Table 1

Characteristics of studies included in the meta-analysis

AuthorIida et al14Iida et al16Soga et al15
Follow-up24 months12 months24 months
Inclusion criteria

  1. De novo FP lesions >50%

  2. Occlusion without inflow lesions

  3. Outflow lesions of below-the-knee arteries of >1 vessel runoff

  4. Symptomatic PAD with claudication (Fontaine 2, 3 or 4)

  1. 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

  1. Symptoms not improved by pharmacotherapy or exercise therapy

  2. Age >18 years and <80 years old

  3. ABI <0.9

  4. DS >50% by visual estimate on angiography

Exclusion criteria

  1. Acute onset critical limb ischaemia

  2. Previous bypass surgery or

  3. Previous angioplasty for the FP lesions

  4. Presence of untreated pelvic lesions

  5. Intolerance to the medication or contrast agents

  1. Treated with coronary DES

  2. Heart failure symptoms with systolic or diastolic dysfunction evaluated by cardiac echocardiography

  3. Inflow aortoiliac lesions

  4. FP lesions with severe calcification

  5. Poor below-the-knee runoff defined as number of below-the-knee runoff <1

  1. Patients with previous lower extremity bypass surgery

  2. Previous EVT in the femoropopliteal artery

  3. Acute onset limb ischaemia

  4. Rutherford category 4, 5 or 6

Control group

  1. Aspirin (100 mg/day)+ticlopidine (200 mg/day)

  1. Aspirin (100 mg/day)

  2. Patients who received stents were also treated with a thienopyridine

  1. Aspirin (81–100 mg/day) and ticlopidine (200 mg/day)

Intervention group

  1. Aspirin (100 mg/day) and cilostazol (200 mg/day)

  1. Aspirin (100 mg/day) and cilostazol (200 mg/day)

  2. Patients who received stents were also treated with a thienopyridine

  1. Aspirin (81–100 mg/day), ticlopidine (200 mg/day) and cilostazol (200 mg/day)

Outcomes definition

  1. Lesion patency: peak systolic velocity ratio >2.4 by DUS

  1. 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

  2. Angiographic restenosis: recurrence of ≥50% diameter stenosis; a peak systolic velocity ratio of >2.0 on Duplex ultrasonography

  1. Target lesion: treated segment from 10 mm proximal to 10 mm distal

  2. TLR: any repeat EVT for restenosis or other complication of the target lesion with a %DS of >50% in angiography

  3. Restenosis: peak systolic velocity ratio of ≥2.4 on Duplex ultrasonography

Endovascular procedureAfter balloon inflation for at least 1 min, self-expanding stent was done if:

  1. Pressure gradient >10 mm Hg OR

  2. >30% residual stenosis OR

  3. 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:

  1. Flow-limiting dissection OR

  2. Pressure gradient >10 mm Hg OR

  3. >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:

  1. Angiographic residual stenosis of >30% OR

  2. 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

  • ABI, Ankle Brachial Index; DES, drug-eluting stent; DS, diameter of stenosis; EVT, endovascular therapy; DUS, distal ultrasound; FP, femoropopliteal lesion; MI, myocardial infarction; PAD, peripheral arterial disease; SMART, stent: Cordis Corp, Miami Lakes; TLR, target lesion revascularisation.