Efficacy of Bare-Metal Stent and Drug-Eluting Stent in Endovascular Treatment of Infrapopliteal Arterial Occlusive Disease: A Meta-Analysis_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

 XINHai , BAIChao , WANGYang , LIXin-xi ,  LUOJun , TIANYe , ZHANGKe-rui

Center of Digestion and Vascular Surgery, Department of Vascular and Thyroid Surgery, The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, Xinjiang Uygur Autonomous Region, China;

Corresponding author：

LUOJun, Email: xmuluo@163.com

Keywords：

Infrapopliteal arterial occlusive disease; Drug eluting stent; Bare metal stent; Randomized controlled trial; Meta-analysis

DOI：

10.7507/1007-9424.20140112

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Objective To evaluate the efficacy and safety of endovascular implantation of bare-metal stent (BMS) and endovascular implantation of drug-eluting stent (DES) in treatment of infrapopliteal arterial occlusive disease by using Meta-analysis. Methods Randomized controlled trial about endovascular implantation of BMS and endovascular implantation of DES in treatment of infrapopliteal arterial occlusive disease were searched in domestic and international databases, literature screening in accordance with inclusion criteria and exclusion criteria was taken firstly, and then quality assessment was performed. Comparison of 1-year restenosis rate, 1-year patency rate, incidence of limb salvage, mortality, and 1-year target lesion revascularization rate after operation between BMS group and DES group were performed by using RevMan 5.2 software for Meta-analysis. Results Six literatures included 572 cases who suffered from infrapopliteal arterial occlusive disease were included at all, including 302 cases in DES group and 270 cases in BMS group. The results of Meta-analysis showed that, compared with BMS group, 1-year patency rate after operation in DES group was higher (OR=1.64, 95% CI:1.35-1.98, P < 0.000 1), but 1-year restenosis rate (OR=0.19, 95% CI:0.12-0.30, P < 0.000 1) and 1-year target lesion revascularization rate after operation (OR=0.09, 95% CI:0.02-0.32, P=0.000 2) were both lower. There were no significance difference between the BMS group and DES group on incidence of postoperative limb salvage (OR=1.29, 95% CI:0.58-2.86, P=0.530 0) and postoperative mortality (OR=0.98, 95% CI:0.58-1.65, P=0.940 0). Conclusions Compared with endovascular implantation of BMS, endovascular implantation of DES can increase the 1-year patency rate and reduce 1-year restenosis rate or 1-year target lesion revascularization rate after operation for infrapopliteal arterial occlusive disease.

Citation： XINHai, BAIChao, WANGYang, LIXin-xi, LUOJun, TIANYe, ZHANGKe-rui. Efficacy of Bare-Metal Stent and Drug-Eluting Stent in Endovascular Treatment of Infrapopliteal Arterial Occlusive Disease: A Meta-Analysis. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2014, 21(4): 467-472. doi: 10.7507/1007-9424.20140112 Copy

1.	陆清声, 景在平.膝下动脉硬化闭塞的血管腔内治疗[J].临床外科杂志, 2006, 14(5):261-262.
2.	Dake MD, Scheinert D, Tepe G, et al. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee:twelve-month safety and effecti-veness results from the Zilver PTX single-arm clinical study[J]. J Endovasc Ther, 2011, 18(5):613-623.
3.	Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease:twelve-month Zilver PTX randomized study results[J]. Circ Cardiovasc Interv, 2011, 4(5):495-504.
4.	Siablis D, Kraniotis P, Karnabatidis D, et al. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia:6-month angiographic results from a nonrandomized prospective single-center study[J]. J Endovasc Ther, 2005, 12(6):685-695.
5.	王可, 王洋, 罗军, 等.高低剂量¹³¹I去除甲状腺癌术后残留功能性甲状腺组织的疗效与安全性评价[J].中国普通外科杂志, 2012, 21(11):1362-1368.
6.	张克瑞, 李新喜, 王洋, 等.腔内修复术与开放手术治疗急性Stanford B型主动脉夹层疗效评价[J].中国普外基础与临床杂志, 2013, 20(10):1092-1099.
7.	Donas KP, Torsello G, Schwindt A, et al. Below knee bare nitinol stent placement in high-risk patients with critical limb ischemia is still durable after 24 months of follow-up[J]. J Vasc Surg, 2010, 52(2):356-361.
8.	Scheinert D, Ulrich M, Scheinert S, et al. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions[J]. EuroIntervention, 2006, 2(2):169-174.
9.	Siablis D, Karnabatidis D, Katsanos K, et al. Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia:enduring 1-year angiographic and clinical benefit[J]. J Endovasc Ther, 2007, 14(2):241-250.
10.	Falkowski A, Poncyljusz W, Wilk G, et al. The evaluation of primary stenting of sirolimus-eluting versus bare-metal stents in the treatment of atherosclerotic lesions of crural arteries[J]. Eur Radiol, 2009, 19(4):966-974.
11.	Siablis D, Karnabatidis D, Katsanos K, et al. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia:analysis of long-term angiographic and clinical outcome[J]. J Vasc Interv Radiol, 2009, 20(9):1141-1150.
12.	Bosiers M, Scheinert D, Peeters P, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease[J]. J Vasc Surg, 2012, 55(2):390-398.
13.	Rastan A, Brechtel K, Krankenberg H, et al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents:long-term results from a randomized trial[J]. J Am Coll Cardiol, 2012, 60(7):587-591.
14.	颜荣华, 肖恩华.下肢动脉闭塞性疾病的血管内介入治疗进展[J].介入放射学杂志, 2005, 14(2):205-209.
15.	Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents:an observational study of drug-eluting versus bare-metal stents[J]. J Am Coll Cardiol, 2006, 48(12):2584-2591.
16.	Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery[J]. N Engl J Med, 2003, 349(14):1315-1323.
17.	李端明.药物洗脱支架与裸支架临床应用的安全性比较[J].中国组织工程研究与临床康复, 2009, 13(26):5129-5132.
18.	Lagerqvist B, James SK, Stenestrand U, et al. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden[J]. N Engl J Med, 2007, 356(10):1009-1019.
19.	刘小平, 郭伟, 尹太, 等. PTA及药物洗脱支架在老年人腘动脉以下临界缺血性病变的临床应用[J].中国实用外科杂志, 2006, 26(10):766-768.
20.	Abizaid A, Popma JJ, Tanajura LF, et al. Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent:the TriMaxx trial[J]. Catheter Cardiovasc Interv, 2007, 70(7):914-919.
21.	田硕, 黄新天.下肢动脉硬化闭塞症血管腔内治疗的研究进展[J].中国现代普通外科进展, 2011, 14(4):302-305.
22.	Hanawa T. Materials for metallic stents[J]. J Artif Organs, 2009, 12(2):73-79.
23.	Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery:long-term results from the SIROCCO trial[J]. J Endovasc Ther, 2006, 13(6):701-710.
24.	Werner M, Schmidt A, Freyer M, et al. Sirolimus-eluting stents for the treatment of infrapopliteal arteries in chronic limb ischemia:long-term clinical and angiographic follow-up[J]. J Endovasc Ther, 2012, 19(1):12-19.
25.	Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons:6-month results from the DEBELLUM randomized trial[J]. J Endovasc Ther, 2012, 19(5):571-580.

1. 陆清声, 景在平.膝下动脉硬化闭塞的血管腔内治疗[J].临床外科杂志, 2006, 14(5):261-262.
2. Dake MD, Scheinert D, Tepe G, et al. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee:twelve-month safety and effecti-veness results from the Zilver PTX single-arm clinical study[J]. J Endovasc Ther, 2011, 18(5):613-623.
3. Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease:twelve-month Zilver PTX randomized study results[J]. Circ Cardiovasc Interv, 2011, 4(5):495-504.
4. Siablis D, Kraniotis P, Karnabatidis D, et al. Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia:6-month angiographic results from a nonrandomized prospective single-center study[J]. J Endovasc Ther, 2005, 12(6):685-695.
5. 王可, 王洋, 罗军, 等.高低剂量¹³¹I去除甲状腺癌术后残留功能性甲状腺组织的疗效与安全性评价[J].中国普通外科杂志, 2012, 21(11):1362-1368.
6. 张克瑞, 李新喜, 王洋, 等.腔内修复术与开放手术治疗急性Stanford B型主动脉夹层疗效评价[J].中国普外基础与临床杂志, 2013, 20(10):1092-1099.
7. Donas KP, Torsello G, Schwindt A, et al. Below knee bare nitinol stent placement in high-risk patients with critical limb ischemia is still durable after 24 months of follow-up[J]. J Vasc Surg, 2010, 52(2):356-361.
8. Scheinert D, Ulrich M, Scheinert S, et al. Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions[J]. EuroIntervention, 2006, 2(2):169-174.
9. Siablis D, Karnabatidis D, Katsanos K, et al. Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia:enduring 1-year angiographic and clinical benefit[J]. J Endovasc Ther, 2007, 14(2):241-250.
10. Falkowski A, Poncyljusz W, Wilk G, et al. The evaluation of primary stenting of sirolimus-eluting versus bare-metal stents in the treatment of atherosclerotic lesions of crural arteries[J]. Eur Radiol, 2009, 19(4):966-974.
11. Siablis D, Karnabatidis D, Katsanos K, et al. Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia:analysis of long-term angiographic and clinical outcome[J]. J Vasc Interv Radiol, 2009, 20(9):1141-1150.
12. Bosiers M, Scheinert D, Peeters P, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease[J]. J Vasc Surg, 2012, 55(2):390-398.
13. Rastan A, Brechtel K, Krankenberg H, et al. Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents:long-term results from a randomized trial[J]. J Am Coll Cardiol, 2012, 60(7):587-591.
14. 颜荣华, 肖恩华.下肢动脉闭塞性疾病的血管内介入治疗进展[J].介入放射学杂志, 2005, 14(2):205-209.
15. Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents:an observational study of drug-eluting versus bare-metal stents[J]. J Am Coll Cardiol, 2006, 48(12):2584-2591.
16. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery[J]. N Engl J Med, 2003, 349(14):1315-1323.
17. 李端明.药物洗脱支架与裸支架临床应用的安全性比较[J].中国组织工程研究与临床康复, 2009, 13(26):5129-5132.
18. Lagerqvist B, James SK, Stenestrand U, et al. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden[J]. N Engl J Med, 2007, 356(10):1009-1019.
19. 刘小平, 郭伟, 尹太, 等. PTA及药物洗脱支架在老年人腘动脉以下临界缺血性病变的临床应用[J].中国实用外科杂志, 2006, 26(10):766-768.
20. Abizaid A, Popma JJ, Tanajura LF, et al. Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent:the TriMaxx trial[J]. Catheter Cardiovasc Interv, 2007, 70(7):914-919.
21. 田硕, 黄新天.下肢动脉硬化闭塞症血管腔内治疗的研究进展[J].中国现代普通外科进展, 2011, 14(4):302-305.
22. Hanawa T. Materials for metallic stents[J]. J Artif Organs, 2009, 12(2):73-79.
23. Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery:long-term results from the SIROCCO trial[J]. J Endovasc Ther, 2006, 13(6):701-710.
24. Werner M, Schmidt A, Freyer M, et al. Sirolimus-eluting stents for the treatment of infrapopliteal arteries in chronic limb ischemia:long-term clinical and angiographic follow-up[J]. J Endovasc Ther, 2012, 19(1):12-19.
25. Fanelli F, Cannavale A, Boatta E, et al. Lower limb multilevel treatment with drug-eluting balloons:6-month results from the DEBELLUM randomized trial[J]. J Endovasc Ther, 2012, 19(5):571-580.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Efficacy of Bare-Metal Stent and Drug-Eluting Stent in Endovascular Treatment of Infrapopliteal Arterial Occlusive Disease: A Meta-Analysis

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