Duda Stephan H, Bosiers Marc, Lammer Johannes, Scheinert Dierk, Zeller Thomas, Oliva Vincent, Tielbeek Alexander, Anderson John, Wiesinger Benjamin, Tepe Gunnar, Lansky Alexandra, Jaff Michael R, Mudde Catharina, Tielemans Hans, Beregi Jean-Paul
Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital Berlin, Heinz-Galinski-Strasse 1, 13347 Berlin, Germany.
J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.
To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents.
Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months.
Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups.
These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.
回顾接受西罗莫司洗脱型与普通SMART镍钛诺自膨式支架治疗的慢性肢体缺血和TASC C型病变患者的临床结局。
数据来自一项分两阶段进行的随机、多中心、双盲研究。所有93例患者均患有慢性肢体缺血和股浅动脉（SFA）闭塞或狭窄（平均病变长度8.3 cm）。总共47例患者（31例男性；平均年龄66.3±9.1岁，范围50 - 84岁）接受了西罗莫司洗脱型SMART支架，46例患者（36例男性；平均年龄65.9±10.8岁，范围38 - 83岁）接受了普通SMART镍钛诺支架。两组均随访平均24个月。
西罗莫司洗脱型和普通SMART支架在使病变的SFA血管再通以及维持无再狭窄状态方面均有效。对于两种类型的支架，踝肱指数（ABI）和间歇性跛行症状在24个月内均保持改善（西罗莫司组24个月时ABI中位数为0.96，普通支架组为0.87，p>0.05）。在24个月时，西罗莫司组的再狭窄率为22.9%，普通支架组为21.1%（p>0.05）。根据双功超声检查，在6、9、18和24个月时，支架内累积再狭窄率分别为4.7%、9.0%（此处原文有误重复，按原文翻译）、15.6%和21.9%；治疗组之间的这些比率无显著差异。西罗莫司组的靶病变血运重建（TLR）率为6%，普通支架组为13%；靶血管血运重建（TVR）率略高，分别为13%和22%。两组之间的死亡率无显著差异。
这些数据表明，西罗莫司洗脱型和普通SMART支架在大多数患者中长达24个月都是有效、安全且无再狭窄的。由于普通支架组的再狭窄率出乎意料地低，因此在西罗莫司洗脱型和普通SMART支架之间未发现显著差异。
