Real-world study of mortality after the Use of Paclitaxel-coated Devices in Peripheral Vascular Intervention

Authors

Jialin Mao, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Art Sedrakyan, Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.
Philip P. Goodney, Section of Vascular Surgery and the Dartmouth Institute, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Misti Malone, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
Kenneth J. Cavanaugh, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
Danica Marinac-Dabic, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
Jens Eldrup-Jorgensen, Maine Medical Center
Daniel J. Bertges

Document Type

Article

Publication Date

8-22-2022

Institution/Department

Surgery

Journal Title

European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery

Abstract

OBJECTIVES: To examine outcomes after peripheral vascular intervention (PVI) with paclitaxel-coated devices (PCD) and non-PCD and evaluate heterogeneity of treatment effect in populations of interest. DESIGN: Observational cohort study. METHODS: We included patients undergoing percutaneous transluminal angioplasty and/or stent placement during 1/10/2015-31/12/2018 in the Vascular Quality Initiative Registry linked to Medicare claims. We determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with/without any other concurrent treatment (n=11 452), (B) those treated for isolated superficial-femoral or popliteal artery disease (n=5 519), and (C) patients with inclusion criteria designed to approximate RCT populations (n=2 278). RESULTS: The mean age of patients was 72.3 (SD=10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had lower mortality (HR 0.88, 95% CI 0.79-0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80-1.04) and C (HR 1.10, 95% CI 0.84-1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (Cohort A: HR=0.84, 95% CI 0.70-1.00; B: HR=0.84, 95% CI 0.67-1.06; C: HR=1.05, 95% CI 0.51-2.14). CONCLUSIONS: We did not find increased patient mortality or major amputation at three years after PVI with PCD vs. non-PCD in this large, linked registry-claims study, after accounting for heterogeneity of treatment effect by population. Our analysis and results from three cohorts intended to mirror the cohorts of prior studies provide robust and niche real-world evidence on PCD safety and help understand and reconcile previously discrepant findings.

Recommended Citation

Mao J, Sedrakyan A, Goodney PP, et al. Real-world study of mortality after the Use of Paclitaxel-coated Devices in Peripheral Vascular Intervention [published online ahead of print, 2022 Aug 22]. Eur J Vasc Endovasc Surg. 2022;S1078-5884(22)00520-2. doi:10.1016/j.ejvs.2022.08.014