Schlager Oliver, Dick Petra, Sabeti Schila, Amighi Jasmin, Mlekusch Wolfgang, Minar Erich, Schillinger Martin
Department of Angiology, Medical University Vienna, Austria.
J Endovasc Ther. 2005 Dec;12(6):676-84. doi: 10.1583/05-1672.1.
To determine and compare the rates of in-stent restenosis, late clinical deterioration, and stent fractures in nitinol stents versus Wallstents implanted for suboptimal angioplasty in the superficial femoral artery (SFA).
Interrogation of an angioplasty database identified 286 consecutive patients (178 men; mean age 67+/-10 years, range 44-87) with severe claudication (n=254) or critical limb ischemia (n=32) who had stents implanted after suboptimal angioplasty over a 5-year period. Wallstents with a mean stented lesion length of 107+/-71 mm were implanted in 116 patients, while nitinol stents were used in 170 patients: 45 SMART stents (mean stented lesion length 139+/-88 mm) and 125 Dynalink/Absolute stents (mean stented lesion length 125+/-84 mm). Patients were followed for in-stent restenosis (>50%) by duplex ultrasound, clinical deterioration by at least 1 Fontaine stage compared to baseline, and stent fractures by biplanar radiography.
In-stent restenosis rates at 1, 2, and 3 years were 46%, 66%, and 72% for Wallstents compared to 20%, 36%, and 53% for nitinol stents (p<0.001), respectively, without significant difference between the 2 nitinol stent groups (p=0.59). Clinical deterioration at 1, 2, and 3 years was found in 10%, 15%, and 18% with Wallstents versus 4%, 5%, and 5% with nitinol stents (p=0.014), respectively, without difference between the 2 nitinol stent groups (p=0.47). Fracture rates were 19% for Wallstents after a mean 43+/-24 months, 28% for SMART stents after mean 32+/-16 months, and 2% for Dynalink/Absolute stents after a mean 15+/-9 months.
Intermediate-term in-stent restenosis remains a major problem even with current nitinol stent technology; however, clinical deterioration seems no matter of serious concern with SMART and Dynalink/Absolute stents. Stent fractures may be lower with Dynalink/Absolute stents, but randomized head-to-head comparisons are needed to validate these data.
确定并比较用于股浅动脉（SFA）次优血管成形术的镍钛合金支架与Wallstent支架的支架内再狭窄率、晚期临床恶化率及支架骨折率。
查询血管成形术数据库，确定286例连续患者（178例男性；平均年龄67±10岁，范围44 - 87岁），这些患者患有严重跛行（n = 254）或严重肢体缺血（n = 32），在5年期间接受次优血管成形术后植入了支架。116例患者植入平均支架病变长度为107±71 mm的Wallstent支架，170例患者使用镍钛合金支架：45例SMART支架（平均支架病变长度139±88 mm）和125例Dynalink/Absolute支架（平均支架病变长度125±84 mm）。通过双功超声随访支架内再狭窄（>50%）情况，与基线相比临床恶化至少1个Fontaine分期，通过双平面X线摄影随访支架骨折情况。
Wallstent支架1年、2年和3年的支架内再狭窄率分别为46%、66%和72%，镍钛合金支架分别为20%、36%和53%（p<0.001），两组镍钛合金支架之间无显著差异（p = 0.59）。Wallstent支架1年、2年和3年的临床恶化率分别为10%、15%和18%，镍钛合金支架分别为4%、5%和5%（p = 0.014），两组镍钛合金支架之间无差异（p = 0.47）。Wallstent支架平均43±24个月后的骨折率为19%，SMART支架平均32±16个月后的骨折率为28%，Dynalink/Absolute支架平均15±9个月后的骨折率为2%。
即使采用当前的镍钛合金支架技术，中期支架内再狭窄仍是一个主要问题；然而，对于SMART和Dynalink/Absolute支架，临床恶化似乎并非严重问题。Dynalink/Absolute支架的支架骨折率可能较低，但需要进行随机的直接比较以验证这些数据。
