Six-month results of stenting of the femoropopliteal artery and predictive value of interleukin-6: Comparison with high-sensitivity C-reactive protein

Abstract

Objectives

To determine the association of pre- and postinterventional serum levels of interleukin-6 and high-sensitivity C-reactive protein at the six-month evaluation of restenosis after stenting of the femoropopliteal artery.

Methods

Sixty-eight consecutive patients with steno-occlusive femoropopliteal artery disease of Rutherford category III or IV who underwent stent implantation were included. Six-month patency was evaluated with color-coded duplex ultrasound. The association of in-stent restenosis with interleukin-6 and high-sensitivity C-reactive protein levels at baseline, and 24-h postintervention was assessed with a multivariate logistic regression analysis.

Results

In-stent restenosis was found in 15 patients (22.1%) within six months. Interleukin-6 and high-sensitivity C-reactive protein levels were significantly increased at 24-h postintervention compared to their preintervention values (p < 0.001 and p = 0.002, respectively). Interleukin-6 values at baseline (odds ratio, 1.11; 95% confidence interval: 1.00, 1.23; p = 0.044) and 24-h postintervention (odds ratio, 1.04; 95% confidence interval: 1.02, 1.06; p < 0.001) were independently associated with six-month in-stent restenosis. Twenty-four-hour postinterventional high-sensitivity C-reactive protein levels were also found to be related to restenosis (odds ratio, 1.15; 95% confidence interval: 1.04, 1.26; p = 0.006), but high-sensitivity C-reactive protein levels at baseline did not show an independent association with in-stent restenosis (odds ratio, 0.57; 95% confidence interval: 0.35, 1.80; p = 0.667). Smoking, diabetes mellitus, and cumulative stent length were other parameters associated with an increased risk for in-stent restenosis.

Conclusions

Femoropopliteal artery angioplasty with stent placement induces an inflammatory response. Interleukin-6 is a powerful independent predictor of intermediate-term outcomes for stenting of the femoropopliteal artery, suggesting that its predictive value may be superior to that of high-sensitivity C-reactive protein.

Keywords

Peripheral artery disease,femoropopliteal artery,stent,interleukin-6

Introduction

Stents were introduced to resolve the problems of residual stenosis, elastic recoil, and flow-limiting arterial dissection, thus improving patency rates after balloon angioplasty; however, in-stent restenosis (ISR) remains the major drawback leading to late clinical failure after primarily successful interventions. The ISR rate at six months in the femoropopliteal arteries is 18%–24%,^1–3 significantly higher than in other vascular beds.

The mechanisms of ISR are complex and incompletely understood. Inflammation was thought to play a critical role in the development and progression of restenosis.⁴ Balloon angioplasty and stent implantation induce a vascular inflammatory response at the treated vessel segment,⁵ which is suggested to stimulate vascular smooth muscle cell (SMC) proliferation and hypertrophic neointimal formation, and SMC proliferation and the ensuing neointimization frequently lead to ISR.⁶ The extent of the vascular inflammatory response postintervention may thus be related to intermediate-term outcomes after stenting.

Interleukin-6 (IL-6) is a pleiotropic cytokine involved in a wide range of actions relating to inflammation, host defense, and tissue injury.⁷ IL-6 can be synthesized and secreted by many cell types including monocytes, T-cells, fibroblasts, and endothelial cells.⁸ High-sensitivity C-reactive protein (hs-CRP) is a marker of inflammation derived from leukocytes in response to IL-6 stimuli.⁹ Elevated baseline and/or postintervention values of hs-CRP were shown to be associated with an increased risk for restenosis after coronary¹⁰ and peripheral¹¹ angioplasty. Serum levels of IL-6 are still controversial in predicting restenosis after coronary angioplasty.^12,13 One small sample observational study indicated that there was no significant correlation between IL-6 and restenosis after peripheral percutaneous transluminal angioplasty (PTA).¹⁴ Studies specifically concerning the relation between IL-6 or hs-CRP and stenting of the lower limb arteries were not available.

The aims of this prospective clinical study were to observe the intermediate-term outcome of the femoropopliteal artery after stent implantation and to determine the association of pre- and postprocedural serum levels of IL-6 at the six-month evaluation of restenosis in comparison with levels of hs-CRP.

Materials and methods

Eligible population

This study was designed as a prospective cohort study. From August 2013 to March 2014, consecutive patients with de novo stenoocclusive femoropopliteal artery disease who underwent successful endovascular treatments were recruited into the study. We excluded patients who underwent PTA only and patients who underwent thrombolysis. Stent implantation was performed in these cases due to unsatisfactory angiographic results after PTA, including substantial residual stenosis, elastic recoil, or dissection with marked stenosis. Patients with ischemic ulceration or tissue loss (Rutherford category V or VI) were not eligible for the study because of the expected influence of inflammation on the serum levels of IL-6 and hs-CRP. Patients with acute or chronic inflammatory diseases and patients with major complications within 48 h after treatment were also excluded from the study for the same reasons. The study was approved by the local ethics committee, and written informed consent was obtained from each patient. Endovascular interventions (PTA or/and stent implantation) of the femoropopliteal arteries for 181 patients during the study period were documented. Forty-six patients (25%) had Rutherford category V or VI peripheral arterial disease (PAD) with ischemic macroscopic tissue damage, 27 patients (15%) underwent femoropopliteal artery PTA only, and 35 (19%) patients had native vessel restenosis or ISR. These patients were eliminated from the study. Seventy-three patients with Rutherford category III or IV PAD who underwent stent implantation with/without PTA of the femoropopliteal artery were eligible for the study. Two patients had early reocclusions at one month and underwent catheter-directed thrombolysis. Three patients were lost to follow-up, leaving 68 patients for the final analysis. The mean age of the 68 patients was 74.1 ± 7.6 years (range, 53 – 87 years), and 51 patients (75%) were males.

Definitions

Primary technical success was defined as restoration of antegrade flow with a residual stenosis diameter of 30% or less at the treated segment on the final angiogram. Restenosis was defined as a proximal systolic peak flow velocity ratio >2.4 based on duplex ultrasound, which was considered indicative of a stenosis of greater than 50%.¹⁵

Clinical data

Routine laboratory tests, urinalysis results, and chest radiography were used to exclude coexistent inflammatory diseases such as infection, collagen disease, or arthritis. A clinical history and physical examination were evaluated with special attention to cardiovascular risk factors and comorbidities, including age, sex, body mass index, smoking habits, diabetes mellitus, hypertension, hyperlipidemia, and coronary arterial disease. A hemodynamic evaluation was performed by measuring the baseline ankle-brachial index (ABI). Findings of angiography, including morphology of the stenosis or occlusion, vessel diameter, length of the lesions, and the number of crural run-off vessels, were documented.

Laboratory parameters

Antecubital venous blood samples for the determination of IL-6 and hs-CRP levels were obtained at baseline before the intervention and at 24 h after the intervention. Serum samples were frozen and stored at −80°C until assayed. IL-6 was measured by enzyme-linked immunosorbent assay using a commercially available assay kit (Roche Diagnostics, Indianapolis, Indiana, USA). hs-CRP was measured by rate nephelometry¹⁶ (Siemens Healthcare Diagnostics, Marburg, Germany).

Interventions

Access to the artery was mostly obtained with a percutaneous retrograde (n = 65, 96%) femoral approach using a 6-F crosses sheath (Cook Medical, Bloomington, Indiana, USA) or 6-F hemostatic sheath (Terumo, Tokyo, Japan). A 0.035-inch hydrophilic guide wire (Terumo, Tokyo, Japan) was used to advance the steno-occlusive segment. Stent placement with/without predilation was then performed. If the stents were not well deployed, postdilatation using the appropriate balloons was needed. All stents used in the cases of this study were nitinol self-expanding stents. The stenting results, including the cumulative stent length, number of stents, and postprocedural residual stenosis, were documented. Pre- and postinterventional complications were recorded after intervention. Hematoma at the puncture site and peripheral emboli were classified as minor complications. Major bleeding (hemoglobin level decrease > 2 mg/dL) and all complications necessitating emergency surgery or thrombolysis within 48 h were classified as major complications. All patients received hypodermic injections of low molecular heparin (0.4 mL, 12 h once) for three to five days after interventions. Patients were discharged on a lifelong oral regimen of aspirin (100 mg/day) and cilostazol (200 mg/day) for at least six months.

Follow-up

Patients were routinely followed for six months in the outpatient clinic to analyze the occurrence of restenosis. ABI, clinical evaluations, physical reexamination, and a mandatory color-coded duplex ultrasound examination were performed at six months in all patients.

Statistical analysis

For continuous variables, values are expressed as the mean ± standard deviation, and for discrete variables, values are given as percentages. Comparisons between the two groups were analyzed by using the Mann–Whitney U test. Differences in the distribution of variables were analyzed by using the chi-square test. Logistic regression analysis was used to identify the independent effect of IL-6 and hs-CRP on six-month patency. Baseline variables with a value of p < 0.2 were entered into the multivariable model. A value of p < 0.05 was considered significant. All calculations were performed with SPSS Version 19.0 (SPSS, Chicago, Illinois, USA), and graphs were made using GraphPad Prism 7.0 software (GraphPad Software Inc., San Diego, California, USA).

Results

Successful stent implantation of the femoropopliteal artery was achieved in all patients (100%). No major complications occurred. The ABI improved from a preinterventional mean of 0.52 ± 0.21 to a 24-h postinterventional mean of 0.83 ± 0.29 (p < 0.001). The ABI at six months had a mean of 0.73 ± 0.26.

ISR of the femoropopliteal artery was diagnosed in 15 patients (22.1%) on the basis of the duplex ultrasound results at six months. Five patients (7.4%) underwent target lesion revascularization because of a recurrence of symptoms or an increase in complaints in the 15 patients classified as having restenosis. Three patients (4.4%) underwent angioplasty or stenting in previously non-treated zones or the contralateral extremities.The clinical and angiographic characteristics of the patients with and without restenosis are shown in Table 1. Restenosis was found more frequently in smokers (p = 0.04) and in patients with diabetes mellitus (p = 0.03). Furthermore, lesion length (p = 0.03) and cumulative stent length (p = 0.003) were associated with six-month ISR.

Table 1.

Clinical and angiographic characteristics.

Characteristics	No restenosis(n = 53)	Restenosis(n = 15)	p ^a
Age, years	74.4 ± 7.6	73.1 ± 8.9	0.55
Male	41 (77)	10 (67)	0.40
Affected limb (left)	30 (57)	8 (53)	0.82
Body mass index	22.5 ± 3.9	22.7 ± 2.6	0.72
Smoking	31 (58)	13 (87)	0.04
Diabetes mellitus	22 (42)	11 (73)	0.03
Hypertension	32 (60)	9 (60)	0.98
Hyperlipidemia	20 (38)	7 (47)	0.53
Coronary arterial disease	19 (36)	5 (33)	0.86
Critical limb ischemia	16 (30)	7 (47)	0.23
ABI at baseline	0.54 ± 0.23	0.49 ± 0.18	0.63
Complete vessel occlusion	36 (68)	12 (80)	0.37
Vessel diameter, mm	6.1 ± 0.3	5.8 ± 0.4	0.58
Lesion length, cm	18.7 ± 8.9	24.9 ± 5.1	0.03
Poor runoff	21 (40)	8 (53)	0.34
Cumulative stent length, cm	17.2 ± 7.9	23.9 ± 5.7	0.003
Number of stents			0.06
1	20 (38)	1 (7)
2	30 (57)	12 (80)
3	3 (5)	2 (13)

Note: Numbers are means ± standard deviation, or no. (%). ABI: ankle-brachial index.

^aKruskall–Wallis used for continuous data and chi-squared test for categorical data.

Serum levels of IL-6 and hs-CRP were both significantly increased at 24-h postintervention compared to their preintervention levels (p < 0.001 and p = 0.002, respectively; Figures 1 and 2). Baseline and 24-h postinterventional IL-6 levels were significantly associated with the occurrence of ISR at six months (p = 0.003 and p < 0.001, respectively; Figure 3). Twenty-four-hour postinterventional hs-CRP levels were also found to be related to restenosis (p = 0.008, Figure 4); however, no association was observed between baseline hs-CRP levels and ISR (p = 0.168, Figure 4).

Figure 1.

Plasma levels of IL-6 in patients undergoing stent implantation of the femoropopliteal artery measured at baseline and 24-h postintervention. IL-6: interleukin-6.

Figure 2.

Plasma levels of hs-CRP in patients undergoing stent implantation of the femoropopliteal artery measured at baseline and 24-h postintervention. hs-CRP: high-sensitivity C-reactive protein.

Figure 3.

IL-6 plasma concentrations in patients with and without restenosis six months after stent implantation. IL-6: interleukin-6.

Figure 4.

hs-CRP plasma concentrations in patients with and without restenosis six months after stent implantation. hs-CRP: high-sensitivity C-reactive protein. n.s.: not significant.

Multivariate logistic regression analysis was performed to assess the independent association of serum levels of IL-6 and hs-CRP with the occurrence of six-month ISR of the femoropopliteal artery and to adjust for the confounding effects of other risk factors. Separate models were applied for baseline and 24-h IL-6 as well as for baseline and 24-h hs-CRP. Smoking, diabetes mellitus, lesion length, cumulative stent length, and number of stents were included as covariates (Table 2). Baseline IL-6, 24-h IL-6, and 24-h hs-CRP were independently associated with six-month postintervention outcomes; hs-CRP level at baseline did not show an independent association with restenosis. Smokers and patients with diabetes mellitus had a greater adjusted risk for ISR. Cumulative stent length was the other factor related to a slightly increased risk of restenosis in the multiple regression model.

Table 2.

Multivariate logistic regression models assessing the risk for in-stent restenosis.^a

Model	OR	95% CI	p
Model 1
Baseline IL-6 level	1.11	1.00, 1.23	0.044
Cumulative stent length	1.01	1.00, 1.02	0.024
Model 2
24-h IL-6 level	1.04	1.02, 1.06	0.001
Model 3
Baseline hs-CRP level	0.57	0.35, 1.80	0.667
Diabetes mellitus	3.87	1.02, 14.77	0.047
Cumulative stent length	1.01	1.00, 1.02	0.009
Model 4
24-h hs-CRP level	1.15	1.04, 1.26	0.006
Smoking	13.99	1.18, 166.38	0.037
Diabetes mellitus	6.25	1.16, 33.60	0.033
Cumulative stent length	1.01	1.00, 1.03	0.037

Note: IL-6: interleukin-6; hs-CRP: high-sensitivity C-reactive protein; OR: odds ratio; CI: confidence interval.

^aModels adjusted for smoking, diabetes mellitus, lesion length, cumulative stent length, and number of stents.

Discussion

ISR after endovascular treatment of atherosclerotic lesions in the peripheral, cerebrovascular, and coronary vessels is the major drawback of this minimally invasive technique. The frequency of ISR in this patient series was 22.1% at six months, which compared well with former published findings.^1–3 Although certain advances have been made in recent years to improve patency rates after endovascular treatment, ISR remains a challenging clinical problem. The high cost and low efficacy of the current ISR therapies make this field still very interesting for future research.

Vascular inflammation after endovascular procedures has been identified as a cornerstone of the restenotic process, and several markers of inflammation have been referred to as potential predictors of intermediate-term outcomes.¹⁷ IL-6 and hs-CRP are two well-studied inflammatory markers. IL-6 is a proinflammatory mediator involved in the pathophysiology of atherosclerosis in general and, more specifically, in PAD. Its protein and gene expression has been demonstrated in human atherosclerotic lesions.¹⁸ CRP is an acute-phase reactant that sensitively reflects the extent of vascular inflammation and indirectly displays the cytokine-dependent inflammatory process in the arterial wall.¹⁹

Our results suggest that peripheral revascularization in the form of stent implantation causes a significant systemic inflammatory response, as demonstrated by increased levels of IL-6 and hs-CRP (Figures 1 and 2). In this study, we compared the predictive value of IL-6 with that of hs-CRP. Our findings showed that both postinterventional IL-6 and hs-CRP levels were significant predictors of ISR in the intermediate term. Baseline IL-6 levels were also found to be associated with ISR, whereas baseline hs-CRP levels did not represent powerful prognostic value. Since it shows a greater sensitive predictive value at baseline, IL-6 may directly reflect vascular inflammation and endothelial injury during the initiation and development of atherosclerosis.

The trans-atlantic inter-society consensus for the management of peripheral arterial disease (TASC II) indicated that clinical stage of disease, length of the lesion, and disease outflow were the most commonly identified independent risk factors for restenosis;²⁰ however, risk factors identified in the present study, particularly for ISR of the femoropopliteal artery as obtained by means of the univariate analysis, were different from the consensus. Smoking, diabetes mellitus, and cumulative stent length were demonstrated to be related to increased risks for restenosis in the multiple regression model. Smoking is a major risk factor for the development of PAD,²⁰ and patients who continue smoking have higher rates of revascularization procedures and amputations;²¹ however, published studies on the association between smoking and ISR reported conﬂicting results. Some early studies indicated that smoking increased the risk for restenosis in coronary and carotid arteries.^22,23 One might expect smoking to affect the risk of disease progression and restenosis because of its known effects on endothelial and platelet function. In contrast, some other published studies in coronary arteries²⁴ and lower limb arteries²⁵ contradict this theory and postulate that smoking might be associated with a lower risk of restenosis. While further research is required to reach an actual conclusion, we obtained a positive result in the present study. Diabetes is also one of the leading risk factors for the development of PAD,²⁰ and the amputation rate in patients with diabetes is many-fold elevated compared with the amputation risk in patients without diabetes.²⁶ Studies have proven that the patency rates after revascularization procedures in patients with diabetes are much lower than those in patients without diabetes. Insulin-dependent diabetes mellitus seems to particularly increase the risk of ISR, which might be caused by less insulin reserve and less well-controlled hyperglycemia.²⁷ Cumulative stent length was the other factor related to a slightly increased risk for restenosis in our study, while in a small database of 65 patients who underwent long-segment femoropopliteal stent implantation, neither the cumulative stent length nor the number of implanted stents were associated with ISR.³

Currently, endovascular therapy for peripheral artery disease has become a widespread technique and has been recognized as a common treatment.²⁸ The patency rate of the femoropopliteal artery has been improved through usage of the self-expanding nitinol stent;²⁹ however, ISR after percutaneous stenting of femoropopliteal lesions remains an area of great concern. The management of ISR can be very challenging and may require repeated interventions. Currently, no consensus exists regarding the treatment of ISR lesions.³⁰ Targeted treatment of the mechanisms of restenosis is not yet available; therefore, unspecific adjunctive measures, such as cutting balloons,³¹ excisional atherectomy,³² excimer laser therapy,³³ stent grafts,³⁴ and drug-coated balloons,³⁵ have been applied to treat ISR. Nevertheless, modulation of factors that influence the vascular inflammatory reaction after stent implantation may become a key for the development of novel therapeutic approaches. Patients with increased IL-6 values at baseline and postintervention should be regarded as being at high risk for ISR and may be good candidates for beneficial adjunctive measures, such as monoclonal antibody therapy.

This study had a few limitations. Specifically, this was a prospective cohort study with a small patient group and a short follow-up period. Thus, a further study with a larger sample size to check the long-term patency of stenting in patients who demonstrate elevated inflammatory response is recommended, and the molecular mechanisms behind these observations need to be delineated to possibly improve treatment strategies.

Conclusion

A significant inflammatory response after stenting of the femoropopliteal artery was observed. Both pre- and postintervention IL-6 levels were independently associated with ISR of the femoropopliteal artery, suggesting that the predictive value of IL-6 may be superior to that of hs-CRP.

Supplemental Material

sj-pdf-1-vas-10.1177_1708538120921005 - Supplemental material for Six-month results of stenting of the femoropopliteal artery and predictive value of interleukin-6: Comparison with high-sensitivity C-reactive protein

Supplemental material, sj-pdf-1-vas-10.1177_1708538120921005 for Six-month results of stenting of the femoropopliteal artery and predictive value of interleukin-6: Comparison with high-sensitivity C-reactive protein by Songlin Guo, Zhang Zhang, Lei Wang, Liangxi Yuan, Junmin Bao, Jian Zhou and Zaiping Jing in Vascular

Footnotes

Authors’ contribution

SG, ZZ, and LW contributed equally to the article.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Natural Science Foundation of China (grant nos. 81273522 and 81370441).

ORCID iD

Songlin Guo

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