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Home > Vascular Annual Meeting^® > LB7. Objective Performance Goals (OPG) for the...

LB7. Objective Performance Goals (OPG) for the Treatment of Critical Limb Ischemia (CLI): Importance of Risk Stratification in Clinical Trial Design and Reporting

Michael S. Conte1, Patrick J. Geraghty2, Andrew W. Bradbury3, Nathanael D. Hevelone1, Gregory L. Moneta4, Mark R. Nehler5, Richard J. Powell6, Anton N. Sidawy7
1University of California San Francisco, San Francisco, CA;2Washington University, Saint Louis, MO;3University of Birmingham, Birmingham, United Kingdom4Oregon Health Sciences University, Portland, OR;5University of Colorado Health Sciences Center, Aurora, CO;6Dartmouth-Hitchcock Medical Center, Lebanon, NH;7Georgetown University, Georgetown, VA

OBJECTIVES: The evaluation of new devices targeting the CLI population presents major challenges in clinical trial design. We sought to develop OPG and to define appropriate outcome measures for CLI trials.

METHODS: We pooled line-item data from three prospective multi-center trials of open surgical revascularization for CLI:PREVENT-III, Circulase II, and BASIL. We included data for patients undergoing surgical bypass using autogenous vein. Test-drug treatment, use of prosthetic, and end-stage renal disease patients were excluded. Endpoints included major adverse cardiac events (MACE), death, amputation, and reintervention. We defined a Major Adverse Limb Event (MALE) as consisting of either amputation or a major reintervention (new bypass graft, thrombolysis, jump or interposition graft revision). Perioperative (30 day) death was combined with any MALE to generate the primary efficacy endpoint MALE(+). Other composite endpoints included amputation-free survival (AFS). Event rates were calculated by Kaplan-Meier. Univariate and multivariate analyses defined risk criteria based on patient characteristics, anatomy, and conduit quality.

RESULTS: Data from 838 surgical cases from the three trials were included. Perioperative MACE was 6.2% including 2.7% mortality. The combination of age >80 years and tissue loss (80+TL) was associated with a 3.1-fold increased risk of 30-day MACE and notably inferior outcomes for all endpoints that included death as an event (Table). Infrapopliteal outflow anatomy (IP) and the use of a high-risk conduit (HRC= non-saphenous, spliced, or small caliber vein) were also significant outcome stratifiers, particularly for the limb-related endpoints.

CONCLUSIONS: Patient age (>80), presence of tissue loss, infrapopliteal disease, and lack of adequate saphenous vein are useful stratification criteria for clinical trial designs in the CLI population. MALE is a clinically relevant efficacy measure for limb revascularization, distinct from AFS. Using these data, risk stratified OPG for catheter-based devices targeting CLI were developed.

AUTHOR DISCLOSURES: M.S. Conte, None; P.J. Geraghty, None; A.W. Bradbury, None; N.D. Hevelone, None; G.L. Moneta, None; M.R. Nehler, Consultant: Anges; R.J. Powell, Consultant: Anges, Inc; A.N. Sidawy, None.