Infrapopliteal balloon angioplasty for the treatment of chronic occlusive disease

Article Outline

• Abstract
• Methods
  • Patients
  • PTA procedure
  • Postprocedure follow-up
  • Definitions and end points
  • Statistical analysis
• Results
  • Complications
  • Follow-up
• Discussion
• Conclusions
• Author contributions
• Appendices I-IV (online only)
• References
• Copyright

Objective

There is little documentation of the effectiveness of percutaneous balloon angioplasty (PTA) of infrapopliteal vessels for the treatment of chronic lower extremity ischemia. This study reviewed our recent experience with infrapopliteal PTA in a large series of patients to determine its effectiveness as a treatment modality.

Methods

All patients undergoing primary infrapopliteal PTA from March 2002 to June 2006 were included. Primary study end points were primary patency, assisted patency, limb salvage, and patient survival assessed by Kaplan-Meier life-table analysis. Factors predictive of PTA failure and patient longevity were evaluated by multivariate methods.

Results

There were 155 PTAs undertaken in 144 patients (70% men; mean age, 74 years), with critical limb ischemia (86%), diabetes (66%), and renal insufficiency (45%). Infrapopliteal lesions were classified as TransAtlantic Inter-Society Consensus A (7%), B (18%), C (39%), and D (35%). PTA was confined to the infrapopliteal segment in 40 (26%), and 115 (74%) underwent multilevel treatment. Five patients (3%) received stents. Technical success was 95%. The 30-day mortality was 2%, and major morbidity was 3%. The mean follow-up was 22 months (range, 0-54 months). The 40-month actuarial primary patency was 62% (standard error, 5%), with assisted patency (infrapopliteal re-PTA, 25 [16%]) of 90%. Interval conversion to bypass surgery occurred in seven (5%). Nonhealing ulcers occurred in 118 patients (76%), of which 76 (64%) healed during follow-up. Of the 42 unhealed ulcers, 15 (13%) required major amputations for a 40-month limb salvage of 86.2%. Multivariate predictors that were negative for primary patency included 0/1 vessel runoff (P = .01), critical limb ischemia (P = .002), and dialysis (P = .03). Negative predictors of limb salvage included dialysis (P = .007) and failure to improve runoff to the foot (P = .006). At 40-months, patient survival was 54%, with negative predictors including severe pulmonary disease (P = .01), coronary artery disease (P = .04), and renal insufficiency (P < .001).

Conclusions

Infrapopliteal angioplasty can be performed safely with favorable results in patients with limited longevity. Primary patency is related to disease extent. Secondary interventions may be necessary to maintain clinical success. These data indicate that PTA should be considered as initial therapy for infrapopliteal occlusive disease in patients with lower extremity ischemia.

Chronic lower extremity ischemia due to atherosclerotic disease remains a significant problem in the United States, accounting for >400,000 hospitalizations and a subsequent 20% mortality annually, mostly related to cardiovascular events.¹, ² As the population continues to age, these numbers are expected to increase, with an estimated 10% to 20% of patients aged >70 years experiencing some degree of chronic lower extremity ischemia.³ Patients with critical limb ischemia (CLI) represent the most advanced of these cases and often have disease affecting multiple levels of arteries in the lower extremity, including the infrapopliteal vessels.

Early studies of percutaneous angioplasty (PTA) with or without stenting of the tibioperoneal vessels reported 1-year patency rates of <15%, leading the authors to conclude this was suboptimal therapy that should be reserved for patients with no other options.⁴, ⁵ Indeed, for patients with CLI, surgical bypass grafting with autogenous conduit remains the gold standard, with 5-year limb salvage rates >80%.⁶, ⁷ However, a substantial portion of patients who require arterial revascularization for CLI do not have an adequate ipsilateral saphenous vein, and alternate conduits with inferior patency and limb salvage rates must be used.⁶, ⁸ CLI also reflects an advanced, systemic form of atherosclerotic disease that renders the patient at high risk for complications after open surgical revascularization.⁹

In 2002 a more aggressive percutaneous approach of revascularization for the treatment of infrainguinal occlusive disease evolved in our group. This study evaluated the midterm results of endovascular treatment of infrapopliteal arterial disease in a contemporary series of patients with chronic lower extremity ischemia. The primary end points were primary and assisted patency, and secondary end points included limb salvage and survival.

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Methods 

Patients 

All patients undergoing primary infrapopliteal PTA between March 2002 and June 2006 were identified. During the study interval, native infrapopliteal arterial lesions in 155 limbs in 144 patients were treated with PTA. The decision to use PTA as first-line therapy was based on the clinical examination, anatomic evaluation, and judgment of the attending surgeon involved. Excluded from the evaluation were patients who presented with acute CLI requiring emergency revascularization or who had a functionally unsalvageable limb. Also excluded were patients who underwent PTA of threatened bypass grafts (vein or prosthetic) or received mechanical thrombectomy, atherectomy, or extended thrombolysis infusion. Individual limbs were counted separately so that patients undergoing staged, bilateral procedures were recorded and evaluated as two entries. This clinical protocol was approved by the Institutional Review Board of the Massachusetts General Hospital.

Demographic, preoperative, perioperative, and postoperative data were collected for each patient. This included clinical presentation according to the Rutherford classification,¹⁰ lesion anatomy as defined by a modified TransAtlantic Inter-Society Consensus (TASC) classification,¹¹, ¹² and follow-up ankle-brachial indices (ABI) or pulse volume recordings (PVR), or both. Lesion characteristics were determined by an examination of the procedure notes, and individual images were reviewed when necessary. The modified TASC classification for tibioperoneal occlusive disease is detailed as follows:

If more than one tibial vessel was treated, the most severe modified TASC classification was used.¹¹, ¹²

Renal insufficiency was defined as a serum creatinine level ≥1.5 mg/dL. Patients were considered to have a history of heart disease even if they had previously undergone revascularization with coronary artery angioplasty or bypass grafting.

PTA procedure 

All infrapopliteal PTAs were performed in our fixed-imaging operating room suite or cardiac catheterization laboratory by vascular surgeons who satisfied Society for Vascular Surgery (SVS) criteria for performance of endovascular procedures. Patients with preoperative renal insufficiency were routinely given oral acetylcysteine and hydration with a bicarbonate solution before interventions.

Selective angiography was performed under local anesthesia through a contralateral retrograde or ipsilateral antegrade common femoral artery approach using 5F or 6F sheaths. No popliteal punctures were used for vascular access. Patients were given a weight-based dose of heparin after the initial diagnostic arteriograms, and levels were monitored with serial activated clotting times. Lesions were crossed with platinum-tipped (0.018- or 0.014-inch) or hydrophilic (0.035-, 0.018-, or 0.014-inch) wires, and balloon angioplasty was performed under systemic anticoagulation. Subintimal angioplasty was not routinely used to traverse occluded lesions.

Balloon catheter diameter was chosen to match the nondiseased artery adjacent to the lesion, and tibial balloon diameters ranged from 1.5 to 3 mm, whereas PTA of the tibioperoneal trunk occasionally required a 4-mm balloon. Indiscriminate use of long angioplasty balloons was avoided to prevent adjacent arterial injury or dissection. Balloon inflation pressures ranged from 4 to 12 atmospheres and were held for at least 60 seconds. A selective approach to the use of nitinol self-expanding stents was used for flow-limiting dissections or when angioplasty alone did not produce a satisfactory result (>30% residual stenosis).

Lesion anatomy was recorded by the operator for further analysis, and lesions were then classified according to the modified TASC criteria.¹¹, ¹² All patients were given a 300-mg loading dose of clopidogrel after the procedure and were maintained on 75 mg daily for 6 to 12 weeks. Patients also received 325 mg of aspirin on the day of the procedure, and this was continued indefinitely unless contraindicated. Sheaths were removed under manual compression and closure devices were rarely used.

Postprocedure follow-up 

Patients with ulcers were treated and their lesions monitored. A noninvasive hemodynamic assessment was routinely performed at 6 weeks after the procedure, which included ABI and PVR. Studies were repeated at 6-month intervals or when the patient's clinical condition dictated. Patients with noncompressible vessels were most commonly assessed with PVR.

Patency was determined according to the Rutherford guidelines,¹⁰ and patients who had a loss of distal pulses, a return of symptoms or worsening ulceration, or a change in ABI or PVR underwent further imaging. Follow-up also involved a review of all outpatient clinic visits and hospital admissions documented in our system-wide electronic medical record.

Definitions and end points 

PTA was considered angiographically successful when all technically accessible lesions were treated with a <20% residual stenosis. Hemodynamic success was defined as an ABI increase of at least 0.10 or improvement in PVR tracing by at least 5 mm for patients with noncompressible vessels. Clinical success was defined as an improvement of at least one clinical category with demonstrable hemodynamic success for patients in categories 1 to 4 and healing of the ulcer or wound in categories 5 and 6 with confirmed improved hemodynamics as defined by published reporting standards.¹⁰ A failure of primary patency included patients who experienced a decrease in ABI of ≥0.10 or PVR ≥5 mm due to recurrent tibioperoneal disease, with or without a return of symptoms by Rutherford reporting standards.¹⁰

Patients who experienced a return of symptoms that was not secondary to tibioperoneal disease (ie, stenosis of the femoropopliteal or iliac segments verified by angiography) were considered clinical failures but not a loss of primary patency. Assisted patency was achieved through secondary PTA involving any tibioperoneal segment regardless of whether the recurrent lesion was a restenosis, occlusion, or a new lesion in the same anatomic segment. Patency was considered to have failed in patients who required surgical bypass, and they were not included in the assisted patency calculations. Limb salvage and preservation included all major amputations both above and below the knee. Planned, staged digit amputations were not considered a failure of limb salvage. Survival data were obtained from medical records and the Social Security database.

Statistical analysis 

Patient demographic and risk factor data associated with intermediate patency and comparisons between the two cohorts were performed using χ² with or without Yates correction, Fisher exact test, t test, and Mann-Whitney tests as appropriate. Actuarial patency and survival analysis was performed using Kaplan-Meier life tables with Mantel-Cox log-rank univariate analysis to identify differences between groups. Relative risk, calculated as the risk ratio (RR) and 95% confidence intervals (CI), were determined using a multivariate Cox proportional hazards model for data with variable follow-up. Multivariate models were constructed for each individual outcome based on significant univariate variables. A value of P < .05 was considered significant for all statistical analysis.

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Results 

During the study period, 144 patients underwent PTA of 155 limbs. Of these, 22 procedures (14%) were performed on patients with lifestyle-limiting claudication (Rutherford classification 1 to 3) and 133 (86%) were performed for CLI presenting as rest pain or tissue loss (Table I). Demographic and clinical factors are summarized in Table II. The mean serum creatinine level was 1.9 mg/dL. PTA was of the tibioperoneal arteries alone in 40 patients (26%). Multilevel treatment was required in 115 (74%), of whom 85 (55%) underwent concomitant PTA of the above knee femoropopliteal segment (infrapopliteal PTA in these patients was thought to be crucial to hemodynamic success), and 21 of these lesions were occlusions. The remaining 30 proximal lesions were confined to the popliteal segment. Lesion characteristics and treatment features are summarized in Table III.

Table I. Clinical presentation of percutaneous angioplasty (Rutherford classification)

Rutherford category	No. (%)
1. Mild claudication	0(0)
2. Moderate claudication	2(1)
3. Severe claudication	20(13)
4. Ischemic rest pain	17(11)
5. Minor tissue loss	111(72)
6. Major tissue loss	5(3)

Table II. Demographic and clinical data

Variable	No (%) or average
Limbs, total	155
Demographics
Male gender	109(63%)
Age, y	74(43-100)
Risk factors
Hypertension	147(94)
Heart disease	90(58)
Diabetes	103(66)
Renal insufficiencya	67(44)
Dialysis	21(14)
Current smoker	9(6)
Previous smoker	90(59)
Hyperlipidemia	98(63)
Congestive heart failure	38(25)

Table III. Anatomic and treatment features

Variable	No. (%), N = 155
Modified TASC classification12
TASC A	11(7)
TASC B	28(18)
TASC C	61(39)
TASC D	55(36)
Angiographic findings
Multiple infrapopliteal vessels treated	85(55)
Stent placed	5(3)
Number of runoff vessels
0	3(2)
1	70(45)
2	68(44)
3	14(9)

TASC, TransAtlantic Inter-Society Consensus.

Angiographic success, defined as the ability to cross and dilate all significant lesions with <20% residual stenosis, was achieved in 148 of 155 (95%) limbs. Five patients were noted to have persistent, flow-limiting arterial dissections that did not respond to repeat balloon inflations. These were managed with balloon-expandable stents.

Complications 

There were three (2%) periprocedural deaths, two were secondary to aspiration pneumonia, and the third occurred of an unknown cause after discharge. Five patients (3%) experienced major procedurally related complications during the study period. Groin hematomas requiring blood transfusion developed in two patients, one had a device malfunction with stent occlusion of the superficial femoral artery requiring a bypass graft, Clostridium difficile colitis developed in one patient, and one patient experienced pulmonary edema requiring intubation for 24 hours. Minor complications included two small groin hematomas that were treated conservatively, two patients with transient iodinated contrast-induced nephropathy, and one patient with symptomatic microemboli to the toes that was managed and resolved with analgesics. No morbidity or mortality occurred in the patients who underwent secondary PTA after primary failure.

Follow-up 

Mean follow-up was 22 months (range, 0-54 months). The actuarial cumulative primary patency (sustained clinical/hemodynamic result without tibioperoneal re-intervention) was 71.5% ± 4.4% at 24 months and 62% ± 5.5% at 40 months (Fig 1). Variables associated with failure to maintain primary patency by univariate analysis included dialysis dependence (P = .005), failure to take postprocedural clopidogrel (P = .003), CLI (P = .005), TASC D lesions (P = .04), 0/1 vessel runoff (P = .02), and failure to improve runoff to the foot (P < .001; Appendix I, online only). However, the multivariate model showed failure to improve runoff to the foot (RR, 1.78; 95% CI, 1.07-2.74, P = .03), 0/1 vessel runoff (RR, 1.55; 95% CI, 1.09-2.27, P = .01), CLI (RR, 11.43; 95% CI, not available; P = .002), and dialysis (RR, 1.61; 95% CI, 1.05-2.37, P = .03) were significant.

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• Fig 1. 

  Kaplan-Meier curves comparing primary patency, assisted patency and primary clinical improvement of patients undergoing PTA of the infrapopliteal vessels.

The assisted patency (maintained by redo PTA) was 90.4% ± 3.0% at 24 and 40 months with 25 (16%) infrapopliteal redo PTA (Fig 1). Factors predictive of failure to maintain assisted patency by univariate analysis included dialysis dependence (P = .003), TASC D lesions (P = .03), and pulmonary disease (P = .02; Appendix II, online only). Multivariate analysis showed that dialysis dependence (RR, 2.71; 95% CI, 1.21-5.51; P = .02), pulmonary disease (RR, 2.63; 95% CI, 1.31-5.1; P = .001), and TASC D lesions (RR, 2.1; 95% CI, 1.1-4.55; P = .02) remained significant.

Failures of primary patency occurred in 39 (25%) of the 155 procedures. Of these, 25 (16%) were managed with repeat PTA, resulting in 15 arteries remaining patent and 10 failing again. Of the 10 that failed redo PTA, three patients required primary major amputation, and four died with no further intervention. The remaining three patients underwent surgical bypass grafting leading to limb salvage in two and eventual amputation in one. Five patients with failure of primary patency underwent major amputation without further attempts at intervention, and three patients underwent surgical bypass with eventual amputation in two. The remaining 6 patients were observed because of comorbidities. Five of these patients died of causes unrelated to the lower extremity occlusive disease. The ulcer in the sixth patient healed before PTA failure and he is alive and amputation-free.

The overall limb preservation rate was 86.2% ± 3% at 24 and 36 months, with no amputations occurring in the claudication group. Significant univariate predictors of limb loss included dialysis dependence (P < .001), failure to take clopidogrel after the procedure (P < .001), need for proximal intervention (P = .004), multilevel treatment (P = .007), and failure to improve runoff to the foot (P = .001; Appendix III, online only). However, only dialysis (RR, 2.4; 95% CI, 1.34-4.12, P = .004) and failure to improve runoff (RR, 2.57; 95% CI, 1.37-4.56, P = .005) remained significant in the multivariate model. Tissue loss (Rutherford classification 5 and 6) occurred in 116 patients (75%), of whom 76 (66%) showed major improvement or complete healing during the follow-up period.

Overall survival was 68.3% ± 4% at 24 months and 54% ± 5% at 40 months (Fig 2). Multivariate negative predictors of survival included CLI (P = .03), history of pulmonary disease (P = .03), dialysis dependence (P < .001), history of congestive heart failure (P < .001) and history of coronary artery disease (P = .004; Appendix IV, online only). Significant predictors identified by the multivariate model included dialysis dependence (RR, 1.58; 95% CI, 1.14-2.15; P = .008), pulmonary disease (RR, 1.45, 95% CI, 1.0-1.99, P = .05), and congestive heart failure (RR, 1.69; 95% CI, 1.02-3.45, P = .04).

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• Fig 2. 

  Kaplan-Meier curves for survival and limb salvage of patients undergoing percutaneous angioplasty of the infrapopliteal vessels.

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Discussion 

This study reviewed our experience with PTA of the infrapopliteal vessels during a 4-year period. This time was chosen because it marks a paradigm shift in the primary management of infrainguinal occlusive disease from surgical bypass to percutaneous revascularization. To date, this represents one of the largest contemporary cohorts of patients with midterm results, and several patients have now been monitored for nearly 5 years. As expected, most patients presented with CLI, and given the complexity of vascular disease in this cohort, these results support the continued use of PTA as the primary mode of revascularization. Several elements of these results warrant further discussion.

Infrapopliteal angioplasty has remained relatively under-reported compared with PTA of femoropopliteal vessels, partly due to early reports of limited technical success and poor outcomes. Soder et al¹³ detailed their experience with infrapopliteal PTA for limb salvage in 72 limbs and noted an initial angiographic success rate of 61% in vessels with occlusions and 18-month primary patency and limb salvage rates of 48% and 80%, respectively. Similarly, Vraux et al¹⁴ reported a technical success rate of 78% in 40 patients undergoing infrapopliteal PTA for CLI with a 1-year primary patency rate of 58%. Finally, Parsons et al⁴ performed tibial PTA in 66 patients, and 1-year primary patency was 13%. These groups concluded that although infrapopliteal PTA was feasible, the results did not justify a general application to patient care.⁴

The application of smaller and more versatile coronary balloon and wire systems to the peripheral vascular circulation has fueled renewed interest in infrapopliteal PTA, and several contemporary series have used these platforms. The largest, by Bosiers et al,¹⁵ detailed infrapopliteal PTA in 443 patients with CLI and reported a 1-year primary patency of 74.2% and limb salvage rate of 96.6%, leading them to predict that primary PTA would become first-line therapy for CLI. Other smaller studies included 76 to 90 patients and reported primary patency rates of 68% to 74% at 1 year.¹⁶, ¹⁷ The 2-year primary patency in this study compares favorably with these results, and the actuarial 40-month follow-up represents the longest in contemporary literature.

A wide range of short-term primary patency rates of tibial PTA has been reported, and these results compare favorably. One reason for this may be that balloon dilation of diseased arteries leads to activation of the inflammatory response. It has been common practice to oversize balloons and stents in the iliac and femoral vessels, and although many reports state that “balloon diameters were chosen based on the size of an adjacent normal artery,” it seems logical that this would be applied to the infrapopliteal vessels. Arterial overdistension is a well established model of intimal hyperplasia, however,¹⁸, ¹⁹ and it is possible that the tibial vessels are more susceptible than other peripheral vessels of the lower extremity.

During this study, it was the practice to approach tibial vessel size and avoid over-distension. This is most often accomplished by beginning with a small coronary balloon (often 1.5 to 2 mm) as a reference and then upsizing as appropriate. This occasionally results in a 2.5- to 3-mm balloon, and no 4-mm balloons were used in the infrapopliteal vessels. Reports by Haider et al²⁰ have detailed a 2-year primary patency of 60% in infrapopliteal vessels with the use of 3- to 4-mm balloons, whereas Vraux et al²¹ reported using 3-mm balloons for all infrapopliteal arteries with short (10- to 20-second), high-pressure (10- to 15-atm) inflations that led to a primary patency of 46%.²¹ Siablis et al²² described oversizing tibial vessels by 0.5 mm (which is at least 20%) during infrapopliteal stenting, with a 1-year in-stent primary patency of 30%. These results suggest the importance of technique and balloon size on outcomes, although further study regarding this is warranted.

An alternative explanation of these results could be the way primary patency was assessed. In this study, angiographic follow-up to determine patency,²² as others have reported, was not done and could not be justified. Only patients with recurrent symptoms or hemodynamic deterioration, as determined by a change in ABI, underwent repeat imaging with angiography, whereas imaging was not done in patients who remained clinically stable and had no ABI changes. In addition, many of the clinical failures resulted from progression of occlusive disease in other vascular beds, which explains why the clinical success rate is lower than the rate of primary patency (Fig 1).

Opponents of the use of PTA of the infrapopliteal vessels as a primary treatment when anatomically feasible have voiced the concern that failure could result in the need for a more distal bypass or endovascular injury of target vessels could result in the inability to identify a distal target bypass for bypass. This was not identified in this cohort, where surgical crossover was undertaken in primary and secondary failures. However, Sanford et al²³ detailed 66 patients who underwent surgical bypass for failed PTA, including 16 tibial vessels (24%), and reported a 12-month primary patency of 61%. They noted that 21% of patients in the PTA failure group required a bypass more distal than the original artery treated, emphasizing that the percutaneous procedure should be always be undertaken with consideration of backup surgical options should the initial PTA fail.

In this study, stents were selectively placed in the infrapopliteal vessels only when angioplasty yielded an inadequate result, which occurred in five patients. Tepe et al²⁴ reported a 1-year restenosis rate of 29 % in 18 patients who received self-expanding nitinol stents in the infrapopliteal vessels for primary PTA failure. A pilot study from Austria randomized 51 patients to primary PTA or PTA/stent treatment of high-grade infrapopliteal lesions. They used angiography to documented a 6-month primary patency rate (70% restenosis threshold) of 83.7% for the stent group and 61.1% for the PTA group (P < .05) and concluded that stents may be better than primary PTA in the short term.²⁵

The application of drug-eluting stents to the infrapopliteal vessels has had mixed results in small series with limited follow-up. In several studies Siablis et al²², ²⁶ reported that drug-eluting stents were associated with a significantly higher 1-year primary patency compared with standard bare metal stents (odds ratio, 10.4; P < .001). Regardless, the paucity of long-term follow-up data after infrapopliteal stent placement supports their continued selective use in patients with acute failure of primary PTA.

Although primary patency has been the benchmark by which the success or futility of procedures for arterial revascularization is determined, the real goal of therapy in patients with CLI is ulcer healing and limb salvage. The limb salvage rate after infrapopliteal PTA of 86% at 40 months in this report is comparable with that of femorotibial bypass with autogenous vein and certainly better than with prosthetic conduit.⁶, ⁷ This has been supported by others who have found that despite an inferior primary patency, tibial PTA leads to limb salvage rates of 80% to 95% at 1 to 3 years.¹³, ²⁷, ²⁸, ²⁹

One reason that primary patency has been stressed in the bypass literature is that graft failure can be the precipitating event that ultimately leads to amputation.³⁰ This has not been the case with failed PTA, and indeed, the 40-month assisted patency rate was 90% and the amputation rate was 14% at 3 years. This supports the assertions that failures of PTA often are amenable to repeat intervention, and that many patients with CLI require a short-term hemodynamic improvement to heal tissue loss.

Chronic renal failure with dialysis was the only demographic variable that remained a negative predictor throughout all outcomes on multivariate analysis. This is not surprising, because it reflects both the advanced disease state in these patients and generalized systemic morbidity. This finding of dialysis as a negative predictor is also identified in the lower extremity bypass literature, where some have suggested that primary amputation is the most appropriate primary option in these patients.³¹ Aulivola et al¹⁶ compared infrapopliteal PTA for limb salvage in patients with and without renal failure. They concluded that although PTA is safe in this population, the poor rates for wound healing and limb salvage bring to question its utility in the infrapopliteal segment. The current study appears to support this view.

The major limiting factor of this study remains its retrospective nature, and continued prospective analysis of PTA as first-line therapy for chronic lower extremity ischemia is necessary. In addition, all patients were treated at a single institution, which opens the potential for selection bias. Finally, although the follow-up on primary patency has reached an intermediate level (mean 22 months), follow-up for assisted patency remains short, and inevitably, this value will change with continued surveillance. However, the high indigenous mortality rate in this patient population during the 40-month study period suggests that many patients will likely be managed solely with percutaneous interventions as they die of their other comorbidities.

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Conclusions 

PTA of the infrapopliteal vessels can be performed safely, with a low periprocedural morbidity and mortality. Although intermediate primary patency rates do not match those reported in the vein bypass literature, excellent assisted patency and limb salvage can be achieved with close follow-up and additional PTA if necessary. On the basis of these results, PTA should be considered initial therapy for patients with CLI and severe claudication. Patients with end-stage renal disease on dialysis have inferior patency, limb salvage, and survival rates and should be treated with PTA only after careful consideration.

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Author contributions 

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Appendices I-IV (online only) 

Appendix I (online only). Analysis of variables affecting primary patency^a

TASC, TransAtlantic Inter-Society Consensus.

Appendix II (online only). Analysis of variables affecting assisted patency^a

TASC, TransAtlantic Inter-Society Consensus.

Appendix III (online only). Analysis of variables affecting limb salvage^a

TASC, TransAtlantic Inter-Society Consensus.

Appendix IV (online only). Analysis of variables affecting overall survival^a

TASC, TransAtlantic Inter-Society Consensus.

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