1. Quantifying patients' preferences on tradeoffs between mortality risk and reduced need for target vessel revascularization for claudication.
- Author
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Reed SD, Sutphin J, Wallace MJ, Gonzalez JM, Yang JC, Reed Johnson F, Tsapatsaris J, Tarver ME, Saha A, Chen AL, Gebben DJ, Malone M, Farb A, Babalola O, Rorer EM, Parikh SA, Simons JP, Jones WS, Krucoff MW, Secemsky EA, and Corriere MA
- Subjects
- Humans, Female, Male, Aged, Risk Assessment, Risk Factors, Middle Aged, Time Factors, Treatment Outcome, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Endovascular Procedures instrumentation, Paclitaxel administration & dosage, Paclitaxel adverse effects, Choice Behavior, Cardiovascular Agents therapeutic use, Cardiovascular Agents adverse effects, Intermittent Claudication mortality, Intermittent Claudication diagnosis, Intermittent Claudication therapy, Intermittent Claudication physiopathology, Patient Preference, Peripheral Arterial Disease mortality, Peripheral Arterial Disease diagnosis, Peripheral Arterial Disease therapy
- Abstract
Background: In 2019, the US Food and Drug Administration issued a warning that symptomatic relief from claudication using paclitaxel-coated devices might be associated with an increase in mortality over 5 years. We designed a discrete-choice experiment (DCE) to quantify tradeoffs that patients would accept between a decreased risk of clinically driven target-vessel revascularization (CDTVR) and increased mortality risk., Methods: Patients with claudication symptoms were recruited from seven medical centers to complete a web-based survey including eight DCE questions that presented pairs of hypothetical device profiles defined by varying risks of CDTVR and overall mortality at 2 and 5 years. Random-parameters logit models were used to estimate relative preference weights, from which the maximum-acceptable increase in 5-year mortality risk was derived., Results: A total of 272 patients completed the survey. On average, patients would accept a device offering reductions in CDTVR risks from 30% to 10% at 2 years and from 40% to 30% at 5 years if the 5-year mortality risk was less than 12.6% (95% CI: 11.8-13.4%), representing a cut-point of 4.6 percentage points above a baseline risk of 8%. However, approximately 40% chose the device alternative with the lower 5-year mortality risk in seven (20.6%) or eight (18.0%) of the eight DCE questions regardless of the benefit offered., Conclusions: Most patients in the study would accept some incremental increase in 5-year mortality risk to reduce the 2-year and 5-year risks of CDTVR by 20 and 10 percentage points, respectively. However, significant patient-level variability in risk tolerance underscores the need for systematic approaches to support benefit-risk decision making., Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Sahil Parikh reports institutional research support from Abbott Vascular, Acotec, Boston Scientific, Concept Medical, Shockwave Medical, Surmodics, Reflow Medical, TriReme Medical, and Veryan Medical; advisory board for: Abbott Vascular, Boston Scientific, Cordis, Medtronic, and Philips; and consulting for Canon, Inari, Penumbra, and Terumo. Eric A. Secemsky reports grants (to institution) from Abbott/CSI, BD, Boston Scientific, Cook Medical, Medtronic, and Philips; and consulting for Abbott/CSI, BD, BMS, Boston Scientific, Cagent, Conavi, Cook, Cordis, Endovascular Engineering, Gore, InfraRedx, Medtronic, Philips, RapidAI, Shockwave, Terumo, Thrombolex, VentureMed, and ZOLL. The remaining authors have no relevant conflicts of interest.
- Published
- 2024
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