Randomized Trial of a Vascular Care Team vs Education for Patients With Peripheral Artery Disease.

Autor:	Hess CN; Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA. Electronic address: connie.hess@cuanschutz.edu., Daffron A; University of Colorado School of Pharmacy, Aurora, Colorado, USA., Nehler MR; CPC Clinical Research, Aurora, Colorado, USA; Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA., Morrison JT; OhioHealth Heart and Vascular Physicians, Columbus, Ohio, USA., Buchanan CE; Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Szarek M; Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA., Anderson VE; CPC Clinical Research, Aurora, Colorado, USA., Cannon CP; CPC Clinical Research, Aurora, Colorado, USA; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA., Hsia J; Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA., Saseen JJ; University of Colorado School of Pharmacy, Aurora, Colorado, USA., Bonaca MP; Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA; CPC Clinical Research, Aurora, Colorado, USA. Electronic address: marc.bonaca@cpcmed.org.
Jazyk:	angličtina
Zdroj:	Journal of the American College of Cardiology [J Am Coll Cardiol] 2024 Jun 25; Vol. 83 (25), pp. 2658-2670.
DOI:	10.1016/j.jacc.2024.04.034
Abstrakt:	Background: Underutilization of therapies to reduce ischemic risk in peripheral artery disease (PAD) persists. Objectives: The purpose was to conduct an implementation trial of lipid management in vascular disease. Methods: The OPTIMIZE PAD-1 (Implementation of Vascular Care Team to Improve Medical Management of PAD Patients) trial randomized patients with peripheral artery disease with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL to management via a vascular care team including a clinical pharmacist and an algorithm of intensive lipid management to achieve goal LDL-C in 1 step vs usual care plus provider education. Medications were obtained using commercial insurance. The primary endpoint was percent change in LDL-C at 12 months. Results: Of 166 enrolled patients, 74.2% did not have an LDL-C level at goal. Among 114 randomized patients (mean age 66 years, 36.0% women, and 15.8% Black), 50.9% received high-intensity statin, and 7.9% received ezetimibe at baseline. The mean 12-month LDL-C change was -49.1% (95% CI: -58.7% to -39.5%) with vascular care team management and -5.4% (95% CI: -15.3% to 4.6%) with usual care; the between-group least-squares mean difference was -43.7% (95% CI: -57.6% to -29.9%; P < 0.0001). Mean LDL-C was reduced in vascular care team patients from 100.6 mg/dL at baseline to 54.8 and 50.1 mg/dL by week 4 and month 12, respectively. At 12 months, vascular care team patients were >3 times as likely to achieve LDL-C <70 mg/dL and 8 times as likely to achieve LDL-C <55 mg/dL (P < 0.0001) than usual care. Conclusions: OPTIMIZE PAD-1 showed that an interprofessional, algorithm-based program can achieve rapid LDL-C lowering in vascular patients using available insurance and therapies, and LDL-C targets can be met in most patients if enabled by optimized systems of care. Competing Interests: Funding Support and Author Disclosures This was an investigator-initiated study funded through a research grant from Amgen to CPC Clinical Research and a Quality Initiative grant awarded by the American College of Cardiology Accreditation Services Foundation (to Dr Hess). The funders had no role in the design, data collection, data analysis, and reporting of this study. Ms Anderson, Drs Hess, Nehler, Szarek, Cannon, Hsia, and Bonaca all receive salary support from CPC, a nonprofit academic research organization affiliated with the University of Colorado, that receives or has received research grant/consulting funding between July 2021 and July 2023 from the following organizations: Agios Pharmaceuticals, Inc, Alexion Pharma Godo Kaisha, Amgen Inc, Anthos Therapeutics, Inc, ARCA biopharma, Inc, AstraZeneca Pharma India, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Ltd, AstraZeneca, Produtos Farmaceuticos, Lda, Atentiv, LLC, Bayer, Bayer (Proprietary) Limited, Bayer Aktiengesellschaft, Bayer Pharma AG, Beth Israel Deaconess Medical Center, Better Therapeutics, Bionest Partners Inc, Boston Clinical Research Institute, LLC, Bristol Myers Squibb, CellResearch Corporation Pte Ltd, Cleerly, Inc, Colorado Dept of Public Health and Environment, Cook Regentec LLC, CSL Behring LLC, Eidos Therapeutics, Inc, EPG Communication Holdings Ltd, Esperion Therapeutics, Inc, Faraday Pharmaceuticals, Inc, HeartFlow Inc, Hummingbird Bioscience PTE Ltd, Insmed, Ionis Pharmaceuticals, IQVIA Inc, Janssen Pharmaceuticals, Inc, Janssen Research and Development, LLC, Janssen Scientific Affairs LLC, Lexicon Pharmaceuticals, Inc, LSG Corporation, MedImmune Limited, Medpace, Inc, Medscape, Merck Sharp and Dohme Corp, Northwell Health, Novartis Pharmaceuticals Corporation, Novo Nordisk, Osiris Therapeutics, Inc, Pfizer, PPD Development, LP, Prothena Biosciences Limited, Regeneron, Regents of the University of Colorado (aka UCD), Sanifit Therapeutics SA, Sanofi, Silence Therapeutics PLC, Stanford University, Stealth BioTherapeutics Inc, The Brigham and Women's Hospital, Inc, Thrombosis Research Institute, UCD iC42 Lab, University of Colorado Denver, University of Pittsburgh, VarmX, and WraSer, LLC. Dr Hess has received a research grant from the American College of Cardiology Accreditation Services Foundation. Dr Szarek has received consulting fees from Amarin, CiVi, NewAmsterdam Pharma, and Silence Therapeutics PLC. Dr Cannon from 2021-2023 has received research grants from Amgen, Better Therapeutics, Boehringer Ingelheim, Daiichi-Sankyo, Merck, Novo Nordisk, and Pfizer; has received consulting fees from Amryt/Chiesi, Alnylam, Amarin, Amgen, Applied Therapeutics, Ascendia, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Eli Lilly, Janssen, Lexicon, Merck, Milestone, Pfizer, Rhoshan, and Sanofi; and is a member of the Data and Safety Monitoring Boards for Applied Therapeutics, Areteia, Novo Nordisk, and the Veterans Administration. Dr Hsia owns AstraZeneca stock. Dr Saseen is a member of the Amgen Lipid Monitoring Committee for the VESALIUS and OCEAN(a) outcome trials. Dr Bonaca has received support from the AHA SFRN under award numbers 18SFRN3390085 (BWH-DH SFRN Center) and 18SFRN33960262 (BWH-DH Clinical Project); and has stock in Medtronic and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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