TY - JOUR
T1 - The Dutch chronic lower limb-threatening ischemia registry (THRILLER)
T2 - A study protocol for popliteal and infrapopliteal endovascular interventions
AU - Nugteren, Michael J
AU - Hazenberg, null
AU - Akkersdijk, George P
AU - Bakker, Olaf J
AU - Dinkelman, Maarten K
AU - Fioole, Bram
AU - van den Heuvel, Daniel A F
AU - Heyligers, Jan M M
AU - Hinnen, Jan-Willem
AU - Pierie, Maurice
AU - Schouten, Olaf
AU - Schreve, Michiel A
AU - Verhoeven, Bart A N
AU - de Borst, Gert J
AU - Ünlü, Çağdaş
N1 - Publisher Copyright:
© 2023 Nugteren et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/7/20
Y1 - 2023/7/20
N2 - INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions.METHODS: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal.DISCUSSION: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.
AB - INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions.METHODS: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal.DISCUSSION: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.
KW - Chronic Disease
KW - Chronic Limb-Threatening Ischemia
KW - Endovascular Procedures/methods
KW - Humans
KW - Ischemia/surgery
KW - Limb Salvage
KW - Lower Extremity
KW - Multicenter Studies as Topic
KW - Observational Studies as Topic
KW - Peripheral Arterial Disease/diagnostic imaging
KW - Registries
KW - Retrospective Studies
KW - Risk Factors
KW - Treatment Outcome
KW - Vascular Patency
UR - http://www.scopus.com/inward/record.url?scp=85165453950&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0288912
DO - 10.1371/journal.pone.0288912
M3 - Article
C2 - 37471351
SN - 1932-6203
VL - 18
SP - 1
EP - 10
JO - PLoS ONE
JF - PLoS ONE
IS - 7
M1 - e0288912
ER -