Renal dysfunction is a major risk factor for peripheral arterial disease (PAD). Infrapopliteal PAD is associated with more co-morbid conditions and worse prognosis than suprapopliteal PAD. Long-term outcomes of patients with renal dysfunction and popliteal or infrapopliteal PAD undergoing peripheral vascular intervention (PVI) are not well described. We retrospectively evaluated long-term outcomes in 726 patients undergoing infrapopliteal PVI categorized into 3 glomerular filtration rate (GFR)–based groups: GFR (≥60 ml/min/1.73 m 2 ), GFR (<60 ml/min/1.73 m 2 ), and those on dialysis. At mean follow-up of 36 ± 20 months, amputation rates were 3%, 5%, and 11% with mortality rates of 23%, 36%, and 56% in normal renal function, chronic kidney disease (adjusted odds ratio [OR] for amputation 1.75, 95% CI 0.73 to 4.21; adjusted OR for mortality 1.53, 95% CI 1.05 to 2.23, p = 0.028), and dialysis (adjusted OR for amputation 2.43, 95% CI 0.84 to 7.02, p = 0.100; adjusted OR for mortality 4.51, 95% CI 2.46 to 8.26, p <0.0001) groups, respectively. Repeat revascularization was similar in all 3 groups at roughly 25%. In conclusion, chronic kidney disease and dialysis were associated with increased major amputations and mortality in patients who received PVI for popliteal and infrapopliteal PAD.
Systemic atherosclerosis in general, and peripheral arterial disease in particular, have been associated with chronic kidney disease (CKD). Several studies have examined the association of peripheral arterial disease (PAD) with outcomes in patients undergoing percutaneous peripheral vascular intervention (PVI) or peripheral bypass surgery in patients with CKD. These studies have demonstrated that baseline renal dysfunction was strongly associated with need for peripheral revascularization, amputation, and mortality among these patients. However, in general, these investigations did not differentiate patients with popliteal and infrapopliteal PAD from those with suprapopliteal PAD. In addition, these previous studies either excluded patients on dialysis or excluded nondialysis CKD patients when studying patients on dialysis. Below knee PAD has been shown to be associated with a higher prevalence of co-morbid conditions and has significantly worse prognosis compared with above the knee PAD. The goal of the present study was to evaluate the clinical characteristics, angiographic features, treatments and in-hospital, and long-term outcomes of patients stratified by renal function in patients with popliteal or infrapopliteal PAD undergoing PVI.
Methods
For the present study, we used data from patients in the Laser in Infra-popliteal and Popliteal Stenosis (LIPS) study. The details of this study have been previously published. In brief, LIPS was a retrospective study examining angiographic and short-term clinical outcomes of patients receiving percutaneous PVI for popliteal and infrapopliteal stenosis. All patients received either laser-assisted balloon angioplasty or balloon angioplasty alone. Data for LIPS were collected through retrospective chart review of the hospital’s electronic medical record. We collected follow-up data on long-term outcomes through review of charts and/or telephone calls. We categorized patients into 3 groups based on their baseline estimated glomerular filtration rate (GFR) value: normal (GFR> 60 ml/min/1.73 m 2 ), CKD (GFR< 60 ml/min/1.73 m 2 ), and those on dialysis. This study was approved by the Institutional Review Board at St. John Hospital.
The most recent preprocedural baseline creatinine was used to estimate GFR, using the modification of diet in renal disease equation. Major amputation was defined as any amputation above the ankle. Repeat revascularization included both peripheral surgical bypass and percutaneous PVI. Major adverse vascular event was defined as a composite of all-cause mortality, ipsilateral amputation, and repeat revascularization. We studied procedural complications, survival free of major ipsilateral amputation, all ipsilateral limb amputations, need for repeat revascularization, and all-cause mortality.
Continuous data are presented as the mean and SD or median and range. Categorical data are presented as frequencies and percentages. Analysis of variance was used to compare the means, followed by multiple pairwise comparisons using the Bonferroni correction of the p value. Differences between the 2 patient groups were evaluated by the chi-square tests or by Student t test or Kruskal–Wallis tests as appropriate. Cumulative incidence plots of observed death at follow-up in the 3 groups were constructed using the Kaplan–Meier method. Multivariate analyses were performed using logistic regression of selected outcomes. A Cox proportional hazards model was used to estimate time to death after controlling for procedure and other variables. Odds ratio (ORs) and hazard ratios (HRs) as appropriate are presented with the associated 95% CIs. All p values were 2-sided with values <0.05 considered to indicate statistical significance. All data were analyzed using SPSS (IBM, Armonk, New York), version 22.0.
Results
Patients in the CKD group were older, whereas those on dialysis were younger compared with subjects with normal renal function ( Table 1 ). Blacks accounted for significantly higher proportion of patients in the dialysis group. The prevalence of co-morbid conditions was higher in the CKD and dialysis groups. A history of previous limb amputation was fourfold greater in the dialysis group compared with the normal renal function group.
| Characteristics | Normal Renal Function (n = 363) | Chronic Kidney Disease (n = 299) | Dialysis (n = 64) | p-value † |
|---|---|---|---|---|
| Age (years) ∗ | 69 ± 12 | 75 ± 10 | 67 ± 10 | <0.001 |
| Men | 225 (62 %) | 133 (45 %) | 35 (55 %) | <0.001 |
| White | 217 (60 %) | 198 (66 %) | 18 (28 %) | <0.001 |
| Black | 134 (37 %) | 85 (28 %) | 44 (69 %) | <0.001 |
| Other | 12 (3 %) | 16 (5 %) | 2 (3 %) | <0.001 |
| Body mass index (kg/m 2 ) ∗ | 28 ± 6 | 29 ± 7 | 30 ± 6 | 0.025 |
| Atrial fibrillation | 52 (15 %) | 75 (26 %) | 11 (17 %) | 0.002 |
| Congestive heart failure | 77 (22 %) | 94 (32 %) | 19 (30 %) | 0.008 |
| Diabetes Mellitus | 186 (52 %) | 175 (60 %) | 57 (89 %) | <0.001 |
| Hypertension | 338 (94 %) | 291 (99 %) | 63 (98 %) | 0.001 |
| Hyperlipidemia | 339 (95 %) | 282 (96 %) | 61 (95 %) | 0.643 |
| Coronary Artery Disease | 232 (65 %) | 216 (74 %) | 48 (75 %) | 0.029 |
| Stroke | 84 (24 %) | 81 (28 %) | 18 (28 %) | 0.424 |
| Coronary artery bypass | 86 (24 %) | 95 (32 %) | 16 (25 %) | 0.052 |
| Peripheral bypass | 18 (5 %) | 22 (8 %) | 5 (8 %) | 0.376 |
| Contralateral limb amputation | 26 (7 %) | 25 (9 %) | 17 (27 %) | <0.001 |
| Tobacco Use | 266 (74 %) | 171 (58 %) | 42 (66 %) | <0.001 |
Postprocedural residual stenosis and procedural success were similar in the 3 groups ( Table 2 ). There was a nonsignificant trend for higher access site hematoma and abrupt vessel closure in the CKD and dialysis groups. Other procedural complications were low and did not differ between the 3 groups.
| Procedural Details | Normal Renal Function (n = 363) | Chronic Kidney Disease (n = 299) | Dialysis (n = 64) | p-value † |
|---|---|---|---|---|
| Total Length of Stay (Days) ∗ | 2 ± 4 | 3 ± 4 | 5 ± 7 | <0.001 |
| Post-Procedure Length of Stay (Days) ∗ | 2 ± 2 | 2 ± 3 | 4 ± 6 | <0.001 |
| Initial Stenosis (%) ∗ | 96 ± 8 | 96 ± 8 | 95 ± 9 | 0.648 |
| Popliteal lesions | 90 (25 %) | 75 (25 %) | 8 (13 %) | 0.026 |
| Tibioperoneal trunk lesions | 49 (14 %) | 27 (9 %) | 3 (5 %) | 0.026 |
| Anterior tibial lesions | 115 (32 %) | 94 (31 %) | 33 (52 %) | 0.026 |
| Posterior tibial lesions | 69 (19 %) | 63 (21 %) | 13 (20 %) | 0.026 |
| Peroneal lesions | 40 (11 %) | 40 (13 %) | 7 (11 %) | 0.026 |
| Chronic total occlusions | 253 (70 %) | 210 (70 %) | 41 (64 %) | 0.615 |
| Transatlantic Society Consensus A/B Lesions | 2 (1 %) | 2 (1 %) | 0 (0 %) | — |
| Transatlantic Society Consensus C Lesions | 70 (19 %) | 56 (19 %) | 1 (2 %) | 0.962 |
| Transatlantic Society Consensus D Lesions | 291 (80 %) | 241 (81 %) | 53 (83 %) | 0.962 |
| Balloon angioplasty during index procedure | 165 (46 %) | 137 (46 %) | 29 (45 %) | 0.995 |
| Residual Stenosis (%) ∗ | 19 ± 21 | 19 ± 21 | 18 ± 18 | 0.818 |
| Successful procedure | 343 (95 %) | 278 (93 %) | 60 (94 %) | 0.724 |
| Access Site Complications | ||||
| Hematoma | 2 (1 %) | 6 (2 %) | 2 (3 %) | 0.126 |
| Arteriovenous Fistula | 0 (0 %) | 1 (0 %) | 0 (0 %) | — |
| Psuedoaneurysm | 9 (3 %) | 5 (2 %) | 1 (2 %) | 0.735 |
| Angiography Complications | ||||
| Distal embolization | 6 (2 %) | 6 (2 %) | 1 (2 %) | 0.934 |
| Abrupt vessel closure | 2 (1 %) | 4 (1 %) | 0 (0 %) | — |
| Perforation | 3 (1 %) | 10 (3 %) | 2 (3 %) | 0.063 |
| Dissection | 47 (13 %) | 40 (13 %) | 6 (9 %) | 0.681 |
| Bail out Stenting | 4 (1 %) | 2 (1 %) | 0 (0 %) | — |
All-cause mortality rate at follow-up (mean 36 ± 20 months) was 1.6- and 2.5- fold higher in the CKD and dialysis groups compared with those with normal renal function ( Table 3 and Figure 1 ). The interval to death after PVI was significantly shorter in the dialysis (average = 24 months) and CKD groups (average = 33 months) compared with the normal renal function cohort (37 months). Major amputations were 3.3-fold higher in the patients on dialysis (adjusted OR2.43, 95% CI 0.84 to 7.02) and 1.4 higher in patients with CKD (adjusted OR 1.75, 95% CI 0.73 to 4.21). Revascularization rates were similar among the 3 groups. The odds for all-cause mortality after adjustment remained highest for patients on dialysis and intermediate for the CKD cohort ( Figure 2 ).
| Outcomes | Normal Renal Function (n = 363) | Chronic Kidney Disease (n = 299) | Dialysis (n = 64) | p-value † |
|---|---|---|---|---|
| All-cause mortality | 82 (23 %) | 108 (36 %) | 36 (56 %) | <0.001 |
| Time to Death (months) ∗ | 38 ± 19 | 34 ± 21 | 26 ± 19 | <0.001 |
| Repeat Angioplasty | 88 (24 %) | 65 (22 %) | 14 (22 %) | 0.730 |
| Repeat Surgical Bypass | ||||
| Femoral-popliteal | 6 (2 %) | 2 (1 %) | 0 (0 %) | — |
| Other | 2 (1 %) | 1 (0 %) | 0 (0 %) | — |
| Repeat revascularization (Angioplasty/Bypass) | 94 (26 %) | 68 (23 %) | 14 (22 %) | 0.576 |
| Time to Revascularization (months) ∗ | 30 ± 21 | 28 ± 22 | 23 ± 20 | 0.022 |
| Major amputation | 12 (3 %) | 14 (5 %) | 7 (11 %) | 0.026 |
| Any amputation (including minor) | 40 (11 %) | 29 (10 %) | 18 (28 %) | <0.001 |
| Major amputation or death | 91 (25 %) | 114 (38 %) | 38 (59 %) | <0.001 |
| Time to amputation or death (months) ∗ | 37 ± 20 | 33 ± 21 | 24 ± 20 | <0.001 |
| Major Adverse Vascular Event | ||||
| Major Amputation | 5 (1 %) | 10 (3 %) | 5 (8 %) | <0.001 |
| Death | 60 (17 %) | 76 (25 %) | 23 (36 %) | <0.001 |
| Revascularization | 94 (26 %) | 69 (23 %) | 14 (22 %) | <0.001 |
| Composite Major Adverse Vascular Event | 159 (44 %) | 155 (52 %) | 42 (66 %) | 0.003 |
| Time to Major Adverse Vascular Event (Months) ∗ | 30 ± 22 | 28 ± 22 | 21 ± 21 | 0.011 |
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