PROPATEN heparin-bonded vascular graft for peripheral arterial disease

Study component

Description

Objectives/hypotheses

To compare 1–year patencies of PROPATEN grafts with those of standard PTFE grafts.

Study design

Blinded, multicentre randomised control trial.

Setting

Eleven vascular centres at Scandinavian hospitals from 2006 to 2009.

All patients included in analyses were followed up for 1 year.

Patency was assessed by detecting pulse and measuring blood pressure at follow‑up appointments up to 12 months. There is no indication of the frequency of these appointments or whether they were at set intervals. At 1 year, duplex ultrasound scanning was used to confirm patency.

Inclusion/exclusion criteria

Inclusion criteria: Clinical indication for femoral‑femoral cross‑over or femoropopliteal bypass above or below the knee with an artificial graft, as determined by angiography.

Exclusion criteria: Acute patients, patients not likely to attend follow‑up, and those with heparin allergies.

Primary outcomes

Primary and secondary patency after 1 year.

Statistical methods

Baseline variables were compared using chi‑squared and Student's t‑test. No significant differences were detected.

A comparison of primary and secondary patencies after 1 year between the two groups was carried out using logistic regression analysis^a, with and without adjusting for bypass type and critical ischaemia.

Post hoc subgroup analyses were also conducted according to bypass type and indication for treatment^b.

The analyses used ITT, excluding those after randomisation who did not undergo the planned bypass but including early (technical) failures and prosthetic infections.

Patients included

Population: patients with intermittent claudication (n=348) or chronically critical ischaemia (n=198). Mean age 65 years; 53% male; 54% smokers.

Randomised n=569, Operated n=555, Included n=546

Intervention (PROPATEN) group: n=272.

Comparator (standard PTFE) group: n=274.

14 patients did not undergo the planned procedure due to technical failures (n=5), use of the wrong graft (n=5) or change of indication (n=4).

4 patients died postoperatively before follow‑up. 7 patients were lost to follow‑up after the procedure. Details and treatment groups for 11 patients were not reported.

Results (Primary patency at 1 year)

PROPATEN: 86.4% (235/272).

Standard PTFE: 79.9% (219/274).

OR 0.627, 95% CI 0.398 to 0.989, p=0.043^a.

Adjusted for bypass type:

OR 0.629, 95% CI 0.393 to 1.001, p=0.051^a.

Conclusions

The authors report that PROPATEN significantly reduced the overall risk of primary graft failure by 37%. There was a reduction in risk when PROPATEN was used in both femoropopliteal bypasses (OR=0.515, p=0.030) and in patients with critical ischaemia (OR=0.490, p=0.036).

Abbreviations: CI, confidence interval; ITT, intention to treat; n, number of patients; OR, odds ratio; PTFE, polytetrafluoroethylene.

^aThese tests were pre‑specified to be Cox regression analyses, but were changed post hoc due to the observation of a substantial number of silent occlusions.

^bThe study was not sufficiently powered to detect differences in subgroup analyses.

PROPATEN group

Standard PTFE group

Analysis

Randomised

n=not clear

n=not clear

–

Efficacy

n=272

n=274

–

Primary patency at 1 year

86.4% (235/272)

79.9% (219/274)

OR 0.627

95% CI 0.398 to 0.989

p=0.043^a

Adjusted for bypass type:

OR 0.629

95% CI 0.393 to 1.001

p=0.051^a

Secondary patency at 1 year

88.2% (240/272)

81.0% (222/274)

OR 0.569

95% CI 0.353 to 0.917

p=0.020^a

Adjusted for bypass type and critical ischaemia:

OR 0.565

95% CI 0.346 to 0.923

p=0.023^a

Primary patency in FP subgroup

81.3% (91/112)

69.0% (87/126)

OR 0.515

95% CI 0.281 to 0.944

p=0.030^b

Primary patency in critical ischaemia subgroup

82.7% (81/98)

70.0% (70/100)

OR 0.490

95% CI 0.249 to 0.962

p=0.036^b

Adjusted for bypass type:

OR 0.47

95% CI 0.26 to 0.86

p=0.036^b

Safety

n=not reported

n=not reported

There is some evidence that postoperative infections occurred, but no details were given.

Serious adverse events

The authors reported that there were 4 deaths in the postoperative period before follow‑up took place. Treatment groups were not specified.

The authors did not report any other SAEs; it is not known whether no other SAEs occurred, or whether they were simply not published.

'Average' perioperative bleeding (millilitres)

399

370

p=0.32

Abbreviations: CI, confidence interval; FP, femoropopliteal; ITT, intention to treat; n, number of patients; OR, odds ratio; PTFE, polytetrafluoroethylene.

^aThese tests were pre‑specified to be Cox regression analyses, but were changed post hoc due to the observation of a substantial number of silent occlusions.

^bThe study was not sufficiently powered to detect differences in subgroup analyses.

Study component

Description

Objectives/hypotheses

To evaluate early and midterm results of tibial bypasses comparing a precuffed ePTFE graft (Distaflo) to PROPATEN with a distal vein patch.

Study design

Retrospective cohort study.

Setting

Single hospital in Italy from April 2004 to December 2010.

Doppler ultrasonography was carried out at the time of discharge; after 1, 3, 6 and 12 months; and thereafter every 6 months. The mean follow‑up was 17 months (range 3–82). Follow‑up outcomes were checked through direct contact with patients or the family.

Inclusion/exclusion criteria

Records of patients undergoing femorotibial revascularisation for critical limb ischemia were obtained retrospectively from a single centre. The 2 groups were selected from the same period of time. None of the patients had a suitable autologous vein available.

Intervention (PROPATEN with distal vein patch) group: n=40.

Comparator (Distaflo ePTFE graft) group: n=39.

The intervention group were treated using a 6 mm thin‑walled PROPATEN graft without external rings. The distal anastomosis was performed using a Linton vein patch.

The comparator group were treated with a premanufactured expanded anastomosis (Distaflo) with a small cuff and externally supported with rings.

Outcomes

Primary and secondary patency and limb salvage determined at regular intervals until 24 months. Estimated survival at 36 months. The primary outcome was not specified by the authors.

Statistical methods

Baseline characteristics were compared using chi‑squared, t test, or Wilcoxon test. Primary and secondary patency, limb salvage and survival were analysed using univariate (Kaplan–Meier curves and log rank test) and multivariate (Cox regression) analyses. The association between groups was evaluated by OR (with CI). Propensity scoring was used to adjust for baseline differences.

Patients included

Population: patients with critical limb ischaemia who underwent femorotibial bypass using a PTFE graft.

Total sample size n=79.

After the operation all patients were given low‑molecular weight heparin. patients underwent oral anticoagulant (warfarin) therapy or treatment with anti‑platelet drugs.

Results

Baseline measures were comparable with the exception of age; the Distaflo group were on average 5 years older (95% CI 0.5 to 9, p=0.03). Though not statistically significant, there were also differences between groups in Rutherford classifications and number of simultaneous adjunctive procedures.

After 2 years neither primary nor secondary patency, nor limb salvage, were significantly different between PROPATEN with vein patch and Distaflo. A significant difference was observed for survival at 36 months (PROPATEN: 84%; Distaflo: 21%, p<0.001).

Factors associated with poorer long‑term primary patency rates were age of >80 years, peroneal artery distal anastomosis, adjunctive procedures, and secondary interventions (all p<0.05).

Conclusions

The authors report that pre‑cuffed Distaflo and PROPATEN with a distal vein patch have similar patency and limb salvage results. Differences in survival rates between groups were attributed to age.

Abbreviations: CI, confidence interval; ePTFE, expanded polytetrafluoroethylene; n, number of patients; OR, odds ratio; PTFE, polytetrafluoroethylene.

PROPATEN + vein patch group (n=40)

Distaflo ePTFE group (n=39)

Analysis

Primary patency at 2 years (95% CI)

33% (21–53)

47% (32–70)

p=0.793

Secondary patency at 2 years

36% (23–57)

49% (33–72)

p=0.855

Limb salvage

65% (51–84)

57% (41–79)

p=0.18

Survival at 36 months (95% CI)

84% (69–100)

21% (7–63)

OR 0.21, 95% CI 0.07 to 0.63, p<0.001

Deaths within 30 days

2.5% (2/79)

Not reported by intervention type.

Non‑fatal perioperative MI

1.3% (1/79)

Not reported by intervention type.

Wound dehiscence

3.8% (3/79)

Not reported by intervention type. All resulted in protracted hospital stay.

Infection

Within 30 days=2.5% (2/79)

Other infections during follow‑up=3.8% (3/79)

Total infections=6.3% (5/79)

Not reported by intervention type.

Those patients with infections that occurred within 30 days died within 6 months. Others were candidates for major amputation.

Operation length (min)

215 (198 to 238)

138 (120 to 162)

Difference 76 (95% CI 45 to 118), p<0.001.

Mean length of stay (days)

11.8

11

No statistical analysis reported.

Abbreviations: CI, confidence interval; ePTFE, expanded polytetrafluoroethylene; MI, myocardial infarction; n, number of patients; OR, odds ratio.

Study component

Description

Objectives/hypotheses

To compare short and midterm infra‑inguinal bypass patency rates between two ePTFE prosthetic grafts: PROPATEN and Spiral Laminar Flow Graft (SLFG).

Study design

Retrospective cohort study.

Setting

Single hospital in the USA from January 2010 to January 2012.

Inclusion/exclusion criteria

Records of patients undergoing infra‑inguinal bypass using prosthetic grafts were reviewed retrospectively for a single centre. The author implies that the indication was PAD.

The two groups were selected from the same period of time.

Intervention (PROPATEN) group: n=39.

Comparator (SLFG) group: n=20.

Outcomes

Primary and secondary patency rates. It was not clear how patency was determined. The primary outcome was not specified by the authors.

Statistical methods

Kaplan–Meier analyses were performed to estimate primary and secondary patency rates.

Patients included

Population: patients undergoing infrainguinal bypass using prosthetic grafts.

Results

70% (14/20) of SLFG cases were FP bypasses, and 30% (6/20) were FT bypasses. The author reported that "similar percentages were seen" in the PROPATEN group, but it is not reported how many of the FP bypasses were above or below the knee.

Primary patency rates for FP bypasses at 24 months were 54% (PROPATEN) and 50% (SLFG); the rates for FT bypasses at 18 months were 37% (PROPATEN) and 17% (SLFG). Secondary patency rates for FP bypasses at 24 months were 66% (PROPATEN) and 57% (SLFG); the rates for FT bypasses at 18 months were 34% (PROPATEN) and 20% (SLFG).

The author stated: "Statistically, the 6‑, 12‑, 18‑, and 24‑month primary and secondary patency rates for both grafts were the same regardless of the distal target artery". Details of statistical results were not reported.

Conclusions

The author reported 'similar' primary and secondary patency rates between the two groups, and suggested that there should be different graft configurations for tibial targets and popliteal artery targets.

Abbreviations: FP, femoropopliteal; FT, femorotibial; n, number of patients; PAD, peripheral arterial disease; SLFG, spiral laminar flow graft.

PROPATEN group (n=39)

SLFG group (n=20)

Analysis

Primary patency

FP:

6 m: 94%

12 m: 61%

18 m: 61%

24 m: 54%

FT:

6 m: 51%

12 m: 36%

18 m: 37%

FP:

6 m: 79%

12 m: 50%

18 m: 50%

24 m: 50%

FT:

6 m: 50%

12 m: 33%

18 m: 17%

Details of statistical results were not reported. The author states: "Statistically, the 6‑, 12‑, 18‑, and 24‑month primary and secondary patency rates for both grafts were the same regardless of the distal target artery".

Secondary patency

FP:

6 m: 94%

12 m: 66%

18 m: 66%

24 m: 66%

FT:

6 m: 54%

12 m: 34%

18 m: 34%

FP:

6 m: 86%

12 m: 57%

18 m: 57%

24 m: 57%

FT:

6 m: 60%

12 m: 40%

18 m: 20%

Details of statistical results were not reported. The author states: "Statistically, the 6‑, 12‑, 18‑, and 24‑month primary and secondary patency rates for both grafts were the same regardless of the distal target artery".

Safety (adverse events)

Not reported

–

Abbreviations: FP, femoropopliteal; FT, femorotibial; m, months; n, number of patients; SLFG, spiral laminar flow graft.

Study component

Description

Objectives/hypotheses

To compare early and follow‑up results of below‑knee bypasses performed in patients with peripheral arterial obstructive disease using PROPATEN and ASV.

Study design

Retrospective cohort study.

Setting

Seven vascular centres in Italy from 2001 to 2010.

Follow‑up examinations were carried out within the third postoperative month, at 12 months and then annually. These included Duplex scans.

Mean duration of follow‑up was 28.5±22.1 months.

Early results refer to the first 30 days after surgery.

Inclusion/exclusion criteria

Data from patients undergoing below‑knee revascularisation for PAD were obtained retrospectively from a multicentre registry. The two groups were selected from the same centres in the same period of time.

Intervention (PROPATEN) group: n=556.

Comparator (ASV) group: n=394.

The procedure for the ASV group used in situ vein bypass (54%, 212/394) or inverted vein bypass (46%, 182/394).

Outcomes

Primary and secondary graft patency, limb salvage (in patients with critical limb ischaemia), and survival. The primary outcome was not specified by the authors.

Statistical methods

Early (safety) results were compared using chi‑squared and Fisher's exact test.

Follow‑up results were compared using a log rank test. Survival was estimated using Kaplan–Meier curves. Univariate and Cox Regression analyses were used to investigate factors related to primary and secondary patency rates.

Patients included

Patients with critical limb ischaemia (n=745) or severe claudication (n=205).

Total sample size n=950.

Results

Baseline measures showed some significant differences. patients in the PROPATEN group were more likely to have a history of smoking, hyperlipidaemia and coronary artery disease. The indication for surgery was more often critical limb ischaemia in the ASV group than in the PROPATEN group. Run‑off status also differed.

Secondary interventions accounted for a greater proportion of the procedures in the PROPATEN group (25%, 141/556) than in the ASV group (19%, 73/394, p=0.001).

Primary patency at 48 months: PROPATEN=45%, ASV=61% (p=0.004).

Multivariate analyses demonstrated that both secondary interventions and use of adjunctive distal procedures were associated with poorer primary and secondary patency rates. Male patients had better primary and secondary patency outcomes than females.

Conclusions

The authors report that PROPATEN provides satisfactory early and mid‑term results in patients undergoing surgical below‑knee revascularisation. While ASV maintains its superiority in terms of primary patency, secondary patency and limb salvage rates are comparable.

It was observed that the wide discrepancy in primary patency rates may be explained by the fact that more of the PROPATEN patients were undergoing secondary interventions. Higher perioperative death rates for the PROPATEN group were attributed to a higher proportion of patients with coronary artery disease.

They authors conclude that PROPATEN can represent a safe alternative to ASV, mainly when it is unusable or of poor quality.

Abbreviations: ASV, autologous saphenous vein; n, number of patients; PAD, peripheral arterial disease.

PROPATEN group (n=556)

ASV group

(n=394)

Analysis

Primary patency at 48 months

44.5%

61%

p=0.004

Log rank 8.1

Secondary patency at 48 months

57%

(SE 0.03)

67.5%

(SE 0.03)

p=0.1

Log rank 1.9

Limb salvage in patients with critical limb ischaemia at 48 months

77.2%

(SE 0.02)

79.5%

(SE 0.03)

p=0.3

Log rank 0.9

Survival (48 month estimate)

81%

74%

p=0.7

Log rank 0.1

Deaths (30 days)

2.0% (11/556)

0.5%

(2/394)

p=0.07

Thromboses (30 days)

6.3% (35/556)

5.1% (20/394)

p=0.3

Major amputations (30 days)

3.4% (19/556)

1.8%

(7/394)

p=0.1

Mean post‑operative hospital stay (days)

13.1

10.2

95% CI 1.5 to 4.6, p<0.001

Abbreviations: ASV, autologous saphenous vein; n, number of patients; SE, standard error.

Study component

Description

Objectives/hypotheses

To compare 1‑ and 2‑year results in patients given heparin‑bonded ePTFE grafts with those patients given ASV grafts during the study period.

Study design

Retrospective cohort study

Setting

Single hospital in Belgium from August 2002 to March 2006.

Follow‑up visits were scheduled for 1 and 6 months post‑operatively and yearly thereafter. Duplex ultrasonography scan was performed in case of clinical problems, if pulses were absent, and routinely during the appointments at 1 and 2 years.

Observations terminated in February 2007. Some patients without sufficient follow‑up data in medical notes were asked to attend an additional visit. Other data were obtained by telephone or from primary care records.

Inclusion/exclusion criteria

Records of patients undergoing above‑ and below‑knee revascularisation for PAD (Rutherford disease stage class ≥3) in whom a PROPATEN or ASV graft was used were obtained retrospectively from a single centre. The two groups were selected from the same period of time.

Intervention (PROPATEN) group: n=240; 8 mm thin‑walled for AK FP, 6 mm ringed for BK FP and FC.

Comparator (ASV) group: n=110; vein diameter ≥ 3 mm.

Outcomes

Primary patency at 1 and 2 years, limb salvage rates, infections. The primary outcome was not specified by the authors.

Statistical methods

Kaplan–Meier was used to assess primary patency and limb salvage for each bypass subgroup separately, with log rank testing used to compare results between treatment groups.

Patients included

Population: All patients who underwent an above‑ or below‑knee bypass for PAD (Rutherford disease stage class ≥3) in whom a PROPATEN or ASV graft was used.

All patients followed similar postoperative antiplatelet and anticoagulant regimen, including 160 mg of aspirin/day. Warfarin therapy continued for patients receiving if before surgery and started for those who underwent secondary interventions.

Total sample size n=350.

Secondary interventions accounted for a greater proportion of the procedures in the PROPATEN group than in the ASV group. There were significantly more above‑knee and less below‑knee femoropopliteal bypasses in the PROPATEN group. Because of this, results were analysed separately by subgroup. Median follow‑up times in months (with range) for living patients in subgroups:

AK FP (PROPATEN): 25.3 (<1–45)

AK FP (ASV): 28.5 (<1–45)

BK FP (PROPATEN): 24.6 (<1–47)

BK FP (ASV): 20.6 (<1–46)

FC (PROPATEN): 18.8 (<1–48)

FC (ASV): 19.6 (<1–44)

Results

At baseline there were no significant differences between groups with respect to age, sex, Rutherford classification, or proportion of smokers.

Primary patency after 2 years was not significantly different between treatments as analysed by subgroup (AK FP, p=0.804; BK FP, p=0.075; FC, p=0.391).

Conclusions

The authors report that PROPATEN had 1‑ and 2‑year primary patency results that were not significantly different from those for ASV grafts. Results in below‑knee applications were especially promising.

Abbreviations: AK FP, above‑knee femoropopliteal; ASV, autologous saphenous vein; BK FP, below‑knee femoropopliteal; CI, confidence interval; ePTFE, expanded polytetrafluoroethylene; FC, femorocrural; n, number of patients; PAD, peripheral arterial disease.

PROPATEN group (n=240)

ASV group (n=110)

Analysis

Primary patency at 1 and 2 years (95% CI)

AK FP 1 yr:

92% (83–96)

AK FP 2 yrs:

83% (72–90)

BK FP 1 yr:

92% (81–97)

BK FP 2 yrs:

83% (68–91)

FC 1 year:

79% (69–86)

FC 2 years:

69% (58–78)

AK FP 1 yr:

91% (51–99)

AK FP 2 yrs:

80% (39–95)

BK FP 1 yr:

72% (59–83)

BK FP 2 yrs:

72% (59–83)

FC 1 year:

69% (54–80)

FC 2 years:

64% (48–76)

AK FP 1 year:

p=not reported

AK FP 2 years:

p=0.804

BK FP 1 year:

p=not reported

BK FP 2 years:

p=0.75

FC 1 year:

p=not reported

FC 2 years:

p=0.391

For FC, primary bypasses performed better than secondary interventions (p=0.006).

Amputations/limb salvage at 2  years, patients with critical ischaemia

AK FP: 3/92%

BK FP: 1/98%

FC: 12/87%

AK FP: 0/100%

BK FP: 3/91%

FC: 2/96%

AK FP: p=0.697

BK FP: p=0.054

FC: p=0.157

Death from all causes

AK FP: 10%

(9/86)

BK FP: 11% (6/57)

FC: 19% (18/97)

AK FP: 8% (1/12)

BK FP: 10% (5/48)

FC: 14% (7/50)

AK FP:

p=0.912

BK FP:

p=0.879

FC:

p=0.075

In‑hospital deaths

0.42% (1/240)

0.91% (1/110)

–

Deep infections

0.83% (2/240)

0% (0/110)

–

Seroma/

haematoma

0% (0/240)

0% (0/110)

–

HIT

0% (0/240)

0% (0/110)

–

Abbreviations: AK FP, above‑knee femoropopliteal; ASV, autologous saphenous vein; BK FP, below‑knee femoropopliteal; CI, confidence interval; FC, femorocrural; HIT, heparin‑induced thrombocytopaenia; n, number of patients; yr/s, year/s.

Study component

Description

Objectives/hypotheses

To retrospectively evaluate immediate and mid‑term results of below‑knee bypasses performed with PROPATEN, compared with results obtained with autologous vein and standard ePTFE.

Study design

Retrospective cohort study.

Setting

Appears to have been conducted at a single hospital in Italy, from March 2002 to December 2004.

Mean duration of follow‑up was 19±11 months.

Clinical and ultrasonographic follow‑up was performed at 1, 6, and 12 months and then once a year.

Inclusion/exclusion criteria

The study collected data for patients undergoing below‑knee revascularisation for PAD that had resulted in critical limb ischaemia or severe intermittent claudication.

Records for patients in the intervention (PROPATEN) group were prospectively collected, then compared retrospectively with randomly selected controls (ASV and standard ePTFE) from an existing database. patients in all three groups appear to have been treated at the same site during the same study period.

Patients in the intervention (PROPATEN) group did not have a suitable autologous vein.

Intervention (PROPATEN) group: n=24.

Comparator 1 (ASV) group: n=25.

Comparator 2 (standard ePTFE) group: n=21.

Outcomes

Early graft thrombosis (within 30 days), primary patency at 18 months, and limb salvage at 18 months. The primary outcome was not specified by the authors.

Statistical methods

Differences between groups in graft patency, amputation rate and mortality at 30 days were analysed using chi‑squared and Fisher's exact tests. Follow‑up data were analysed by Kaplan–Meier life table (survival) analysis and log rank tests.

Patients included

Population: patients undergoing below‑knee revascularisation after critical limb ischaemia or severe intermittent claudication.

Total sample size n=70.

Results

There were no significant differences in baseline measures between the three groups in terms of sex, age, preoperative clinical status, or run‑off scores. Numbers of re‑do (secondary) interventions were similar for PROPATEN (13%, 3/24), ASV (8%, 2/25) and ePTFE (5%, 1/21). Adjunctive procedures (such as patching of distal anastomosis) were performed in 50% (12/24) patients in the PROPATEN group, 16% (4/25) patients in the ASV group, and 48% (10/21) patients in the ePTFE group.

Early graft thrombosis occurred in 5 (21%) patients in the PROPATEN group, 3 (12%) in the ASV group, and 10 (48%) in the ePTFE group. Both PROPATEN and ASV performed significantly better than ePTFE (p=0.002 and p=0.003); there were no differences between PROPATEN and ASV in early graft thrombosis.

At 18 months follow‑up, ASV grafts had higher primary patencies (75%) than ePTFE grafts (40%), but were not significantly higher than PROPATEN (53%). The difference between the two prosthetic grafts was not statistically significant (p=0.07).

Conclusions

The authors report that the use of a PROPATEN graft seems to significantly reduce the rate of early graft thrombosis compared with standard synthetic materials and provides also slightly better mid‑term results, making it a possible graft of choice in the absence of suitable autologous veins.

Abbreviations: ASV, autologous saphenous vein; ePTFE, expanded polytetrafluoroethylene; n, number of patients; PAD, peripheral arterial disease.

PROPATEN group (n=24)

ASV group (n=25)

ePTFE group (n=21)

Analysis

Early graft thrombosis (within 30 days)

21% (5/24)

12% (3/25)

48% (10/21)

PROPATEN better than ePTFE (p=0.002).

ASV better than ePTFE (p=0.003).

PROPATEN not significantly different to ASV (p=0.4).

Estimated primary patency at 18 months

53%

75%

40%

ASV better than ePTFE (p=0.01, log rank 6.7), but not significantly better than PROPATEN (p=0.05, log rank 3.3).

PROPATEN not significantly different to ePTFE (p=0.07, log rank 1.2).

Limb salvage at 18 months

68%

83%

64%

ASV better than PROPATEN (p=0.03, log rank 2.6), but reported as not significantly better than ePTFE (p=0.05, log rank 3.3).

PROPATEN not significantly different than ePTFE (p=0.08, log rank 2.9).

Survival at 18 months

93% (65/70)

–

Perioperative deaths

0% (0/24)

0% (0/25)

0% (0/21)

–

Major amputations (perioperative)

8.3% (2/24)

4.0% (1/25)

9.5% (2/21)

No significant differences between all 3 groups.

Severe bleeding

0% (0/24)

0% (0/25)

0% (0/21)

–

Abbreviations: ASV, autologous saphenous vein; ePTFE, expanded polytetrafluoroethylene; n, number of patients.