Iliac Artery Occlusive Disease Research Articles

Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.

Iliac artery angioplasty with stenting is an effective alternative treatment modality for aortoiliac occlusive diseases. Few randomized controlled trials have compared the efficacy and safety between self-expandable stent (SES) and balloon-expandable stent (BES) in atherosclerotic iliac artery disease. In this randomized, multicenter study, patients with common or external iliac artery occlusive disease were randomly assigned in a 1:1 ratio to either BES or SES. The primary end point was the 1-year clinical patency, defined as freedom from any surgical or percutaneous intervention due to restenosis of the target lesion after the index procedure. The secondary end point was a composite event from major adverse clinical events at 1year. A total of 201 patients were enrolled from 17 major cardiovascular intervention centers in South Korea. The mean age of the enrolled patients was 66.8 ± 8.5years and 86.2% of the participants were male. The frequency of critical limb ischemia was 15.4%, and the most common target lesion was in the common iliac artery (75.1%). As the primary end point, the 1-year clinical patency as primary end point was 99% in the BES group and 99% in the SES group (p > 0.99). The rate of repeat revascularization at 1year was 7.8% in the BES group and 7.0% in the SES group (p = 0.985; confidence interval, 1.011 [0.341-2.995]). In our randomized study, the treatment of iliac artery occlusive disease with self-expandable versus balloon-expandable stent was comparable in 12-month clinical outcomes without differences in the procedural success or geographic miss rate regardless of the deployment method in the distal aortoiliac occlusive lesion (ClinicalTrials.gov, NCT01834495).

FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited. The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease. A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12‑month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5years. Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023. The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease. ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364. PRR1-10.2196/51480.

Comparison of complete multi-level vs. iliac-only revascularization for concomitant iliac and superficial femoral artery occlusive disease.

The aim of this study is to compare the efficacy and safety of complete multi-level vs. iliac-only revascularization for the treatment of concomitant iliac and superficial femoral artery (SFA) occlusive disease. A total of 139 consecutive adult patients with severe stenosis and occlusive iliac and SFA disease with Rutherford categories 2-5 underwent multi-level (n = 71) and iliac-only (n = 68) revascularization at the Department of Intervention Vascular Surgery, Peking University Third Hospital, and Aerospace Center Hospital, between March 2015 and June 2017. Improvement in Rutherford class, perioperative major adverse events, the length of stay, survival rate, and limb salvage rate were assessed. The neutrophil-lymphocyte ratio and platelet-lymphocyte ratio were compared between the two groups. At 48 months, improvement in the Rutherford category was observed in the two groups with no significant difference (P = 0.809). Additionally, the two groups were similar concerning the primary patency (84.0% vs. 79.1%, P = 0.717) and limb salvage rate (93.1% vs. 91.3%, P = 0.781). A higher proportion of the perioperative major adverse events (33.8% vs. 27.9%, P = 0.455), the all-cause mortality (11.3% vs. 8.8%, P = 0.632), and the average length of hospital stay [7.0 (6.0, 11.0) vs. 7.0 (5.0, 8.0), P = 0.037] were seen in the multi-level group compared with the iliac-only group. For concomitant iliac and superficial femoral artery occlusive disease, iliac-only revascularization has favorable efficacy and safety outcomes compared with complete multi-level revascularization in selected patients with patent profunda femoris artery and at least one healthy outflow tract of the infrapopliteal artery.

Outcomes of Self-Expanding Covered Stents for the Treatment of External ILIAC Artery Obstructive Disease

PurposeTo describe the early results and mid-term patency rates of external iliac artery (EIA) stenting using self-expanding covered stents.MethodsWe conducted a multicenter retrospective study (2015–2021), including patients receiving primary endovascular treatment of external iliac artery occlusive disease with self-expanding covered stents. All patients were treated with the Viabahn (W.L Gore & Associates, Inc., Flagstaff, AZ–USA) stent. Patency and limb salvage rates were estimated with Kaplan–Meier curves.ResultsNinety-three patients (mean age, 69 ± 9 years; 81% males) were treated for disabling claudication in 44%, rest pain in 28%, and tissue loss in 28%. TASC C/D lesions were present in 72% and iliac complete occlusion in 30%. Mean lesion length was 6.9 ± 2.4 cm; 30% had moderate/severe EIA calcifications; and the mean iliac tortuosity index was 1.17 ± 0.13. Technical success was 100%. There was one perioperative death (1.4%) and procedural complication rate was 6.5%. At 42 months (mean, 25 months), primary patency was 89.8% (95%CI 83–98); the presence of EIA tortuosity (tortuosity index > 1.25, 87.7 ± 11% vs 89.9 ± 8%; P = .6) or severe calcifications (87.6 ± 9% vs 96.0 ± 8%; P = .400) had no significant impact. After univariate analysis, the use of a stent with diameter < 8 mm (HR 8.5, 95%CI 3.24–14.22; P < .001) was negatively associated with primary patency.ConclusionsThe use of self-expanding covered stents provided excellent early and mid-term results in the treatment of obstructive disease of the EIA, also in cases of high EIA tortuosity and high grade of calcifications. The use of a < 8 mm-diameter stent was associated with a reduced primary patency.

Popliteal access for endovascular procedures in femoropopliteal artery occlusive disease.

Even though it has been reported that femoropopliteal artery endovascular revascularization is often performed with antegrade femoral artery interventions, which are technically relatively challenging, having the advantage of better control, it has also been reported that recanalization failure may occur in approximately 20% of patients and some materials have been developed for this reason. To evaluate the safety of retrograde popliteal artery intervention and our procedural success rate for symptomatic femoropopliteal artery occlusive disease. A total of 95 endovascular revascularization procedures were performed for treating symptomatic occlusive peripheral artery disease in the study period. Inclusion criteria were defined as patients who underwent endovascular revascularization procedures for symptomatic femoropopliteal artery occlusive disease. Patients who underwent a percutaneous endovascular procedure for iliac artery or below-knee arterial occlusive disease in the same session and patients who had previously undergone peripheral arterial bypass grafting or endovascular treatment for existing femoropopliteal artery disease were excluded. We evaluated 45 peripheral endovascular procedures performed on 39 patients with a mean age of 62.49 ±11.38 years in our hospital for chronic femoropopliteal artery occlusive disease. Twelve (26.7%) of the endovascular treatment procedures were performed with retrograde access through the popliteal artery (Group 2). In neither group were any complications of arterial rupture, distal embolism, early thrombosis, or pseudoaneurysms observed. We are of the opinion that the retrograde popliteal artery technique is an effective and safe intervention option in endovascular revascularization, particularly in the revascularization of the long segment and complex femoropopliteal artery occlusions.

Self-Expanding Versus Balloon-Expandable Stents for treatment of Iliac Artery Occlusive Disease

Self-Expanding Versus Balloon-Expandable Stents for treatment of Iliac Artery Occlusive Disease

Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial

The aim of this non-inferiority randomised trial was to compare the short and midterm safety and efficacy of hybrid repair (HR) and open reconstruction (OR) for patients with co-existing iliac and common femoral artery (CFA) occlusive disease.

Editor's Choice – Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial

The aim of this non-inferiority randomised trial was to compare the short and midterm safety and efficacy of hybrid repair (HR) and open reconstruction (OR) for patients with co-existing iliac and common femoral artery (CFA) occlusive disease. The study was registered on the ClinicalTrials.gov register (identifier: NCT02580084). From 2015 to 2017, eligible patients presenting with combined iliac and CFA occlusive disease were randomised to either HR or OR. HR group patients underwent recanalisation and stenting of iliac arteries combined with CFA endarterectomy and patch angioplasty. The OR group underwent aortofemoral bypass with simultaneous CFA endarterectomy. Short (30 day) and midterm (36 month) outcomes including morbidity, mortality, and patency rates were compared between groups. Of 427 patients assessed, 202 were randomised (102 HR and 100 OR). The average hospital length of stay was shorter in the HR group (8.2 ± 4.2 days HR group vs. 15.7 ± 6.9 days OR group, p < .001); the 30 day peri-operative morbidity rate was 8.8% in the HR group vs. 21% in the OR group (p= .030). There was no significant difference in the 36 month mortality rate (p= .16). The cumulative primary patency rates were 93% (HR) vs. 93% (OR) at 12 months and 91% (HR) vs. 89% (OR) at 36 months (p= .38). The limb salvage rates were 99% (HR) vs. 99% (OR) at 12 months and 98% (HR) vs. 97% (OR) at 36 months (p= .49). The results of this first non-inferiority randomised study support the safety and midterm efficacy of hybrid procedures for patients with iliofemoral peripheral arterial disease. HR patients had a shorter length of stay with reduced peri-operative morbidity and similar medium term patency rates.

Angioplasty versus stenting for iliac artery lesions

Angioplasty versus stenting for iliac artery lesions

Hybrid-based iliofemoral endarterectomy for severe and complete iliofemoral occlusive disease

ObjectivePrimary endovascular approaches are now the dominant modality for the treatment of iliac occlusive disease. However, stenting of the external iliac artery is plagued with high in-stent restenosis rates. This hybrid approach with fluoroscopic, retrograde iliofemoral endarterectomy combined with stenting was previously demonstrated to be both a safe and effective alternative to bypass and primary stenting alone for TransAtlantic Inter-Society Consensus (TASC) II C and D lesions. In this study, early outcomes and hemodynamic improvements of this hybrid approach are evaluated with an expanded patient population. MethodsThis was a single-institution, retrospective review of all hybrid-based retrograde iliofemoral endarterectomies from the common femoral artery extending to the proximal external iliac artery from January 1, 2010, to November 15, 2017. Data were collected from the electronic medical record and analyzed using standard quantitative statistical techniques. All preprocedure and postprocedure imaging was independently reviewed by two vascular surgeons. Variables included patient demographics, degree of ischemia, and stent characteristics. The primary outcomes were mortality and freedom from amputation, with secondary outcomes including changes in the ankle-brachial index and toe pressure. ResultsThe procedure was performed on 63 limbs in 51 total patients. In 33 limbs, the indication was critical limb ischemia (tissue loss/gangrene = 17, rest pain = 16) and 30 for lifestyle-limiting claudication. The cohort consisted of 84% TASC D and 16% TASC C. External iliac stenting was required in 68% (modal diameter, 10 mm) and ipsilateral common iliac stenting was completed in 75% (modal diameter, 9 mm). The ankle-brachial index significantly improved from 0.42 ± 0.25 to 0.73 ± 0.27 (P < .001) as did toe pressure from 29 ± 27 mm Hg to 59 ± 34 mm Hg (P < .001). Thirteen limbs ultimately required an infrainguinal procedure. One patient experienced an intraoperative iliac perforation that resolved with stenting. One death occurred within 90 days. Ninety-five percent of patients remained free from amputation. ConclusionsExtensive hybrid-based, retrograde iliofemoral endarterectomy with stenting is a safe and efficacious approach to severe iliac arterial occlusive disease, with excellent early outcomes. This series promulgates the hypothesis that extensive endarterectomy with selective iliac stenting yields superior results to external iliac stenting alone. Given the superb hemodynamic improvements in a larger patient population, this hybrid-based, extensive iliofemoral endarterectomy should be recommended as a minimally invasive, first-line treatment for severe iliac occlusive disease.

Balloon-assisted remote external iliac artery endarterectomy: A safe and durable technique for the treatment of iliac artery occlusive disease

BackgroundHistorically, the treatment of iliac artery occlusive disease required a surgical bypass usually consisting of an aortobifemoral bypass or an iliofemoral bypass. With the advent of balloon angioplasty and stenting, these procedures are frequently replaced with endovascular options. However, the treatment of diffuse occlusive disease of the external iliac artery (EIA) using balloon angioplasty and/or stenting does not carry a favorable long-term patency rate. Remote endarterectomy of the EIA using ring dissectors with balloon assistance provides a novel, controlled, safe, and durable treatment of the diseased and/or occluded EIA. MethodsA retrospective review over the past 6 years was performed at our institution identifying patients treated with balloon-assisted remote endarterectomy of the EIA by the current five practicing vascular surgeons. The technique involves exposure of the ipsilateral common femoral artery. With nonocclusive disease, direct access into the common femoral artery is performed, a wire is traversed through the diseased EIA, and a balloon is inflated at the origin of the vessel providing hemostasis and control. A femoral endarterectomy is performed, and a ring dissector is passed over the endarterectomized material including the wire and balloon catheter and advanced remotely through the EIA up to the balloon. The balloon is briefly deflated, repositioned within the ring dissector, and reinflated, thus cutting the plaque. This allows for retraction of the inflated balloon and cutter, removing the endarterectomized core plaque. The procedure is similar for the treatment of an occluded EIA, but wire access across the occluded vessel is normally achieved with contralateral access. In both cases, the balloon provides control and hemostasis and is critically important in the rare treatment of vessel rupture. ResultsA total of 101 vessels were treated in 97 patients. The procedure was successful in 98 vessels (97%) with failure related to vessel rupture requiring conversion to an iliofemoral bypass. The estimated patency rate at three years was 94% with a median follow-up of 20 months. Restenosis/occlusion in four patients seemed to be related to a severe sclerotic response. The EIA was occluded 32% of the time. The common iliac artery (CIA) was diseased requiring angioplasty and stenting 29% of the time and a stent was placed at the transition zone between endarterectomized vessel and nontreated proximal most EIA or distal most CIA 58% of the time. There were no perioperative deaths. ConclusionsBalloon-assisted remote endarterectomy of the diffusely diseased and/or occluded EIA is a safe and durable option. It precludes the need for a prosthetic conduit and the risk of associated infection. It also involves a single groin incision and negates the need for retroperitoneal exposure of the CIA.

Use, Safety and Effectiveness of Subintimal Angioplasty and Re-Entry Devices for the Treatment of Iliac Artery Chronic Total Occlusions: A Systematic Review of 30 Studies and 1112 Lesions

Management of iliac artery occlusive disease has changed dramatically over the past few decades. Secondary to advancement in endovascular technologies and techniques, percutaneous interventions have gradually replaced open surgical approaches even for the most difficult cases. In difficult to cross chronic total occlusions (CTO) of the iliac artery, subintimal angioplasty (SIA) with or without the use of re-entry devices (RED) offers a valuable alternative to intra-luminal crossing. To systematically review the literature for studies reporting procedural or short- and long-term clinical outcomes after the use of SIA, with or without RED use for iliac CTOs. PRISMA guidelines were followed. Literature search (PubMed, Cochrane CENTRAL and EMBASE) and data extraction were performed by two independent researchers. Quantitative synthesis of the reported outcomes was applied when possible. Thirty studies met the inclusion criteria and were selected as eligible for this systematic review, with a total of 1002 patients (61.3% males) and 1112 lesions treated with SIA. RED were used in 21.9% of the lesions. Critical limb ischemia was the indication in 51.4%. The overall procedural success rates were 85.8% for SIA and 88.5% for RED. The complication rate ranged from 0 to 10% among different series, but overall it was similar among the two groups (6.9% in the RED group and 6.7% among the SIA group). One year primary patency rates were around 60% in the RED. In the SIA only arm, there was a large heterogeneity, with patency rates ranging from 51.7% to 96.8%. SIA with or without RED use is a safe and effective treatment for the treatment of iliac artery CTOs. Future studies are needed to delineate whether intraluminal crossing or SIA is more effective for endovascular treatment of iliac CTOs.

Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

PurposeThis study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. MethodsA total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). ResultsAt 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%–23.2%), primary patency was 89.1% (95% CI: 82.6%–93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%–94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%–9.4%) experienced MAEs, but none were determined to be related to device or procedure. ConclusionsThe LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.

Balloon-Assisted Remote External Iliac Artery Endarterectomy: A Safe and Durable Technique for the Treatment of Iliac Artery Occlusive Disease

Historically, the treatment of iliac artery occlusive disease required a surgical bypass usually consisting of an aortobifemoral bypass or an iliofemoral bypass. With the advent of balloon angioplasty and stenting, these procedures are frequently replaced with endovascular options. However, the treatment of diffuse occlusive disease of the external iliac artery (EIA) does not carry a favorable long-term patency rate using balloon angioplasty and/or stenting. Remote endarterectomy of the EIA using ring dissectors with balloon assistance provides a novel, controlled, safe, and durable treatment of the diseased and/or occluded EIA. A retrospective review over the past 5 years was performed at our institution identifying patients treated with balloon-assisted remote endarterectomy of the EIA by the current five practicing vascular surgeons. The technique involves exposure of the ipsilateral common femoral artery. With nonoccluded disease, direct access into the common femoral artery is performed, a wire is traversed through the diseased EIA, and a balloon is inflated at the origin of this vessel to provide hemostasis and control. A femoral endarterectomy is performed and a ring dissector is passed over the endarterectomized material including the wire and balloon catheter, and advanced remotely through the EIA up to the balloon. The balloon is briefly deflated and repositioned within the ring dissector and reinflated, thus cutting the plaque and allowing for retraction of the inflated balloon and cutter, removing the endarterectomized core plaque. The procedure is similar for the treatment of an occluded EIA, but wire access across the occluded vessel is normally achieved with contralateral access. In both cases, the balloon provides control and hemostasis and is critically important in the rare treatment of vessel rupture. A total of 78 vessels were treated in 74 patients. The procedure was successful in 76 of the vessels with failure related to vessel rupture requiring conversion to an iliofemoral bypass. The primary patency was 97% with a mean follow-up of 28 months. Restenosis in the two patients seemed to be related to a severe sclerotic response. The EIA was occluded 38% of the time. The common iliac artery (CIA) was diseased requiring angioplasty and stenting 28% of the time and a stent was place at the transition zone between endarterectomized vessel and nontreated proximal most EIA or distal most CIA 59% of the time. There were no perioperative deaths. Balloon-assisted remote endarterectomy of the diffusely diseased and or occluded EIA is a safe and durable option. It precludes the need for a prosthetic conduit and the risk of associated infection. It involves a single groin incision, negating the need for retroperitoneal exposure of the CIA.

Longterm Outcomes of Eversion Endarterectomy for Iliac Artery Occlusive Disease

Longterm Outcomes of Eversion Endarterectomy for Iliac Artery Occlusive Disease

Endovascular Treatment of Claudication Due to Isolated Internal Iliac Artery Occlusive Disease

Endovascular Treatment of Claudication Due to Isolated Internal Iliac Artery Occlusive Disease

Secondary aortoenteric fistula: Review of a case and literature

The objective of this study was to assess early diagnosis and management of hematemesis in patients who have a history of aortic reconstructive surgery. A 70-year-old male presented with complaints of active hematemesis and melena for 2 days at the emergency room. He gave a history of aortobifemoral bypass for bilateral iliac arterial occlusive disease 9 years ago. Urgent computed tomography (CT) angiography was suggestive of large aortic anastomotic pseudoaneurysm with aortoenteric fistula (AEF). Urgent endovascular repair of pseudoaneurysm with right femoral artery to left femoral artery crossover with ligation of left femoral artery, left common iliac artery, and left graft limb was done. The patient did well after the surgical management. Routine follow-up was done. Repeat CT angiography was done. No any major complication was encountered. Secondary AEF is a life-threatening complication of abdominal aortic reconstruction. The clinical manifestation of the AEF is always hematemesis. Treatment of the disease is urgent hybrid surgical intervention.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial

ObjectivesAtherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. BackgroundSo far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. MethodsIn this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. ResultsSix hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. ConclusionsThe treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174)

Midterm Results of Low-Profile Stents to Treat Atherosclerotic Iliac Artery Disease

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.

TCTAP C-258 A Complication Case of Distal Embolism During Endovascular Therapy for External Iliac Artery Occlusive Disease

TCTAP C-258 A Complication Case of Distal Embolism During Endovascular Therapy for External Iliac Artery Occlusive Disease