Methods, design, and initial results of an angiographic core lab from VOYAGER-PAD

Author:

Rogers R Kevin12ORCID,Herold Joerg3,Govsyeyev Nicholas12,Iezzi Roberto4,Morrison Justin1ORCID,Hogan Shea E12,Nehler Mark12,Bricker Rory1,Andring Brice5,Bergmark Brian6,Cavender Matt7,Malgor Emily1,Jacobs Donald1,Young Michael N8,Capell Warren12,Yčas Joseph W2,Anand Sonia S9ORCID,Berkowitz Scott D12,Debus E Sebastian2,Haskell Lloyd P10,Muehlhofer Eva11,Patel Manesh R12,Hess Connie N12,Bauersachs Rupert M13,Anderson Victoria2,Bonaca Marc P12ORCID

Affiliation:

1. Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA

2. CPC Clinical Research, Aurora, CO, USA

3. Department of Angiology, Darmstadt Hospital, Darmstadt, Germany

4. Department of Radiology, Agostino Gemelli University Hospital, IRCCS, Catholic University, Rome, Italy

5. RAYUS Radiology, DeSoto, TX, USA

6. Thrombolysis in Myocardial Infarction Study Group, Brigham and Women’s Hospital, Boston, MA, USA

7. Division of Cardiology, University of North Carolina School of Medicine, Chapel Hill, NC, USA

8. Division of Cardiology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

9. Vascular Medicine, McMaster University, Hamilton, ON, Canada

10. Janssen Pharmaceuticals LLC, Raritan, NJ, USA

11. Eva Muehlhofer, BAYER AG, Wuppertal, Germany

12. Division of Cardiology, Duke Medical Center, Durham, NC, USA

13. Goethe University Frankfurt, Darmstadt, Germany

Abstract

Background: Anatomy is critical in risk stratification and therapeutic decision making in coronary disease. The relationship between anatomy and outcomes is not well described in PAD. We sought to develop an angiographic core lab within the VOYAGER-PAD trial. The current report describes the methods of creating this core lab, its study population, and baseline anatomic variables. Methods: Patients undergoing lower-extremity revascularization for symptomatic PAD were randomized in VOYAGER-PAD. The median follow up was 2.25 years. Events were adjudicated by a blinded Clinical Endpoint Committee. Angiograms were collected from study participants; those with available angiograms formed this core lab cohort. Angiograms were scored for anatomic and flow characteristics by trained reviewers blinded to treatment. Ten percent of angiograms were evaluated independently by two reviewers; inter-rater agreement was assessed. Clinical characteristics and the treatment effect of rivaroxaban were compared between the core lab cohort and noncore lab participants. Anatomic data by segment were analyzed. Results: Of 6564 participants randomized in VOYAGER-PAD, catheter-based angiograms from 1666 patients were obtained for this core lab. Anatomic and flow characteristics were collected across 16 anatomic segments by 15 reviewers. Concordance between reviewers for anatomic and flow variables across segments was 90.5% (24,417/26,968). Clinical characteristics were similar between patients in the core lab and those not included. The effect of rivaroxaban on the primary efficacy and safety outcomes was also similar. Conclusions: The VOYAGER-PAD angiographic core lab provides an opportunity to correlate PAD anatomy with independently adjudicated outcomes and provide insights into therapy for PAD. (ClinicalTrials.gov Identifier: NCT02504216)

Funder

bayer

janssen pharmaceuticals

Publisher

SAGE Publications

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