Purpose: To evaluate the safety and effectiveness of low-profile 4-F stents for the treatment of atherosclerotic iliac artery lesions. Methods: Between January 2009 and December 2015, 63 patients (mean age 69.3 years; 42 men) received low-profile stents (Astron Pulsar or Pulsar-18) at the discretion of the operator to treat iliac artery occlusive disease. The majority of patients (40, 63.5%) had critical limb ischemia; 36 of 82 lesions were total occlusions. All procedures were performed with 4-F equipment. Outcomes evaluated included mortality, patency (primary, assisted primary, and secondary), absence of target lesion revascularization (TLR), and limb salvage. Associations of patient and procedure variables with patency and TLR outcomes were sought with univariate and multivariate analysis. Results: Via a brachial (n=46/63) or femoral (n=17/63) access, 82 stents were successfully deployed to treat the 82 lesions, with <30% residual stenosis. The overall access-related complication rate was 1.6% (brachial artery occlusion). Mean duration of follow-up was 24.1±22.3 months (range 1–72), during which 3 patients died and 1 major amputation occurred at 10 months. The 4-year Kaplan-Meier estimate of primary patency was 76.9% (95% CI 70.2% to 83.6%); the assisted primary and secondary patency estimates were 79.3% (95% CI 73% to 85.6%) and 91% (95% CI 84.5% to 97.5%). The 4-year freedom from TLR estimate was 73.8% (95% CI 67.4% to 80.2%). On multivariate analysis, the only associations confirmed involved Rutherford category 5/6 with primary patency (hazard ratio [HR] 5.7, 95% CI 4.4 to 7, p=0.02) and assisted primary patency (HR 6.1, 95% CI 4.9 to 7.3, p=0.01). Conclusion: Use of a low-profile 4-F stent in atherosclerotic iliac lesions was safe and effective. At 4 years, the overall patency and the absence of TLR were good. Midterm outcomes were poor in patients with Rutherford category 5/6 ischemia. Finally, the use of stents with a ≥6-mm diameter and postdeployment balloon dilation are recommended in all cases.
TimaranCHPraultTLStevensSLIliac artery stenting versus surgical reconstruction for TASC (TransAtlantic Inter-Society Consensus) type B and type C iliac lesions. J Vasc Surg. 2003;38:272–278.
2.
KashyapVSPavkovMLBenaJFThe management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg. 2008;48:1451–1457.
3.
IndesJEMandawatATuggleCTEndovascular procedures for aorto-iliac occlusive disease are associated with superior short-term clinical and economic outcomes compared with open surgery in the inpatient population. J Vasc Surg. 2010;52:1173–1179.
4.
NorgrenLHiattWRDormandyJAInter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–S67.
5.
TASC Steering Committee, JaffMRWhiteCJAn update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Endovasc Ther. 2015;22:663–677.
6.
European Stroke Organisation, TenderaMAboyansVESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851–2906.
7.
GoodneyPPBeckAWNagleJNational trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009;50:54–60.
8.
GoodeSDClevelandTJGainesPA;w STAG trial collaborators. Randomized clinical trial of stents versus angioplasty for the treatment of iliac artery occlusions (STAG trial). Br J Surg. 2013;100:1148–1153.
9.
AbuRahmaAFHayesJDFlahertySKPrimary iliac stenting versus transluminal angioplasty with selective stenting. J Vasc Surg. 2007;46:965–970.
10.
YeWLiuCWRiccoJBEarly and late outcomes of percutaneous treatment of TransAtlantic Inter-Society Consensus class C and D aorto-iliac lesions. J Vasc Surg. 2011;53:1728–1737.
11.
AggarwalVWaldoWArmstrongEJ.Endovascular revascularization for aortoiliac atherosclerotic disease. Vasc Health Risk Manag. 2016;12:117–127.
12.
BalloutJAndréFCottinYRandomized comparison of 4F and 6F catheters for diagnostic coronary angiographies via the femoral approach. Arch Mal Coeur Vaiss. 2000;93:35–39.
13.
DurstRLotanCNassarHComparison of 4 and 6 French catheters for coronary angiography: real-world modeling. Isr Med Assoc J. 2007;9:290–293.
14.
TroisiNErcoliniLChisciEUse of a low-profile stent in atherosclerotic iliac artery disease: the results of 4-FIRST (4-French Iliac Revascularization with low-profile Stent Technology) Registry. Italian J Vasc Endovasc Surg. 2015;22:171–180.
15.
OurielKVeithFJSasaharaAA.A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators. N Engl J Med. 1998;338:1105–1111.
16.
DudaSHWiskirchenJTepeGPhysical properties of endovascular stents: an experimental comparison. J Vasc Interv Radiol. 2000;11:645–654.
17.
DyetJFWattsWGEttlesDFMechanical properties of metallic stents: how do these properties influence the choice of stent for specific lesions?Cardiovasc Intervent Radiol. 2000;23:47–54.
18.
BoschJLHuninkMG.Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology. 1997;204:87–96.
19.
HenryMAmorMEthevenotGPalmaz stent placement in iliac and femoropopliteal arteries: Primary and secondary patency in 310 patients with 2–4 year follow-up. Radiology. 1995;197:167–174.
20.
DyetJFGainesPANicholsonAATreatment of chronic iliac artery occlusions by means of percutaneous endovascular stent placement. J Vasc Interv Radiol. 1997;8:349–353.
21.
PonecDJaffMRSwischukJThe Nitinol SMART stent vs Wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results. J Vasc Interv Radiol. 2004;15:11–18.
22.
MurphyTPAriaratnamNSCarneyWIJrAortoiliac insufficiency: long-term experience with stent placement for treatment. Radiology. 2004;231:243–249.
23.
PulliRDorigoWFargionAEarly and long-term comparison of endovascular treatment of iliac artery occlusions and stenosis. J Vasc Surg. 2011;53:92–98.
24.
TimaranCHPraultTLStevensSLIliac artery stenting versus surgical reconstruction for TASC (Trans-Atlantic Inter-Society Consensus) type B and type C iliac lesions. J Vasc Surg. 2003;38:272–278.
25.
SaketRRRazaviMKPadidarANovel intravascular ultrasound-guided method to create transintimal arterial communications: initial experience in peripheral occlusive disease and aortic dissection. J Endovasc Ther. 2004;11:274–280.
26.
IchihashiSHigashiuraWItohHLong-term outcomes for systematic primary stent placement in complex iliac artery occlusive disease classified according to Trans-Atlantic Inter-Society Consensus (TASC)–II. J Vasc Surg. 2011;53:992–999.
27.
TimaranCHStevensSLFreemanMBExternal iliac and common iliac artery angioplasty and stenting in men and women. J Vasc Surg. 2001;34:440–446.
28.
KudoTRigbergDAReilTDThe influence of the ipsilateral superficial femoral artery on iliac angioplasty. Ann Vasc Surg. 2006;20:502–511.
29.
BosiersMDelooseKCallaertJ4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial. J Endovasc Ther. 2013;20:746–756.
30.
LichtenbergMKolksOHailerBPEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions. J Endovasc Ther. 2014;21:373–380.
31.
MlekuschWDickPHaumerMArterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur P.A.D.) versus conventional manual compression: a randomized controlled trial. J Endovasc Ther. 2006;13:23–31.
32.
BallykPD.Intramural stress increases exponentially with stent diameter: a stress threshold for neointimal hyperplasia. J Vasc Interv Radiol. 2006;17:1139–1145.
