Author | Iida et al14 | Iida et al16 | Soga et al15 |
Follow-up | 24 months | 12 months | 24 months |
Inclusion criteria |
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De novo FP lesions >50% -
Occlusion without inflow lesions -
Outflow lesions of below-the-knee arteries of >1 vessel runoff -
Symptomatic PAD with claudication (Fontaine 2, 3 or 4)
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Patients with symptomatic PAD greater than Rutherford 1 screened by non-invasive tests to detect limb ischaemia and the presence of de novo FP lesions
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Symptoms not improved by pharmacotherapy or exercise therapy -
Age >18 years and <80 years old -
ABI <0.9 -
DS >50% by visual estimate on angiography
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Exclusion criteria |
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Acute onset critical limb ischaemia -
Previous bypass surgery or -
Previous angioplasty for the FP lesions -
Presence of untreated pelvic lesions -
Intolerance to the medication or contrast agents
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Treated with coronary DES -
Heart failure symptoms with systolic or diastolic dysfunction evaluated by cardiac echocardiography -
Inflow aortoiliac lesions -
FP lesions with severe calcification -
Poor below-the-knee runoff defined as number of below-the-knee runoff <1
|
-
Patients with previous lower extremity bypass surgery -
Previous EVT in the femoropopliteal artery -
Acute onset limb ischaemia -
Rutherford category 4, 5 or 6
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Control group |
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Aspirin (100 mg/day)+ticlopidine (200 mg/day)
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Aspirin (100 mg/day) -
Patients who received stents were also treated with a thienopyridine
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Aspirin (81–100 mg/day) and ticlopidine (200 mg/day)
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Intervention group |
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Aspirin (100 mg/day) and cilostazol (200 mg/day)
|
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Aspirin (100 mg/day) and cilostazol (200 mg/day) -
Patients who received stents were also treated with a thienopyridine
|
-
Aspirin (81–100 mg/day), ticlopidine (200 mg/day) and cilostazol (200 mg/day)
|
Outcomes definition |
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Lesion patency: peak systolic velocity ratio >2.4 by DUS
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Target lesion revascularisation: reintervention performed for >50% diameter stenosis identified by angiography within 5 mm of the target lesion after documentation of recurrent symptoms of PAD -
Angiographic restenosis: recurrence of ≥50% diameter stenosis; a peak systolic velocity ratio of >2.0 on Duplex ultrasonography
|
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Target lesion: treated segment from 10 mm proximal to 10 mm distal -
TLR: any repeat EVT for restenosis or other complication of the target lesion with a %DS of >50% in angiography -
Restenosis: peak systolic velocity ratio of ≥2.4 on Duplex ultrasonography
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Endovascular procedure | After balloon inflation for at least 1 min, self-expanding stent was done if:
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Pressure gradient >10 mm Hg OR -
>30% residual stenosis OR -
flow-limiting dissection A nitinol stent (Luminexx, CR Bard, Murray Hill, NJ) or cobalt metallic stent (Wallstent, Boston Scientific, Natick, Mass) with the diameter 1 mm larger than the reference diameter was used Stents of 6 mm in diameter were used in most cases | After balloon inflation for at least 1 min, stent was done if:
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Flow-limiting dissection OR -
Pressure gradient >10 mm Hg OR -
>30% residual stenosis Patients received SMART stents (Cordis Corp, Miami Lakes, Florida, USA) with a diameter 1 mm larger than the reference vessel diameter | After balloon inflation for at least 1 min, self-expanding stent was done if:
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Angiographic residual stenosis of >30% OR -
Flow-limiting dissection A commercially available self-expandable stent was used Stent type was determined by the operators, and the stent size was chosen to be 1–2 mm larger than the vessel diameter determined |