Efficacy and Safety of Two Different Doses of rt-PA Catheter-Directed Thrombolysis for Lower Limb Ischemia: A Meta-Analysis_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

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

Department of Vascular and Thyroid Surgery, The First Affiliated Hospital, Xinjiang Medical University, Urumqi 830054, Xinjiang Uygur Autonomous Region, China;

Corresponding?author：

LUOJun, Email: 809644399@qq.com

Keywords：

Catheter-directed thrombolysis; Lower limb ischemia; Randomized cControlled trial; Meta-analysis

DOI：

10.7507/1007-9424.20150125

Video：

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Objective To assess the efficacy and safety of low-(10 mg) and high-dose (20 mg) of recombinant tissue typeplasminogen activator (rt-PA) catheter-directed thrombolysis for lower limb ischemia by using meta-analysis. Methods The literatures of randomized clinical trials (RCT) concerning low-versus high-dose rt-PA catheter-directed thrombolysis for lower limb ischemia study were searched using the national and international electronic databases.The literatures were screened and quality evaluated according to the inclusion and exclusion criteria, and analyzed by using the Cochrane Center the RevMan 5.2 software. Results A total of 4 RCT studies, with a total of 360 patients (192 patients in low dose group and 168 patients in high-dose group) were included.No statistical difference were noted in low-versus high-dose group with regard to ankle-brachial index (RR=0.20, 95%CI=-0.43-0.02, P=0.07), 30 days amputation-free survival (RR=1.00, 95%CI=0.94-1.08, P=0.91), 6 months the probability of restenosis (RR=1.00, 95%CI=0.60-1.67, P=1.00), and the incidence of groin hematoma (< 5 cm, RR=1.24, 95%CI=0.56-2.77, P=0.59).But the incidence of bleeding and the incidence of stress ulcer in low-dose group were lower than those in high-dose group (RR=2.38, 95%CI=1.10-5.15, P=0.03;RR=2.49, 95%CI=1.21-5.13, P=0.01). Conclusion Two doses of rt-PA treatment of limb ischemia similar efficacy, but the incidence of low-dose regimen of complications is significantly lower than the high dose regimen.

Citation： ZHUANGFeng, LIXin-xi, LUOJun, WANGYang, TIANYe, BAIChao, ZHANGKe-rui. Efficacy and Safety of Two Different Doses of rt-PA Catheter-Directed Thrombolysis for Lower Limb Ischemia: A Meta-Analysis. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2015, 22(4): 475-481. doi: 10.7507/1007-9424.20150125 Copy

1.	吳田方, 代遠斌.不同材料周圍動脈支架置入治療動脈硬化閉塞癥的研究與進展.中國組織工程研究, 2012, 15(12):2261-2264.
2.	Reekers JA.Percutaneous intentional extraluminal (subintimal) revascularization (PIER) for critical lower limb ischemia:too good to be true? J Endovasc Ther, 2002, 9(4):419-421.
3.	Holdsworth J.District hospital management and outcome of critical lower limb ischaemia:comparison with national figures.Eur J Vasc Endovasc Surg, 1997, 13(2):159-163.
4.	Zeller T.Current state of endovascular treatment of femoro-popli-teal artery disease.Vasc Med, 2007, 12(3):223-234.
5.	Wicky S, Pinto EG, Oklu R.Catheter-directed thmmbolysis of arterial thrombosis.Semin Thromb Hemost, 2013, 39(4):441-445.
6.	辛海, 白超, 等.支架植入與內膜剝脫治療頸動脈狹窄的療效與安全性評價.中國組織工程研究, 2013, 17(51):8920-8927.
7.	Falkowski A, Poncyljusz W, Samad RA, et al.Safety and efficacy of ultra-high-dose, short-term thrombolysis with rt-PA for acute lower limb ischemia.Eur J Vasc Endovasc Surg, 2013, 46(1):118-123.
8.	張楊, 張望德, 李談.短時rt-PA導管接觸溶栓聯合腔內介入治療下肢缺血療效分析.中華醫學雜志, 2014, 94(13):1017-1020.
9.	Plate G, Jansson I, Forssell C, et al.Thrombolysis for acute lower limb ischaemia-a prospective, randomised, multicentre study comparing two strategies.Eur J Vasc Endovasc Surg, 2006, 31(6):651-660.
10.	Tsetis DK, Katsamouris AN, Giannoukas AD, et al.Potential benefits from heating the high-dose rtPA boluses used in catheter-directed thrombolysis for acute/subacute lower limb ischemia.J Endovasc Ther, 2003, 10(4):739-744.
11.	Yuan B, Li T, Zhang Y, et al.Effects of delivering recombinant tissue plasminogen activator on a new infusion system during endovascular intervention in patients with lower limb ischemia.Thorac Cardiovasc Surg, 2013, 61(5):445-452.
12.	Shigematsu H.Endovaseular procedures for peripheral arterial disease.Nihon Geka Gakkai Zasshi, 2003, 104(8):562-566.
13.	Fads PL, Brophy D, LoGerfo FW, et al.Combined iliac angioplasty and infrainguinal revascularization surgery are effective in diabetic patients with multilevel arterial disease.Ann Vasc Surg, 2001, 15(1):67-72.
14.	Heimig T, Martin M, Fiebach BJ, et al.Lysis block technique--a new method of fibrinolytic treatment with tissue-type plasminogen activator (rt-PA).Vasaul Suppl, 1993, 39:23-28.
15.	張彬, 孫曉江.溶栓藥物的基礎和臨床研究的新進展.中國臨床神經科學, 2003, 16(1):108-111.
16.	Geier B, Mumme A, K?ster O, et al.Is initial SUCCESS of thrombolytic therapy with rt-PA in patients with lower limb ischemia durable? A long term follow-up series.Vasa, 2007, 36(2):114-120.
17.	王建設.重組組織型纖溶酶原激活劑治療下肢深靜脈血栓形成的薈萃分析.中國醫藥指南, 2010, 2(8):31-34.
18.	Berridge DC, Kessel D, Robertson I.Surgery versus thrombolysisfor acute limb ischaemia:initial management.CochraneDatabase Syst Rev, 2002, (3):CD002784.
19.	Swischuk JL, Fox PF, Young K, et al.Transcatheter intraarterial infusion of rt-PA for acute lower limb ischemia:results and complications.J Vasc Interv Radiol, 2001, 12(4):423-430.
20.	Nehler MR, Mueller RJ, McLafferty RB, et al.Outcome of catheter-directed thrombolysis for lower extremity arterial bypass occlusion.J Vasc Surg, 2003, 37(1):72-78.
21.	景在平, 梅志軍.下肢急性缺血的救治.臨床外科雜志, 2006, 14(5):259-260.
22.	Eliason JL, Wainess RM, Proctor MC, et al.A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia.Ann Surg, 2003, 238(3):382-389.
23.	Kessel DO, Berridge DC, Robertson I.Infusion techniques for peripheral arterial thrombolysis.Cochrane Database Syst Rev, 2004, (1):CD000985.
24.	Earnshaw JJ, Whitman B, Foy C.National Audit of Thrombolysis for Acute Leg Ischemia(NATALI):clinical factors associated with early outcome.J Vasc Surg, 2004, 39(5):1018-1025.
25.	劉小平, 郭偉, 尹太, 等.導管接觸溶栓治療下肢急性動脈閉塞性疾病(附8例報告).中國實用外科雜志, 2008, 28(8):660-662.
26.	Kim C, Jeon W, Shin T, et al.Stent-assisted recanalisation of acute occlusive arteries in patients with acute limb ischaemia.Eur J Vasc Endovase Surg, 2010, 39(1):89-96.

1. 吳田方, 代遠斌.不同材料周圍動脈支架置入治療動脈硬化閉塞癥的研究與進展.中國組織工程研究, 2012, 15(12):2261-2264.
2. Reekers JA.Percutaneous intentional extraluminal (subintimal) revascularization (PIER) for critical lower limb ischemia:too good to be true? J Endovasc Ther, 2002, 9(4):419-421.
3. Holdsworth J.District hospital management and outcome of critical lower limb ischaemia:comparison with national figures.Eur J Vasc Endovasc Surg, 1997, 13(2):159-163.
4. Zeller T.Current state of endovascular treatment of femoro-popli-teal artery disease.Vasc Med, 2007, 12(3):223-234.
5. Wicky S, Pinto EG, Oklu R.Catheter-directed thmmbolysis of arterial thrombosis.Semin Thromb Hemost, 2013, 39(4):441-445.
6. 辛海, 白超, 等.支架植入與內膜剝脫治療頸動脈狹窄的療效與安全性評價.中國組織工程研究, 2013, 17(51):8920-8927.
7. Falkowski A, Poncyljusz W, Samad RA, et al.Safety and efficacy of ultra-high-dose, short-term thrombolysis with rt-PA for acute lower limb ischemia.Eur J Vasc Endovasc Surg, 2013, 46(1):118-123.
8. 張楊, 張望德, 李談.短時rt-PA導管接觸溶栓聯合腔內介入治療下肢缺血療效分析.中華醫學雜志, 2014, 94(13):1017-1020.
9. Plate G, Jansson I, Forssell C, et al.Thrombolysis for acute lower limb ischaemia-a prospective, randomised, multicentre study comparing two strategies.Eur J Vasc Endovasc Surg, 2006, 31(6):651-660.
10. Tsetis DK, Katsamouris AN, Giannoukas AD, et al.Potential benefits from heating the high-dose rtPA boluses used in catheter-directed thrombolysis for acute/subacute lower limb ischemia.J Endovasc Ther, 2003, 10(4):739-744.
11. Yuan B, Li T, Zhang Y, et al.Effects of delivering recombinant tissue plasminogen activator on a new infusion system during endovascular intervention in patients with lower limb ischemia.Thorac Cardiovasc Surg, 2013, 61(5):445-452.
12. Shigematsu H.Endovaseular procedures for peripheral arterial disease.Nihon Geka Gakkai Zasshi, 2003, 104(8):562-566.
13. Fads PL, Brophy D, LoGerfo FW, et al.Combined iliac angioplasty and infrainguinal revascularization surgery are effective in diabetic patients with multilevel arterial disease.Ann Vasc Surg, 2001, 15(1):67-72.
14. Heimig T, Martin M, Fiebach BJ, et al.Lysis block technique--a new method of fibrinolytic treatment with tissue-type plasminogen activator (rt-PA).Vasaul Suppl, 1993, 39:23-28.
15. 張彬, 孫曉江.溶栓藥物的基礎和臨床研究的新進展.中國臨床神經科學, 2003, 16(1):108-111.
16. Geier B, Mumme A, K?ster O, et al.Is initial SUCCESS of thrombolytic therapy with rt-PA in patients with lower limb ischemia durable? A long term follow-up series.Vasa, 2007, 36(2):114-120.
17. 王建設.重組組織型纖溶酶原激活劑治療下肢深靜脈血栓形成的薈萃分析.中國醫藥指南, 2010, 2(8):31-34.
18. Berridge DC, Kessel D, Robertson I.Surgery versus thrombolysisfor acute limb ischaemia:initial management.CochraneDatabase Syst Rev, 2002, (3):CD002784.
19. Swischuk JL, Fox PF, Young K, et al.Transcatheter intraarterial infusion of rt-PA for acute lower limb ischemia:results and complications.J Vasc Interv Radiol, 2001, 12(4):423-430.
20. Nehler MR, Mueller RJ, McLafferty RB, et al.Outcome of catheter-directed thrombolysis for lower extremity arterial bypass occlusion.J Vasc Surg, 2003, 37(1):72-78.
21. 景在平, 梅志軍.下肢急性缺血的救治.臨床外科雜志, 2006, 14(5):259-260.
22. Eliason JL, Wainess RM, Proctor MC, et al.A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia.Ann Surg, 2003, 238(3):382-389.
23. Kessel DO, Berridge DC, Robertson I.Infusion techniques for peripheral arterial thrombolysis.Cochrane Database Syst Rev, 2004, (1):CD000985.
24. Earnshaw JJ, Whitman B, Foy C.National Audit of Thrombolysis for Acute Leg Ischemia(NATALI):clinical factors associated with early outcome.J Vasc Surg, 2004, 39(5):1018-1025.
25. 劉小平, 郭偉, 尹太, 等.導管接觸溶栓治療下肢急性動脈閉塞性疾病(附8例報告).中國實用外科雜志, 2008, 28(8):660-662.
26. Kim C, Jeon W, Shin T, et al.Stent-assisted recanalisation of acute occlusive arteries in patients with acute limb ischaemia.Eur J Vasc Endovase Surg, 2010, 39(1):89-96.

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CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Efficacy and Safety of Two Different Doses of rt-PA Catheter-Directed Thrombolysis for Lower Limb Ischemia: A Meta-Analysis

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