Sustained Effectiveness of Cilostazol After Endovascular Treatment of Femoropopliteal Lesions: Midterm Follow-up From the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study.

PURPOSE: To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy. METHODS: The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study ( ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test. RESULTS: The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95). CONCLUSION: These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment.

New Endovascular Technique to Prevent Distal Embolism for Iliofemoral Occlusive Disease: Reverse Flow Aspiration With Proximal Sheath Blockage.

PURPOSE: To report the safety and efficacy of a new technique to prevent distal embolism during treatment of iliofemoral occlusions: reverse flow aspiration with proximal sheath blockage (ReFLAP). METHOD: Between October 2013 and December 2014, 90 patients (mean age 74 years; 66 men) were prospectively enrolled in a study to evaluate the ReFLAP technique during treatment of 110 occlusions in the iliac artery (72, 65%) or superficial femoral artery (SFA; 38, 35%). The mean occlusion lengths of iliac and SFA lesions were 79 and 179 mm, respectively. The concept of ReFLAP is to aspirate debris after balloon dilation using reverse flow through collaterals without antegrade flow. The main endpoints were the incidence of distal embolization, amputation, complications, and the ReFLAP capture rate, which was visually estimated during aspiration using 4 prespecified grades (0, none; 1, foamy debris; 2, small particles; 3, massive particles). RESULTS: ReFLAP was successful in 105 (95.4%) of the 110 lesions attempted; the 5 failures were due to severe vessel tortuosity or calcification. The incidences of distal embolization and amputation were both 0. Minor complications unrelated to ReFLAP were observed in 8 patients. The ReFLAP procedure aspirated debris in 57 (54%) of the 105 lesions. Aspirated material, including marked clots (grades 2 and 3), was confirmed in 40 (38%) of the lesions. The distribution of aspiration grades was significantly different between iliac and SFA lesions (p=0.02). CONCLUSION: Our results suggest that the ReFLAP endovascular technique to prevent distal embolization during iliofemoral occlusive disease treatment is simple, safe, and effective.