Abstract 16977: Determining Rates of Meaningful 30-day Health Status Changes Following Transfemoral Carotid Artery Stenting

Introduction: While carotid artery revascularization studies have focused on clinical endpoints such as death, MI, and stroke, few cover these treatments’ effect on health status. We previously established minimal clinically important differences (MCIDs) to assess clinical improvement or worsening in generic health status for patients undergoing transfemoral carotid artery stenting (TF-CAS) and aimed to use these to study the distribution of health status responders following TF-CAS.

Methods: We studied patients in the multicenter Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) registry who underwent TF-CAS between 2010 and 2014 and completed either the EQ-5D-3L or SF-36 (two generic health-related quality-of-life surveys) within the first 28 days before TF-CAS and 30 days after. Patients were classified as improving, worsening, or experiencing no change based on score changes relative to distribution-based MCIDs of 0.09 and 11.00 for the EQ-5D-3L index value and visual analog scale (VAS) subscales, respectively, and 4.70 and 5.40 for the SF-36 mental and physical component summaries (MCS and PCS), respectively. We then stratified both cohorts by symptom status, defining symptomatic patients as having symptoms suggesting prior stroke or TIA.

Results: This study included 3,930 patients (27.74% symptomatic) who completed the EQ-5D-3L and 3,018 (30.45% symptomatic) who completed the SF-36. For the full cohorts across the four subscales, 21.17%-26.11% improved, 10.53-16.67% worsened, and 57.22-66.06% experienced no change. The distributions of changes in scores by symptom status overlapped significantly (Figure 1).

Conclusions: Roughly 20-25% of patients, regardless of symptom status, improved in terms of generic health status following TF-CAS, while about 70-80% worsened or experienced no change. Disease-specific instruments would further elucidate the effect of TF-CAS on patients' health status.