Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.
| Autor: | Hess CN; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA. Electronic address: connie.hess@cuanschutz.edu., Patel MR; Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, North Carolina, USA., Bauersachs RM; Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz, Germany., Anand SS; Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada., Debus ES; Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg, Germany., Nehler MR; CPC Clinical Research, Aurora, Colorado, USA; Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA., Fanelli F; Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy., Yeh RW; Smith Center for Outcomes Research in Cardiology, Department of Medicine, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Secemsky EA; Smith Center for Outcomes Research in Cardiology, Department of Medicine, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Beckman JA; Department of Medicine, Division of Cardiology, Vanderbilt University, Nashville, Tennessee, USA., Mauri L; Medtronic, Inc, Minneapolis, Minnesota, USA., Govsyeyev N; CPC Clinical Research, Aurora, Colorado, USA; Department of Surgery, Division of Vascular Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA., Capell WH; CPC Clinical Research, Aurora, Colorado, USA; Department of Medicine, Division of Endocrinology, University of Colorado School of Medicine, Aurora, Colorado, USA., Brackin T; CPC Clinical Research, Aurora, Colorado, USA., Berkowitz SD; Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany, New Jersey, USA., Muehlhofer E; Bayer, Wuppertal, Germany., Haskell LP; Janssen Research and Development, Raritan, New Jersey, USA., Hiatt WR; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA., Bonaca MP; Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of the American College of Cardiology [J Am Coll Cardiol] 2021 Nov 02; Vol. 78 (18), pp. 1768-1778. |
| DOI: | 10.1016/j.jacc.2021.08.052 |
| Abstrakt: | Background: Paclitaxel drug-coated devices (DCDs) were developed to improve lower extremity revascularization (LER) patency in peripheral artery disease (PAD) but have been associated with long-term mortality. Objectives: This study assessed DCD safety and effectiveness in LER for PAD. Methods: VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) randomized patients with PAD who underwent LER to rivaroxaban or placebo. The primary VOYAGER PAD study efficacy and safety outcomes were composite cardiovascular and limb events and Thrombolysis In Myocardial Infarction major bleeding. For prespecified DCD analyses, primary safety and effectiveness outcomes were mortality and unplanned index limb revascularization (UILR). Major adverse limb events (MALE) were a secondary outcome. Inverse probability treatment weighting was used to account for each subject's propensity for DCD treatment. Effects of rivaroxaban were assessed with Cox proportional hazards models. Results: Among 4,316 patients who underwent LER, 3,478 (80.6%) were treated for claudication, and 1,342 (31.1%) received DCDs. Median follow-up was 31 months, vital status was ascertained in 99.6% of patients, and there were 394 deaths. After weighting, DCDs were not associated with mortality (HR: 0.95; 95% CI: 0.83-1.09) or MALE (HR: 1.08; 95% CI: 0.90-1.30) but were associated with reduced UILR (3-year Kaplan-Meier: 21.5% vs 24.6%; HR: 0.84; 95% CI: 0.76-0.92). Irrespective of DCD use, consistent benefit of rivaroxaban for composite cardiovascular and limb events (P Conclusions: In >4,000 patients with PAD who underwent LER, DCDs were not associated with mortality or MALE but were associated with persistent reduction in UILR. These findings provide insight into the safety and effectiveness of DCDs in PAD. (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD [VOYAGER PAD]; NCT02504216). Competing Interests: Funding Support and Author Disclosures VOYAGER PAD was funded by Bayer and Janssen Pharmaceuticals. A Pan-Industry Consortium (Medtronic, Boston Scientific, Cook, Philips, Bard, Surmodics, TriReme) provided funding through a grant to CPC Clinical Research to support statistical analyses performed at CPC Clinical Research. Dr Bonaca was supported by the American Heart Association Strategically Focused Research Network in Vascular Disease under award numbers 18SFRN3390085 (BWH-DH SFRN Center) and 18SFRN33960262 (BWH-DH Clinical Project). Dr Hess has received grants to CPC Clinical Research from Bayer, Janssen, and Amgen during the conduct of the study; and has received grants from Merck and Amgen outside the submitted work. Dr Patel has received grants and personal fees from Bayer and from Janssen during the conduct of the study; has received grants and personal fees from AstraZeneca and Heartflow, outside the submitted work; and has received grants from the National Heart, Lung, and Blood Institute, Medtronic, and Phillips Healthcare. Dr Bauersachs has received personal fees from Bayer during the conduct of the study; and has received personal fees from Bristol Myers Squibb, Daiichi-Sankyo, and Pfizer, outside the submitted work. Dr Anand has received personal fees from Bayer AG and Janssen during the conduct of the study; and has received personal fees from Bayer AG and Janssen outside the submitted work. Dr Debus has received grants and personal fees from Bayer AG; and has received grants from Cook LTD and Terumo Aortic during the conduct of the study. Dr Nehler has received grants from Bayer and Janssen; and has received salary support from CPC Clinical Research during the conduct of the study. Dr Yeh has been a consultant and has received grants from Abbott Vascular, Boston Science, and Medtronic; and has received grants from BD Bard, Cook Medical, and Philips Medical. Dr Secemsky has received research grants to BIDMC from the NIH/NHLBI K23HjL150290, Harvard Medical School’s Shore Faculty Development Award, AstraZeneca, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic, and Philips; and has received consulting/speaking fees from Abbott, Bayer, BD, Boston Scientific, Cook, CSI, Inari, Janssen, Medtronic, Philips, and Venture Medical. Dr Beckman has been a consultant for Janssen and Bayer during the conduct of the study. Dr. Capell has received grants from Bayer and Janssen to CPC Clinical Research during the conduct of the study. Dr Berkowitz has received personal fees from Bayer U.S., LLC during the conduct of the study and outside of the submitted work from employment as a Clinical Research Physician. Dr Haskell was employed by Janssen Pharmaceuticals LLC during the conduct of the study; and holds stock in Johnson & Johnson. Dr Hiatt has received grants to CPC Clinical Research from Bayer and Janssen during the conduct of this study. Dr Bonaca has received grants to CPC Clinical Research from Bayer AG and Janssen Pharmaceuticals during the conduct of the study; and has received grants from Amgen, AstraZeneca, Merck, NovoNordisk, Pfizer, and Sanofi outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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