Journal of Vascular Surgery
Volume 51, Issue 3 , Pages 600-609 , March 2010

Efficacy and safety of alfimeprase in patients with acute peripheral arterial occlusion (PAO)

  • Sukgu M. Han, MD

      Affiliations

    • Division of Vascular Surgery and Endovascular Therapy, CardioVascular Thoracic Institute, University of Southern California, Los Angeles, Calif
    • ,
  • Fred A. Weaver, MD, MMM

      Affiliations

    • Division of Vascular Surgery and Endovascular Therapy, CardioVascular Thoracic Institute, University of Southern California, Los Angeles, Calif
    • Corresponding Author InformationReprint requests: Fred A. Weaver, MD, MMM, Division of Vascular Surgery and Endovascular Therapy, 1520 San Pablo, Suite 4300, Los Angeles, CA 90033
    • ,
  • Anthony J. Comerota, MD

      Affiliations

    • Toledo Vascular Institute, Toledo, Ohio
    • ,
  • Bruce A. Perler, MD, MBA

      Affiliations

    • Division of Vascular Surgery, Johns Hopkins Medical Center, Baltimore, Md
    • ,
  • Mark Joing, MBA

      Affiliations

    • ARCA biopharma, Inc, Broomfield, Colo

References 

  1. STILE investigators. Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. Ann Surg. 1994;220:251–268
  2. Comerota AJ, Weaver FA, Hosking JD, Froehlich J, Folander H, Sussman B, et al. Results of a prospective, randomized trial of surgery versus thrombolysis for occluded lower extremity bypass grafts. Am J Surg. 1996;172:105–112
  3. Ouriel K, Veith FJ, Sasahara AA Thrombolysis or Peripheral Arterial Surgery (TOPAS) investigators. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. N Engl J Med. 1998;338:1105–1111
  4. Moise MA, Kashyap VS. Alfimeprase for the treatment of acute peripheral arterial occlusion. Expert Opin Biol Ther. 2008;8:683–689
  5. Deitcher SR, Toombs CF. Nonclinical and clinical characterization of a novel acting thrombolytic: alfimeprase. Pathophysiol Haemost Thromb. 2005;34:215–220
  6. TASC Working Group. Treatment for acute limb ischemia. J Vasc Surg. 2000;31:S160–S173
  7. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis. 1974;27:365–375
  8. Ouriel K, Cynamon J, Weaver FA, Dardik H, Akers D, Blebea J, et al. A phase I trial of alfimeprase for peripheral arterial thrombolysis. J Vasc Intervent Radiol. 2005;16:1075–1083
  9. Ouriel K, Cynamon J, Pinto D. Safety and activity of alfimeprase for catheter-directed thrombolysis in patients with lower extremity, acute peripheral arterial occlusion: report of a phase 2, multi-center, multi-national, open-label, dose-escalation study (NAPA-1). Presented at Transcatheter Cardiovascular Therapeutics Symposium 2004, Washington DC, 9/30/2004.
  10. Ouriel K, Shortell CK, DeWeese JA, Green RM, Francis CW, Azodo MVU, 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
  11. Weaver FA, Comerota AJ, Youngblood M, Froehlich J, Hosking JD, Papanicolaou G STILE investigators. Surgical revascularization versus thrombolysis for nonembolic lower extremity native artery occlusions: results of a prospective randomized trial. J Vasc Surg. 1996;24:513–523
  12. McDermott MM, Liu K, Guralnik JM, Martin GJ, Criqui MH, Greenland P. Measurement of walking endurance and walking velocity with questionnaire: validation of the walking impairment questionnaire in men and women with peripheral arterial disease. J Vasc Surg. 1998;28:1072–1081

 Competition of interest: Mr Joing was an employee of ARCA biopharma, Inc (formerly named Nuvelo, Inc) at the time of the study.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(09)01698-X

doi: 10.1016/j.jvs.2009.08.053

Journal of Vascular Surgery
Volume 51, Issue 3 , Pages 600-609 , March 2010

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