Journal of Vascular Surgery
Volume 46, Issue 5 , Pages 965-970.e2, November 2007

Primary iliac stenting versus transluminal angioplasty with selective stenting

Presented at the Thirty-fifth Annual Symposium of the Society for Clinical Vascular Surgery, Orlando, Fla, March 21-24, 2007.

Department of Surgery, Robert C. Byrd Health Sciences Center, West Virginia University, Charleston, WVa.

Received 16 March 2007; accepted 12 July 2007. published online 02 October 2007.

Article Outline

Background

The preferential use of primary iliac stenting vs selective stenting is controversial. This study compares the early and late clinical outcomes of primary vs selective iliac stenting at our institution.

Methods

A total of 110 consecutive patients with iliac stenosis (149 lesions) underwent primary stenting over a recent 5-year period (primary stent group). The early technical and clinical success and late clinical outcomes were compared with 41 patients (41 iliac lesions) who had percutaneous transluminal angioplasty (PTA) followed by selective stenting for suboptimal PTA (selective stent group). All patients were evaluated clinically and by duplex scanning with ankle-brachial indexes at 1, 6, and 12 months and every 12 months thereafter.

Results

The perioperative complication rate for the primary stent group was 2.7% (three minor hematomas) vs 24% for the selective stent group (P < .0001). The overall early clinical success rate was 97% for the primary stent group vs 83% for the selective stent group (P = .002), however, the rate was 100% for short stenosis (A and B lesions <5 cm TASC classification) in both groups; in contrast to 93% for the primary stent group vs 46% for the selective stent group for longer stenoses (TASC - C and D lesions, P = .0003). The overall late clinical success was comparable for both groups: 88% for the primary stent group vs 80% for the selective stent group, however, this rate was superior for the longer lesions in the primary stent group, 84% vs 46% (P = .007). The primary patency rates at 1, 2, 3, and 5 years were 98%, 94%, 87%, and 77% for the primary stent group vs 83%, 78%, 69%, and 69% for the selective stent group (P = .030). These rates were comparable in both groups for shorter lesions: 100%, 98%, 98%, and 87% for the primary stent group vs 100%, 93%, 85%, and 85% for the selective stent group (P = .637). However, they were superior for the primary stent group in longer lesions: 96%, 90%, and 72% vs 46%, 46%, and 28% for the selective stent group at 1, 2, and 3 years (P < .0001).

Conclusions

The overall early clinical success rate was superior for the primary stent group. However, the initial (early) and late clinical success rates were comparable for short lesions (TASC - A and B lesions), but were inferior in selective stenting for longer lesions (TASC - C and D). Therefore, primary stenting should be offered to all TASC - C and D lesions.

 

Iliac artery percutaneous transluminal angioplasty (PTA) has become standard therapy, particularly for short lesions (Transatlantic InterSociety Consensus [TASC] - A & B) and some selected long lesions (TASC - C & D), with a long-term patency rate range of 60% to >90% over 3 to 5 years.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 However, the success of iliac PTA is generally reduced by initial residual stenosis and late restenosis. Iliac stent placement is indicated for initial suboptimal PTA results which include: residual stenosis of >30%, as measured by angiography; a mean pressure gradient of ≥5 mm Hg across the treated site; and/or extensive intimal dissection.14, 15, 16, 17, 18 Indeed, several studies reported improvement of the immediate hemodynamic and angiographic results of iliac PTA in patients with suboptimal results.14, 15, 16, 17, 18 In contrast, the efficacy of stents is widely recognized as limited in the long-term, secondary to narrowing of the luminal diameter of the stents caused by intimal proliferation.19

The Dutch randomized iliac study which demonstrate equivalent results of primary vs selective stenting of iliac artery lesions is the only randomized study to compare the efficacy these two approaches in the endovascular treatment of iliac artery occlusive disease.20, 21 However, in spite of the equivalency of primary and selective stenting in the Dutch study, the preferential use of primary iliac stenting vs PTA with selective stenting is still controversial, particularly for TASC C and D lesions. Many authorities advocate routine primary iliac stenting after an otherwise uncomplicated PTA of such lesions in an attempt to improve the long-term results.22, 23, 24 Because of the initial angiographic and hemodynamic advantages of iliac stent insertion, and the significant number of our earlier patients with TASC - C and D lesions who failed with PTA only, we adopted a policy of routine primary iliac stenting in the last few years instead of selective stenting. This study compares the early and late clinical outcome of primary iliac stenting vs iliac PTA with selective stenting in our institution over the last several years.

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Patient population and methods 

One hundred and ten consecutive patients with iliac artery stenosis (149 iliac lesions) underwent iliac PTA with primary stenting over a recent 5-year period (July 2000 to June 2005; primary stent group). The early technical and clinical success and late clinical outcomes of these patients were compared with 41 patients (41 iliac lesions) who had PTA followed by selective stenting for only patients with suboptimal results that were done 5 years prior to that (July 1994 to June 1999; selective stent group). This earlier group included both all patients with successful PTA only and those patients undergoing selective stenting, with selective stenting being indicated for suboptimal PTA results including residual stenosis of ≥30%, the presence of a pressure gradient of ≥5 to 10 mm Hg, or the presence of gross long dissection after PTA. All procedures were done by the senior author (AFA). All primary stent patients were treated in the Circulatory Dynamics Laboratory (CDL, an independent vascular invasive laboratory suite outside the operating room). The earlier group (selective stent group) was treated either in the operating room (earlier) using a special vascular suite equipped with an ISS imaging system (International Surgical System, Phoenix, Ariz) or later in the CDL lab. The study protocol was approved by our local Institutional Review Board.

Patients’ clinical evaluations 

All patients were judged to be candidates for PTA and/or stenting if they reported disabling claudication, had failed medical therapy, or demonstrated rest pain or ischemic tissue loss. All patients underwent preoperative duplex ultrasound examinations and ankle-brachial indexes prior to angiography to determine the need for iliac PTA. The clinical/demographic characteristics for both groups were comparable except for the mean age and hypertension (see Table I). The indications for PTA/stenting were similar in both the primary stenting and the selective stenting groups, as shown in Table II. The iliac lesion distribution and status of the superficial femoral artery is shown in Table III. As noted in this table, there were no statistically significant differences between the distribution of the disease, whether common iliac vs external iliac; in both groups, however, the primary stenting group was less likely to have a superficial femoral artery occlusion (P = .025).

Table I. Demographic/clinical characteristics
Primary TASC A & B lesions (n = 61)Selective TASC A & B lesions (n = 28)Primary TASC C & D lesions (n = 49)Selective TASC C & D lesions (n = 13)P value
Age (mean)62.9(±10 y)72.6(±9.6 y)64.5(±11.5 y)68.5(±8.8 y).0007
Gender
Male28(46%)12(43%)29(59%)7(54%)NS
Female33(54%)16(57%)20(41%)6(46%)NS
Smoking34(56%)18(64%)28(57%)10(77%)NS
Diabetes mellitus23(38%)8(29%)20(41%)5(39%)NS
Hypertension51(84%)20(71%)41(84%)6(46%).015
Hypercholesterolemia28(46%)11(39%)20(41%)7(54%)NS
Coronary artery disease34(56%)17(61%)26(53%)8(62%)NS

NS, Not significant.

Table II. Indications of PTA/stenting
IndicationsPrimary stentingSelective stentingP value
Stage I PVD (disabling claudication)41(37%)14(34%)NS
Stage II PVD (critical ischemia: rest pain)51(46%)18(44%)NS
Stage III PVD (critical ischemia: trophic changes)18(16%)9(22%)NS

NS, Not significant; PTA, percutaneous transluminal angioplasty; PVD, peripheral vascular disease.

Table III. Iliac lesion distribution and superficial femoral artery status
Primary stentingSelective stentingP value
Common iliac artery89(60%)29(71%)P = .47
External iliac artery31(21%)7(17%)
Combined common and external iliac arteries29(19%)5(12%)
No SFA occlusion71(65%)21(51%)P = .025
SFA occlusion11(10%)12(29%)
Bilateral SFA occlusion28(25%)8(20%)

SFA, superficial femoral artery.

PTA/stent techniques 

After completion of diagnostic angiography, the lesion was crossed with a guidewire and the pressure gradient across the lesion was measured before and after PTA. Low-profile Meditech ultra-thin balloon catheters (Boston Scientific, Watertown, Mass) in 2 to 4 cm lengths and 7 to 12 mm in diameter were used, according to the length of the lesion and the size of the artery, as judged by intraoperative arteriograms. Primary stenting was done using self-expanding Smart stents (Cordis, Johnson & Johnson, Warren, NJ). Both Wall stents (Boston Scientific, Watertown, Mass) and Palmaz stents (Cordis, Johnson & Johnson, Warren, NJ) were used in the selective stent group. All patients were given 325 mg of oral aspirin prior to the procedure, 325 mg of aspirin and 300 mg of Plavix (clopidogrel, Bristol-Myers Squibb, New York, NY) immediately postoperatively, 75 mg of Plavix for 6 weeks postoperatively and 325 mg of aspirin indefinitely. Patients were generally discharged within 24 hours after the procedure.

Postoperative surveillance 

All patients were followed clinically and PTA/stent patency was assessed by duplex ultrasound examination and measurement of ankle/brachial indexes at 1 month, 6 months, 12 months, and every year thereafter. Arteriograms were obtained when new symptoms developed, a 15% drop in the ankle-brachial index was detected, or a duplex ultrasound examination documented >50% stenosis or occlusion of the iliac PTA/stenting site. The mean follow-up was 24 months (range: 1 to 81 months) for the primary stenting group vs 34 months (range: 1 to 66 months) for the selective stenting group. Every effort was made to comply with the Reporting Standards for the Lower Extremity Endovascular Procedures as advocated by the Ad Hoc Committee of the Society of Vascular Surgery.25

Study design and statistical analysis 

The following terms are used in this manuscript: early clinical success (30 days perioperatively) is defined as symptom resolution or improvement by defined clinical criteria, an increase of the ankle/brachial index by ≥0.15, and the presence of residual stenosis of <30% of a normal diameter on imaging. Late continued clinical success is defined when sustained improvement in each of the three categories was documented (clinical, hemodynamic, and anatomic success). Clinical patency of the PTA/stent is defined if the patient has sustained objective hemodynamic improvement and patency on duplex ultrasound imaging.

Lesions treated were classified according to the TASC classification.8 Lesions were then combined into groups of short lesions consisting of A and B lesions (≤5 cm) and long lesions consisting of C and D lesions (>5 to 10 cm, and >10 cm) for analysis. There were 28 TASC - A and B lesions in the selective stenting group, 24 of which had successful PTA only and four which required selective stenting; and 13 TASC - C and D lesions, 12 of which required selective stenting. In the primary stenting group, there were 61 TASC - A and B lesions and 49 TASC - C and D lesions.

Standard analysis was done using chi square and ANOVA (with Bonferroni post tests) for numerical data. Association of hemodynamic, anatomic, and symptomatic improvement in the segment of a treated artery and the placement of the stent was determined by chi square analysis. The Kolmogorov-Smirnov and Anderson-Darling goodness of fit tests were run to assure normal distribution of the data. All four groups (TASC A and B lesions and TASC C and D lesions - Primary Stenting Group, TASC A and B lesions, TASC C and D lesions - Selective Stenting Group) were found to be normally distributed (using both test methods) at a 95% confidence level. Primary patency of the PTA site was analyzed using the Kaplan Meier lifetable analysis and the log-rank and Wilcoxon analysis for primary vs selective stenting comparison was applied.

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Results 

Perioperative technical outcomes and complications 

The immediate technical success rate was 100% for both groups. The perioperative complication rate for the primary iliac stenting group was 2.7% (3 out of 110 patients), which included three minor hematomas. For the selective stenting group, the perioperative complication rate was 24% (10 out of 41 patients) (P < .0001). These 10 patients included: two patients with short (TASC - A and B) lesions, one who had a postoperative deep vein thrombosis and one who had bleeding requiring operative intervention (with an uneventful recovery); and eight patients with longer (TASC - C and D) lesions, including one patient who had superficial cellulitis that was treated with antibiotics and seven who had early postprocedure iliac artery thrombosis. Two of these occurred within 24 hours and both were treated with thrombectomy while the five other patients had thrombosis within 1 to 21 days and were treated with thrombectomy and/or bypasses. There were no perioperative deaths and/or amputations in either group.

Early and late clinical outcomes 

The overall early clinical success rate was 97% for the primary stenting group vs 83% for the selective stenting group (P = .002) Table IV). However, the early clinical success rate was 100% for short stenoses (TASC - A and B lesions) in both groups vs 93% for primary stenting and 46% for selective stenting for longer stenoses (TASC - C and D lesions, P = .003). The overall late clinical success rates were comparable for both groups: 88% for primary stenting vs 80% for selective stenting and the late clinical success was also comparable for the shorter stenoses: 95% for primary stenting vs 96% for selective stenting. In contrast, the late clinical success rate was again better in the primary stenting group; for longer stenosis: 84% in the primary stenting group vs 46% for selective stenting group (P = .007). The limb salvage rate was also better after primary stenting; 100% for the primary stenting group vs 93% for the selective stenting group (P = .02). There was no significant relationship between any risk factors (comorbidities), indications for PTA/stenting, or the status of the superficial femoral artery (occlusion vs patency) and early or late clinical success.

Table IV. Early and late clinical success
Success (N)%P value
Early clinical success
Primary stenting (n = 149)14597.002
Selective stenting (n = 41)3483
Primary A & B lesions (n = 92)92100NS
Selective A & B lesions (n = 28)28100
Primary C & D lesions (n = 57)5393.0003
Selective C & D lesions (n = 13)646
Late clinical success
Primary stenting (n = 142)12588NS
Selective stenting (n = 41)3380
Primary A & B lesions (n = 92)8795NS
Selective A & B lesions (n = 28)2796
Primary C & D lesions (n = 57)4884.007
Selective C & D lesions (n = 13)646

NS, Not significant.

Late primary patency 

The primary patency rates at 1, 2, 3, and 5 years were: 98%, 94%, 87%, and 77% for the primary stenting group vs 83%, 78%, 69%, and 69% for the selective stenting group (log rank P value 0.03, Wilcoxon P value < .0001, Fig 1 and Table V, online only). The primary patency rates for patients treated for shorter stenoses (TASC - A and B lesions) were comparable regardless of treatment type: 100%, 98%, 98%, and 87% for the primary stenting group vs 100%, 93%, 85%, and 85% for selective stenting group (log rank P value .637, Wilcoxon P value .132, and Fig 2 and Table VI, online only). In contrast, the primary patency rates for the patients treated for longer stenoses (TASC - C and D lesions) were significantly better for patients undergoing primary stenting: 96%, 90%, and 72% for primary stenting vs 46%, 46%, and 28% for selective stenting at 1, 2, and 3 years, respectively (log rank P value < .0001 and Wilcoxon P value < .0001, Fig 3 and Table VII, online only).

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Discussion 

The controversial aspects of iliac PTA and stenting that we tried to address in this study deal with whether stenting should be performed primarily, or only selectively, based on certain criteria, and also which iliac lesions, based on TASC stratification, are amenable to PTA/stenting. The Dutch randomized trial (primary stenting vs selective stenting) showed that selective iliac artery stenting was as effective as primary stenting.21 However, the Dutch randomized trial excluded patients with stenosis >10 cm (TASC- D) or occlusion >5 cm.21 Similarly, Cambria et al advocated PTA with selective stenting due to an inability to show a significant improvement in patency rates with primary stenting, a high overall complication rate of 18%, and resultant major amputations in 12% of 141 patients.28 However, again the average length of stenosis treated in their series was 3.3 ± 0.1 cm, which was similar to our observation of comparable early and late clinical success with both primary and selective stenting of such short lesions. Also, the overall complication rates in a recent series with primary stenting have been lower (1.4% to 4.8%)29, 30, 31, 32 and the overall complication rate for primary stenting in our series was 2.7%.

Despite the results from the Dutch randomized trial, many authors advocate the use of primary stenting for endovascular treatment of iliac artery lesions.22, 23, 24 In addition, a meta-analysis by Bosch and Hunink comparing six series of PTA alone (1300 patients) and eight series of PTA with stent placement (816 patients) published after 1990, showed that routine PTA/stenting was associated with better 4-year patency rates than PTA alone for patients with claudication or critical ischemia. Furthermore, a 39% reduction of the risk of long-term failure after stent placement was demonstrated.26

Our data further supports the contention that shorter lesions (TASC- A and B) can be adequately treated with either primary or selective stenting following PTA. The early clinical success rate for short lesions after both types of treatment was 100%. The late clinical success was also comparable for short lesions after both primary and selective stenting, 95% and 96%, respectively. Similarly, Galaria et al reported on their retrospective 10-year review of patients undergoing PTA with or without stenting (based on surgeon preference) and concluded that primary PTA and selective stenting was a safe and durable intervention for TASC - A and B lesions.13

The presence of external iliac artery disease and increased lesion length (TASC C and D) have been reported to adversely affect the outcomes from iliac PTA with selective stenting.5, 12, 13 Becquemin et al observed a poorer 2-year patency with selective stenting of lesions ≥3 cm length (69.7% ± 6.5%), suggesting that primary stenting might have improved their results.5 Silva et al, using a protocol of selective stenting, also observed that the length of the lesion was a predictor of the clinical success, with lesions >5 cm showing poorer initial and continued success rates, compared with lesions <5 cm (82% and 62% vs 96% and 82%, respectively).27 However, few studies have specifically compared the use of stenting, selective or primary, for longer (TASC - C and D) lesions.

The superior primary patency rates and clinical success rates observed in our series for TASC - C and D lesions treated by primary stenting were also observed by Leville et al.34 In their study, 89 patients underwent 92 procedures, 30 TASC - C lesions (33.7%) and 37 TASC - D lesions (41.6%), with primary and secondary patency rates at 3 years of 73% and 93% for TASC - C lesions and 80% and 83% for TASC - D lesions.34 Similarly, De Roeck et al33 reported the results of 38 patients who underwent percutaneous recanalization of an occluded iliac artery with subsequent stenting for TASC - B lesions in 12 patients, TASC - C in 10 patients, and TASC - D in 16 patients. The technical success rate was 97% and the 30-day mortality rate was 2.7%. The primary patency rates at 1, 3, and 5 years were 94%, 89%, and 77%, respectively. Three re-occlusions (8.1%) and one restenosis (2.7%) were observed during follow-up, at a mean of 26 months. They concluded that long-term results of iliac recanalization were excellent without major complications, if the procedure was technically successful. Early and late clinical success notes for such longer, complex lesions were also delineated to show superiority of primary stenting over selective stenting in our series.

Our study has several limitations. The inferior outcome of the selective stent group can be partially attributed to our early operative experience and the result of seven cases of perioperative thrombosis in the TASC - C and D lesions in the selective stenting group. The PTAs that were done for these extensive lesions in the early series may have caused extensive dissection or arterial damage prior to the stenting, which initiated the perioperative thrombosis. These patients may have also been inadequately treated with stenting as only one stent was placed in each patient in the early series. Another limitation of this study is the fact that two types of stents (Palmaz stainless steel stents and Wallstents) were used in the selective stenting group while only the Smart Nitinol stent was used in the primary stenting group, which may or may not explain the difference in the results of these two series. Furthermore, a significant number of patients in the selective study group who were lost for follow-up at the later stage since they were done several years earlier, which may have impacted the results. Additionally, the groups are different in regards to age distribution, and the small sample size of the selective stenting group may have affected our statistical analysis. Finally, it should be noted that the interpretation of our results cannot be taken in the same context of the Dutch study, since 92% of the patients in the Dutch study were treated for intermittent claudication, while only one-third of our patients had PTA and/or PTA/stenting for claudication.

In conclusion, the early clinical success rate after endovascular treatment of iliac artery lesions was superior for patients undergoing the primary stenting. However, the early and late clinical success rates were comparable treatment of short lesions (TASC - A and B lesions) regardless of whether primary or selective stenting was done, but were inferior for selective stenting of longer lesions (TASC - C and D). Therefore, primary stenting of the iliac artery lesions may be of value in patients with TASC - C and D lesions.

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Author contributions 


Conception and design: AA, JH

Analysis and interpretation: AA, SF

Data collection: JH, WP

Writing the article: AA, JH

Critical revision of the article: AA

Final approval of the article: AA, JH, SF, WP

Statistical analysis: AA, SF

Obtained funding: Not applicable

Overall responsibility: AA

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Appendix 

Additional material for this article may be found online at www.jvascsurg.org.

Table V, online only. Primary patency: Primary stenting vs selective stenting (whole group)
Primary stentingSelective stenting
Time (mos.)No. at riskNo. failedNo. censoredPatencySt. errorNo. at riskNo. failedNo. censoredPatencySt. error
014903100%0%4100100%0%
1120252100%0%4170100%0%
128511498%1%341183%6%
24562994%3%272478%7%
36301587%4%160569%8%
48160677%7%110169%8%
6041277%7%50269%8%

Log-rank P value .030; Wilcoxon P value <.0001.

Table VI, online only. Primary patency: Primary stenting vs selective stenting for short stenosis (TASC - A and B lesions)
Primary stentingSelective stenting
Time (mos.)No. at riskNo. failedNo. CensoredPatencySt. errorNo. at riskNo. failedNo. censoredPatencySt. error
09201100%0%2800100%0%
172038100%0%2800100%0%
124909100%0%2811100%0%
24320698%3%242393%5%
36201398%3%150485%7%
48110487%8%110185%7%
6041287%8%50285%7%

Log rank P value .637; Wilcoxon P value .132.

Table VII, online only. Primary patency: Primary stenting vs. selective stenting for long stenosis (TASC - C and D lesions)
Primary stentingSelective stenting
Time (mos.)No. at riskNo. failedNo. CensoredPatencySt. errorNo. at riskNo. failedNo. censoredPatencySt. error
05702100%0%1300100%0%
148214100%0%1370100%0%
12371596%3%60046%5%
24242390%5%40146%5%
36100272%9%10128%7%
4850263%12%
60

Log rank P value <.0001; Wilcoxon P value <.0001.

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 Competition of interest: none.

 Additional material for this article may be found online at www.jvascsurg.org.

PII: S0741-5214(07)01189-5

doi:10.1016/j.jvs.2007.07.027

Journal of Vascular Surgery
Volume 46, Issue 5 , Pages 965-970.e2, November 2007

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