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Published online before print September 27, 2002, 10.1148/radiol.2252011407
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(Radiology 2002;225:345-352.)
© RSNA, 2002

Vascular and Interventional Radiology

Long-term Outcome of Patients with Claudication after Balloon Angioplasty of the Femoropopliteal Arteries1

Tiia S. Jämsén, MD, Hannu I. Manninen, MD, PhD, Pekka A. Jaakkola, MD, PhD and Pekka J. Matsi, MD, PhD

1 From the Departments of Clinical Radiology (T.S.J., H.I.M., P.J.M.) and Surgery (P.A.J.), Kuopio University Hospital, Puijonlaaksontie 2, 70200 Kuopio, Finland. From the 2001 RSNA scientific assembly. Received August 20, 2001; revision requested October 11; final revision received March 21, 2002; accepted April 29. Supported in part by Kuopio University Hospital (grant number 5063510), the Finnish Cultural Foundation, the Pohjois-Savo Regional Fund, the Nycomed AS Foundation, the Radiological Society of Finland, the Finnish Society of Angiology, and the Foundation of Aarne and Aili Turunen. Address correspondence to T.S.J. (e-mail: tiia.jamsen@kuh.fi).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
PURPOSE: To report the long-term outcome of patients with lifestyle-limiting claudication after percutaneous transluminal angioplasty (PTA) of the femoropopliteal arteries.

MATERIALS AND METHODS: Between 1989 and 1992, 173 consecutive claudicant patients (mean age, 65 years; age range, 41–90 years) underwent PTA in 218 limbs; all interventions included femoral and/or popliteal arterial segments, and additional iliac (n = 27) and infrapopliteal (n = 11) arterial lesions were also treated. Patients were followed up for 7–10 years. Altogether, 37 (17%) limbs were classified as Fontaine class 2A, and 181 (83%) were class 2B. Average length of the primary lesion was 5.2 cm. Reinterventions were analyzed. Patency rates and patient survival were assessed by means of life table analysis. Cox-Mantel tests and Cox proportional hazards models were used to define associated independent determinants. Development of chronic critical ischemia (CCI) and its determinants was assessed by using the Pearson {chi}2 test and multiple logistic regression analysis.

RESULTS: The primary and secondary patencies (± standard error of the estimate), respectively, were 46% ± 3 and 63% ± 3 at 1 year, 25% ± 3 and 41% ± 4 at 5 years, and 14% ± 3 and 22% ± 4 at 10 years. One-third (71 of 218) of the limbs required repeat interventions, including surgical revascularization in 35 limbs. Fourteen (6.4%) limbs developed CCI, resulting in a 0.8% incidence per year. In multivariate analysis, poor postinterventional peripheral runoff was an indicator of increased risk of CCI development (P = .03).

CONCLUSION: Although the long-term patency rates of PTA of the femoropopliteal arteries in claudicant patients were poor, the acceptable number of reinterventions and the low frequency of development of CCI imply the long-term benefits achievable with this treatment.

© RSNA, 2002

Index terms: Arteries, extremities, 921.1282, 924.1282 • Arteries, femoral, 921.1282 • Arteries, popliteal, 924.1282 • Arteries, transluminal angioplasty, 921.1282, 924.1282


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
The prevalence of claudication increases with age; it is about 1.8% in populations aged up to 60 years, 3.7% in those aged 60–70 years, and 5.2% in those aged 70 years or older (1). Although claudication is generally considered benign, the progression of the disease to chronic critical ischemia (CCI, defined as rest pain or ischemic tissue defect combined with an ankle systolic pressure <= 50 mmHg [2]) and threat of limb loss is a feared end stage of the disease in the long term (3,4). Atherosclerotic lesions that produce claudication are most often located in the femoropopliteal arteries (5). The role of percutaneous transluminal angioplasty (PTA) has been established in the treatment of claudicant patients with focal femoropopliteal disease during the past decade (6–9). The precise definition of "focal disease" is open to debate, however, and the threshold of what can be treated with endovascular procedures is shifting as more sophisticated devices appear on the market (10).

Surgical bypass by means of saphenous veins has been considered the treatment of choice for long lesions, since the outcome of PTA has been shown to be less favorable (11). However, results of a prospective randomized multicenter study (12) in which surgical revascularization and PTA were compared revealed no significant difference in outcomes during a median follow-up of 4 years. In a cost-effectiveness analysis, PTA was found to be the preferred initial treatment in patients with disabling claudication due to femoropopliteal arterial disease (7), in spite of some concern over the need for repeat PTA and surgical revascularization to treat restenosis.

We are not aware of any studies on PTA of femoropopliteal segments with consecutive claudicant patients reporting life table patency rates exceeding 6 years, according to current standards. In the long term, the demand for repeat PTA, other endovascular treatments, and surgical revascularizations remains undetermined. The effect of PTA on disease progression to CCI and subsequent amputations is also unclear.

The aim of this study was to report the long-term outcome of patients with lifestyle-limiting claudication after femoropopliteal PTA.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
REFERENCES
 
This prospective study was performed between September 1989 and December 1999. The study population consisted of 173 consecutive patients who had agreed to undergo invasive treatment and were treated for lifestyle-limiting claudication (absolute walking distance less than 200 m or manifest deficiency in occupational or recreational activities) with PTA in a university hospital between 1989 and 1992. The patient population consisted of 128 men (74%) and 45 women (26%). The mean age of the patients was 65 years (age range, 41–90 years). Patient characteristics are given in Table 1.


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  		TABLE 1. Patient Population and Preoperative Categories according to Severity of Claudication

 
The primary lesion responsible for clinical symptoms was in the femoral or popliteal artery in all patients. Limbs treated previously with endovascular procedures or vascular surgery were excluded. Altogether, 313 PTAs in 218 limbs consisting of one to five separate procedures per treated limb (mean, 1.4 procedures; median, 1.0 procedure) were performed. The approval of the institutional ethical committee was obtained, as well as informed consent from all patients.

Imaging
Digital subtraction angiography of the aorta and runoff vessels was performed routinely on an outpatient basis prior to PTA. Duplex ultrasonographic (US) examination of the common femoropopliteal arteries was performed in all patients immediately before the procedure and on the day of discharge from the hospital. Preoperative angiograms were used for scoring the limbs according to the number of arteries with more than 50% diameter stenosis (theoretical maximum of 10 arteries, including common and external iliac arteries; common, deep, and superficial femoral arteries; popliteal artery; tibiofibular trunk; anterior and posterior tibial arteries; and peroneal artery). There was a mean of 3.1 (median, 3; range, 1–7) diseased arteries per treated limb. To separate claudicant patients with focal and more extensive disease, two groups were created (group 1: one to two diseased vessels per limb [n = 87]; group 2: three to seven diseased vessels per limb [n = 131]). The type of procedure and the locations of treated lesions are shown in Table 2. The average total length of treated lesions per limb was 8.8 cm (range, 1–31 cm), the average length of individual lesions was 5.2 cm (range, 1–20 cm), and the length of single occlusions was up to 15 cm. The calf vessel was considered patent if it reached the ankle and was not narrowed by more than 75% of its diameter (8). Peripheral runoff after PTA was classified as good in 137 (62.8%) limbs with two to three patent calf arteries and poor in 81 limbs (37.2%) with zero to one patent calf artery.


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  		TABLE 2. Type and Location of PTA

 
PTA and Definition of Immediate Success
PTA procedures were performed in an angiography suite. An ipsilateral femoral antegrade puncture technique was primarily used. Contralateral femoral access (n = 13) was used if occlusive changes at the origin of the superficial femoral artery made the antegrade approach unsuitable, and popliteal access (n = 28) was used if the antegrade technique failed or if short proximal superficial femoral artery occlusions were present. The lesions were assessed visually by the interventional radiologist who performed the procedure, and the balloon diameter was selected to equal the diameter of the artery that was measured electronically with the aid of the digital subtraction angiography software, which was calibrated with a radiopaque external ruler. Lesions were routinely treated with a 5-F conventional balloon angioplasty catheter and Glidewire (Terumo, Piscataway, NJ). Stent placement was performed in two limbs and directional atherectomy in six limbs to make the primary result acceptable.

Patients routinely received 250 mg of acetylsalicylic acid (Alka-Seltzer; Bayer, Bridgend, England) on the day of the procedure. Prophylactic doses of nifedipine (10 mg, Adalat; Bayer, Leverkusen, Germany) were given by mouth 5–10 minutes before PTA. When the introducer sheath was in place, 5,000 U of heparin (Heparin Leo; Leo Pharma, Ballerup, Denmark) was administered intraarterially. A dose of 2,500 U was given after every additional hour of the procedure. Intraarterial boluses of 125 µg of nitroglycerin (Perlinganit; Orion Pharma, Turku, Finland) were administered in cases of popliteal artery access or when spasm occurred in the infrapopliteal vessels. A 24–48-hour heparin infusion was administered in patients with long segments, intimal irregularities induced at PTA, PTA-related embolus, or poor peripheral runoff.

Primary failures refer to both technical and early hemodynamic failures. The need for an additional procedure (atherectomy or stent placement) during primary PTA was considered a primary failure. Technical failure refers to the inability to pass through the lesion or to residual stenosis greater than 30% at angiography immediately after PTA. The early hemodynamic result of PTA was based on results of duplex US examination performed 24 hours after the procedure. Doppler velocity waveforms were classified into three categories: normal (diastolic backflow present), no diastolic backflow, and no flow (13).

Early hemodynamic success was defined as an improvement in the category of the Doppler velocity waveform (14) or at least doubling of the peak velocity in the popliteal artery distal to the site of PTA (8,15,16). Complications were classified according to recommended standards (17): Major complications included those that caused death or permanent disability, necessitated repeat surgery or other invasive treatment, or prolonged hospital stay; minor complications included small hematomas or pseudoaneurysms that did not require treatment or prolonged hospital observation.

Patient Follow-up and Long-term Outcome
Follow-up examinations took place at 1, 3, 6, and 12 months after primary PTA. Annual outpatient visits were arranged thereafter for up to 3 years, and further visits were arranged according to the clinical situation. Fifty-eight patients (78 treated limbs) with ongoing follow-up attended the examination in 1999, 82–122 months (mean, 104 months) after primary PTA. Sixteen patients refused to come because of poor general health or unwillingness to travel long distances. Beyond the last date of objectively proved patency, limbs were considered lost to follow-up. All follow-up visits included subjective history, clinical examination, and determination of ankle-brachial index. Duplex US or angiography was performed in patients with subjective or objective deterioration. Altogether, 131 (75.7%) patients were continuously medicated with acetylsalicylic acid (250 mg) until the last visit, and 17 (9.8%) patients were permanently being treated with oral anticoagulants because of other medical conditions. The records of deceased patients and patients lost to follow-up were reviewed and the causes of death defined according to the records of Statistics Finland.

CCI was defined as rest pain or ischemic tissue defect combined with an ankle systolic pressure of 50 mmHg or less (2). Primary and secondary (including additional procedures and repeat PTA) cumulative patency, patient survival, and development of CCI despite endovascular treatment were determined by means of life table analysis performed according to recommended standards (17). The primary end point of the study was primary patency at the end of 1999. Patency rates were based either on the maintenance of the achieved improvement in the ankle-brachial index, which had to be no less than 0.10 below the highest postoperative index, or on duplex US or angiographic findings that indicated the patent segment (17).

Primary patency refers to uninterrupted patency with either no procedure or an endovascular procedure performed to deal with disease progression in the adjacent native vessel. If vessel patency was restored with endovascular procedures after occlusion, it was listed as secondary patency. The follow-up for patency ended at the time of occlusion, surgical revascularization, or the latest follow-up visit.

Indications for secondary intervention were objectively proved early reobstruction or recurrence of subjective symptoms due to reobstruction during follow-up. The census date for CCI was at the end of 1999, if CCI had not developed earlier. Survival in the patient population was compared with that in an age- and sex-matched control population living in the same area to see whether there were differences in mortality between claudicant patients and the general population.

Statistical Analysis
Survival analyses were constructed by using the life table method. Sex, age, coronary arterial disease, hypertension, diabetes, preoperative Fontaine classification, number of diseased vessels in the treated limb, total length of treated lesions, type of procedure, peripheral runoff, medication during follow-up, and history of smoking were used as determinants in univariate analyses. The statistically significant difference between survival curves was determined by means of the Cox-Mantel test. Variables that reached statistical significance (P < .05) were used as covariates in the stepwise Cox proportional hazards model. The Pearson {chi}2 test for discrete variables was used to analyze the determinants of CCI development. Factors reaching statistical significance (P < .05) were included in stepwise multiple logistic regression analysis. The level of significance for inclusion in the model in both logistic regression and Cox multiple regression analyses was less than .10, and the level of significance for removal from the model was greater than .15.

Odds ratios and 95% CIs were calculated for the significant determinants in logistic regression and Cox multiple regression analyses. Statistical analyses were performed with BMDP (University of California, Berkeley) and SPSS for Windows version 9.0 (SPSS, Chicago, Ill) statistical software.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
REFERENCES
 
The early hemodynamic success rate was 83.5% (182 of 218 limbs). Fourteen (6.4%) major complications required treatment. The most frequent major complications were distal embolizations (n = 4), puncture site hematomas (n = 4), and pseudoaneurysms (n = 3). The 30-day mortality rate was 0.6%, consisting of one non-procedure-related death after repeat PTA.

Clinical Events during Follow-up
Twelve of 218 limbs (5.5%) were lost to follow-up. Primary patency was lost in 162 of 218 (74.3%) of the treated limbs. Altogether, 71 of 218 (32.6%) limbs required vascular reinterventions because of deterioration in the clinical situation: Endovascular procedures were performed in 36 limbs, surgical revascularizations were performed in seven, and both endovascular and surgical reinterventions were needed in 28. The most frequently used vascular reintervention was repeat PTA (n = 52) and bypass performed by using either the in situ technique (n = 15) or a prosthetic graft (n = 15). In 91 of 162 (56.2%) limbs with restenosis or reocclusion, the loss of patency did not lead to recurrence of subjective symptoms, and therefore, further treatment was not warranted.

The mean interval between primary PTA and repeat endovascular intervention was 22 months (median, 11 months; range, 0–117 months); surgical revascularizations were performed a mean of 38 months (median, 39 months; range, 0–106 months) after primary PTA. PTA was performed in segments other than the primary one(s) in 36 of 218 (16.5%) limbs. The total number of procedures for limb ischemia, including primary PTA, repeat or additional endovascular interventions, surgical revascularizations, and amputations, was 380 (range, 1–7 procedures per treated limb; mean, 1.7; median, 1.0).

Long-term Success
The primary patency rate for all 218 treated limbs (± standard error of estimate) was 46% ± 3 at 1 year, 25% ± 3 at 5 years, and 14% ± 3 at 10 years (Fig 1) (Table 3). The corresponding secondary patency rates were 63% ± 3, 41% ± 4, and 22% ± 4 (Table 3). In the univariate analysis, the number of diseased vessels in the treated limb proved to be the only statistically significant determinant of primary patency (P = .002) (Table 4). The total length of treated lesions was the only factor predictive of secondary patency (P = .002). The number of diseased vessels was also slightly, though not significantly (P = .09), associated with secondary patency. The other variables tested (sex, age, hypertension, diabetes, coronary arterial disease, preoperative Fontaine and Rutherford classifications, type of procedure, runoff, medication during follow-up, and smoking) were not predictors of either primary or secondary patency.



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  		Figure 1. Life table plot indicates primary and secondary patency rates in the study population (standard error of estimate <= 0.04 throughout follow-up).

 

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  		TABLE 3. Primary and Secondary Cumulative Patencies

 

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  		TABLE 4. Determinants of Primary and Secondary Patencies according to Results of Life Table Analysis

 
Development of CCI and Amputations
Eight of 218 (3.7%) limbs developed CCI after endovascular treatment (mean follow-up, 4.6 years). An additional six limbs developed CCI after surgical revascularization (mean follow-up, 7.6 years), resulting in 14 limbs (6.4%) progressing to CCI during follow-up. Thus, the incidence of CCI development was 0.8% per year, regardless of whether the repeat surgeries were included or not. In three limbs, CCI was indicated by means of rest pain; eight limbs developed ulcers; and another three limbs developed gangrene. CCI was diagnosed 6–88 months (mean, 52 months; median, 58 months) after primary PTA. Poor postoperative peripheral runoff was an independent predictor of increased risk of CCI development (Table 5).


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  		TABLE 5. Determinants of CCI Development after Endovascular Interventions

 
Four amputations were performed after endovascular treatment and an additional three after surgical bypass. These amputations consisted of one metatarsal, one above-knee, and five below-knee amputations, resulting in an overall amputation rate of 3.2%. Amputations became unavoidable 15–88 months (mean, 63 months) after primary PTA. All seven patients who ultimately underwent amputation initially had four to five diseased vessels in the treated limb, and five of seven limbs had poor runoff after primary PTA.

Survival
Sixty-three patients (36.4%) died during follow-up of 0–122 months (mean, 87 months; median, 96 months) after primary PTA. The most common cause of death was cardiovascular disease (n = 34; 54.0%). Six patients (10.0%) died of cerebrovascular disease, and 11 patients (17.5%) died of cancer. Cumulative survival rates (standard errors of the estimate) of the patient population at 1, 5, and 10 years after primary PTA, respectively, were 97% ± 1, 83% ± 3, and 60% ± 4. Factors associated with decreased survival according to multivariate analysis were diabetes and preoperative Fontaine class 2B instead of 2A (Table 6), which also maintained significance after stratification by age. Ischemic heart disease at the time of primary PTA was not associated with decreased survival (P = .19). Cumulative survival was slightly lower than that in the age- and sex-matched control population (Fig 2). Figure 3 shows that diabetic patients had poorer survival than that of the control subjects (47% vs 70% at 10 years, respectively), as had patients with a preoperative claudication distance of 200 m or less when compared with that of the control subjects (58% vs 63%, respectively).


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  		TABLE 6. Patient Survival: Results of Univariate and Cox Multiple Regression Analyses

 


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  		Figure 2. Life table plot indicates cumulative patient survival rates compared with those of the control population.

 


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  		Figure 3. Graph indicates differences in survival rates between various subpopulations and their age- and sex-matched control populations.

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
Long-term Success of PTA in the Femoropopliteal Arteries
There are only a few studies of PTA in the femoropopliteal arteries that include cumulative patency rates at 5 years on the basis of objective outcome criteria (Table 7). Beyond 6 years, the primary and secondary patencies remain unestablished. In addition, all previous studies with long-term follow-up include patients with CCI, and we are not aware of any studies on claudicant populations only. Our primary patency rate at 5 years (25%) is somewhat lower than the rates reported (37%–58%) in other studies (Table 7). In the present study, however, the length of the treated lesions was longer and the proportion of recanalizations higher than those in other series, and both factors have been reported to contribute to poorer outcome (6,8,18). In fact, in most other centers, many of our patients would have been treated surgically because of the length of the lesions and the high prevalence of occlusive disease. After the sharp decline during the first 12 months, cumulative primary and secondary patency curves have a constant, slow decrease over time, ending at 14% and 22% at 10 years, respectively (Fig 1).


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  		TABLE 7. Review of 5-year Results of PTA of the Femoropopliteal Arteries

 
Following infrainguinal bypass surgery in claudicant patients, a primary patency rate of 45% at 9 years has been reported (19). However, the patency rates in studies with long follow-up times should be analyzed with caution, since the higher the number of patients lost to follow-up, the more biased the results (20). In our study, the percentage of limbs lost to follow-up was only 5.5%, which is acceptable.

The best results of femoropopliteal PTA have been achieved in patients with focal short lesions (8,21). Other reported factors favoring patency during a 1–5-year follow-up period are good status of crural runoff vessels (6,22), less severe type of lesion treated (stenosis instead of occlusion) (6,18), and short length of treated lesions (8). In the present study, with extended follow-up, the number of diseased vessels in the treated limb was the only determinant that was associated significantly with primary patency (Table 4). Secondary patency was affected by the total length of primary treated lesions.

In many cases, restenosis at the primary PTA site or progression of atherosclerosis in adjacent arterial segments results in the recurrence or even worsening of clinical symptoms during extended follow-up, leading to a subsequent need for reinterventions. Failure of primary PTA does not preclude successful repeat PTA (8) or surgical revascularization (23), nor does it result in increased amputation rates (12). The total number of invasive treatments needed per limb (mean, 1.7) and the number of limbs requiring surgical revascularization (16.1%) remained within acceptable limits in the present study when compared with 17.8% following bypass surgery in a study of 409 claudicant patients with a similar follow-up period (19).

Therefore, it can be stated that endovascular treatment of claudication does not evoke an extra burden on the facilities of vascular surgery in the form of numerous bypass surgeries required because of failed PTA. On the basis of cumulative patency rates alone, a considerably worse clinical outcome could have been expected.

Development of CCI and Patient Survival
Femoropopliteal PTA in claudicant patients may protect against the development of CCI in the long term. According to the results of one study (4), 25% of patients with claudication without any invasive interventions will eventually develop CCI in 4–7 years. According to results of another study (3), 32 of the 218 limbs (14.7%) in our study could have been expected to develop CCI by the end of the follow-up period; however, the total number was 14 limbs (6.4%). The frequency (0.8% per year of follow-up) of the development of CCI in our patients was substantially smaller than the mean of 4.4% reported previously (4) as a natural progression in claudicant populations. Comparison with findings in the study of Rosenbloom et al (24) shows the same effect: 24% of claudicant patients treated with observation only, compared with 6.4% in our study, progressed to critical ischemia at 5 years. Explanations for this protective effect of PTA for claudication could be the extra time gained for the development of collateral circulation in an ischemic limb and a closer follow-up with appropriately timed reinterventions.

Factors associated with the development of CCI, according to previous reports on claudicant patients without invasive treatment, are ankle-brachial index less than 0.50 (3), smoking, and diabetes (4). In our study, the only statistically significant indicator of increased risk of CCI development following femoropopliteal PTA, according to results of multivariate analysis, was poor postprocedural runoff (Table 5). Runoff has previously been found to be determinant of long-term success following PTA of the femoropopliteal arteries (14).

Mortality among patients with claudication has been found to be higher than that among control populations, with an expected 5-year survival rate of 70% (3,4); in the present study, 5-year survival was 83%. At 10 years, the cumulative survival rate of our patients was 60%. Mortality at that time point was only 4% higher than that among the control population. Advanced age, male sex, low ankle systolic pressures, and hypertension have been found to be associated with decreased survival among claudicant patients (3). In the present study, similar association was found with diabetes and preoperative Fontaine classification 2B, both of which are potential indicators of more advanced and diffuse atherosclerosis. Although cardiovascular disease was the most common cause of death, the presence of symptomatic coronary arterial disease at the time of primary PTA did not impair survival.

Our study has some limitations. The determination of patency was based on the ankle-brachial index, which is an acceptable objective method that fulfills the current reporting standards (17), although duplex US would have been a more accurate method. The requirements for prospective studies were met, but there were minor violations: The follow-up was not uniform in all the patients in the middle of the study. Some patients were monitored more often than others because of clinical deterioration and reinterventions. The primary lesion was in the femoral or popliteal arteries in all patients, but in 19% of the limbs, additional iliac and infrapopliteal arterial PTA was required to improve inflow or outflow. In 3.7% of the treated limbs, atherectomy or stent placement was performed to make the primary result acceptable.

Recently, the beneficial effect of stent placement has been found in the treatment of PTA failures (25), and the limited use of stents in the treatment of patients with acute PTA failures or complications has been recommended (26). Because of the lack of conservatively managed control subjects, the comparisons of the development of CCI had to be made with historic control subjects.

Although the long-term patency rates of PTA of the femoropopliteal arteries in claudicant patients were poor, the acceptable number of reinterventions and the low frequency of CCI development imply the long-term benefits achievable with this treatment. Patients with focal disease and short lesions benefit the most. In most claudicant patients, primary PTA was the only invasive procedure needed to treat lower-limb ischemia, and it seems to prevent the development of CCI.


   ACKNOWLEDGMENTS
 
We thank Juha Hentunen, MSc, for his help with the statistical analysis. We also thank research secretary Tuula Bruun for her assistance. We are grateful to Pekka Hippeläinen, MSc, for providing the Riski program for calculating the cumulative survival of the age- and sex-matched control population.


   FOOTNOTES
 
Abbreviations: CCI = chronic critical ischemia, PTA = percutaneous transluminal angioplasty

Author contributions: Guarantor of integrity of entire study, T.S.J.; study concepts, H.I.M., P.J.M., P.A.J.; study design, H.I.M.; literature research, T.S.J.; clinical studies, all authors; data acquisition, T.S.J.; data analysis/interpretation, T.S.J., H.I.M.; statistical analysis, T.S.J., H.I.M.; manuscript preparation, T.S.J.; manuscript definition of intellectual content, T.S.J., H.I.M.; manuscript editing, H.I.M.; manuscript revision/review, P.J.M., P.A.J., H.I.M.; manuscript final version approval, all authors.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 

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