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.	陸清聲, 景在平.膝下動脈硬化閉塞的血管腔內治療[J].臨床外科雜志, 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, 羅軍, 等.高低劑量¹³¹I去除甲狀腺癌術后殘留功能性甲狀腺組織的療效與安全性評價[J].中國普通外科雜志, 2012, 21(11):1362-1368.
6.	張克瑞, 李新喜, 王洋, 等.腔內修復術與開放手術治療急性Stanford B型主動脈夾層療效評價[J].中國普外基礎與臨床雜志, 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.	顏榮華, 肖恩華.下肢動脈閉塞性疾病的血管內介入治療進展[J].介入放射學雜志, 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.藥物洗脫支架與裸支架臨床應用的安全性比較[J].中國組織工程研究與臨床康復, 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.	劉小平, 郭偉, 尹太, 等. PTA及藥物洗脫支架在老年人腘動脈以下臨界缺血性病變的臨床應用[J].中國實用外科雜志, 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.	田碩, 黃新天.下肢動脈硬化閉塞癥血管腔內治療的研究進展[J].中國現代普通外科進展, 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. 陸清聲, 景在平.膝下動脈硬化閉塞的血管腔內治療[J].臨床外科雜志, 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, 羅軍, 等.高低劑量¹³¹I去除甲狀腺癌術后殘留功能性甲狀腺組織的療效與安全性評價[J].中國普通外科雜志, 2012, 21(11):1362-1368.
6. 張克瑞, 李新喜, 王洋, 等.腔內修復術與開放手術治療急性Stanford B型主動脈夾層療效評價[J].中國普外基礎與臨床雜志, 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. 顏榮華, 肖恩華.下肢動脈閉塞性疾病的血管內介入治療進展[J].介入放射學雜志, 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.藥物洗脫支架與裸支架臨床應用的安全性比較[J].中國組織工程研究與臨床康復, 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. 劉小平, 郭偉, 尹太, 等. PTA及藥物洗脫支架在老年人腘動脈以下臨界缺血性病變的臨床應用[J].中國實用外科雜志, 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. 田碩, 黃新天.下肢動脈硬化閉塞癥血管腔內治療的研究進展[J].中國現代普通外科進展, 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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