ORIGINAL ARTICLE  PERIPHERAL ARTERIAL DISEASE Free access

International Angiology 2022 February;41(1):56-62

DOI: 10.23736/S0392-9590.21.04816-1

Copyright © 2021 EDIZIONI MINERVA MEDICA

lingua: Inglese

Prevalence of VOYAGER PAD trial exclusion criteria in unselected patients undergoing lower limb revascularization

Maria A. MOLL ¹, Daniela ZWERGER ¹, Kristina J. GRASSL ¹, Werner WESTREICHER ¹, Sabrina B. NEURURER ², Clemens W. MOLL ¹, Sabine H. WIPPER ¹, Josef KLOCKER ¹ ✉

¹ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria; ² Department of Clinical Epidemiology, Tyrolean Federal Institute for Integrated Care, Tirol Kliniken GmbH, Innsbruck, Austria

BACKGROUND: The VOYAGER PAD trial investigated data on dual pathway inhibition after lower limb revascularization for peripheral arterial disease (PAD). Multiple exclusion criteria were applied. However, neither data on the prevalence of exclusion criteria nor on the total number of patients screened for inclusion was discussed.
METHODS: We performed a single-center prospective observational study in unselected PAD patients undergoing lower limb revascularization. Demographic and disease-specific data was collected.
RESULTS: One hundred fifty patients were included with only 29 patients (19.3%) as potential candidates for the VOYAGER PAD study medication. Poorly controlled diabetes or severe uncontrolled hypertension (33.3%), major tissue loss (18.7%), acute limb ischaemia within prior 2 weeks (17.3%) and a history of intracranial hemorrhage, stroke or TIA (16%) were amongst the exclusion criteria most frequently met. Compared to VOYAGER PAD study patients, significant differences regarding sex (36.7% female vs. 25.8%), renal insufficiency (29.0% vs. 20.1%), previous myocardial infarction (16.7% vs. 11.1%) and known carotid artery disease (18.7% vs. 8.6%) revealed. Patients presented significantly more frequently with critical limb ischemia (56.7% vs. 30.4%) and a history of previous peripheral revascularization (72.0% vs. 35.9%). Fewer endovascular interventions (52% vs. 65.5%) and more surgeries (58% vs. 34.5%) were performed.
CONCLUSIONS: In unselected patients undergoing revascularization for peripheral arterial disease, the majority presents with characteristics that, at present, preclude prescription of rivaroxaban in addition to aspirin. This patient cohort represents a population with higher rates of comorbidities and more complex vascular interventions, but might also benefit from dual pathway inhibition strategy.

KEY WORDS: Peripheral arterial disease; Rivaroxaban; Limb; Ischemia