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Journal of Drug Assessment Volume 8, 2019 - Issue 1
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Cardiovascular Medicine

Phase 2, randomized, open-label study on catheter-directed thrombolysis with plasmin versus rtPA and placebo in acute peripheral arterial occlusion

Anthony J. ComerotaMedical Director Eastern Region, Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, VA, USA; Correspondence[email protected]
,
Lazar DavidovicFaculty of Medicine, University of Belgrade, Clinic for Vascular and Endovascular Surgery, Serbian Clinical Center, Belgrade, Serbia;
,
Kim HannaDepartment of Clinical Development, Grifols Inc, Research Triangle Park, NC, USA;
,
Kecia L. CourtneyDepartment of Clinical Development, Grifols Inc, Research Triangle Park, NC, USA;
&
Richard D. Shlansky-GoldbergDepartment of Radiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA
Pages 43-54 | Received 03 Aug 2018, Accepted 21 Feb 2019, Published online: 09 Apr 2019

References

  • Working Party on Thrombolysis in the Management of Limb I. Thrombolysis in the management of lower limb peripheral arterial occlusion–a consensus document. J Vasc Interv Radiol. 2003;14:S337–S349.
  • Collen D. On the regulation and control of fibrinolysis. Edward Kowalski Memorial Lecture. Thromb Haemost. 1980;43:77–89.
  • Wiman B, Lijnen HR, Collen D. On the specific interaction between the lysine-binding sites in plasmin and complementary sites in alpha2-antiplasmin and in fibrinogen. Biochim Biophys Acta. 1979;579:142–154.
  • Cederholm-Williams SA, De Cock F, Lijnen HR, et al. Kinetics of the reactions between streptokinase, plasmin and alpha 2-antiplasmin. Eur J Biochem. 1979;100:125–132.
  • Marder VJ, Landskroner K, Novokhatny V, et al. Plasmin induces local thrombolysis without causing hemorrhage: a comparison with tissue plasminogen activator in the rabbit. Thromb Haemost. 2001;86:739–745.
  • Stewart D, Kong M, Novokhatny V, et al. Distinct dose-dependent effects of plasmin and TPA on coagulation and hemorrhage. Blood. 2003;101:3002–3007.
  • Marder VJ, Novokhatny V. Direct fibrinolytic agents: biochemical attributes, preclinical foundation and clinical potential. J Thromb Haemost. 2010;8:433–444.
  • The STILE Investigators. Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. Ann Surg. 1994;220(3):251–266.
  • Ouriel K, Veith FJ, Sasahara AA. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators. N Engl J Med. 1998;338:1105–1111.
  • Berridge DC, Kessel DO, Robertson I. Surgery versus thrombolysis for initial management of acute limb ischaemia. Cochrane Database of Systematic Reviews. 2013, 6. Art. No.: CD002784. DOI: 10.1002/14651858.CD002784.pub2
  • Marder VJ, Comerota AJ, Shlansky-Goldberg RD, et al. Safety of catheter-delivered plasmin in patients with acute lower extremity arterial or bypass graft occlusion: phase I results. J Thromb Haemost. 2012;10:985–991.
  • Patel NH, Krishnamurthy VN, Kim S, et al. Quality improvement guidelines for percutaneous management of acute lower-extremity ischemia. J Vasc Interv Radiol. 2013;24:3–15.
  • Han SM, Weaver FA, Comerota AJ, et al. Efficacy and safety of alfimeprase in patients with acute peripheral arterial occlusion (PAO). J Vasc Surg. 2010;51:600–609.
  • Novokhatny V, Taylor K, Zimmerman TP. Thrombolytic potency of acid-stabilized plasmin: superiority over tissue-type plasminogen activator in an in vitro model of catheter-assisted thrombolysis. J Thromb Haemost. 2003;1:1034–1041.
  • Shlansky-Goldberg RD, Matsumoto AH, Baumbach GA, et al. A first-in-human phase I trial of locally delivered human plasmin for hemodialysis graft occlusion. J Thromb Haemost. 2008;6:944–950.
  • Shlansky-Goldberg R. Phase 1 study of human plasma-derived plasmin (TAL-05-00018) in hemodialysis graft occlusion. Thromb Res. 2008;122:S16–S19.
  • Ouriel K, Shortell CK, DeWeese JA, et al. A comparison of thrombolytic therapy with operative revascularization in the initial treatment of acute peripheral arterial ischemia. J Vasc Surg. 1994;19:1021–1030.
  • Ouriel K, Veith FJ, Sasahara AA. Thrombolysis or peripheral arterial surgery: phase I results. TOPAS Investigators. J Vasc Surg. 1996;23:64–73.
  • Ouriel K, Kandarpa K. Safety of thrombolytic therapy with urokinase or recombinant tissue plasminogen activator for peripheral arterial occlusion: a comprehensive compilation of published work. J Endovasc Ther. 2004;11:436–446.
  • Ouriel K, Gray B, Clair DG, et al. Complications associated with the use of urokinase and recombinant tissue plasminogen activator for catheter-directed peripheral arterial and venous thrombolysis. J Vasc Interv Radiol. 2000;11:295–298.

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