Randomized clinical trial

Randomized clinical trial comparing endovenous laser ablation,

radiofrequency ablation, foam sclerotherapy and surgical
stripping for great saphenous varicose veins
L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof
Danish Vein Centres, Naestved, and Surgical Centre Roskilde, Roskilde, Denmark
Correspondence to: Dr L. H. Rasmussen, Danish Vein Centres, Eskadronsvej 4A, 4700 Naestved, Denmark (e-mail: lhr@varix.dk)

Background: This randomized trial compared four treatments for varicose great saphenous veins (GSVs).
Methods: Five hundred consecutive patients (580 legs) with GSV reflux were randomized to
endovenous laser ablation (980 and 1470 nm, bare fibre), radiofrequency ablation, ultrasound-guided
foam sclerotherapy or surgical stripping using tumescent local anaesthesia with light sedation.
Miniphlebectomies were also performed. The patients were examined with duplex imaging before
surgery, and after 3 days, 1 month and 1 year.
Results: At 1 year, seven (5·8 per cent), six (4·8 per cent), 20 (16·3 per cent) and four (4·8 per cent)
of the GSVs were patent and refluxing in the laser, radiofrequency, foam and stripping groups
respectively (P < 0·001). One patient developed a pulmonary embolus after foam sclerotherapy and
one a deep vein thrombosis after surgical stripping. No other major complications were recorded.
The mean(s.d.) postintervention pain scores (scale 0–10) were 2·58(2·41), 1·21(1·72), 1·60(2·04) and
2·25(2·23) respectively (P < 0·001). The median (range) time to return to normal function was 2 (0–25),
1 (0–30), 1 (0–30) and 4 (0–30) days respectively (P < 0·001). The time off work, corrected for weekends,
was 3·6 (0–46), 2·9 (0–14), 2·9 (0–33) and 4·3 (0–42) days respectively (P < 0·001). Disease-specific
quality-of-life and Short Form 36 (SF-36 ) scores had improved in all groups by 1-year follow-up. In the
SF-36 domains bodily pain and physical functioning, the radiofrequency and foam groups performed
better in the short term than the others.
Conclusion: All treatments were efficacious. The technical failure rate was highest after foam
sclerotherapy, but both radiofrequency ablation and foam were associated with a faster recovery and less
postoperative pain than endovenous laser ablation and stripping.

Paper accepted 15 March 2011

Published online in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.7555

Introduction damage. Major complications are rare5 . Conventional

Varicose veins are common and affect approximately
25 per cent of Western adults1 . The condition is most
often associated with great saphenous vein (GSV)
reflux. Until recently, standard treatment has been
surgery, with high ligation and stripping to knee
level, combined with phlebectomies. Such treatment
efficiently reduces symptoms, improves quality of life
(QoL), and reduces the rate of reoperation compared
with high ligation and phlebectomies only2 – 4 . However,
the operation may occasionally be associated with
significant postoperative morbidity, including bleeding,
groin infection, thrombophlebitis and saphenous nerve
surgery is most often performed in hospital and using
general or regional anaesthesia, which may increase costs.
In the past decade, alternative treatments such as
endovenous ablation of the GSV with laser (EVLA),
radiofrequency ablation (RFA) and ultrasound-guided
foam sclerotherapy (UGFS) have gained popularity. Per-
formed as office-based procedures using tumescent local
anaesthesia, the new minimally invasive techniques have
been shown in numerous studies to eliminate the GSV from
the circulation safely and effectively6 – 9 . A few randomized
trials have compared the endovascular methods with con-
ventional surgery. The first-generation RFA device, VNUS

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1080 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof
TM
Closure (VNUS Medical Technologies, San Jose, Cali-
fornia, USA), had comparable efficacy to surgery, but was
associated with an earlier return to normal activity and
improved QoL in the short term. The randomized trials
of EVLA have shown efficacy comparable to surgery, but
conflicting results concerning recovery10 – 13 . Recently, an
improved version of the first generation of RFA device,
called ClosureFAST
TM
(VNUS Medical Technologies),
was introduced9 . There are only two randomized trials
comparing UGFS with surgery; they showed no differ-
ence in short-term efficacy but less postoperative pain and
earlier return to normal activities in patients treated with
UGFS8,14,15 .
The new minimally invasive methods have not pre-
viously been compared with each other and conven-
tional surgery in the same randomized trial. The aim
of this randomized trial was to compare EVLA, RFA
TM
(ClosureFAST ), UGFS and surgical stripping in patients
with varicose veins and GSV insufficiency.
Methods
The regional ethics committee approved the study, which
was designed as a consecutive randomized trial, and
conducted in two private surgical centres that work under
contract to the national healthcare system in Denmark.
Every treatment procedure was performed by one of
three experienced surgeons who had performed more
than 100 EVLA procedures, 100 UGFS treatments, 25
TM
ClosureFAST procedures and more than 1000 stripping
procedures before the start of the study. RFA was
performed in only one centre (Naestved). Consecutive
patients referred for varicose vein treatment by the family
physician were randomized in the two sites in blocks of
12 sealed envelopes to one of the four treatments. In
addition to treatment of the GSV, miniphlebectomies were
performed with the intention of removing all varicosities
during the same procedure.
Inclusion criteria were: age 18–75 years; symptomatic
varicose veins; Clinical Etiologic Anatomic Pathophys-
iologic (CEAP) class C2 – 4 Ep As Pr ; GSV incompetence,
defined by a reflux time of more than 0·5 s on duplex
imaging (Hawk 7–10-MHz probe; BK Medical, Herlev,
Denmark)16 ; and informed consent provided. The patients
were examined in the standing position, and reflux was
measured after manual compression and release of the
calf. Bilateral treatment was permitted, provided that both
legs had the same treatment during the same operation.
Patients with recurrent varicose veins were also included if
the GSV was preserved to the groin on duplex imaging.
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Exclusion criteria were: duplication of the saphenous
trunk or an incompetent anterior accessory saphenous vein;
small saphenous vein reflux (until 3 months after removal
of such a vein); previous deep vein thrombosis (DVT);
history of arterial insufficiency or ankle : brachial pressure
index below 0·9, or both; axial deep venous insufficiency
(femoral or popliteal vein, or both); and tortuous GSV
rendering the vein unsuitable for endovenous treatment.
Treatment
All treatments were performed in a treatment room under
tumescent local anaesthesia, using a solution of 0·1 per cent
lidocaine with adrenaline and bicarbonate. The solution
was administered using an infusion pump (Nouvag,
Goldach, Switzerland) under ultrasound guidance. In the
UGFS group, only the varicosities were anaesthetized.
The aim was to administer 10 ml per cm GSV tumescent
anaesthesia in the other groups. A light sedative and
analgesic (midazolam and alfentanil or diazepam) were
administered intravenously before the procedure in most
patients.
The surgical procedure was carried out through a 4–6-
cm incision in the groin, with flush ligation of the GSV
and division of all tributaries to the second level of division.
The GSV was then removed using a pin-stripper to just
below the knee.
The EVLA procedure was performed under duplex
guidance with a 980-nm diode laser (Ceralas D 980;
Biolitec, Jena, Germany) for the first 17 patients and
a 1470-nm diode laser (Ceralas D 1470) for the rest.
A bare-tip fibre was used for all EVLA treatments.
In one centre (Roskilde) the pulse mode was used (20
patients), whereas continuous mode was used in Naestved.
For thermoablation, the GSV was cannulated just below
the knee or at the lowest point of reflux on the thigh.
The laser fibre was advanced until 2 cm below the
saphenofemoral junction, after which the GSV was ablated
during withdrawal of the fibre.
The RFA procedure was performed according to the
manufacturer’s recommendations as described elsewhere9 .
In brief, the treatment consisted of segmental heating of the
GSV, using a catheter with a 7-cm heating element (VNUS
Medical Technologies). The catheter was advanced under
ultrasound guidance to 2 cm below the saphenofemoral
junction before the start of ablation. The temperature
was maintained at 120° for 20 s per segment using a
thermocouple on the heating element, which provided
a feedback loop to the generator during withdrawal.
The UGFS treatment was performed with the patient in
the reversed Trendelenburg position. A 5-Fr cannula was
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Treatments for great saphenous varicose veins
inserted in the GSV just above the knee under ultrasound
guidance. The foam consisted of a 3 per cent solution
of polidocanol (Aethoxysclerol ; Kreussler, Wiesbaden,
Germany); 2 ml solution mixed with 8 ml air was prepared
according to the method of Tessari8 . Before injection,
the table was tilted to the Trendelenburg position. The
injection of foam was monitored using ultrasound, and
continued until the foam reached the saphenofemoral
junction, and the GSV was seen to contract for its entire
length in the thigh.
As the last step of the treatment, all varicose veins were
removed by phlebectomy in all groups. Retreatment with
foam was allowed within 1 month in the UGFS group.
After the procedure, the leg was wrapped in sterile
absorbent bandages and covered with a cohesive compres-
sion bandage for 48 h. In the UGFS group the patients
were then instructed to use a 30-mmHg compression stock-
ing to the groin, whereas the other patients used a short
20-mmHg stocking, for 2 weeks. No specific analgesia was
prescribed. All patients were encouraged to resume work
and normal activity as soon as they were able.
Assessments
The patients were examined at the time of randomization,
and after 3 days, 1 month and 1 year. It is intended to
continue follow-up yearly for 5 years after the treatment.
At the initial visit, the surgeon obtained the medical
history, performed a clinical and duplex examination, and
determined the CEAP class and Venous Clinical Severity
Score (VCSS)17,18 . The duration of reflux and the diameter
of the GSV 3 cm below the saphenofemoral junction
were measured. The Aberdeen Varicose Vein Symptom
Severity Score (AVVSS) and the Medical Outcomes Study
Short Form 36 (SF-36 ; QualityMetric, Lincoln, Rhode
Island, USA) health-related QoL score were completed
by the patients and recorded. The AVVSS is a validated
instrument for measurement of disease-specific QoL in
patients with varicose veins. It produces a score from 0
(no venous symptoms) to 100 (worst venous symptoms)19 .
The SF-36 is a generic QoL instrument, which consists
of eight domains: physical functioning, role – physical,
bodily pain, general health, vitality, social functioning,
role – emotional and mental health. Each domain is scored
form 0 (worst) to 100 (best)20 .
At all subsequent visits, the patients were examined
clinically and with duplex imaging by the surgeon. They
were asked to indicate the exact date of return to work and
normal activity. The technical result and complications
were recorded, and patients completed the AVVSS and
the SF-36 . The patients also registered a pain score on
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1081
a visual analogue scale from 0 (no pain) to 10 (worst
imaginable pain) for the first 10 days after treatment21 .
The research nurse recorded the pain score, AVVSS and
SF-36 responses, and a statistician calculated the scores.
Criteria for technical success were closed or absent
GSV with lack of flow. A recanalized GSV or treatment
failure was defined as an open part of the treated vein
segment more than 10 cm in length. Complications were
regarded as minor if they required no therapy, and major
if they required treatment, admission to hospital, or led to
permanent adverse sequelae or death.
Calculation of costs was based on the standard
reimbursement for high ligation and stripping, with the
addition of the costs of equipment for thermoablation and
the standard salary and productivity level in Denmark. The
impact of sick leave on costs was corrected for weekends.
Statistical analysis
The primary endpoint for the study was GSV closure, and
secondary endpoints were pain, absence from work and
normal activity, scores for SF-36 , AVVSS and VCSS, and
recurrence rates. A priori sample size calculations indicated
that, to detect a 15 per cent difference in closed or absent
GSVs between the groups with α = 5 and β = 80, 60 legs
would be needed in each group. With respect to pain
score and the bodily pain domain in SF-36 , 46 patients
in each group would be necessary to describe a significant
difference of 20 per cent.
Efficacy and safety were assessed for the full analysis set,
comprising all patients undergoing treatment. Descriptive
summary statistics were used for safety analysis. The
primary endpoint was analysed using logistic regression.
ANCOVA models with repeated measurements were used
for analysis of efficacy endpoints, AVVSS, SF-36 scores
and pain scores. The time from treatment to resumption
of work or normal activity was analysed using log rank
statistics. The Kruskal–Wallis test was used to compare
VCSS values. Significance was set at the 5 per cent level.
The analyses were performed in SAS version 9.1 (SAS
Institute, Cary, North Carolina, USA).
Results
Between February 2007 and July 2009, 500 consecutive
patients (580 legs) were randomized to receive treatment
(Fig. 1) There was no difference between the groups
regarding the numbers lost or length of follow-up. The four
groups were well matched for demographic data, CEAP
class and GSV details (Table 1). The energy deposition in
the EVLA group and volume of foam used per leg is also
shown in Table 1.
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1082 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof

Assessed for eligibility n = 1223 Excluded n = 723

Enrolment Did not meet inclusion
criteria or, declined to
Randomized n = 500 (580 legs) participate

Allocated to EVLA Allocated to RFA Allocated to UGFS Allocated to stripping

n = 125 (144 legs) n = 125 (148 legs) n = 125 (145 legs) n = 125 (143 legs)
Allocation

Received intervention Received intervention Received intervention Received intervention

n = 125 (144 legs) n = 125 (148 legs) n = 124 (144 legs) n = 124 (142 legs)
Did not receive Did not receive Did not receive Did not receive
intervention n = 0 intervention n = 0 intervention n = 1 (1 leg) intervention n = 1 (1 leg)
(0 legs) (0 legs) Patient’s wishes n = 1 Dizziness n = 1

Completed follow-up at 3 Completed follow-up at 3 Completed follow-up at 3 Completed follow-up at 3

days n = 124 (143 legs) days n = 124 (146 legs) days n = 123 (143 legs) days n = 123 (141 legs)
Lost to follow-up or not Lost to follow-up or not Lost to follow-up or not Lost to follow-up or not
seen n = 1 (1 leg) seen n = 1 (2 legs) seen n = 1 (1 leg) seen n = 1 (1 leg)

Completed follow-up at 1 Completed follow-up at 1 Completed follow-up at 1 Completed follow-up at 1

Follow-up

month n = 125 (144 legs) month n = 121 (141 legs) month n = 124 (144 legs) month n = 119 (135 legs)
Lost to follow-up or not Lost to follow-up or not Lost to follow-up or not Lost to follow-up or not
seen n = 0 (0 legs) seen n = 4 (7 legs) seen n = 0 (0 legs) seen n = 5 (7 legs)

Completed follow-up at 1 Completed follow-up at 1 Completed follow-up at 1 Completed follow-up at 1

year n = 107 (121 legs) year n = 106 (124 legs) year n = 107 (123 legs) year n = 97 (108 legs)
Lost to follow-up or not Lost to follow-up or not Lost to follow-up or not Lost to follow-up or not
seen n = 18 (23 legs) seen n = 19 (24 legs) seen n = 17 (21 legs) seen n = 27 (34 legs)

Fig. 1CONSORT diagram for the trial. EVLA, endovenous laser ablation; RFA, radiofrequency ablation; UGFS, ultrasound-guided
foam sclerotherapy

Primary outcome measure: failure rates
The number of GSVs that were patent or not stripped
successfully at follow-up is shown in Table 2. Significantly
more GSVs were open and refluxing at 1 year in the UGFS
group than in the other groups (P < 0·001). There was no
statistically significant difference in patent GSVs in the
three other groups (P = 0·543). Four stripping procedures
failed because the veins broke and could not be retrieved
from below the knee. All recanalized GSVs had flow and
were refluxing, except one in the EVLA group, which was
open at 1 year, contracted but not refluxing. The five GSVs
that were open in the foam group during the first month
were re-treated with foam sclerotherapy. After the first
month, no further sclerotherapy was allowed. Fourteen
(11·6 per cent), nine (7·3 per cent), 17 (13·8 per cent) and
16 (14·8 per cent) legs had recurrent varicose veins at 1-
year follow-up in the EVLA, RFA, UGFS and stripping
group respectively (P = 0·155).
Complications
Complications were mostly minor (Table 3). Only two
events were classified as major complications. One patient
had an iliac vein thrombosis and pulmonary embolus
within 1 week of UGFS. The patient was subsequently
treated with catheter-directed thrombolysis. The other had
thrombosis of the popliteal vein within the first month after
stripping. Significantly more patients in the RFA and foam
groups developed postintervention superficial phlebitis. It
was not recorded specifically whether the phlebitis was
related to the GSV or the tributaries.

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Treatments for great saphenous varicose veins 1083

Table 1 Demographic data and treatment characteristics for patients with varicose veins and great saphenous vein incompetence

EVLA RFA UGFS Stripping

No. of patients 125 125 124 124

No. of legs 144 148 144 142
Bilateral veins 19 23 20 18
Age (years)* 52 (18–74) 51 (23–75) 51 (18–75) 50 (19–72)
Women (%) 72 70 76 77
CEAP C2–C3 (legs) 95 92 96 97
CEAP C4–C6 (legs) 5 8 4 3
Previous surgery 9 7 4 8
GSV diameter (mm)* 7·6 (3–12) 7·2 (3–12) 8·7 (3–20) 7·8 (3–14)
Length of treated GSV (cm)* 35 (14–49) 34 (13–51) — —
Energy (J/cm)* 76·5 (43–128) — — —
Volume of foam (ml)* — — 8 (4–15) —
No. of phlebectomies* 14 (1–43) 16 (10–80) 15 (1–43) 15 (1–48)
Tumescence (ml)* 293 (50–650) 335 (32–690) 8·5 (4–100) 316 (50–900)
Surgeon’s time (min)* 26 (12–80) 27 (12–80) 19 (5–145) 32 (15–80)

*Values are mean (range). EVLA, endovenous laser ablation; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy; CEAP,
Clinical Etiologic Anatomic Pathophysiologic; GSV, great saphenous vein.

Table 2 Failure rates up to 1 year after treatment of varicose veins Table 3 Complications in the first month after treatment of
varicose veins
EVLA RFA UGFS Stripping P*
EVLA RFA UGFS Stripping
3 days 0 (0) 0 (0) 3 (2·1) 4 (2·8) 0·053
1 month 1 (0·7) 0 (0) 2 (1·4) 3 (2·2) 0·202 Major
1 year 7 (5·8) 6 (4·8) 20 (16·3) 4 (4·8) < 0·001 Deep vein thrombosis 0 0 1* 1
Pulmonary embolism 0 0 1* 0
Values in parentheses are percentage of legs. Failure was defined as a Minor
patent great saphenous vein (GSV) with reflux, or GSV not stripped Phlebitis 4 12 17 5
successfully. EVLA, endovenous laser ablation; RFA, radiofrequency Infection 0 1 4 1
ablation; UGFS, ultrasound-guided foam sclerotherapy. *χ2 test. Paraesthesia 3 6 2 5
Hyperpigmentation 3 8 8 6
Haemorrhage 1 0 1 1
Secondary outcome measures
*Same patient. EVLA, endovenous laser ablation; RFA, radiofrequency
Pain scores ablation; UGFS, ultrasound-guided foam sclerotherapy. There was a
The sequence of pain scores during the first 10 days after significant difference in the incidence of phlebitis (P = 0·006, Fisher’s
the procedure is shown in Fig. 2. Patients in the RFA and exact test).
UGFS groups reported significantly less postoperative pain
than those in the EVLA and stripping groups (P < 0·001).
significant difference between laser treatment and surgery
Mean(s.d.) pain scores during the first 10 days were
concerning return to normal activities and work (P = 0·184
2·58(2·41), 1·21(1·72), 1·60(2·04) and 2·25(2·23) in the
and P = 0·258 respectively).
EVLA, RFA, UGFS and stripping groups respectively.
There was no statistically significant difference between
EVLA and stripping or between RFA and UGFS. The Venous Clinical Severity Score
number of phlebectomies did not significantly influence the The mean scores improved significantly after the procedure
pain scores (P = 0·136). Among patients who had EVLA, in all groups, with no significant difference between them
there was no significant difference in pain scores between (P < 0·001). Although the score improved in the majority
treatments with the two different laser wavelengths. of patients, one, one, seven and two patients had a worse
score after EVLA, RFA, UGFS and stripping respectively.
Return to normal activities and work
The time to resumption of normal activities and work Aberdeen Varicose Vein Symptom Severity Score
was shorter in the groups treated with RFA and UGFS The score improved significantly in all groups from
than in the EVLA and stripping groups (P < 0·001 for 1 month after surgery, with no difference between groups
both RFA and UGFS) (Table 4). There was no statistically at any time (Fig. 3).

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1084 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof

10 Table 4 Time to resume normal activities and work, and cost of

EVLA UGFS
9 RFA Stripping
treatments
8
EVLA RFA UGFS Stripping
7
Pain score

6 Time to resume 2 (0–25) 1 (0–30) 1 (0–30) 4 (0–30)

5 normal activity
(days)*
4
Time to resume 3·6 (0–46) 2·9 (0–14) 2·9 (0–33) 4·3 (0–42)
3 work (days)*
2 Procedure-related
1 costs (¤)
Pretreatment 189 189 189 189
0
1 2 3 4 5 6 7 8 9 10 examination
Time after treatment (days) Reimbursement 644 644 644 729
Laser equipment 366 — — —
Radiofrequency — 442 — —
Fig. 2Mean(s.d.) pain scores on a visual analogue scale from 0 to
equipment
10 for the first 10 days after treatment of varicose veins with Control duplex 161 161 161 161
endovenous laser ablation (EVLA), radiofrequency ablation imaging
(RFA), ultrasound-guided foam sclerotherapy (UGFS) and Total 1360 1436 994 1079
surgical stripping. P = 0·012 (ANOVA) Indirect costs (¤)
Lost work 840 560 560 1120
Total costs (¤) 2200 1996 1554 2199
60 EVLA UGFS
RFA Stripping *Values are median (range). Time to return to work was corrected for
50 weekends. EVLA, endovenous laser ablation; RFA, radiofrequency
ablation; UGFS, ultrasound-guided foam sclerotherapy.
Aberdeen score

40
Costs
30 A comparison of costs is shown in Table 4. The calculations
were based on the reimbursement and productivity level
20 in Denmark. Procedure-related costs were highest in the
RFA group because of the higher cost of the catheter, and
10 lowest in the UGFS group. When the cost of lost work
was included in the total costs, UGFS was the cheapest,
0 whereas EVLA and stripping were the most expensive
Baseline 3 days 1 month 1 year
procedures.
Time after treatment

Fig. 3 Mean(s.d.) disease-specific quality-of-life score (AVVSS) Discussion

up to 1 year after treatment of varicose veins with endovenous
laser ablation (EVLA), radiofrequency ablation (RFA),
ultrasound-guided foam sclerotherapy (UGFS) and surgical
stripping
Short Form 36 results
For all the groups and in all domains, there was a statistically
significant improvement in most scores from pretreatment
to 1 year (Table S1, supporting information). At 3 days,
a clear reduction in scores was seen in all groups but,
for the domains bodily pain, physical functioning and
role – physical, patients treated with radiofrequency and
foam had significantly better scores than the other two
groups, indicating that patients in the stripping and EVLA
groups had more pain and discomfort at 3 days. At 1 month,
the difference between groups had disappeared.
Minimally invasive methods for ablation of the GSV
have gained increasing popularity in the treatment of
varicose veins. In the USA and elsewhere the endovenous
techniques have more or less replaced conventional
surgery. Although no longer-term randomized trials
comparing the different methods with conventional
surgery have been published, EVLA, RFA and UGFS
have previously been compared with each other or with
conventional surgery in randomized trials with short- and
medium-term follow-up. Until now, no single trial has
studied all methods together, and only two short-term
TM
studies have compared the ClosureFAST device with
EVLA22,23 .
The present study demonstrated no difference in EVLA,
RFA and stripping with regard to eliminating the GSV.

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Treatments for great saphenous varicose veins
The failure rates in the present trial compare well with the
rates published in most other studies11,24,25 . In the present
trial approximately 5 per cent of the GSVs were open and
refluxing after 1 year in the stripping and thermoablation
groups. A recent meta-analysis described failure rates
of 9–28 per cent 1 year after surgery, EVLA, RFA and
UGFS25 . A higher level of energy in the thermoablation
groups, and the use of a flexible wire stripper with a
large olive in the stripping group, might have prevented
some of the failures26 . Still, complications might then have
increased, and a higher energy dose than used in the present
study is not recommended. Most cases of recanalized or
missed GSVs can easily be treated later with UGFS if
necessary. With regard to elimination of the GSV in the
present study, UGFS was significantly less efficient than
the other methods; 16·3 per cent of the GSVs treated with
foam were patent and refluxing after 1 year. The protocol
allowed one extra sclerotherapy session if the GSV was
patent during the first month, and five patients were
re-treated accordingly. It is likely, however, that further
sessions of sclerotherapy might have reduced the number
of failures at 1 year. In addition, it may be speculated
that a larger volume than the mean of 8 ml foam per leg
used in the present patients might also have improved the
results8 . Still, as in the case of thermoablation, the risk of
complications might then increase. In a recent consensus
meeting in Europe, it was recommended not to use volumes
of foam above 10 ml per GSV per session27 . As the patients
are followed, time will show whether the failures represent
a relevant clinical problem. Because most of the GSVs
in the present study were invisible on ultrasound imaging
after 1 year, it is not expected that there will be many cases
of recanalization later. Thus, the present findings confirm
previous suggestions that all four treatments are efficacious
with regard to elimination of the GSV, but that surgery
and thermoablation are more efficient than foam.
The recurrent varicose veins seen in this study had
minor clinical relevance at 1-year follow-up. The frequency
of recurrent varicose veins was not significantly different
between the groups. Recurrence is well described after
standard surgery but not so much in studies of endovenous
ablation. The present study has confirmed previous
findings that about 10 per cent of patients may develop new
varices within the first year after endovenous ablation28 .
Complications were few and mostly minor. Still, one
DVT occurred after foam sclerotherapy and one after
surgery. Thrombus extension into the common femoral
vein has been reported before11 , but was not seen in this
study. This was probably because the tip of the fibre or
catheter was kept 2 cm from the saphenofemoral junction
in the thermoablation groups. This distance is currently a
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Published by John Wiley & Sons Ltd
1085
generally accepted standard. Because the patients were
examined clinically and with ultrasonography at each
follow-up visit, relevant complications were unlikely to pass
undetected. It is noteworthy that no groin infections were
reported in the stripping group. There were significantly
more cases of superficial phlebitis in the UGFS and
RFA groups; phlebitis is a relatively frequently reported
complication of foam sclerotherapy but not so much of
RFA8,23 . Nevertheless, the phlebitis had little clinical
relevance. It is possible that use of 1 per cent polidocanol
instead of 3 per cent might have reduced the rate of
superficial phlebitis in the foam group without jeopardizing
the efficacy of sclerotherapy29 .
Although most patients consider postoperative pain
after varicose vein treatment acceptable, it is sometimes
quite unpleasant and may occasionally be severe. It also
influences recovery, including time off work. Patients
treated with UGFS and RFA experienced significantly
less postoperative pain than those who had laser
treatment and conventional surgery, confirming previous
observations8,10,22,23 . There was no significant difference
in efficacy, complications and recovery between the two
wavelengths of laser used in the study. EVLA is thought
to lead to more postoperative pain than RFA because the
laser beam sometimes perforates the vein wall. This may
be particularly true when a bare cutting fibre is used.
Modification of the fibre tip, by use of a radial emitting
fibre in combination with a 1470-nm laser, has been shown
to reduce postoperative pain and bruising30 .
Return to normal activities and work was influenced
by the method of treatment. The shortest time to return
was seen in the radiofrequency and foam groups. Easier
recovery after RFA, UGFS and EVLA compared with
surgery has been reported previously10,31 . Although the
recovery time was short in patients who had conventional
surgery compared with previous findings, the patients
treated with endovenous ablation fared even better24 .
When stripping is performed using ultrasound-guided
tumescent anaesthesia the recovery rate might improve.
Return to work is influenced by employment and social
status as well as the treatment32 . These parameters were not
examined here, but the fact that time off work and normal
activities correlated well in the present study strengthens
the conclusion that RFA and UGFS are gentler to the
patient than conventional surgery.
The mean VCSS improved similarly in all groups,
confirming that all four treatments are efficacious28 .
Similarly, QoL improved significantly following treatment
in all the groups as indicated by the AVVSS and most
SF-36 domain scores. Such improvement in QoL after
treatment of varicose veins is well known20 .
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1086 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof
The mean cost per treatment was lowest in the UGFS
group and highest in the thermoablation groups. However,
the reduced time off work in the endovenous group reduced
the total costs compared with surgery. The extra cost of
the fibre and catheter in the thermoablation groups was
offset by the reduction in time off work. It should be noted,
however, that the costs presented here are short term, and
it was not possible to estimate the cost of treatment failures
that may emerge later. It should also be emphasized that
the cost calculations were based on the fixed procedure-
related price system and productivity level in Denmark.
Thus, the cost comparisons may not apply directly to other
countries.
One shortcoming of the present study is that,
for practical reasons, the treatment and follow-up
examinations were not blinded. However, the patients
completed the QoL questionnaires, including drawing
new varices on the AVVSS form and recording pain
scores, before examination by the surgeon. Furthermore,
the patient information sheet was neutral in tone and,
as requested by the ethics committee, did not favour
any of the treatments. In addition, at 1 year it was most
often impossible, on ultrasonography, to see any difference
between the groups because the GSV was absent. A further
limitation is the variation in technique within the laser
group, for example retraction of the laser fibre in pulse
mode in 20 patients and treatment of 17 patients with a
980-nm instead of a 1470-nm laser generator. However,
subanalysis did not show any difference between the two
wavelengths.
The present study was powered to detect a 15 per cent
difference in failure rate between the groups as this
difference is clinically relevant. Such a significant difference
was demonstrated and, accordingly, the present study was
a robust comparison of the four treatments.
Acknowledgements
The authors thank Julie Serup and Birgit Lawaetz
for skilful logistic handling and database management.
This study was financed by a grant from the Public
Health Insurance Research Foundation of Denmark.
Radiofrequency equipment was provided by VNUS
Medical Technologies. The authors declare no conflict
of interest.
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Supporting Information

Additional supporting information may be found in the online version of this article:
Table S1 Short Form 36 health-related quality-of-life outcomes after treatment of varicose veins with endovenous
ablation, radiofrequency ablation, ultrasound-guided foam sclerotherapy or surgical stripping (Word document)
Please note: John Wiley & Sons Ltd is not responsible for the functionality of any supporting materials supplied
by the authors. Any queries (other than missing material) should be directed to the corresponding author for the
article.

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Published by John Wiley & Sons Ltd
1088 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof

Commentary

Randomized clinical trial comparing endovenous laser ablation,

radiofrequency ablation, foam sclerotherapy and surgical stripping
for great saphenous varicose veins (Br J Surg 2011; 98: 1079–1087)

This well conducted randomized controlled trial by Rasmussen and colleagues is the first to compare endovenous laser
ablation, radiofrequency ablation, ultrasound-guided foam sclerotherapy and surgery of the great saphenous system
directly. It highlights the effectiveness of all treatment modalities in improving the impaired quality of life noted in
patients with varicose veins1 .
Foam sclerotherapy was found to be less effective in obliterating the great saphenous vein, but despite this the
improvements in quality of life, clinical success and recurrence rates were comparable to those of the other treatments. In
the short term foam sclerotherapy was substantially cheaper, despite the fact that the reimbursement for this procedure in
Denmark appears to be equivalent to that of the more time-consuming endothermal treatment options. Given the similar
benefit with regard to patient-reported outcomes, and the ease with which treatment can be repeated, foam sclerotherapy
will be considered by many to remain the preferred treatment option.
Despite the findings in favour of radiofrequency ablation compared with laser therapy in terms of postoperative pain and
earlier return to work, the debate regarding the most cost-effective method of thermal ablation will continue. Proponents
of laser therapy argue that the use of a radial-tip fibre would result in equivalent recovery2 .
A surprising finding of this study was the quick return to work and lower costs associated with surgery and
stripping performed under tumescent anaesthesia and light sedation. Furthermore, the incidence of paraesthesia and
hyperpigmentation was comparable for surgery and radiofrequency ablation.
A meta-analysis has shown that laser therapy has the highest anatomical success rates up to 3 years3 . However, longer-
term data regarding more meaningful outcomes such as quality of life and cost-effectiveness, which will be available from
this study, are required to determine which treatment should be offered.

J. Brittenden
Department of Vascular Surgery, University of Aberdeen, c/o ward 36, Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 2ZN, UK
(e-mail: j.brittenden@abdn.ac.uk)
DOI: 10.1002/bjs.7572

References

1 Davies AH, Berridge DC, Bradbury AW, Stansby G. VEnous INtervention (VEIN) 2 Project: Introduction. Phlebology 2010;
25(Suppl 1): 1.
2 Doganci S, Demirkilic U. Comparison of 980 nm laser and bare tip fibre with 1740 nm laser and radial fibre in the treatment of great
saphenous vein varicosities: a prospective randomised clinical trial. Eur J Vasc Endovasc Surg 2010; 40: 254–259.
3 van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a
meta-analysis. J Vasc Surg 2009; 49: 230–239.

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