All endpoints of THRILLER.

IntroductionChronic 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.MethodsTHRILLER 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.DiscussionDespite 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.引言 慢性肢体威胁性缺血（Chronic limb-threatening ischemia, CLTI）是外周动脉疾病（Peripheral arterial disease, PAD）的终末阶段，与高截肢率、高死亡率及疾病相关的高额医疗成本密切相关。针对腘下动脉疾病（Infrapopliteal arterial disease, IPAD），多数解剖学及临床亚型的CLTI患者应考虑接受血管腔内血运重建术。然而，该领域目前仍存在高质量证据缺口。荷兰慢性下肢威胁性缺血注册研究（Dutch Chronic Lower Limb-Threatening Ischemia Registry, THRILLER）旨在收集腘动脉及腘下动脉血管腔内干预的真实世界数据。 方法 THRILLER是一项由临床医生主导的前瞻性多中心观察性注册研究，纳入荷兰7家医院中所有连续接受腘动脉或腘下动脉血管腔内干预的患者。研究预计每年将纳入400~500例干预病例。将在干预后6~8周及12个月安排标准化随访，随访内容包括伤口监测、趾压测量及双功超声检查。主要独立终点为一期通畅率、肢体挽救率及无截肢生存率。患者需签署知情同意书后方可入组，入组将遵循预先设定的报告标准。同时将留存符合纳入标准但未被纳入注册研究的患者数据日志。研究计划在入组开始两年后开展首次中期分析，最终研究结果将发表于科学期刊。 讨论 尽管药物治疗及血运重建技术已有革新，接受血管腔内血运重建的CLTI患者预后仍仅为中等水平。既往前瞻性队列研究受限于样本量较小或报告异质性较高的问题。随机对照试验（Randomized controlled trials, RCTs）成本高昂，存在潜在利益冲突，且难以充分反映日常临床实践情况。THRILLER旨在构建目前规模最大、表型特征精准的最新CLTI患者治疗结局前瞻性数据集，以解答诊断、药物治疗、患者筛选、治疗策略及干预后随访等多个尚未得到充分探索的研究问题。