Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial

• Published in: Journal of the American Heart Association Vol. 9; no. 19; p. e016573
• Main Authors: Rymer, Jennifer A, Mulder, Hillary, Smolderen, Kim G, Hiatt, William R, Conte, Michael S, Berger, Jeffrey S, Norgren, Lars, Mahaffey, Kenneth W, Baumgartner, Iris, Fowkes, F Gerry, Katona, Brian G, Rockhold, Frank, Jones, W Schuyler, Patel, Manesh R
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 20-10-2020; Wiley
• Subjects: Cardiovascular Diseases - diagnosis; Cardiovascular Diseases - epidemiology; Double-Blind Method; Female; Health Status Indicators; health status instruments; Humans; Lower Extremity - blood supply; Lower Extremity - surgery; Male; Middle Aged; Original Research; Outcome Assessment, Health Care; Peripheral Arterial Disease - diagnosis; Peripheral Arterial Disease - drug therapy; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - psychology; peripheral artery disease; Platelet Aggregation Inhibitors - administration & dosage; Quality of Life; Surveys and Questionnaires; Symptom Assessment - methods; Ticagrelor - administration & dosage; Vascular Surgical Procedures - methods; Vascular Surgical Procedures - statistics & numerical data; Visual Analog Scale; quality of life; health status instruments; peripheral artery disease
• ISSN: 2047-9980; 2047-9980
• DOI: 10.1161/JAHA.120.016573

Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5-Dimensions [EQ-5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization procedures during trial follow-up and the association between 12-month health status change scores and subsequent end points during follow-up. There were 13 217 (95%) patients with EQ-5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ-5D tertile (0 to <0.69) were more likely to be female with severe claudication compared with the highest tertile (0.79-1.0;
<0.01). Patients in the lowest VAS (0-60) and peripheral artery questionnaire (0-49) tertiles had lower ankle-brachial indices compared with the highest tertiles (80-100 and 76-108, respectively;
<0.01). There was a significant association between baseline EQ-5D, VAS, and peripheral artery questionnaire scores and adjusted major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization (
<0.05). Improved EQ-5D and VAS scores over 12 months were associated with reduced risk of subsequent major adverse cardiovascular events or lower-extremity revascularization (all
<0.01). Conclusions Although health status instruments are rarely used in clinical practice, these measures are associated with outcomes, including major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization. Further research is needed to determine the relationship between changes in these instruments, revascularization, and outcomes.