Quantifying patients' preferences on tradeoffs between mortality risk and reduced need for target vessel revascularization for claudication.

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.