Quality of life after epic nitinol stent placement: 12-month outcomes from the orion study

Abstract

Symptoms of peripheral arterial disease (PAD) are frequently associated with impaired health-related quality-of-life (HRQOL), which, in turn, impacts overall life satisfaction. However, there are few reports of patient expectations related to PAD interventions. The purpose of this analysis was to evaluate treatment-related changes in HRQOL in the ORION study. METHODS: ORION enrolled 125 patients, at 28 US centers, who had been diagnosed with chronic, symptomatic iliac disease. Patients received ≤2 nitinol stents in the common and/or external iliac artery. The Walking Impairment Questionnaire (WIQ), a validated PAD-specific quality-of-life instrument, was completed by each patient to assess his or her walking distance, walking speed, and stairclimbing ability. RESULTS: Significant improvements (p<.0001) in all 3 domain scores of the WIQ were reported at 12 months postintervention. The walking distance mean score increased from 14.56±19.36 at baseline to 55.88±38.02 at 12 months. Walking speed and stair-climbing mean scores increased from 18.38±19.18 and 26.14±26.91, respectively, at baseline to 47.96±31.80 and 57.72±37.17 at 12 months. Prior to intervention, 20.2% of patients were able to walk no more than 50 feet and 21.0% could walk at least 1500 feet. Improvement in maximum walking distance was observed; at 12 months, only 5.5% of patients could walk no more than 50 feet, while 63.3% could walk at least 1500 feet. Postintervention, there was an approximately 5-fold increase in patients who could run/jog one city block at 12 months (34.9%), compared to baseline (7.3%) and an approximately 2-fold increase in those who could climb at least 3 flights of stairs at 12 months (62.4%), compared to baseline (32.3%). CONCLUSIONS: Significant improvements in HRQOL, related to walking and stair climbing ability, were observed after nitinol stent placement. Future studies will target whether pretreatment HRQOL patient education affects patient perception and satisfaction related to the procedure and provider.