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Quantifying patients' preferences on tradeoffs between mortality risk and reduced need for target vessel revascularization for claudication
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DOI：10.1177/1358863X241290233.png)
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Abstract
En 中文
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.
Keywords:
discrete-choice experiment
paclitaxel-coated devices
patient centered
patient preferences
peripheral artery disease (PAD)
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