Pure Endovascular versus Hybrid Approach for Management of Iliofemoral Arterial Disease: A Randomized Controlled Trial

Abstract

Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adoption of endovascular repair as the first-line treatment, easy surgical accessibility, and, last but not least, favorable long-term outcomes, still making CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures.

A single-center randomized prospective study of 36 symptomatic (Rutherford 2–4) CFA stenotic or occlusive lesions were included, and patients were randomized over two groups based on the management approach SUPERA versus hybrid technique.

Patients had a mean age 60.8 ± 8.2 years. Thirty-two (88.9%) patients reported improvement of the clinical symptoms, 28 (87.5%) patients had intact pulse postoperatively, and 28 (87.5%) had patent vessels. Follow-up showed that none developed reocclusion or restenosis during the period of follow-up. Comparison of difference in peak systolic velocity ratio (PSVR) among study groups showed that the hybrid technique had more reduction of PSVR postintervention compared to the SUPERA group with a p -value of < 0.0001.

Safety and feasibility of endovascular approach with the SUPERA stent to the CFA (no stent zone) has low incidence of postoperative morbidity and mortality in well experienced surgical hands.

Introduction

Combined iliofemoral endarterectomy and stenting of the external iliac artery (EIA) for treatment of severe occlusive lesions provided acceptable midterm results, probably because of the gain of diameter provided by bare metal. This avoids complications due to clamping as well as complications related to the presence of a prosthetic implant in the abdominal vessels. ¹

Atherosclerotic lesions in the common femoral artery (CFA) are now one of the remaining barriers to the use of endovascular repair as the first-line therapy. CFA disease therapy remains a surgical area due to the bulky, eccentric, calcified nature of the plaques, involvement of the femoral bifurcation, simple surgical accessibility, and positive long-term results. ²

New technologies in endovascular equipment and operator technical skills have resulted in a rise in percutaneous CFA operations during the past 5 years. With its crush resistance (if properly implanted), the vascular mimetic implant SUPERA Peripheral Stent System (Abbott Vascular) appears to be an effective tool for dealing with eccentric calcified plaques, crush danger, and maintaining access options. ³

Patients and Methods

This is a prospective study conducted on 36 patients, presenting to the Department of Vascular and Endovascular Surgery, Kasr-Al Ainy Hospital, Cairo University, Cairo, Egypt, over 2 years. The study targeted the outcome of patients with critical limb ischemia having iliofemoral arterial occlusion. CFA SUPERA stenting (complete endovascular) versus combined CFA endarterectomy with or without EIA stenting (hybrid management) was analyzed.

All patients received oral and written information about the procedure and the lack of an existing long-term efficacy study and they all gave informed consent in order to participate to this study. The work has been approved by the local institutional review board. Pre- and postprocedure clinical notes, admission history, and physical examination documentation were used to identify clinical presentation as well as postprocedure outcomes and medical management. The category of limb ischemia was defined using the Rutherford classification.

Each patient had one or both limbs treated during the study. Lesions were classified in four groups based on the Azéma classification. ⁴ Type I represents lesions located at the EIA that are extended to the CFA. Type II lesions are those limited to the CFA. Type III represents lesions located at the CFA and its bifurcation, and type IV lesions represent proximal or distal stenosis of bypass anastomosis from atheromatous disease.

Inclusion Criteria

• All patients presented with critical limb ischemia ranging from rest pain, minor tissue loss, and gangrene according to Rutherford classification class (3—4).

Exclusion Criteria

• Patients who have limbs requiring primary amputation.

• Patients with connective tissue disorder or immunological disease.

By arterial duplex and conventional angiography two groups were formed with either having a steno-occlusive CFA lesion with distal landing zone (DLZ), when there was an infrainguinal portion of the artery refilled through collaterals and patent down to the bifurcation, or having steno-occlusive lesions without DLZ (no-DLZ) if the occlusive lesion extended to and beyond the bifurcation.

All patients were evaluated by history taking, meticulous physical examination, and imaging.

Clinical Examination

General: Vital signs, cardiovascular, neurological, and respiratory assessment were done.

Local: Clinical assessment of the patient, degree of ischemia, and tissue loss was determined:

• If there were minor tissue loss as ulcers which were examined according to the site, size, shape, depth, edge, margin, surroundings, and duration.

• If there were major tissue as the gangrene were examined (regarding the extent of the gangrene involving the toes, forefoot, midfoot, or hindfoot, and the type of gangrene, dry gangrene or moist gangrene). The heel was particularly highlighted.

Investigations and workup: Routine laboratory and imaging was done.

Endovascular Procedure

Patients included in this study were suffering from symptomatic combined iliac and CFA lesions. Target lesions have > 60% stenosis or chronic total occlusion, Rutherford class (3 to 6), and fit for regional anesthesia.

Patients excluded from this study were suffering from failed lesion crossing, artertic lesions, thrombophilia, life expectancy < 1 year, if there were contraindications of contrast, cerebral vascular disease, who require interventional management first, inability to comply with the follow-up schedule (as mental disability), or patient has had prior ipsilateral bypass or endarterectomy.

Primary stenting were performed according to a standardized protocol via a transfemoral crossover technique using a 6-F or 7-F long sheath (45 cm, Destination, Terumo, St Quentin en Yvelines, France), or via a brachial approach using a dedicated 6-F or 7-F long sheath (90 cm) . Heparin (50 UI/kg) was administered intra-arterially. The lesion was passed with a hydrophilic 0.035- or 0.018-inch guidewire and primary stenting with predilatation routinely performed, angioplasty with a 1-mm balloon more than the stent size was done to allow stent placement. Systematic stenting was performed in 18 procedures. The stent dimensions were chosen such that the nominal diameter was equal to the reference vessel diameter and the length exceeded the lesion length by 5 to 10 mm proximally and distally.

Hybrid Technique

Hybrid approach was performed under spinal anesthesia for open surgery of CFA lesions and local anesthesia for endovascular interventions for other femoral lesions.

The femoral vessels were exposed first through longitudinal or oblique incisions then the endarterectomy began in CFA and arteriotomy was closed with a vein or synthetic patch. This patch was used to serve as an access. Access to the target iliac lesion was done by transbrachial puncture with using long sheath (better) or retrograde ipsilateral CFA puncture through the patch or contralateral femoral puncture and performing a crossover technique. Then in patients of associated iliac lesions, routine stenting was done using Visi-Pro, a balloon-expandable peripheral stent system of 7 to 9 mm according to the target lesion diameter (ev3, Plymouth, Minnesota, United States) to EIA lesions.

Postoperative Follow-Up

• Medications : All patients were maintained on dual antiplatelet agents, acetyl salicylic acid 75 mg forever and clopidogrel 75 mg for at least 2 months. If patients were in need for oral anticoagulant, only aspirin was added. Cases underwent foot care comprising dressings, minor debridement, limited amputations (up to transmetatarsal amputation), and appropriate footwear.

• Schedule : Clinical follow-up consisted of assessment of pulse and healing of ulcer or amputation site or infection resolution. Clinical outcomes, patency rates, and complications following the procedure were reported. All patients were reexamined after 1 week to check for access site and operative bed complications and to confirm patency. All patients were followed for 1 year with regular visits at 1, 6, and 12 months. Follow-up was in the form of clinical examination and duplex ultrasound ± computed tomography angiography (CTA) if needed in cases of absent or diminished pulse or recurrence of symptoms.

Statistical Analysis

Statistical analysis was conducted using SPSS 22nd edition, qualitative variables were presented in mean and standard deviation, and means comparison between study groups was conducted using Mann–Whitney U test. Qualitative variables were presented in frequency and percentages, it was compared using chi-square test. Any p -values < 0.05 was considered significant.

Results

A total of 36 patients were included in our study, patients were randomized over two groups based on the management approach: SUPERA versus hybrid technique. The included patients had a mean age 60.8 ± 8.2 years. Males-to-females ratio was 2:1. The most common comorbidity reported among the included patients was hypertension and cardiac diseases affecting 63.9% each, followed by diabetes 58.3% then dyslipidemia 50% and stroke in 11.1%. The largest proportion of the include patients were smoker accounting for 63.9% of participants. Thirty-two (88.9%) patients reported improvement of the clinical symptoms, 28 (87.5%) patients had intact pulse postoperatively, and 28 (87.5%) had patent vessels. Follow-up showed that none developed reclusion or restenosis during the period of follow-up ( Figs. 1 and 2 ).

Fig. 1.

An 82-year-old female presented with rest pain and minor tissue loss of right foot and the underlying disease was coronary artery disease (CAD). Computed tomography angiography (CTA) showed severe circumferential calcified chronic total occlusion (CTO) lesion of right common femoral artery (CFA) and proximal superficial femoral artery (SFA). SUPERA stenting of CFA and SFA with angioplasty of profunda femoris artery (PFA).

Fig. 2.

Steps of hybrid approach of right lower limb multilevel lesions.

Demographics

Comparison of demographics and chronic illnesses between study groups showed that smokers were significantly more frequent in hybrid group versus SUPERA with p -values of 0.015. There was no significant difference between study groups in terms of age, gender, prevalence of diabetes, hypertension, cardiac disease, and stroke with p -values > 0.05 ( Table 1 ).

Table 1. Comparison of demographic and chronic illness.

		Group				p -Value
		Hybrid		SUPERA
		Mean	SD	Mean	SD
Age (y)		60.8	8.3	60.8	8.3	1.0
Gender	Male	12	50.0%	12	50.0%	1.0
	Female	6	50.0%	6	50.0%
Diabetes	No	13	86.7%	2	13.3%	0.0001
	Yes	5	23.8%	16	76.2%
Dyslipidemia	No	11	61.1%	7	38.9%	0.18
	Yes	7	38.9%	11	61.1%
Hypertension	No	5	38.5%	8	61.5%	0.29
	Yes	13	56.5%	10	43.5%
Smoker	No	3	23.1%	10	76.9%	0.015
	Yes	15	65.2%	8	34.8%
Cardiac	No	5	38.5%	8	61.5%	0.29
	Yes	13	56.5%	10	43.5%
CKD	No	18	50.0%	18	50.0%	NA
	Yes	0	0.0%	0	0.0%
Stroke	No	16	50.0%	16	50.0%	1.0
	Yes	2	50.0%	2	50.0%

Abbreviations: CKD, chronic kidney disease; SD, standard deviation.

Clinical Picture

Claudication was more commonly reported in the hybrid group compared to the SUPERA group with p -values of 0.016; however, there was no significant difference in the prevalence of rest pains and minor and major tissue loss with p -values > 0.05. Short segment occlusion was more frequently observed among the hybrid group with p -value of 0.007, as well. EIA affection was more commonly reported in the hybrid group with p -values of 0.001. However, there was no statistically significant difference in terms of degree of stenosis and affected vessels with p -values > 0.05 ( Table 2 ).

Table 2. Comparison of clinical picture.

		Group				p -Value
		Hybrid		SUPERA
		Count	Column, N %	Count	Column, N %
Claudication	No	13	72.2	18	100.0	0.016
	Yes	5	27.8	0	0.0
Rest pain	No	10	55.6	10	55.6	1.0
	Yes	8	44.4	8	44.4
Minor tissue loss/unhealed ulcer	No	13	72.2	9	50.0	0.17
	Yes	5	27.8	9	50.0
Major tissue loss/gangrene	No	14	77.8	9	50.0	0.083
	Yes	4	22.2	9	50.0

Perioperative Details

Comparison of perioperative details showed no significant difference between the study groups in terms of availability of CTA, access, pedal arch status, placement of stents, and successful recanalization in both groups with p -values > 0.05 ( Table 3 ).

Table 3. Comparison of perioperative details.

		Group				p -Value
		Hybrid		SUPERA
		Count	Column, N %	Count	Column, N %
CTA	No	12	66.7	12	66.7	1.0
	Yes	6	33.3	6	33.3
Antegrade	No	14	77.8	14	77.8	1.0
	Yes	4	22.2	4	22.2
Retrograde	No	4	22.2	4	22.2	1.0
	Yes	14	77.8	14	77.8
Complete arch	No	18	100.0	18	100.0	NA
	Yes	0	0.0	0	0.0
Incomplete arch	No	14	77.8	14	77.8	1.0
	Yes	4	22.2	4	22.2
PTA with stent	No	0	0.0	0	0.0	NA
	Yes	18	100.0	18	100.0
Successful	No	0	0.0	0	0.0	NA
	Yes	18	100.0	18	100.0
Stent placement	No	13	72.2	14	77.8	0.70
	Yes	5	27.8	4	22.2

Abbreviations: CTA, computed tomography angiography; PTA, percutaneous transluminal angioplasty.

Outcomes

Comparison of outcome between the study groups showed that there was no statistically significant difference between the study groups in terms of clinical improvement, intact pulse postoperatively, and lumen patency with p -values > 0.05 ( Table 4 ).

Table 4. Comparison of outcomes.

		Group				p -Value
		Hybrid		SUPERA
		Count	Column, N %	Count	Column, N %
Clinically improved	No	2	11.1	2	11.1	1.0
	Yes	16	88.9	16	88.9
Intact pulse	No	2	12.5	2	12.5	1.0
	Yes	14	87.5	14	87.5
Patent	No	2	12.5	2	12.5	1.0
	Yes	14	87.5	14	87.5

Peak Systolic Velocity Ratio

Comparison of peak systolic velocity ratio (PSVR) between the study groups showed that there was a statistically significant difference between the study groups in baseline PSVR which was significantly higher in the SUPERA group with p -value of 0.003; however, this difference was not significant in the postangiography settings with p -value of 0.34 ( Fig. 3 ).

Fig. 3.

Box plot showing baseline peak systolic velocity ratio (PSVR) among study groups.

Comparison of difference in PSVR among study groups showed that the hybrid technique had more reduction of PSVR postintervention compared to the SUPERA group with p -values of 0.0001 ( Fig. 4 ).

Fig. 4.

Box plot showing difference in peak systolic velocity ratio (PSVR) between pre- and postangioplasty.

Discussion

The mean age in the current study was younger than that reported by Tao et al, who compared outcomes of hybrid technique versus endovascular SUPERA stenting for CFA occlusion management with mean age of 70.2 years old. ⁵ Males were predominant among several trials. ^{6 7}

In the present study, the current cohort had a mean PSVR preangioplasty 0.78 ± 0.45 versus 0.96 ± 0.2 postangioplasty, comparison of difference in PSVR among study groups showed that the hybrid technique had more reduction of PSVR postintervention compared to the SUPERA group with p -values of 0.0001. These findings were inconsistent to study conducted by Tao et al, who reported mean PSVR presenting 3.74 ± 7.11 versus 1.12 ± 0.56; however, this difference was not statistically significant ( p  = 0.11). ⁵

In the present study, 32 (88.9%) patients reported improvement of the clinical symptoms, 28 (87.5%) patients had intact pulse postoperatively, and 28 (87.5%) had patent vessels. Follow-up showed that none developed reclusion or restenosis during the period of follow-up.

These findings were consistent with the recent study conducted by Tao et al, who stated that 9/13 patients who underwent SUPERA stent insertion had reported clinical improvement, while 1 patient reported no improvement of symptoms and 3 patients worsened. ⁵

In the current study, short segment occlusion was more frequently observed among the hybrid group with p -value of 0.007, as well, EIA affection was more commonly reported in the hybrid group with p -values of 0.001. However, there was no statistically significant difference in terms of degree of stenosis and affected vessels with p -values > 0.05.

Our data showed that comparison of outcome between study groups showed that there was no statistically significant difference between the study groups in terms of clinical improvement, intact pulse postoperatively, and lumen patency with p -values > 0.05.

These findings were consistent with Toa et al and Gouëffic et al, who reported noninferiority of endovascular technique versus hybrid and open angioplasty techniques in terms of clinical improvement, patency, and intact pulse postoperatively. ^{5 7}

In the current study we did not report any major complications regarding cardiovascular events, cerebrovascular events, stent fracture, 30-day mortality, and morbidity. These findings are better than that reported by several studies investigating the endovascular management of CFA. ^{4 8 9}

These findings can be explained by the younger age of the included patients compared to other studies and lower severity of disease, of the included patients only 8 (44.4%) had rest pain (Rutherford 4). Additionally, lower prevalence of hypertension and cardiac diseases compared to other cohorts such as by Tao et al and Gouëffic et al. ^{5 7}

Limitations

The limitations of the current study were mainly lack of blinding, lack of randomizations, and low number of patients due to no funding and the high cost of SUPERA stents.

Recommendations

We do recommend the following:

• Conduction of large prospective randomized trial to compare hybrid technique and endovascular management of CFA occlusion.

• Comparison of standard stents versus SUPERA stenting in terms of clinical outcomes, postoperative complications, and mortality.