月。
两处病变（3%）支架植入失败。最小管腔直径从1.01（0.54）毫米增加至2.94（0.49）毫米，直径狭窄率从66（15）%降至7（11）%。发生1例院内非Q波心肌梗死、1例40天后猝死以及17例靶病变血管重建术（27%）。19处病变（血管造影随访的所有病变的36%）记录到血管造影再狭窄（直径狭窄≥50%），平均残余直径狭窄率为43（21）%，最小管腔直径为1.63（0.74）毫米。再狭窄在参考直径<2.5毫米的血管中（45%）以及长度超过15毫米的病变中（46%）更为常见。
NIR支架可在大多数病变中成功应用，能取得最佳血管造影结果，且院内或亚急性心脏事件极少。在这一不良病变亚组中，尤其是小血管病变和长病变，血管造影再狭窄率及靶病变血管重建术的需求仍然较高。
