Eur J Vasc Endovasc Surg (2009) 37, 457e463

Dacron or ePTFE for Femoro-popliteal Above-Knee

Bypass Grafting: Short- and Long-term Results of
a Multicentre Randomised Trial
R.J. van Det a,*, B.H.R. Vriens a, J. van der Palen b, R.H. Geelkerken a

a
Department of Vascular Surgery, Medisch Spectrum Twente Hospital, PO Box 50.000, 7500 KA Enschede, The Netherlands
b
Department of Clinical Epidemiology, Medisch Spectrum Twente Hospital, Enschede, The Netherlands

Submitted 20 August 2008; accepted 25 November 2008

Available online 20 February 2009

KEYWORDS Abstract Objectives: To compare expanded polytetrafluoroethylene (ePTFE) prosthesis and

Dacron; collagen-impregnated knitted polyester (Dacron) for above-knee (AK) femoro-popliteal bypass
Femoro-popliteal grafts.
bypass; Design: A prospective multicentre randomised clinical trial.
Peripheral arterial Patients and Methods: Between 1992 and 1996, 228 AK femoro-popliteal bypass grafts were
occlusive disease; randomly allocated to either an ePTFE (n Z 114) or a Dacron (n Z 114) vascular graft (6 mm
Peripheral bypass; in diameter). Patients were eligible for inclusion if presenting with disabling claudication, rest
Polyester; pain or tissue loss.
PTFE Follow-up was performed and included clinical examination and duplex ultrasonography at
all scheduled intervals. All patients were treated with warfarin.
The main end-point of this study was primary patency of the bypass graft at 2, 5 and 10 years
after implantation. Secondary end-points were mortality, primary assisted patency and secondary
patency. Cumulative patency rates were calculated with life-table analysis and with log-rank test.
Results: After 5 years, the primary, primary assisted and secondary patency rates were 36%
(confidence interval (CI): 26e46%), 46% (CI: 36e56%) and 51% (CI: 41e61%) for ePTFE and 52%
(CI: 42e62%) (p Z 0.04), 66% (CI: 56e76%) (p Z 0.01) and 70% (CI: 60e80%) (p Z 0.01) for Dacron,
respectively. After ten years these rates were respectively 28% (CI:18-38%), 31% (CI:19-43%) and
35% (CI: 23-47%) for ePTFE and 28% (CI: 18-38%), 49% (CI: 37-61%) and 49% (CI: 37-61%) for Dacron.
Conclusion: During prolonged follow-up (10 years), Dacron femoro-popliteal bypass grafts have
superior patency compared to those of ePTFE grafts. Dacron is the graft material of choice if
the saphenous vein is not available.
ª 2009 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

* Corresponding author. Tel.: þ31 53 4872510; fax: þ31 53 4872526.

E-mail address: [email protected] (R.J. van Det).

1078-5884/$34 ª 2009 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.ejvs.2008.11.041
458 R.J. van Det et al.

Introduction Patients and Methods

Femoro-popliteal bypass grafting has been shown to be an Recruitment for this multicentre randomised trial was
effective treatment for arterial occlusive disease in carried out from July 1992 until August 1996. The follow-up
patients with severe claudication or critical ischaemia. was extended until June 2007. The protocol followed the
Autogenous venous conduits are associated with improved rules of the Helsinki declaration and the Consolidated
patency for both above- and below-knee femoro-popliteal Standards of Reporting Trials (CONSORT) reporting stan-
bypass.1,2 Prosthetic graft material is still a frequently used dards have been used. Patient consent was obtained in all
alternative to venous conduits due to the absence of cases. Patients were eligible for inclusion if they presented
a good-quality long saphenous vein in many patients.3 The with symptoms of disabling claudication, rest pain or tissue
choice of prosthetic graft material, such as expanded pol- loss and suprageniculate femoro-popliteal bypass was
ytetrafluoroethylene (ePTFE) or Dacron, for femoro-popli- feasible. Exclusion criteria were previous ipsilateral fem-
teal bypass grafts has been controversial over the past oro-popliteal procedures, contraindication to long-term
decade.4 Seven randomised clinical trials have been con- anticoagulant therapy, life expectancy less than 1 year and
ducted to compare the outcome of ePTFE or Dacron for current treatment with chemotherapy or radiotherapy.
femoro-popliteal bypass.5e13 However, interpretation of The preoperative assessment followed The Society for
these studies is difficult due to a number of problems in the Vascular Surgery/International Society for Cardiovascular
design of the investigations, including short follow-up time, Surgery (SVSeISCVS) risk score,16 including detailed
the inclusion of both supra- and infrageniculate bypasses evaluation of patient history, cardiovascular risk factors,
and the inclusion of different graft diameters. Conse- physical examinations, ankleebrachial index (ABI) and
quently, no firm conclusions have been reached on whether intra-arterial digital subtraction angiography (DSA).
ePTFE or Dacron is preferable.14,15 Randomisation was stratified for each centre using
The present study was conducted to answer the ques- sealed envelopes. The physician treating the patient could
tion whether an ePTFE or a Dacron prosthesis should be not be blinded to the treatment allocation.
used for suprageniculate femoro-popliteal allograft bypass The operation was performed with general or regional
grafting. anaesthesia. All patients received antibiotic prophylaxis

Table 1 Patient characteristics

Parameter ePTFE n (%) Dacron n (%) df Test p-value
value
N 114 114
Gender limbs M/F 74/40 73/41 1 c2 Z 0.02 0.89a
Age (yrs) mean, (range) 66 (43e89) 67 (39e92) 226 t Z 0.60 0.99b
Co-morbidity (%)
DM 37 (32.5) 30 (26.3) 1 c2 Z 1.04 0.31a
Hypertension 45 (39.5) 38 (33.3) 1 c2 Z 0.93 0.34a
Cerebrovascular disease 19 (16.7) 8 (7.0) 1 c2 Z 5.08 0.02a
Cardiac disease 41 (36.0) 33 (28.9) 1 c2 Z 1.28 0.26a
Smoking 3 c2 Z 5.94 0.12a
Never 21 (18.4) 16 (14.0)
<10 per day 26 (22.8) 18 (15.8)
>10 per day 35 (30.7) 31 (27.2)
Quit 32 (28.1) 49 (43.0)
Ischaemia category (Rutherford classification) 4 c2 Z 0.82 0.94a
1 3 (2.6) 5 (4.4)
2 44 (38.6) 40 (35.1)
3 42 (36.8) 42 (36.8)
4 10 (8.8) 10 (8.8)
5 15 (13.2) 17 (14.9)
No. patent crural vesselsc 3 c2 Z 2.04 0.56a
0 1 (0.9) 0 (0.0)
1 31 (27.2) 27 (24.1)
2 38 (33.3) 45 (40.2)
3 44 (38.6) 40 (35.7)
a
For categorical variables Pearson’s chi-square test were used.
b
For continuous variables Student’s t-test was used.
c
A vessel was still ‘patent’, even if a significant stenosis was present.
Above-knee Fem-pop Bypass Dacron or ePTFE 459

consisting of Cefazoline according to local guidelines. a physical examination, ABI and a duplex scan. After
Before arterial clamping, 5000 units of heparin were given surgery and at 1 year a DSA was performed.
intravenously. Anastomoses were performed end-to-side, The main end-points of this study were primary patency
with 6/0 Prolene (Johnson & Johnson; Ethicon, St Stevens- rates of the bypass 2, 5 and 10 years after implantation.
Woluwe, Belgium), proximal to the common femoral artery Secondary end-points were mortality, primary assisted
and distal to the above-knee popliteal artery. Post- patency and secondary patency.
operatively, all patients were given Warfarin. In accordance with the SVSeISCVS16 guidelines, primary
The grafts used were either 6-mm expanded, stretched, patency was defined as uninterrupted patency without any
thin-walled PTFE (Goretex, W.L. Gore & Ass., Flagstaff, manipulation of the graft. Primary assisted patency was
AZ, USA) or a 6-mm collagen-impregnated Dacron (Hema- defined as uninterrupted graft patency, but maintained by
shield, Meadox, Oakland, NJ, USA) (Boston Scientific, prophylactic intervention like angioplasty, patch angio-
Maquet). The patients were scheduled for follow-up after 3 plasty or small graft interpositions. Secondary patency was
and 6 weeks, 3, 6, 9, 12, 18 and 24 months, and yearly up to defined as restored patency after occlusion with or without
10 years. Review consisted of clinical consultation, revision of the graft.

Assessed for eligibility

(not available)

Excluded (n=not available)

Enrollment Not meeting inclusion criteria

(n=not available)
Refused to participate
(n=not available)
Other reasons
(n=not available)

Allocated to ePTFE Allocated to Dacron

(n=114) (n=114)
Received allocated intervention Received allocated intervention
(n=114) Allocation (n=114)
Did not receive allocated intervention Did not receive allocated intervention
(n=0) (n=0)

Lost to follow-up (n=3) Lost to follow-up (n=1)

- incomplete follow-up - incomplete follow-up

Discontinued intervention (n=74) Follow-Up Discontinued intervention (n=67)

- Death: 73 - Death: 65
- Graft Removal: 1 - Graft Removal: 2

Analyzed (n=114) Analyzed (n=114)

Analysis
Excluded from analysis (n=0) Excluded from analysis (n=0)

Figure 1 CONSORT-flowchart of participants in the study.

460 R.J. van Det et al.

Table 2 Cumulative patency rates (%)

Patency Follow-up time ePTFE SE 95% CI Dacron 95% CI SE df c2 p-value
(years) (%) (%) (%) (%)
Primarya 2 64 0.05 54e74 70 62e78 0.04 1 0.78
5 36 0.05 26e46 52 42e62 0.05 1 4.39 0.04
10 28 0.05 18e38 28 18e38 0.05 1 2.39 0.12
a
Primary assisted 2 72 0.04 72e80 77 69e84 0.04 1 0.93
5 46 0.05 36e56 66 56e76 0.05 1 6.64 0.01
10 31 0.06 19e43 49 37e61 0.06 1 7.45 0.01
Secondarya 2 78 0.04 70e86 84 76e92 0.04 1 1.04
5 51 0.05 41e61 70 60e80 0.05 1 6.50 0.01
10 35 0.06 23e47 49 37e61 0.06 1 6.10 0.01
a
Based on life-tables, corrected for censored patients at the respective end of each interval.

Statistics A p-value of <0.05 was considered significant. All anal-

yses were done on an intention-to-treat basis and per-
Patients could be included in the study twice for operations formed with SPSS, V.15.01.
performed on different legs. Analyses of the end-points
were performed per limb. Results
When testing the hypothesis there was a 20% difference
in primary patency between both grafts at the end of 5-year A total of 228 limbs (219 patients) were randomly
follow-up, it was calculated by a two-sided power analysis allocated for reconstruction with either Dacron
that the study needed at least 110 grafts in each group to (n Z 114) or ePTFE (n Z 114) between July 1992 and
obtain sufficient statistical power (a Z 0.05 and August 1996 in five hospitals in the Netherlands (Medisch
power Z 85%). Spectrum Twente, Enschede, n Z 60/60, Twenteborg
Cumulative patency rates were calculated with life-table Hospital, Almelo, n Z 18/19; Slingeland Hospital, Doe-
analysis by the KaplaneMeier method and compared with tinchem, n Z 17/15 General Hospital Midden-Twente,
the log-rank test. Differences between the two groups for Hengelo n Z 18/20, Koningin Beatrix Hospital, Winter-
categorical data were analysed by means of Pearson’s chi- swijk n Z 1/0).
square test and for continuous variables by Student’s t-test. The group consisted of 147 (64%) male and 81 (36%)
female limbs. Preoperative risk factors were diabetes

100 100 Prothesis

Prothesis
PTFE PTFE
Dacron Dacron
Cumulative Primary Assisted Patency

PTFE PTFE
Dacron 80 Dacron
80
Cumulative Primary Patency

60 60

40 40

20 20

0 0

0 12 24 36 48 60 72 84 96 108 120 0 12 24 36 48 60 72 84 96 108 120

Follow-up (months) Follow-up (months)
Grafts at risk: Grafts at risk:
PTFE 114 90 64 51 40 29 19 16 13 11 9 PTFE 114 96 73 60 47 37 26 19 16 13 10
Dacron 114 91 74 64 53 45 39 31 25 21 15 Dacron 114 94 81 74 65 58 50 45 39 31 23

Figure 2 KaplaneMeier analysis of primary patency rates for Figure 3 KaplaneMeier analysis of primary assisted patency
PTFE and Dacron. rates for PTFE and Dacron.
Above-knee Fem-pop Bypass Dacron or ePTFE 461

Patients included in the trial were distributed between

100 Prothesis chronic limb ischaemia (CLI) grade I e 77% (category 1, 2
PTFE
Dacron and 3, respectively, 3%, 37% and 37%), CLI grade II e 9% and
PTFE CLI grade III e 14%, based on the Rutherford classification.
Dacron
Cumulative Secondary Patency

80 One hundred and twenty-two of the bypass grafts were

performed under general anaesthesia (62 in the ePTFE group
and 60 in the Dacron group). The remaining bypasses were
60
performed with regional anaesthesia. All patients received
heparin intra-operatively, and, in 224 limbs, the anasto-
moses of the bypass grafts were performed with prolene.
After 10 years only four (1.8%) patients were lost to
40 follow-up. There was no in-hospital mortality, but two
patients died in the first 30 days postoperatively, one in
each group. The postoperative infection grade III was 0.9%.
20 After 2, 5 and 10 years, 28 (12.8%), 70 (32.0%) and 133
(60.7%), respectively, of the initial 219 patients had died; of
whom, 22 (78.6%), 41 (58.6%) and 67 (50.4%) patients,
respectively, had a primary patent bypass.
0
Patient allocation and follow-up is outlined in Fig. 1.
0 12 24 36 48 60 72 84 96 108 120 Occlusion of the bypass graft within 30 days post-
Follow-up (months) operatively was seen in three limbs; of these, one (0.9%)
Grafts at risk: was in the ePTFE group and two (1.8%) were in the Dacron
PTFE 114 99 79 67 52 40 29 20 17 14 11 group. Overall primary patency rates were 66.2%, 49.6% and
Dacron 114 96 88 78 69 62 53 48 43 34 24 40.4% at 2, 5 and 10 years postoperatively.
The 2-year primary, primary assisted and secondary
Figure 4 KaplaneMeier analysis of secondary patency rates patency rates were 64%, 72% and 78% for ePTFE and 70%
for PTFE and Dacron. (log-rank test, p Z 0.38), 77% (log-rank test, p Z 0.33) and
84% (log-rank test, p Z 0.31) for Dacron, respectively. The
5-year primary, primary assisted and secondary patency
(n Z 67; 29.4%), hypertension (n Z 83; 36.4%), cardiac rates were 36%, 46% and 51% for ePTFE and 52% (log-rank
disease (n Z 74; 32.5%), cerebrovascular disease (n Z 27; test, p Z 0.04), 66% (log-rank test, p Z 0.01) and 70% (log-
11.8%) and smoking (n Z 110; 48.2%). Baseline character- rank test, p Z 0.01) for Dacron, respectively. The 10-year
istics were equally divided between both groups, except for primary, primary assisted and secondary patency rates
cerebrovascular disease, which was significantly lower in were 28%, 31% and 35% for ePTFE and 28% (log-rank test,
the Dacron group (Table 1). p Z 0.12), 49% (log-rank test, p Z 0.01) and 49% (log-rank

Table 3 Patency results from existing RCT on femoro-popliteal bypass comparing PTFE versus Dacron
Patients Above-knee Follow-up time Primary patency p-value Secondary patency p-value
(no) n (%) (years) PTFE (%) Dacron (%) PTFE (%) Dacron (%)
Erasmi, 1996 103 103 (100) 1.5 e e 79.6 87.1 NS
Green, 2000 240 240 (100) 5 43 45 NS 68 68 NS
Robinson, 1999 108 75 (69) 1 72 70 NS 74 78 NS
2 52 56 NS 54 70 NS
3 52 47 NS 54 53 NS
Devine, 2004a 209 179 (86) 1 66 76 NS 63 73 NS
3 49 59 NS 48 55 NS
5 41 50 NS 36 47 NS
Post, 2001 194 141 (73) 3 70 62 NS 75 81 NS
Robinson, 2003 129 76 (59) 0.5 71 50 NS 77 66 NS
1 56 36 NS 60 49 NS
2 47 36 P Z 0.00 48 46 NS
Jensen, 2007 427 427 (100) 2 57 70 P Z 0.02 65 76 P Z 0.04
Van Det, 2008 228 228 (100) 2 64 70 NS 78 84 NS
5 36 52 P Z 0.04 51 70 P Z 0.01
10 28 28 NS 35 49 P Z 0.01
a
Com, compared heparin-bonded Dacron with PTFE.
462 R.J. van Det et al.

test, p Z 0.01) for Dacron, respectively (Table 2 and Figs. patency rates for the above-knee bypasses in that study
2e4). were 71%, 54% and 45% at 1, 3 and 5 years, respectively.
After 10 years, seven above-knee amputations had been Their 5-year result resembles our overall patency of 40% at 5
performed: three (2.6%) in the ePTFE group and four (3.5%) years.8,12 It is possible that this difference in patency ach-
in the Dacron group. Below-knee amputations had been ieved between heparin-bonded Dacron and PTFE may be due
performed 4 (3.5%) times in the group with ePTFE and 5 to the influence of heparin bonding.
(4.4%) times in the Dacron group. In the most recent randomised controlled trial, Jensen
et al. found better primary and secondary graft patency
rates for Dacron as compared to PTFE. The primary and
Discussion secondary patency rates were 70% and 76% for Dacron and
57% (p Z 0.02) and 65% (p Z 0.04) for PTFE at 2 years,
This study showed that Dacron provided significantly respectively.13
improved long-term graft patency compared to ePTFE when Evidence from the present study has shown that for
used for suprageniculate femoro-popliteal bypass. a suprageniculate femoro-popliteal bypass, Dacron has
In the last decade, it has become clear that the patency significant superior primary, primary assisted and secondary
rates for venous grafts are superior to that of ePTFE for patency rates at 5 years of follow-up. After 10 years, the
femoro-popliteal bypass.1,4,8,17e19 primary patency rates approach each other; however, the
In the last three decades, nearly exclusively based on primary assisted and secondary patency rates still signifi-
personal preference and experience, opinion leaders have cantly favour the use of Dacron prosthesis.
suggested that if autologous graft material was not avail- Based on these results, we propose that Dacron should
able, PTFE was the preferred prosthetic material for fem- be preferentially used for prosthetic femoro-popliteal
oro-distal bypass surgery.19e28 However, until the present above-knee reconstructions. This graft choice is also sup-
study, there has been no conclusive evidence on which to ported by the fact that a Dacron graft is less expensive than
base the choice of prosthetic graft material for a supra- a PTFE prosthesis.
geniculate femoro-popliteal bypass. Retrospective studies Developments in graft technology continue and varia-
comparing PTFE with knitted Dacron at 5 years had tions of ePTFE and Dacron grafts with different coatings
produced varied results.23,29 Several randomised controlled have been introduced into the market. These new grafts
trials have been published comparing PTFE and Dacron, have currently not been shown to be superior to older grafts
again with varied results (Table 3).6,7,9e12 in well-conducted randomised trials.
One of the first published trials comparing PTFE and The results from our study would justify the preferential
knitted Dacron polyester suprageniculate grafts rando- use of Dacron in patients with intermittent claudication or
mised 244 patients. After 3 years, there was no statistically CLI selected to undergo femoro-popliteal bypass, where
significant difference in primary or secondary patency rates a suitable saphenous vein is absent and a distal above-knee
between the two grafts.6 In a further trial, the 5-year anastomosis is possible.
primary patency rates of PTFE and Dacron were similar;
however, different graft diameters were used in this trial, Conflicts of Interest
making interpretation of results difficult.9
Post et al. compared PTFE with Dacron prosthesis in 203
For this study we received an unrestricted grant from
patients. They included both supra- and infrageniculate
W.L. Gore & Ass., Flagstaff, AZ, and from Meadox, Oakland,
femoro-popliteal bypasses, but primary patency rates of
NJ (Boston Scientific).
both groups were analysed separately. Patency rates for
suprageniculate grafts were similar at 3 years.10
The trial of Robinson and co-workers also included both Role of Funding Source
supra- and infrageniculate femoro-popliteal bypasses. They
found no significant difference in primary and secondary None.
patency rates at 1, 2 and 3 years. The patency rates
reported in that study were considerably lower than found Acknowledgements
in the current trial.7 The same Australian group compared
fluoropolymer-coated Dacron to PTFE in 129 patients We thank J. Hermans and W. Zuijderduijn of the Depart-
receiving both above- and below-knee reconstructions and ment of Medical Statistics, University of Leiden and B.P
used grafts of different sizes. A significant difference was Bertelink of the Department of Surgery, Medisch Spectrum
reported in primary patency after 2 years in favour of PTFE Twente, Enschede, for their contribution to this trial.
(47%) over Dacron (36%), whereas the difference in
secondary patency was not significant.11
Devine et al. reported that heparin-bonded Dacron grafts Appendix
had improved patency compared to PTFE at the 3-year
follow-up (p Z 0.04). Again, this study included both supra-
and infrageniculate bypasses. When they analysed the group Other trial participants:
of the above-knee bypasses separately, the 3-year primary
patency results were 46% for PTFE and 61% for Dacron, which 1. S.G. van Baal, MD. Department of Vascular Surgery,
was significantly different (p Z 0.04). The overall primary Twenteborg Hospital, Almelo, The Netherlands.
Above-knee Fem-pop Bypass Dacron or ePTFE 463

2. J.G.J.M. van Iersel, MD. Department of Vascular 14 Mamode N, Scott RN. Graft type for femoro-popliteal
Surgery, Slingeland Hospital, Doetinchem, The bypass surgery. Cochrane Database Syst Rev 2000;(2):
Netherlands. CD001487.
3. P. van der Sar, MD. Department of Vascular Surgery, 15 Gisbertz SS, Hissink RJ, de Vries JP, Moll FL. Future
perspectives in the treatment of femoro-popliteal arte-
General Hospital Midden-Twente, Hengelo, The
rial occlusions. J Cardiovasc Surg (Torino) 2005 Aug;
Netherlands. 46(4):371e84.
4. A.A. Vafi, MD. Department of Vascular Surgery, Koningin 16 Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM,
Beatrix Hospital, Winterswijk, The Netherlands. Ahn S, et al. Recommended standards for reports dealing with
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