PMID- 32891803 OWN - NLM STAT- MEDLINE DCOM- 20211011 LR - 20211204 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 73 IP - 4 DP - 2021 Apr TI - The cost-effectiveness of intensive low-density lipoprotein cholesterol lowering in people with peripheral artery disease. PG - 1396-1403.e3 LID - S0741-5214(20)32015-2 [pii] LID - 10.1016/j.jvs.2020.08.129 [doi] AB - BACKGROUND: People with peripheral artery disease are at a high risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Randomized controlled trials suggest that intensive lowering of low-density lipoprotein cholesterol (LDL-C) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors is an effective strategy to prevent these events. This study estimated the potential benefit and cost-effectiveness of administrating PCSK9 inhibitors to a cohort of participants with peripheral artery disease. METHODS: A total of 783 participants with intermittent claudication (IC; n = 582) or chronic limb-threatening ischemia (CLTI; n = 201) were prospectively recruited from three hospitals in Australia. Serum LDL-C was measured at recruitment, and the occurrence of MACE and MALE was recorded over a median (interquartile range) follow-up of 2.2 years (0.3-5.7 years). The potential benefit of administering a PCSK9 inhibitor was estimated by calculating the absolute risk reduction and numbers needed to treat (NNT) based on relative risk reductions reported in published randomized trials. The incremental cost-effectiveness ratio per quality-adjusted life year gained was estimated. RESULTS: Intensive LDL-C lowering was estimated to lead to an absolute risk reduction in MACE of 6.1% (95% confidence interval [CI], 2.0-9.3; NNT, 16) and MALE of 13.7% (95% CI, 4.3-21.5; NNT, 7) in people with CLTI compared with 3.2% (95% CI, 1.1-4.8; NNT, 32) and 5.3% (95% CI, 1.7-8.3; NNT, 19) in people with IC. The estimated incremental cost-effectiveness ratios over a 10-year period were $55,270 USD and $32,800 USD for participants with IC and CLTI, respectively. CONCLUSIONS: This analysis suggests that treatment with a PCSK9 inhibitor is likely to be cost-effective in people with CLTI. CI - Copyright (c) 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Nastasi, Domenico R AU - Nastasi DR AD - Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia. FAU - Moxon, Joseph V AU - Moxon JV AD - Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, the Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia. FAU - Norman, Richard AU - Norman R AD - School of Public Health, Curtin University, Perth, Western Australia, Australia. FAU - Trollope, Alexandra F AU - Trollope AF AD - Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, the Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia. FAU - Rowbotham, Sophie AU - Rowbotham S AD - School of Medicine, University of Queensland, Brisbane, Queensland, Australia; Department of Vascular and Endovascular Surgery, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia. FAU - Quigley, Frank AU - Quigley F AD - Department of Vascular and Endovascular Surgery, Mater Hospital, Townsville, Queensland, Australia. FAU - Jenkins, Jason AU - Jenkins J AD - Department of Vascular and Endovascular Surgery, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia. FAU - Golledge, Jonathan AU - Golledge J AD - Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia; Centre for Molecular Therapeutics, the Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia; Department of Vascular and Endovascular Surgery, Townsville University Hospital, Townsville, Queensland, Australia. Electronic address: Jonathan.Golledge@jcu.edu.au. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20200903 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 RN - 0 (Anticholesteremic Agents) RN - 0 (Biomarkers) RN - 0 (Cholesterol, LDL) RN - 0 (PCSK9 Inhibitors) RN - EC 3.4.21.- (PCSK9 protein, human) SB - IM MH - Aged MH - Anticholesteremic Agents/adverse effects/*economics/*therapeutic use MH - Biomarkers/blood MH - Cholesterol, LDL/*blood MH - Chronic Disease MH - Cost-Benefit Analysis MH - Down-Regulation MH - *Drug Costs MH - Dyslipidemias/blood/*drug therapy/*economics/mortality MH - Female MH - Humans MH - Intermittent Claudication/*economics/mortality/*therapy MH - Ischemia/*economics/mortality/*therapy MH - Male MH - Middle Aged MH - PCSK9 Inhibitors MH - Peripheral Arterial Disease/*economics/mortality/*therapy MH - Quality-Adjusted Life Years MH - Queensland MH - Retrospective Studies MH - Risk Assessment MH - Risk Factors MH - Time Factors MH - Treatment Outcome MH - Western Australia OTO - NOTNLM OT - Cholesterol OT - Cost-benefit analysis OT - Cost-effectiveness OT - PAD OT - PCSK9 inhibitors EDAT- 2020/09/07 06:00 MHDA- 2021/10/12 06:00 CRDT- 2020/09/06 20:25 PHST- 2020/03/31 00:00 [received] PHST- 2020/08/12 00:00 [accepted] PHST- 2020/09/07 06:00 [pubmed] PHST- 2021/10/12 06:00 [medline] PHST- 2020/09/06 20:25 [entrez] AID - S0741-5214(20)32015-2 [pii] AID - 10.1016/j.jvs.2020.08.129 [doi] PST - ppublish SO - J Vasc Surg. 2021 Apr;73(4):1396-1403.e3. doi: 10.1016/j.jvs.2020.08.129. Epub 2020 Sep 3.