Leyla Schweiger, Katharina Gütl, Peter Rief, Clemens Reiter, Michael Janisch, Ido Weinberg, Raghu Kolluri, Larry E Miller, Marianne Brodmann
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Secondary outcome measures included acute vessel recoil, perioperative death, angiographic late lumen loss between post-procedure and 6 months, as well as primary patency, major amputation, change in Rutherford class, and wound healing through 12 months.</p><p><strong>Results: </strong>The study included 26 patients (mean age 71 years, 62% male, 88% Rutherford 5) with 28 treated infrapopliteal lesions (36% occluded, 54% TASC B/C). Acute vessel recoil, measured in seven patients, was negligible (2.4 mm after treatment vs. 2.3 mm 15 minutes after deployment). A 6-month primary safety event occurred in 11.5% of patients (1 all-cause mortality, 1 major amputation, 1 clinically driven target lesion revascularization). Late lumen loss at 6 months was 0.7±0.7 mm. At 12 months, primary patency was 89.5%, improvement in Rutherford class was observed in 68.2% of patients, 90% of patients were deemed very low/low major limb amputation risk based on Wound, Ischemia, and foot Infection (WIfI) scores, and no additional major amputations or clinically driven target lesion revascularizations were reported.</p><p><strong>Conclusions: </strong>Retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty demonstrated promising safety and efficacy through 12 months in patients with infrapopliteal artery disease.</p><p><strong>Level of evidence iv: </strong>Case Series.</p>","PeriodicalId":9591,"journal":{"name":"CardioVascular and Interventional Radiology","volume":" ","pages":"297-303"},"PeriodicalIF":2.8000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11889002/pdf/","citationCount":"0","resultStr":"{\"title\":\"Retrievable Scaffold Therapy Combined with Sirolimus-coated Balloon Angioplasty for Infrapopliteal Artery Disease: Final Results from the DEEPER LIMUS Trial.\",\"authors\":\"Leyla Schweiger, Katharina Gütl, Peter Rief, Clemens Reiter, Michael Janisch, Ido Weinberg, Raghu Kolluri, Larry E Miller, Marianne Brodmann\",\"doi\":\"10.1007/s00270-025-03987-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate the safety and efficacy of retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty for treating infrapopliteal artery lesions.</p><p><strong>Methods: </strong>The DEEPER LIMUS study enrolled Rutherford class 3 to 5 patients with infrapopliteal artery disease. 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A 6-month primary safety event occurred in 11.5% of patients (1 all-cause mortality, 1 major amputation, 1 clinically driven target lesion revascularization). Late lumen loss at 6 months was 0.7±0.7 mm. 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引用次数: 0
摘要
目的：评价可回收支架联合西罗莫司包被球囊血管成形术治疗膝下动脉病变的安全性和有效性。方法：deep LIMUS研究纳入了卢瑟福3至5级腘下动脉疾病患者。患者接受可回收支架治疗的血管准备，随后进行西罗莫司包被球囊血管成形术。主要的安全结局指标是全因死亡率、主要截肢或临床驱动的6个月靶病变血运重建的综合指标。次要结局指标包括急性血管后坐力、围手术期死亡、术后至6个月的血管造影晚期管腔丧失、原发性通畅、主要截肢、卢瑟福分级改变和12个月的伤口愈合。结果：研究纳入26例患者（平均年龄71岁，62%男性，88% Rutherford 5），其中28例治疗了腘窝下病变（36%闭塞，54% TASC B/C）。7例患者的急性血管后坐力可忽略不计（治疗后2.4 mm vs部署后15分钟2.3 mm）。11.5%的患者发生了6个月的主要安全事件（1例全因死亡，1例主要截肢，1例临床驱动的靶病变血运重建）。6个月时晚期管腔损失为0.7±0.7 mm。12个月时，原发性通畅率为89.5%，68.2%的患者Rutherford分级改善，90%的患者根据伤口、缺血和足部感染（WIfI）评分被认为是非常低/低的主要截肢风险，没有额外的主要截肢或临床驱动的目标病变血运重建的报道。结论：可回收支架治疗联合西罗莫司包被球囊血管成形术在12个月的治疗中显示出良好的安全性和有效性。证据级别iv：案例系列。
Retrievable Scaffold Therapy Combined with Sirolimus-coated Balloon Angioplasty for Infrapopliteal Artery Disease: Final Results from the DEEPER LIMUS Trial.
Purpose: To evaluate the safety and efficacy of retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty for treating infrapopliteal artery lesions.
Methods: The DEEPER LIMUS study enrolled Rutherford class 3 to 5 patients with infrapopliteal artery disease. Patients underwent vessel preparation with retrievable scaffold therapy followed by sirolimus-coated balloon angioplasty. The primary safety outcome measure was a composite of all-cause mortality, major amputation, or clinically driven target lesion revascularization at 6 months. Secondary outcome measures included acute vessel recoil, perioperative death, angiographic late lumen loss between post-procedure and 6 months, as well as primary patency, major amputation, change in Rutherford class, and wound healing through 12 months.
Results: The study included 26 patients (mean age 71 years, 62% male, 88% Rutherford 5) with 28 treated infrapopliteal lesions (36% occluded, 54% TASC B/C). Acute vessel recoil, measured in seven patients, was negligible (2.4 mm after treatment vs. 2.3 mm 15 minutes after deployment). A 6-month primary safety event occurred in 11.5% of patients (1 all-cause mortality, 1 major amputation, 1 clinically driven target lesion revascularization). Late lumen loss at 6 months was 0.7±0.7 mm. At 12 months, primary patency was 89.5%, improvement in Rutherford class was observed in 68.2% of patients, 90% of patients were deemed very low/low major limb amputation risk based on Wound, Ischemia, and foot Infection (WIfI) scores, and no additional major amputations or clinically driven target lesion revascularizations were reported.
Conclusions: Retrievable scaffold therapy combined with sirolimus-coated balloon angioplasty demonstrated promising safety and efficacy through 12 months in patients with infrapopliteal artery disease.
期刊介绍：
CardioVascular and Interventional Radiology (CVIR) is the official journal of the Cardiovascular and Interventional Radiological Society of Europe, and is also the official organ of a number of additional distinguished national and international interventional radiological societies. CVIR publishes double blinded peer-reviewed original research work including clinical and laboratory investigations, technical notes, case reports, works in progress, and letters to the editor, as well as review articles, pictorial essays, editorials, and special invited submissions in the field of vascular and interventional radiology. Beside the communication of the latest research results in this field, it is also the aim of CVIR to support continuous medical education. Articles that are accepted for publication are done so with the understanding that they, or their substantive contents, have not been and will not be submitted to any other publication.
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