NDT Advance Access published online on July 2, 2008
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfn378
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Long-term outcome of percutaneous transluminal angioplasty in chronic haemodialysis patients with peripheral arterial disease
1 Department of Cardiovascular Surgery 2 Department of Cardiology, Cardiovascular Center, Nagoya Kyoritsu Hospital 3 Department of Cardiology 4 Department of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Japan
Correspondence and offprint requests to: Hideki Ishii, Department of Cardiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan. Tel: +81-52-744-2147; Fax: +81-52-744-2210; E-mail: hkishii{at}med.nagoya-u.ac.jp
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Abstract |
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Background. Chronic haemodialysis patients are at an increased risk of peripheral artery disease (PAD). Although percutaneous transluminal angioplasty (PTA) has become a widely used therapeutic intervention for PAD, its outcome in haemodialysis patients remains poorly understood. The aim of this study was to clarify the long-term outcome of PTA as a primary treatment for PAD in haemodialysis patients.
Methods. Consecutive 118 haemodialysis patients with 205 lesions and 108 non-haemodialysis patients with 143 lesions who underwent successful PTA as a first-choice therapeutic option for PAD were enrolled. Outcome measures included primary patency, limb salvage and survival.
Results. Incidence of diabetes, history of coronary artery disease and femoropopliteal lesion were significantly more frequent in haemodialysis patients (P = 0.008, 0.005 and 0.0001, respectively), but critical limb ischaemia and TransAtlantic Inter-Society Consensus (TASC) lesion types occurred with comparable frequency in both groups. No patients had in-hospital complications. The 5-year primary patency, limb salvage and survival rates were significantly lower in haemodialysis patients (P = 0.01, 0.029 and 0.0024, respectively). On Cox multivariate analysis, haemodialysis was strongly predictive of amputation and all-cause death, but not of restenosis. In haemodialysis patients, TASC C+D lesion and ulceration/gangrene were independent predictors for restenosis and amputation.
Conclusions. The long-term outcome after PTA may be fully acceptable in haemodialysis patients who are at the highest risk of cardiovascular disease. PTA is a useful therapeutic strategy in haemodialysis patients with PAD, but PTA for TASC C+D lesions remains controversial.
Keywords: haemodialysis; peripheral artery disease; percutaneous transluminal angioplasty
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Introduction |
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Peripheral artery disease (PAD) is a common disease in chronic kidney disease (CKD) patients undergoing dialysis, and its prevalence in this patient population is now 15% in the US [1]. In the absence of dialysis, the prevalence of PAD [defined as ankle brachial index (ABI) <0.9] was
2.5 times higher even after adjustment for other risk factors in patients with CKD [estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2] than in those without CKD [2]; furthermore, the 1-year mortality rate increases with more advanced stages of CKD in PAD patients with critical limb ischaemia (CLI) [3]. Lower extremity surgical revascularization is considered a therapeutic option for PAD, but the resulting perioperative mortality is higher (10% versus 2%) [4] and postoperative limb salvage and survival are poorer [5–9] in haemodialysis patients than in the general population. Recognized as a feasible, safe and effective procedure in the general population, percutaneous transluminal angioplasty (PTA) is the primary choice for the treatment of PAD [10–12]. PTA has been used to treat haemodialysis patients with PAD as well, but only limited information about the outcome of PTA in this population has been published [13,14]. The aim of this study was to clarify the long-term outcome of PTA as a primary treatment for PAD in haemodialysis patients and to compare this outcome with that in the general population.
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Subjects and methods |
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Patients
From January 1998 to July 2002, we enrolled 226 consecutive patients who underwent successful PTA as their first-choice therapeutic option for PAD at Nagoya Kyoritsu Hospital. Our institution is associated with a large haemodialysis unit in its catchment area. All patients had >75% angiographic stenosis and <10 cm lesion length before the procedure. The target lesion morphology was classified by angiographic findings according to TransAtlantic Inter-Society Consensus (TASC) guidelines [15]. In advance, patients with stenosis in only below-the-knee level artery (9 on haemodialysis and 10 not on haemodialysis) were excluded because of no available devise for the artery at below-the-knee levels in Japan. Furthermore, patients with acute occlusive disease (three on haemodialysis and three not on haemodialysis) or unsuccessful PTA (three on haemodialysis and two not on haemodialysis) were also excluded. Those included in the study were divided into a haemodialysis group (118 patients with 205 lesions) and a non-haemodialysis group (108 patients with 143 lesions). All patients gave their informed consent to participate, and the study protocol received local Ethics Committee approval.
Protocol
The procedures of PTA were performed through anterograde puncture of the ipsilateral femoral artery, and in the case of obstruction close to the ipsilateral access site, the approach was from the ipsilateral access site. Then, a 6–7 French sheath was positioned, followed by injection of 5000 IU heparin intra-arterially. In most cases, crossing was made by using 0.035-inch wire techniques. In some cases for treatment to a total occlusive lesion, 0.014-inch wire techniques were attempted. After insertion of guide wires, balloon catheters were delivered to the lesions, and were inflated. When residual stenosis (>30%) or residual dissection after balloon angioplasty was seen, a stent was implanted. All patients were also routinely given dual anti-platelet therapy (aspirin with ticlopidine or cilostazol) before the procedure, and aspirin was continuously given thereafter. Follow-up Doppler ultrasound scanning and clinical examinations were conducted 3 months after PTA and every 6 months thereafter. If patients had abnormal Doppler waveform or worsened clinical symptoms, angiography was performed. Restenosis was defined as angiographic luminal diameter <50%, and was treated with repeat PTA. ABI was also measured before and 3 months after the procedure.
The endpoints were restenosis (defined above), major amputation (defined as loss of a functional limb including a part of the foot with requirement for a prosthesis; TASC recommendation 81) [15] and all-cause death.
Statistical analysis
Statistical analysis was performed using Stat View 5.0 (SAS Institute, Cary, NC, USA). Rates of primary patency, limb salvage and all-cause survival were estimated by the Kaplan–Meier method, and the differences in survival rates between groups were evaluated by the log-rank (Mantle–Cox) method. For comparison of the baseline data between two groups, an 
2-test for categorical variables and the Student t-test for continuous variables were used. Predictive factors for restenosis, amputation and all-cause mortality were determined using Cox models with the variables including sex, age, duration of dialysis, diabetes, hypertension, hyperlipidaemia, smoking, coronary artery disease, stroke, ulceration/gangrene, femoropopliteal lesion, TASC C+D type and stenting. Factors with P <0.05 on Cox univariate models were entered into multivariable Cox regression models. Data are expressed as the mean value ± SD. Differences were considered significant when the P-value was < 0.05.
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Result |
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Demographic information
Demographic information is shown in Table 1. The percentage of males was lower among dialysis patients than non-dialysis patients (57.6% versus 70.3%, P = 0.046). Dialysis patients were younger (64 ± 10 years versus 69 ± 9 years, P = 0.001) and more frequently had diabetes (72.0% versus 52.7%, P = 0.008) and history of coronary artery disease (50.8% versus 31.5%, P = 0.005). A higher percentage of dialysis patients than non-dialysis patients had CLI (an indication for PTA), but the difference was not statistically significant (64.4% versus 52.8%, P = 0.15). Preoperative ABI was also similar between the groups (0.61 ± 0.20 versus 0.63 ± 0.21, P = 0.69). The mean number of target lesions was higher in dialysis patients than non-dialysis patients (1.7 ± 0.9 lesions versus 1.3 ± 0.9 lesions, P = 0.010).
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Femoropopliteal lesions were clearly more common (68.3% versus 45.5%, P = 0.0001) and occlusive lesions below the knee tended to be more common (59.0% versus 49.7%, P = 0.083) in dialysis patients. However, TASC A or B type lesions occurred with comparable frequency in both groups (53.7% versus 59.4%, P = 0.29). In non-dialysis patients, the mean GFR was 76.5 ± 17.5 ml/min/1.73 m2.
Initial outcome
No procedural death or major complication requiring hospitalization occurred in either group. Haematoma and/or minor bleeding occurred in two patients in each group (1.7% and 1.8%, respectively). Also, one haemodialysis patient had distal embolization, which was relieved by intravascular nitrates and/or additional heparin infusion. At 3 months after the PTA procedure, ABI markedly increased in both groups (from 0.61 ± 0.31 to 0.88 ± 0.24 in dialysis patients and from 0.63 ± 0.21 to 0.94 ± 0.31 in non-dialysis patients, both P < 0.0001).
Long-term outcome
Follow-up was concluded in January 2003 (mean follow-up duration, 32 ± 21 months). Because no patients discontinued follow-up visits to our hospital or annexes, data on major and all-cause death were collected for all patients. Target lesion revascularization (TLR) was performed in 104 lesions (50.7%) of dialysis patients and 60 lesions (42.0%) of non-dialysis patients. Thirteen dialysis patients (8 above-knee and 5 below-knee) and three non-dialysis patients (1 above-knee and 2 below-knee) underwent amputation. Also, 36 dialysis patients (20 cardiovascular, 10 infection and 6 others) and 12 non-dialysis patients (3 cardiovascular, 5 infection and 4 others) died (Table 2).
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Dialysis patients had significantly lower 5-year primary patency rate [51.7% versus 68.0%, hazard ratio (HR) 1.50, 95% confidential interval (CI) 1.08–2.10, P = 0.015], 5-year limb salvage rate (85.0% versus 97.0%, HR 5.02, 95% CI 1.43–17.85, P = 0.0074) and 5-year all-cause survival rate (61.5% versus 84.2%, HR 3.58, 95% CI 1.87–6.89, P = 0.0001) (Table 3 and Figure 1). On Cox multivariate analysis, haemodialysis was a strongly predictive risk of amputation (HR 5.98, 95% CI 1.23–19.91, P = 0.032) and all-cause death (HR 3.45, 95% CI 1.77–6.71, P = 0.0003), but not for restenosis (HR 1.18, 95% CI 0.71–1.97, P = 0.51). TASC C+D lesion, femoropopliteal lesion and ulceration/gangrene were also independent predictors for restenosis; TASC C+D lesion and ulceration/gangrene were independent predictors for amputation and ulceration/gangrene and history of stroke were independent predictors for all-cause death (Table 4). Diabetes was not a significant predictor for any endpoints on Cox univariate analysis (HR 1.22, 95% CI 0.85–1.77, P = 0.27 for restenosis, HR 2.71, 95% CI 0.58–12.65, P = 0.20 for amputation and HR 1.21, 95% CI 0.80–2.07, P = 0.21, respectively).
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Sub-analysis in haemodialysis patients
The results of the Cox multivariate analysis in only haemodialysis patients are shown in Table 5. For restenosis after PTA, the independent predictors were age (HR 1.02, 95% CI 1.01–1.04, P = 0.027), TASC C+D lesion (HR 2.41, 95% CI 1.87–3.10, P = 0.0005), femoropopliteal artery lesion (HR 1.81, 95% CI 1.11–2.94, P = 0.017) and ulceration/gangrene (HR 2.01, 95% CI 1.07–3.77, P = 0.029); for amputation, the independent predictors were TASC C+D lesion (HR 8.40, 95% CI 3.13–22.64, P = 0.031) and ulceration/gangrene (HR 17.24, 95% CI 5.89–51.36, P = 0.0084) and for all-cause mortality, they were age (HR 1.06, 95% CI 1.04–1.07, P = 0.0032), ulceration/gangrene (HR 3.03, 95% CI 2.06–4.44, P = 0.0039) and history of stroke (HR 4.32, 95% CI 1.38–13.51, P = 0.011). Diabetes was not a significant predictor for any endpoints on Cox univariate analysis (HR 1.26, 95% CI 0.75–2.11, P = 0.78 for restenosis, HR 1.29, 95% CI 0.67–6.21, P = 0.74 for amputation and HR 1.17, 95% CI 0.56–2.46, P = 0.67, respectively).
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Primary patency for 5 years was significantly lower (1) in those with TASC C+D lesions than in those with TASC A+B lesions (30.1% versus 62.1%, P < 0.0001), (2) in those with femoropopliteal artery lesions than in those with iliac artery lesions (42.6% versus 62.7%, P = 0.011) and (3) in those with ulceration/gangrene than in those without these wounds (36.6% versus 55.8%, P = 0.022). Five-year limb salvage was significantly lower in (1) patients with TASC C+D lesions than in those with TASC A+B lesions (52.3% versus 93.1%, P = 0.0002) and (2) patients with ulceration/gangrene than those without these wounds (56.4% versus 90.2%, P = 0.015). Also, 5-year survival was significantly lower in patients with ulceration/gangrene than in those without these (55.6% versus 75.0%, P = 0.030).
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Discussion |
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Although PTA is performed in patients on dialysis as well as the general population, published studies about the outcome of revascularization for PAD in dialysis patients are almost all about bypass surgery. Garziani et al. [13] reported the feasibility and effectiveness of PTA in 107 dialysis patients with CLI, and Jaar et al. [14] reported that prognosis (amputation-free survival) was improved more by PTA than by bypass surgery in a large cohort of dialysis patients. However, neither paper evaluated long-term patency nor compared their results in dialysis patients with those in the general population. To our knowledge, the present study is the first report to clarify both technically and clinically the long-term outcome of PTA as the primary treatment for PAD in haemodialysis patients relative to the same outcome in non-dialysis patients.
Initial and long-term outcome
PTA was confirmed to be safe by the absence of perioperative death or major complication requiring hospitalization in both groups. The previous report found about a four times higher perioperative mortality after surgical revascularization in patients on dialysis than in patients without CKD (10% versus 2%) [4], and suggested that this higher mortality might be due to comorbid conditions such as systemic arteriosclerosis, chronic inflammation, or malnutrition in dialysis patients [8,16]. Thus, less-invasive procedures such as PTA should be considered the first-choice therapeutic option for those dialysis patients who are at the highest risk of cardiovascular disease.
In the present study, though the 5-year primary patency rate was lower in dialysis patients than non-dialysis patients, multivariate Cox analysis revealed that being on dialysis was not a significant risk of restenosis. The between-group difference in the frequency of femoropopliteal artery lesions as the target lesion might explain these paradoxical findings. The 5-year primary patency rate is usually lower in those with femoropopliteal artery lesions than those with iliac artery lesions in the general population (42–50% versus 71%, respectively), and the results in our haemodialysis patients were similar (42.6% with femoropopliteal artery lesions and 62.7% with iliac artery lesions). Thus, the patency rate after PTA in dialysis patients might be similar to that in non-dialysis patients.
Although the patency rate after PTA was similar in dialysis and non-dialysis patients, limb salvage and survival rates were obviously poorer [the risk of amputation and mortality (even after adjustment for other risk factors) being, respectively, 5.9-fold and 3.5-fold higher] in dialysis patients. O’Hare et al. have also reported an increased rate of amputation and mortality after surgical revascularization with increasing degree of renal insufficiency, especially at high rates for dialysis patients [9]. This poor prognosis might be explained by the high risk of cardiovascular morbidity and mortality among dialysis patients [8,16]. However, the survival rate in our dialysis population [even with PAD including CLI (61.5%)], which is compatible with the 5-year overall rate in Japanese patients on dialysis (59%) as determined by the Japanese Society of Dialysis Therapy [17], might also be due to the earlier detection of symptoms by our follow-up surveillance using Doppler ultrasound scanning and/or angiography every 6 months after PTA. However, further study is needed.
Sub-analysis in haemodialysis patients
The outcome of PTA in haemodialysis patients with PAD were previously reported in only two papers [13,14]; however, the characteristics of their subjective patients markedly differed with those in the present study. For example, 80% of the patients had ulcer/gangrene and 30% of the target lesions were arteries at below-the-knee levels in one study [13], and no data was available about the details above in another study [14]. In contrast, only 30% of the patients had ulcer/gangrene and no treated arteries at below-the-knee levels because of no available devise for the artery at below-the-knee levels in Japan. Thus, the comparison directly among previously published data and the present data might be not appropriate. However, on consideration for these differences, all-cause survival might be obviously higher in our patients (56% for 5 years in the patients with ulcer/gangrene) than 23% for 4 years [13] and 57% for 2 years [14]. These differences might be explained as following. First, compared with a TLR rate of 27% [13], we performed TLR in 51% of our patients due to aggressive surveillance using Doppler ultrasound scanning and/or angiography every 6 months after PTA. Aggressive TLR might affect the survival in haemodialysis patients as the population at a high risk of cardiovascular disease. Second, general conditions are basically different in overall haemodialysis patients among countries. Held et al. [18] reported that 5-year survival in overall haemodialysis patients were 54% in Japan, 48% in Europe and 40% in the USA, respectively. These differences, which maybe reflected to a comorbid condition, might affect the survival.
In the present study, ulceration/gangrene was an independent predictor for restenosis, amputation and death in dialysis patients. Patients without ulceration/gangrene had better outcomes. These results strongly suggest the necessity of detection at the earlier stage of PAD. O’Hare et al. [3] reported that 1-year mortality was 13%, 20% and 33% in dialysis patients with rest pain, ulceration and gangrene, respectively. Also, they pointed out that the incidence of PAD defined as ABI <0.9 was 2.5 times higher even after adjustment for other risk factors, even in patients with moderate CKD [2]. Meanwhile, Jarr et al. [14] reported that the type of medical insurance that leads to delay in diagnosis of PAD and poor access to medical care in dialysis patients was a prognostic factor. These previous findings support our conclusion that detection should be at an earlier stage of the disease process in dialysis patients who are at the highest risk of cardiovascular disease.
TASC C+D lesion was also an independent predictor for both restenosis and amputation in dialysis patients. Especially, the 5-year primary patency rate was markedly poorer in dialysis patients with TASC C+D lesions (30.1%) than with TASC A+B lesions (62.1%). Thus, PTA for TASC C+D lesions remains controversial. Further study of individual TASC types in a larger cohort might be needed.
Diabetes was not a significant predictor for any endpoints. Because our study population consisted of a high incidence of diabetes (72.0% in the HD group and 52.7% in the non-HD group), it is possible that diabetes was not a predictor for endpoints in these populations. However, some Japanese groups have reported that long-term survival was comparable between diabetic and non-diabetic haemodialysis patients with coronary artery disease after coronary revasculariziation [19,20], and we also reported the similar results that diabetes was not a predictor for survival after coronary revasculariziation in haemodialysis patients with coronary artery disease [21]. Aoki et al. [19] described that diabetes affected the cardiac morbidity, cardiac mortality and all-cause mortality after initiation of haemodialysis therapy but not after coronary revasculariziation. These previous reports suggest the possibility that the detection and intervention at an earlier stage of PAD similar to coronary artery disease may improve the clinical outcome even in diabetic dialysis patients.
Exercise therapy as a part of the initial treatment for claudication has been recommended by TASC [15]; however, limited data have been documented in haemodialysis patients. Meanwhile, we previously reported that artificial carbon dioxide foot bathing, which strongly improves subcutaneous microcirculation, improved limb salvage in haemodialysis patients with ulceration/gangrene and without indication for any revascularization [22]. A combination therapy such as carbon dioxide foot bathing after PTA might be more effective in haemodialysis patients who are at the highest risk of cardiovascular disease.
Study limitations
This study had various limitations that may have influenced our results. First, this study had a single-centre design. Larger multi-centre studies are warranted to corroborate our findings. Second, the choice of PTA procedure and of medications during the chronic phase depended on the person in charge. These might affect clinical outcomes. Third, although we could gather other endpoints for all patients, we did not gather restenosis endpoints for all patients since follow-up angiography was not performed in every case. Therefore, the actual restenosis rate might be higher.
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Conclusions |
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The long-term outcome of PTA might be fully acceptable in haemodialysis patients who are at the highest risk of cardiovascular disease. PTA is a useful therapeutic strategy in haemodialysis patients with PAD, but PTA for TASC C+D lesions remains controversial. The detection at an earlier stage of PAD might improve survival and therefore is necessary.
Conflict of interest statement. None declared.
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References |
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Accepted in revised form: 12. 6.08
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