Suggested objective performance goals and clinical trial design for evaluating catheter- based treatment of critical limb ischemia Michael S. Conte, MD,

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Presentation transcript:

Suggested objective performance goals and clinical trial design for evaluating catheter- based treatment of critical limb ischemia Michael S. Conte, MD, Patrick J. Geraghty, MD, Andrew W. Bradbury, MD, Nathanael D. Hevelone, MPH, Stuart R. Lipsitz, ScD, Gregory L. Moneta, MD, Mark R. Nehler, MD, Richard J. Powell, MD, Anton N. Sidawy, MD Journal of Vascular Surgery Volume 50, Issue 6, Pages 1462-1473.e3 (December 2009) DOI: 10.1016/j.jvs.2009.09.044 Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 1 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. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 2 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. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 3 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. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 4 (online only) 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. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 5 (online only) K-M plot for the key secondary endpoint, amputation-free survival (AFS), open surgery controls, full dataset N = 838. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 6 (online only) K-M plot for the secondary endpoint of freedom from reintervention or amputation (RAO), open surgery controls, full dataset N = 838. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions

Fig 7 (online only) K-M plot for the secondary endpoint of freedom from reintervention, amputation or stenosis (RAS), open surgery controls, N = 605. Journal of Vascular Surgery 2009 50, 1462-1473.e3DOI: (10.1016/j.jvs.2009.09.044) Copyright © 2009 Society for Vascular Surgery Terms and Conditions