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

Lindsey E Scierka; Qurat-Ul-Ain Jelani; Kim G Smolderen; Kensey Gosch; John A Spertus; Carlos Mena-Hurtado; Philip Jones; Rachel P Dreyer

doi:10.1016/j.cct.2021.106624

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

Contemp Clin Trials. 2022 Jan:112:106624. doi: 10.1016/j.cct.2021.106624. Epub 2021 Nov 16.

Authors

Lindsey E Scierka¹, Qurat-Ul-Ain Jelani¹, Kim G Smolderen¹, Kensey Gosch², John A Spertus³, Carlos Mena-Hurtado¹, Philip Jones², Rachel P Dreyer⁴

Affiliations

¹ Vascular Medicine Outcomes Program, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University, New Haven, CT, USA.
² Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
³ Saint Luke's Mid America Heart Institute, Kansas City, MO, USA; University of Missouri-, Kansas City, MO, USA.
⁴ Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA; Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, New Haven, CT, USA. Electronic address: rachel.dreyer@yale.edu.

PMID: 34793986
DOI: 10.1016/j.cct.2021.106624

Abstract

Introduction: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT01419080?term=portrait&rank=1NCT01419080.

Keywords: Clinical trial representativeness/external validity; Disparities; Peripheral artery disease; Randomized control trial.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Ankle Brachial Index
Female
Health Status
Humans
Male
Peripheral Arterial Disease* / epidemiology
Peripheral Arterial Disease* / therapy
Quality of Life*
Registries

Associated data

ClinicalTrials.gov/NCT01419080