Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1462-1473.e3 , December 2009

Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia

Presented at the Annual Meeting of the Society for Vascular Surgery, Denver, CO, Jun 11-14, 2009.

  • Michael S. Conte, MD

      Affiliations

    • Division of Vascular and Endovascular Surgery, University of California, San Francisco, Calif
    • Corresponding Author InformationReprint requests: Michael S. Conte, MD, Division of Vascular and Endovascular Surgery, University of California San Francisco, 400 Parnassus Avenue, A-581, San Francisco, CA 94143-0222
    • ,
  • Patrick J. Geraghty, MD

      Affiliations

    • Department of Surgery, Washington University School of Medicine, St. Louis, Mo
    • ,
  • Andrew W. Bradbury, MD

      Affiliations

    • Department of Vascular Surgery, Birmingham University, Heart of England NHS Trust, Birmingham, United Kingdom
    • ,
  • Nathanael D. Hevelone, MPH

      Affiliations

    • Division of Vascular and Endovascular, Surgery University of California, San Francisco, Calif
    • ,
  • Stuart R. Lipsitz, ScD

      Affiliations

    • Division of Surgery, Brigham and Women's Hospital, Boston, Mass
    • ,
  • Gregory L. Moneta, MD

      Affiliations

    • Department of Surgery, Division of Vascular Surgery, Oregon Health and Science University, Portland, Ore
    • ,
  • Mark R. Nehler, MD

      Affiliations

    • Division of Vascular Surgery, University of Colorado Denver, Aurora, Colo
    • ,
  • Richard J. Powell, MD

      Affiliations

    • Department of Surgery (Vascular Surgery), Dartmouth Medical School, Hanover, NH
    • ,
  • Anton N. Sidawy, MD

      Affiliations

    • Department of Surgery, Washington VA Medical Center, Washington, DC

Received 14 September 2009 ,Accepted 23 September 2009.

  • Image Result

    Primary (Panel A: Peri-operative death or any Major Adverse Limb Event [MALE+POD]) and Key Secondary (Panel B: Amputation Free Survival [AFS]) endpoints from the surgical control dataset, dichotomized

    Primary (Panel A: Peri-operative death or any Major Adverse Limb Event [MALE+POD]) and Key Secondary (Panel B: Amputation Free Survival [AFS]) endpoints from the surgical control dataset, dichotomized by clinical risk (high risk defined as being both age 80 or older and having tissue loss). N = 136 for high risk and 702 for low risk.

  • Image Result
    Primary (Panel A: Peri-operative death or any Major Adverse Limb Event [MALE+POD]) and Key Secondary (Panel B: Amputation Free Survival [AFS]) endpoints from the surgical control dataset, dichotomized

    Primary (Panel A: Peri-operative death or any Major Adverse Limb Event [MALE+POD]) and Key Secondary (Panel B: Amputation Free Survival [AFS]) endpoints from the surgical control dataset, dichotomized by anatomic risk (infra-popliteal vs otherwise). N = 505 for infra-popliteal target and 333 for more proximal vessel.

  • Image Result
    Primary (Panel A: Peri-operative death or any Major Adverse Limb Event [MALE+POD]) and Key Secondary (Panel B: Amputation Free Survival [AFS]) endpoints from the surgical control dataset, dichotomized

    Primary (Panel A: Peri-operative death or any Major Adverse Limb Event [MALE+POD]) and Key Secondary (Panel B: Amputation Free Survival [AFS]) endpoints from the surgical control dataset, dichotomized by conduit risk (high risk defined by use of non-single segment great saphenous vein [SSGSV] or vein diameter < 3mm). N = 163 for high risk grafts and 442 for low risk grafts.

  • Image Result
    K-M plot for the primary efficacy endpoint: freedom from perioperative death or any Major Adverse Limb Event (MALE+POD), open surgery controls, full dataset N = 838.

    K-M plot for the primary efficacy endpoint: freedom from perioperative death or any Major Adverse Limb Event (MALE+POD), open surgery controls, full dataset N = 838.

  • Image Result
    K-M plot for the key secondary endpoint, amputation-free survival (AFS), open surgery controls, full dataset N = 838.

    K-M plot for the key secondary endpoint, amputation-free survival (AFS), open surgery controls, full dataset N = 838.

  • Image Result
    K-M plot for the secondary endpoint of freedom from reintervention or amputation (RAO), open surgery controls, full dataset N = 838.

    K-M plot for the secondary endpoint of freedom from reintervention or amputation (RAO), open surgery controls, full dataset N = 838.

  • Image Result
    K-M plot for the secondary endpoint of freedom from reintervention, amputation or stenosis (RAS), open surgery controls, N = 605.

    K-M plot for the secondary endpoint of freedom from reintervention, amputation or stenosis (RAS), open surgery controls, N = 605.

 Competition of interest: Patrick Geraghty is a consultant for WL Gore and Cook Medical; Richard Powell is a consultant for AnGes, Inc.

 Additional material for this article may be found online at www.jvascsurg.org.

 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)01934-X

doi: 10.1016/j.jvs.2009.09.044

Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1462-1473.e3 , December 2009

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