Salvatore Cassese1, Florian Wolf2, Maja Ingwersen3, Christian M Kinstner2, Michele Fusaro4, Gjin Ndrepepa1, Tareq Ibrahim5, Ilka Ott1, Johannes Lammer2, Hans Krankenberg3, Massimiliano Fusaro1. 1. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany (S.C., G.N., I.O., Massimiliano Fusaro). 2. Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Austria (F.W., C.M.K., J.L.). 3. Klinik für Angiologie, Asklepios Klinikum Harburg, Hamburg, Germany (M.I., H.K.). 4. Department of Diagnostic and Interventional Radiology, Santa Maria di Ca' Foncello Hospital, Treviso, Italy (Michele Fusaro). 5. 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany (T.I.).
Abstract
BACKGROUND: The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. METHODS AND RESULTS: Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned toDCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14-0.46]; P<0.001) and recurrent ISR (0.19 [0.10-0.35]; P<0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. CONCLUSIONS: In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated.
RCT Entities:
BACKGROUND: The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. METHODS AND RESULTS:Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned to DCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14-0.46]; P<0.001) and recurrent ISR (0.19 [0.10-0.35]; P<0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. CONCLUSIONS: In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated.
Authors: Michael H Vu; Glaiza-Mae Sande-Docor; Yulun Liu; Shirling Tsai; Mitul Patel; Chris Metzger; Mehdi H Shishehbor; Emmanouil S Brilakis; Nicolas W Shammas; Peter Monteleone; Subhash Banerjee Journal: J Interv Cardiol Date: 2022-07-15 Impact factor: 1.776