Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: Long-term results from the SIROCCO trial
Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: Long-term results from the SIROCCO trial
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DOI：
10.1583/05-1704.1
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发表时间：
2006-12-01
影响因子：
2.6
通讯作者：
Beregi, Jean-Paul
中科院分区：
文献类型：
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作者：
Duda, Stephan H.;Bosiers, Marc;Beregi, Jean-Paul
目的：回顾西罗莫司洗脱支架与裸 SMART 镍钛合金自膨式支架治疗慢性肢体缺血和 TASC C 型病变患者的临床结果。方法：数据来自分两个阶段进行的随机、多中心、双盲研究。所有93名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厘米）。总共有 47 名患者（31 名男性；平均年龄 66.3 +/- 9.1 岁，范围 50-84）接受了西罗莫司洗脱 SMART 支架，46 名患者（36 名男性；平均年龄 65.9 +/- 10.8 岁，范围 38-83）接受了裸 SMART 镍钛合金支架。两组患者的随访时间平均为 24 个月。结果：西罗莫司洗脱支架和裸 SMART 支架均可有效使患病 SFA 血运重建并维持免于再狭窄。对于两种类型的支架，踝臂指数 (ABI) 和跛行症状的改善均维持超过 24 个月（西罗莫司组的中位 24 个月 ABI 为 0.96，而裸支架组为 0.87，p>0.05）。 24 个月时，西罗莫司组的再狭窄率为 22.9%，而裸支架组的再狭窄率为 21.1%（p>0.05）。根据双功超声，6、9、18和24个月时的累积支架内再狭窄率分别为4.7%、9.0%、15.6%和21.9%；治疗组之间的比率没有显着差异。西罗莫司组的 TLR 率为 6%，裸支架组的 TLR 率为 13%； TVR 率略高：分别为 13% 和 22%。各组之间的死亡率没有显着差异。 结论：这些数据表明，西罗莫司洗脱支架和裸 SMART 支架在长达 24 个月的时间内对大多数患者有效、安全且无再狭窄。由于裸支架组的再狭窄率出乎意料地低，因此西罗莫司洗脱支架和裸SMART支架之间没有发现显着差异。
Purpose: 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.Methods: 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.Results: 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.Conclusion: 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.