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The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and
Michael J Nugteren1,2, Constantijn E V B Hazenberg2, George P Akkersdijk3
1Department of Vascular Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.
Insights
The THRILLER registry collects real-world data on endovascular interventions for chronic limb-threatening ischemia (CLTI). This aims to improve treatment strategies and patient outcomes for this severe peripheral arterial disease.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Public Health
Background:
- Chronic limb-threatening ischemia (CLTI) represents the advanced stage of peripheral arterial disease (PAD), characterized by high rates of amputation, mortality, and healthcare expenditures.
- Endovascular revascularization is a key treatment for infrapopliteal arterial disease (IPAD) in CLTI patients, yet high-quality evidence is limited.
- Existing studies often suffer from small sample sizes, heterogeneous reporting, or do not fully reflect daily clinical practice.
Purpose of the Study:
- To establish the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) for collecting real-world data on endovascular interventions in the popliteal and infrapopliteal arteries.
- To address the gap in high-quality evidence regarding the effectiveness and outcomes of endovascular treatments for CLTI.
- To generate a comprehensive dataset for exploring underexplored research questions in CLTI management.
Main Methods:
- A prospective, multicenter, observational registry of consecutive patients undergoing popliteal or infrapopliteal endovascular interventions in seven Dutch hospitals.
- Standardized follow-up including wound monitoring, toe pressure measurement, and duplex ultrasonography at 6-8 weeks and 12 months.
- Primary endpoints include primary patency, limb salvage, and amputation-free survival, with patient informed consent and predefined reporting standards.
Main Results:
- The registry is designed to include an estimated 400-500 interventions annually.
- The first interim analysis is planned two years after the commencement of patient inclusion.
- Results will be published in a scientific journal following the interim analysis.
Conclusions:
- The THRILLER registry will provide the largest prospective, well-phenotyped dataset on CLTI treatment outcomes.
- This initiative aims to enhance understanding and optimize diagnostics, medication, patient selection, treatment strategies, and follow-up care for CLTI.
- The collected data will contribute to improving the moderate prognosis currently observed in CLTI patients undergoing endovascular revascularization.
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.
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