Patient representativeness of a peripheral artery disease cohort in a randomized control trial versus a real-world cohort: The CLEVER trial versus the PORTRAIT registry

• Published in: Contemporary clinical trials Vol. 112; p. 106624
• Main Authors: Scierka, Lindsey E., Jelani, Qurat-ul-ain, Smolderen, Kim G., Gosch, Kensey, Spertus, John A., Mena-Hurtado, Carlos, Jones, Philip, Dreyer, Rachel P.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-01-2022
• Subjects: Ankle Brachial Index; Clinical trial representativeness/external validity; Disparities; Female; Health Status; Humans; Male; Peripheral Arterial Disease - epidemiology; Peripheral Arterial Disease - therapy; Peripheral artery disease; Quality of Life; Randomized control trial; Registries; Peripheral artery disease; Disparities; Clinical trial representativeness/external validity; Randomized control trial
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2021.106624

Peripheral artery disease (PAD) is a burdensome disease. It is unclear whether PAD cohorts enrolled in contemporary randomized control trials (RCT) are representative of the real-world PAD populations in terms of their patient characteristics.
We compared baseline patient characteristics and health status (as measured by the Peripheral Artery Questionnaire [PAQ]) between the randomized CLEVER study, and the real-world PORTRAIT registry. CLEVER was an RCT of PAD patients enrolled from 29 centers across the US and Canada comparing revascularization with stenting versus optimal medical therapy (OMT) and supervised exercise therapy (SET) plus OMT. PORTRAIT was a multicenter, prospective study of patients with new or worsening PAD symptoms across ten sites in the US.
The final cohort consisted of 879 patients (n = 119 from CLEVER, n = 760 from PORTRAIT (24.5% black, 41.4% women). While CLEVER enrolled patients with aortoiliac disease, only 16.0% of the PORTRAIT cohort had isolated aortoiliac disease. Compared with CLEVER, patients from PORTRAIT were older (64.0 ± 9.5 versus 68.9 ± 9.5 yrs., p ≤0.001), had more severe disease as measured by the ankle brachial index (0.7 ± 0.2 versus 0.9 ± 0.2, p ≤0.001) and a higher prevalence of cardiovascular risk factors including hyperlipidemia and diabetes (all p values<0.05). Both cohorts had similar disease-specific health status as measured by the PAQ summary score (47.4 ± 21.9 versus 43.6 ± 18.4, p = 0.07).
In this comparative study, real-world patients with PAD were older and sicker when compared to an RCT with similar indications. This gap may be bridged by improving enrollment of underrepresented high-risk patients in PAD trials testing strategies for PAD symptom relief.
https://clinicaltrials.gov/ct2/show/NCT01419080?term=portrait&rank=1NCT01419080.