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Meta-Analysis
. 2021 Aug 11;8(8):CD005624.
doi: 10.1002/14651858.CD005624.pub4.

Interventions for great saphenous vein incompetence

Jade Whing #  1 , Sandip Nandhra #  1 , Craig Nesbitt  1 , Gerard Stansby  1
Affiliations
Meta-Analysis

Interventions for great saphenous vein incompetence

Jade Whing et al. Cochrane Database Syst Rev. .

Abstract

Background: Great saphenous vein (GSV) incompetence, causing varicose veins and venous insufficiency, makes up the majority of lower-limb superficial venous diseases. Treatment options for GSV incompetence include surgery (also known as high ligation and stripping), laser and radiofrequency ablation, and ultrasound-guided foam sclerotherapy. Newer treatments include cyanoacrylate glue, mechanochemical ablation, and endovenous steam ablation. These techniques avoid the need for a general anaesthetic, and may result in fewer complications and improved quality of life (QoL). These treatments should be compared to inform decisions on treatment for varicosities in the GSV. This is an update of a Cochrane Review first published in 2011.

Objectives: To assess the effects of endovenous laser ablation (EVLA), radiofrequency ablation (RFA), endovenous steam ablation (EVSA), ultrasound-guided foam sclerotherapy (UGFS), cyanoacrylate glue, mechanochemical ablation (MOCA) and high ligation and stripping (HL/S) for the treatment of varicosities of the great saphenous vein (GSV).

Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 2 November 2020. We undertook reference checking to identify additional studies.

Selection criteria: We included randomised controlled trials (RCTs) treating participants for varicosities of the GSV using EVLA, RFA, EVSA, UGFS, cyanoacrylate glue, MOCA or HL/S. Key outcomes of interest are technical success, recurrence, complications and QoL.

Data collection and analysis: Two review authors independently selected trials, applied Cochrane's risk of bias tool, and extracted data. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and assessed the certainty of evidence using GRADE.

Main results: We identified 11 new RCTs for this update. Therefore, we included 24 RCTs with 5135 participants. Duration of follow-up ranged from five weeks to eight years. Five comparisons included single trials. For comparisons with more than one trial, we could only pool data for 'technical success' and 'recurrence' due to heterogeneity in outcome definitions and time points reported. All trials had some risk of bias concerns. Here we report the clinically most relevant comparisons. EVLA versus RFA Technical success was comparable up to five years (OR 0.98, 95% CI 0.41 to 2.38; 5 studies, 780 participants; moderate-certainty evidence); over five years, there was no evidence of a difference (OR 0.85, 95% CI 0.30 to 2.41; 1 study, 291 participants; low-certainty evidence). One study reported recurrence, showing no clear difference at three years (OR 1.53, 95% CI 0.78 to 2.99; 291 participants; low-certainty evidence), but a benefit for RFA may be seen at five years (OR 2.77, 95% CI 1.52 to 5.06; 291 participants; low-certainty evidence). EVLA versus UGFS Technical success may be better in EVLA participants up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low-certainty evidence), and over five years (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low-certainty evidence). There was no clear difference in recurrence up to three years and at five years (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; and OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low-certainty evidence, respectively). EVLA versus HL/S Technical success may be better in EVLA participants up to five years (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low-certainty evidence). No clear difference in technical success was seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low-certainty evidence). Recurrence was comparable within three years and at 5 years (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; and OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate-certainty evidence, respectively). RFA versus MOCA There was no clear difference in technical success (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low-certainty evidence), or recurrence (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low-certainty evidence). Long-term data are not available. RFA versus HL/S No clear difference in technical success was detected up to five years (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low-certainty evidence); over five years, there was no evidence of a difference (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low-certainty evidence). No clear difference in recurrence was detected up to three years (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate-certainty evidence); but a possible long-term benefit for RFA was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low-certainty evidence). UGFS versus HL/S Meta-analysis showed a possible benefit for HL/S compared with UGFS in technical success up to five years (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low-certainty evidence), and over five years (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate-certainty evidence). No clear difference was detected in recurrence up to three years (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low-certainty evidence), and after five years (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low-certainty evidence). Complications were generally low for all interventions, but due to different definitions and time points, we were unable to draw conclusions (very-low certainty evidence). Similarly, most studies evaluated QoL but used different questionnaires at variable time points. Rates of QoL improvement were comparable between interventions at follow-up (moderate-certainty evidence).

Authors' conclusions: Our conclusions are limited due to the relatively small number of studies for each comparison and differences in outcome definitions and time points reported. Technical success was comparable between most modalities. EVLA may offer improved technical success compared to UGFS or HL/S. HL/S may have improved technical success compared to UGFS. No evidence of a difference was detected in recurrence, except for a possible long-term benefit for RFA compared to EVLA or HL/S. Studies which provide more evidence on the breadth of treatments are needed. Future trials should seek to standardise clinical terminology of outcome measures and the time points at which they are measured.

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Conflict of interest statement

JW: none known SN: none known CN: none known GS: none known

Figures

1
1
Study flow diagram
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies
3
3
Methodological quality summary: review authors' judgements about methodological quality for each domain for each included study
1.1
1.1. Analysis
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 1: Technical success < 5 years
1.2
1.2. Analysis
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 2: Long‐term technical success > 5 years
1.3
1.3. Analysis
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 3: Recurrence
1.4
1.4. Analysis
Comparison 1: Endovenous laser ablation versus radiofrequency ablation, Outcome 4: Long‐term recurrence > 5 years
2.1
2.1. Analysis
Comparison 2: Endovenous laser ablation versus endovenous steam ablation, Outcome 1: Technical success < 5 years
3.1
3.1. Analysis
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 1: Technical success < 5 years
3.2
3.2. Analysis
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 2: Technical success > 5 years
3.3
3.3. Analysis
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 3: Recurrence
3.4
3.4. Analysis
Comparison 3: Endovenous laser ablation versus ultrasound‐guided foam sclerotherapy, Outcome 4: Long‐term recurrence > 5 years
4.1
4.1. Analysis
Comparison 4: Endovenous laser ablation versus cyanoacrylate glue, Outcome 1: Technical success < 5 years
4.2
4.2. Analysis
Comparison 4: Endovenous laser ablation versus cyanoacrylate glue, Outcome 2: Recurrence
5.1
5.1. Analysis
Comparison 5: Endovenous laser ablation versus mechanochemical ablation, Outcome 1: Technical success < 5 years
5.2
5.2. Analysis
Comparison 5: Endovenous laser ablation versus mechanochemical ablation, Outcome 2: Recurrence
6.1
6.1. Analysis
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 1: Technical success < 5 years
6.2
6.2. Analysis
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 2: Technical success > 5 years
6.3
6.3. Analysis
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 3: Recurrence
6.4
6.4. Analysis
Comparison 6: Endovenous laser ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 4: Long‐term recurrence > 5 years
7.1
7.1. Analysis
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 1: Technical success < 5 years
7.2
7.2. Analysis
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 2: Long‐term technical success > 5
7.3
7.3. Analysis
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 3: Recurrence
7.4
7.4. Analysis
Comparison 7: Radiofrequency ablation versus ultrasound‐guided foam sclerotherapy, Outcome 4: Long‐term recurrence > 5 years
8.1
8.1. Analysis
Comparison 8: Radiofrequency ablation versus cyanoacrylate glue, Outcome 1: Technical success < 5 years
9.1
9.1. Analysis
Comparison 9: Radiofrequency ablation versus mechanochemical ablation, Outcome 1: Technical success < 5 years
9.2
9.2. Analysis
Comparison 9: Radiofrequency ablation versus mechanochemical ablation, Outcome 2: Recurrence
10.1
10.1. Analysis
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 1: Technical success < 5 years
10.2
10.2. Analysis
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 2: Technical success > 5 years
10.3
10.3. Analysis
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 3: Recurrence
10.4
10.4. Analysis
Comparison 10: Radiofrequency ablation versus SFJ ligation and stripping (HL/S, surgery), Outcome 4: Long‐term recurrence > 5 years
11.1
11.1. Analysis
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 1: Technical success < 5 years
11.2
11.2. Analysis
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 2: Technical success > 5 years
11.3
11.3. Analysis
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 3: Recurrence
11.4
11.4. Analysis
Comparison 11: Ultrasound‐guided foam sclerotherapy versus SFJ ligation and stripping (HL/S, surgery), Outcome 4: Long‐term recurrence (≥ 5 years)
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Calik 2019 {published data only}
    1. Calik ES, Arslan U, Erkut B. Ablation therapy with cyanoacrylate glue and laser for refluxing great saphenous veins - a prospective randomised study. VASA. Zeitschrift fur Gefasskrankheiten. Journal for Vascular Diseases 2019;48(5):405-12. - PubMed
Darwood 2008 {published data only}
    1. Beale R, Theivacumar N, Mavor AID, Gough MJ. Endovenous Laser Treatment (EVLT) or surgery of varicose veins? A randomised controlled trial in patients with saphenofemoral and long saphenous incompetence. The Vascular Society of Great Britain and Ireland Yearbook 2005:77.
    1. Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. British Journal of Surgery 2008;95(3):294-301. - PubMed
EVOLVeS 2003 {published data only}
    1. Lurie F, Creton D, Eklof B, et al. Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): 2-year follow-up. Journal of Vascular Surgery 2005;42(1):178. - PubMed
    1. Lurie F, Creton D, Eklof B, Kabnick L, Kistner R, Pichot O, et al. Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and stripping (evolves study): early results and one year follow-up. In: European Society for Vascular Surgery, Programme and Abstract Book, XVII Annual Meeting and Course on Vascular Surgical Techniques. Dublin, Ireland, 2003:74-5.
    1. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up. European Journal of Vascular and Endovascular Surgery 2005;29(1):67-73. - PubMed
    1. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). Journal of Vascular Surgery 2003;38(2):207-14. - PubMed
Flessenkämper 2013 {published data only}
    1. Flessenkämper I, Hartmann M, Hartmann K, Stenge D, Roll S. Endovenous laser ablation with and without high ligation compared to high ligation and stripping for treatment of great saphenous varicose veins: results of a multicentre randomised controlled trial with up to 6 years follow-up. Phlebology 2016;31(1):23-33. [DOI: 10.1177/0268355514555547] - DOI - PubMed
    1. Flessenkämper I, Hartmann M, Stenger D, Roll S. Endovenous laser ablation with and without high ligation compared with high ligation and stripping in the treatment of great saphenous varicose veins: initial results of a multicentre randomized controlled trial. Phlebology 2013;28(1):16-23. - PubMed
    1. Flessenkaemper I, Hartmann M, Stenger D. RCT for differentiated open and endoluminal therapies for degenerative disease of the great saphenous vein. Union Internationale de Phlebologie World Congress 2009.
    1. Flessenkamper I, Stenger D, Hartmann M, Roll S. Endovenous laser therapy vs. high ligation/stripping for varicosity of the great saphenous vein: clinical and sonographic findings. Phlebologie 2013;42(1):7-11.
FOAM 2010 {published data only}
    1. Lam L, Lawson JA, Toonder IM, Shadid NH, Sommer A, Veenstra M, et al. Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein. British Journal of Surgery 2018;105:692-98. - PubMed
    1. NCT01103258. Cost minimization study comparing surgery versus duplex guided foam sclerotherapy of varicose veins (FOAM Study). clinicaltrials.gov/ct2/show/NCT01103258 (first received 14 April 2010).
    1. Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. British Journal of Surgery 2012;99(8):1062-70. - PubMed
    1. Shadid N, Nelemans P, Sommer A. Duplex guided foam sclerotherapy vs surgery for the incompetent great saphenous vein: a randomised controlled trial. Phlebology 2010;25:306-7.
Helmy ElKaffas 2011 {published data only}
    1. Helmy ElKaffas K, ElKashef O, ElBaz W. Great saphenous vein radiofrequency ablation versus standard stripping in the management of primary varicose veins - a randomized clinical trial. Angiology 2011;62(1):49-54. - PubMed
HELP‐1 2011 {published data only}
    1. Carradice D, Mekako A, Hatfield J, Chetter I. Recurrent varicose veins are more common following surgery than EVLT - results of a randomised controlled trial. The Vascular Society of Great Britain and Ireland Yearbook 2009:86.
    1. Carradice D, Mekako AI, Hatfield J, Chetter IC. A randomised trial of EVLT vs surgery for varicose veins. The Vascular Society of Great Britain and Ireland Yearbook 2008:91.
    1. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. British Journal of Surgery 2011;98(8):1117-23. - PubMed
    1. Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. British Journal of Surgery 2011;98(4):501-10. - PubMed
    1. Carradice D, Wallace T, Samuel N, Gohil R, Chetter I. A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency. Vascular Society of Great Britain and Ireland Yearbook 2012:38. - PubMed
Lane 2017 {published data only}
    1. Bootun R, Lane TR, Dharmarajah B, Lim CS, Najem M, Renton S, et al. Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: the multicentre Venefit TM versus ClariVein® for varicose veins trial. Phlebology 2016;31(1):61-5. - PubMed
    1. Lane T, Bootun R, Dharmarajah B, Lim CS, Najem M, Renton S, et al. A multi-centre randomised controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins - final results of the Venefit versus Clarivein for varicose veins trial. Phlebology 2017;32(2):89-98. - PubMed
LAST 2014 {published data only}
    1. NCT02046967. Steam ablation versus endovenous laser ablation for the treatment of great saphenous veins (LAST). clinicaltrials.gov/show/NCT02046967 (first received 28 January 2014).
    1. Van den Bos RR, Malskat WS, De Maeseneer MG, Roos KP, Groeneweg DA, Kockaert MA, et al. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. British Journal of Surgery 2014;101(9):1077-83. - PubMed
Magna 2013 {published data only}
    1. Biemans AA, Kockaert M, Akkersdijk GP, Van den Bos RR, Maeseneer MG, Cuypers P, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. Journal of Vascular Surgery 2013;58(3):727-34. - PubMed
    1. Biemans AA, Kockaert M, Van den Bos RR, Cuypers P, Neumann HA, Nijsten TE. A randomized comparative study of the three most commonly performed treatments for varicose veins, results after one year. Nederlands Tijdschrift voor Dermatologie en Venereologie 2012;22(2):78-84.
    1. NCT00529672. Surgery or non invasive therapy for varicose veins (Magna). clinicaltrials.gov/ct2/show/NCT00529672 (first received 14 September 2014).
    1. Van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, et al. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. British Journal of Surgery 2015;102(10):1184-94. - PubMed
MARADONA 2019 {published data only}
    1. Holewijn S, Van Eekeren RJ, Vahl A, De Vries JP, Reijnen MM. Two year results of a multicentre randomised control trial comparing mechanochemical endovenous ablation to radiofrequency ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial). Journal of Vascular Surgery 2019;7(3):364-74. - PubMed
    1. NCT01936168. MOCA versus RFA in the treatment of primary great saphenous varicose veins (MARADONA). clinicaltrials.gov/show/NCT01936168 (first received 5 September 2013).
Morrison 2015 {published data only}
    1. Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery 2015;61(4):985-94. - PubMed
    1. Morrison N, Kolluri R, Vasquez M, Madsen M, Jones A, Gibson K. Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-month outcomes of the VeClose randomized controlled trial. Phlebology 2019;34(6):380-90. - PMC - PubMed
Nordon 2011 {published data only}
    1. Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black S, Thompson M, et al. A prospective double-blind randomised controlled trial of radiofrequency versus laser treatment of great saphenous varicose veins. Cardiovascular and Interventional Radiology 2011;34:503-4. - PubMed
    1. Nordon IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Annals of Surgery 2011;254:876-81. - PubMed
Pronk 2010 {published data only}
    1. Gauw SA, Lawson JA, Van Vlijmen-Van Keulen CJ, Pronk P, Gaastra MT, Mooij MC. Five-year follow-up of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia. Journal of Vascular Surgery 2016;63(2 Suppl):420-8. - PubMed
    1. Pronk P, Gauw SA, Mooij MC, Gaastra MT, Lawson JA, Van Goethem AR, et al. Randomised controlled trial comparing sapheno-femoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anaesthesia: one year results. European Journal of Vascular and Endovascular Surgery 2010;40(5):649-656 e61. - PubMed
Rasmussen 2007 {published data only}
    1. ISRCTN16747172. Randomized controlled study comparing endovenous laser ablation with stripping, in patients with varicose veins due to greater saphenous vein insufficiency. isrctn.com/ISRCTN16747172 (first received 15 November 2005).
    1. Lawaetz M, Bjoern L, Rasmussen L. Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein. Clinical outcome and recurrence after 5 years. Scientific Programme and Book of Abstracts of the 14th Annual Meeting of the European Venous Forum 2013:41. - PubMed
    1. Rasmussen L, Lawaetz M, Bjoern L, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. Journal of Vascular Surgery 2013;58(2):421-6. - PubMed
    1. Rasmussen LH, Bjoern L, Lawaetz B, Blemings A, Eklof B. Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years. European Journal of Vascular and Endovascular Surgery 2010;39(5):630-5. - PubMed
    1. Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. Journal of Vascular Surgery 2007;46(2):308-15. - PubMed
Rasmussen 2011 {published data only}
    1. ISRCTN08060326. Endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for treatment of varicose veins. isrctn.com/ISRCTN08060326 (first received 31 July 2009).
    1. Lawaetz M, Rasmussen LH, Bjoern L, Blemings A, Eklof B. Randomized trial comparing RF, laser, foam sclerotherapy and stripping in varicose veins. Phlebology 2010;25:307. - PubMed
    1. Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings A, Eklof B, et al. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. International Angiology 2017;36(3):281-8. - PubMed
    1. Rasmussen L. Randomised trial shows higher technical failure rate with foam. Vascular News 2010;May:33.
    1. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. British Journal of Surgery 2011;98(8):1079-87. - PubMed
Rautio 2002 {published data only}
    1. Perala J, Rautio T, Biancari F, Ohtonen P, Wiik H, Heikkinen T, et al. Radiofrequency endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study. Annals of Vascular Surgery 2005;19(5):669-72. - PubMed
    1. Rautio T, Ohinmaa A, Perala J, Ohtonen P, Heikkinen T, Wiik H, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. Journal of Vascular Surgery 2002;35(5):958-65. - PubMed
Recovery 2009 {published data only}
    1. Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, et al. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). Journal of Vascular and Interventional Radiology 2009;20(6):752-9. - PubMed
RELACS 2012 {published data only}
    1. Rass K, Frings N, Glowacki P, Graber S, Tilgen W, Vogt T. Same site recurrence is more frequent after endovenous laser ablation compared with high ligation and stripping of the great saphenous vein: 5 year results of a randomized clinical trial (RELACS Study). European Journal of Vascular and Endovascular Surgery 2015;50(5):648-56. - PubMed
    1. Rass K, Frings N, Glowacki P, Hamsch C, Graber S, Vogt T, et al. Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study). Archives of Dermatology 2012;148(1):49-58. - PubMed
Shepherd 2010 {published data only}
    1. Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. British Journal of Surgery 2010;97(6):810-8. - PubMed
    1. Shepherd AC, Ortega-Ortega M, Gohel MS, Epstein D, Brown LC, Davies AH. Cost-effectiveness of radiofrequency ablation versus laser for varicose veins. International Journal of Technology Assessment in Health Care 2015;31(5):289-96. - PubMed
Subramonia 2010 {published data only}
    1. Balakrishnan A, Mylankal K, Nalachandran S, Subramonia S, Lees T. A randomized controlled trial of radiofrequency ablation and conventional surgery for primary long saphenous varicose veins. Phlebology 2008;23(4):198.
    1. Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. European Journal of Vascular and Endovascular Surgery 2010;39:104-11. - PubMed
    1. Subramonia S, Lees T. Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. British Journal of Surgery 2010;97(3):328-36. - PubMed
Syndor 2017 {published data only}
    1. Sydnor M, Mavropoulos J, Slobodnik N, Wolfe L, Strife B, Komorowski D. A randomized prospective long-term (>1 year) clinical trial comparing the efficacy and safety of radiofrequency ablation to 980 nm laser ablation of the great saphenous vein. Phlebology 2017;32(6):415-24. - PubMed
Vähäaho 2019 {published data only}
    1. Vähäaho S, Mahmoud O, Halmesmäki K, Albäck A, Noronen K, Vikatmaa P, et al. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. British Journal of Surgery 2019;106(5):548-54. - PubMed
Vernermo 2016 {published data only}
    1. Vähäaho S, Halmesmäki K, Albäck A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. British Journal of Surgery 2018;105:686-91. - PubMed
    1. Venermo M, Saarinen J, Eskelinen E, Vähäaho S, Saarinen E, Railo M, et al. Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy for the treatment of great saphenous varicose veins. British Journal of Surgery 2016;103(11):1438-44. - PMC - PubMed

References to studies excluded from this review

Basela 2011 {published data only}
    1. Basela H, Aydina C, Aya Y, Inana B, Ekimb H, Goyac C, et al. Endovenous laser ablation (EVLA) versus high ligation and striping (HL/S): two-years follow up. Eastern Journal of Medicine 2012;17(2):83-7.
Campos 2015 {published data only}
    1. Campos W, Torres IO, da Silva ES, Casella IB, Puech-Leão P. A prospective randomised study comparing polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and ulcer. Annals of Vascular Surgery 2015;29(6):1128-35. - PubMed
Chant 1972 {published data only}
    1. Beresford SA, Chant AD, Jones HO, Piachaud D, Weddell JM. Varicose veins: a comparison of surgery and infection/compression sclerotherapy. Five-year follow-up. Lancet 1978;1(8070):921-4. - PubMed
    1. Chant AD, Jones HO, Weddell JM. Varicose veins: a comparison of surgery and injection/compression sclerotherapy. Lancet 1972;2(7788):1188-91. - PubMed
Christenson 2010 {published data only}
    1. Christensen JT, Gueddi S, Gemayel G, Bounameaux H. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. Journal of Vascular Surgery 2010;52(5):1234-41. - PubMed
CLASS 2014 {published data only}
    1. Brittenden J, Cotton SC, Elders A, Ramsay CR, Norrie J, Burr J, et al. A randomized trial comparing treatments for varicose veins. New England Journal of Medicine 2014;371(13):1218-27. - PubMed
Compagna 2010 {published data only}
    1. Compagna R, De Vito D, Rossi R, Fappiano F, De Magistris L, Sodano L, et al. A prospective randomised controlled trial comparing foam sclerotherapy combined with sapheno-femoral ligation to surgical treatment of varicose veins. European Surgical Research 2010;45(3-4):267.
De Medeiros 2006 {published data only}
    1. De Medeiros CA, Luccas GC. Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins. Dermatologic Surgery 2005;31(12):1685-94. - PubMed
    1. De Medeiros CAF. Comparison of endovenous laser therapy vs conventional stripping of the great saphenous vein: midterm results. Jornal Vascular Brasileiro 2006;5(4):277-87.
De Oliveira 2018 {published data only}
    1. De Oliveira AC, Sobreira ML, Bertanha M, Jaldin RG, Rosa FD, Angeleli P, et al. Comparison of the efficacy and safety of endovenous radiofrequency ablation, endovenous laser ablation, foam sclerotherapy, and elastic compression for the treatment of severe chronic venous insufficiency (CEAP 6). Vascular and Endovascular Surgery 2018;52(8 Suppl 1):S44-45. [DOI: 10.1177/1538574418797220] - DOI
Desai 2009 {published data only}
    1. Desai DJ, Pedgoankar P, Sekhar R. Endovascular venous laser vs oesch pin stripper in management of primary varicosities of the great saphenous vein: a randomized control trial. ANZ Journal of Surgery 2009;79(S1):A88-91.
Disselhoff 2008 {published data only}
    1. Disselhoff BC, Buskens E, Kelder JC, Kinderen DJ, Moll FL. Randomised comparison of costs and cost-effectiveness of cryostripping and endovenous laser ablation for varicose veins: 2-year results. European Journal of Vascular and Endovascular Surgery 2009;37(3):357-63. - PubMed
    1. Disselhoff BC, Kinderen DJ, Kelder JC, Moll FL. Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins. British Journal of Surgery 2011;98(8):1107-11. - PubMed
    1. Disselhoff BC, Kinderen DJ, Kelder JC, Moll FL. Randomized clinical trial comparing endovenous laser ablation of the great saphenous vein with and without ligation of the sapheno-femoral junction: 2-year results. European Journal of Vascular and Endovascular Surgery 2008;36(6):713-8. - PubMed
    1. Disselhoff BC, der-Kinderen DJ, Kelder JC, Moll FL. Randomized clinical trial comparing endovenous laser with cryostripping for great saphenous varicose veins. British Journal of Surgery 2008;95(10):1232-8. - PubMed
dos Santos 2020 {published data only}
    1. dos Santos JB, Júnior WC, Porta RM, Puggina J, da Silva DF, Puech-Leao P, et al. Catheter-directed foam sclerotherapy with tumescence of the great saphenous vein versus ultrasound-guided foam sclerotherapy: a randomized controlled trial. Phlebology 2020;35(2):84-91. - PubMed
Einarsson 1993 {published data only}
    1. Einarsson E, Eklof B, Neglen P. Sclerotherapy or surgery as treatment for varicose veins: a prospective randomized study. Phlebology 1993;8:22-6.
Eroglu 2018 {published data only}
    1. Eroglu E, Yasim A. A randomised clinical trial comparing N-butyl cyanoacrylate, radiofrequency ablation and endovenous laser ablation for the treatment of superficial venous incompetence: two year follow up results. European Journal of Vascular and Endovascular Surgery 2018;56(4):553-60. - PubMed
Figueiredo 2009 {published data only}
    1. Figueiredo M, Araujo S, Barros N Jr, Miranda F Jr. Results of surgical treatment compared with ultrasound-guided foam sclerotherapy in patients with varicose veins: a prospective randomised study. European Journal of Vascular and Endovascular Surgery 2009;38(6):758-63. - PubMed
Honek 2019 {published data only}
    1. Honek T, Horvath M, Horvath V, Slais M, Kneifl T, Honek J, et al. Catheter laser ablation of superficial veins of the lower extremities in the symptomatic treatment of venous reflux comparison of the immediate results of two types of laser [Katetrizacni laserova ablace povrchovych zil dolnich koncetin v lecbe symptomatickeho zilniho refluxu s varixy - porovnani bezprostredni ucinnosti dvou typu laserovych]. Rozhledy v chirurgii: mesicnik Ceskoslovenske chirurgicke spolecnosti 2019;98(6):248-51. - PubMed
Jindal 2018 {published data only}
    1. Jindal R. A single center randomized controlled trial comparing radiofrequency and mechanical occlusion chemically assisted ablation of varicose veins in patients with bilateral involvement: Initial experience. International Angiology 2018;37(1 Suppl 1):20.
Kalodiki 2012 {published data only}
    1. Kalodiki E, Azzam M, Schnatterbeck P, Geroulakos G, Lattimer CR. The Discord Outcome Analysis (DOA) as a reporting standard at three months and five years in randomised varicose vein treatment trials. European Journal of Vascular and Endovascular Surgery 2019;57(2):267-74. - PubMed
    1. Kalodiki E, Lattimer CR, Azzam M, Shawish E, Bountouroglou D, Geroulakos G. Long-term results of a randomized controlled trial on ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation vs standard surgery for varicose veins. Journal of Vascular Surgery 2012;55(2):451-7. - PubMed
Karathanos 2019 {published data only}
    1. Karathanos C, Spanos K, Nana P, Batzalexis K, Kouvelos G, Giannoukas A. A randomized clinical study of radiofrequency ablation versus 1470nm laser for great saphenous vein reflux. European Journal of Vascular and Endovascular Surgery 2019;58(6 (Suppl 3)):e705-6.
Kikuchi 2009 {published data only}
    1. Kikuchi R, Neto EA, Carnevale F. Clinical comparison of radiofrequency ablation (RFA) versus endovenous laser ablation (EVLA) in great saphenous vein insufficiency treatment. In: XVI World Congress of the Union Internationale de Phlebologie Abstract Book. Vol. 14. 2009.
Lattimer 2012 {published data only}
    1. Lattimer CR, Azzam M, Geroulakos G, Kalodiki E. The anterior accessory saphenous vein in the treatment of a great saphenous vein reflux with laser versus foam: five-year results of a randomized controlled trial. Vasomed 2017;29(5):222-3.
    1. Lattimer CR, Azzam M, Kalodiki E, Shawish E, Trueman P, Geroulakos G. Cost and effectiveness of laser with phlebectomies compared with foam sclerotherapy in superficial venous insufficiency. Early results of a randomised controlled trial. European Journal of Vascular and Endovascular Surgery 2012;43(5):594-600. - PubMed
    1. Lattimer CR, Kalodiki E, Azzam M, Makris GC, Somiayajulu S, Geroulakos G. Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy. International Angiology 2013;32(4):394-403. - PubMed
Leon 2018 {published data only}
    1. Leon I, Blando JS, Alarcon H. Randomized, comparative and prospective study between radiofrequency venous ablation and sclerotherapy with polidocanol foam 3% versus only radiofrequency venous ablation in saphenous veins of 1.5 cm. of diameter or more. Phlebology 2018;33(10):NP3-NP4. [DOI: 10.1177/0268355518804484] - DOI
Leung 2019 {published data only}
    1. Leung C, Carradice D, Mohamed A, Wallace T, Chetter I. The Lama Trial - a randomized controlled trial comparing endovenous laser ablation versus mechanochemical ablation in the treatment of superficial venous incompetence. European Journal of Vascular and Endovascular Surgery 2019;58(6 Suppl 1):e118-9.
    1. Leung CC, Carradice D, Wallace T, Chetter IC. Endovenous laser ablation versus mechanochemical ablation with ClariVein® in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials 2016;17(1):421. [DOI: 10.1186/s13063-016-1548-1] - DOI - PMC - PubMed
Lin 2007 {published data only}
    1. Lin Y, Ye CS, Huang XL, Ye JL, Yin HH, Wang SM. A random, comparative study on endovenous laser therapy and saphenous veins stripping for the treatment of great saphenous vein incompetence. Chung-Hua i Hsueh Tsa Chih [Chinese Medical Journal] 2007;87(43):3043-6. - PubMed
Mendes 2016 {published data only}
    1. Mendes CA, Martins AA, Fukuda JM, Parente JB, Munia MA, Fioranelli A, et al. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know. Clinics (Sao Paulo, Brazil) 2016;71(11):650-6. - PMC - PubMed
Mozafar 2014 {published data only}
    1. Mozafar M, Atqiaee K, Haghighatkhah H, Taheri MS, Tabatabaey A, Lotfollahzadeh S. Endovenous laser ablation of the great saphenous vein versus high ligation: long-term results. Lasers in Medical Science 2014;29(2):765-71. - PubMed
Oster 2018 {published data only}
    1. Öster M, Nelzén O. Venous insufficiency treatment and the effect on quality of life. Phlebology 2018;33(10):NP14-5.
Ouvry 2008 {published data only}
    1. Ouvry P, Allaert FA, Desnos P, Hamel-Desnos C. Efficacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlled trial with a 2-year follow-up. European Journal of Vascular and Endovascular Surgery 2008;36(3):366-70. - PubMed
Ovali 2019 {published data only}
    1. Ovali C, Sevin MB. Twelve-month efficacy and complications of cyanoacrylate embolization compared with radiofrequency ablation for incompetent great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2019;7(2):210-216. [DOI: 10.1016/j.jvsv.2018.10.019] - DOI - PubMed
Shadid 2015 {published data only}
    1. NCT02304146. Long-term ultrasound guided foam sclerotherapy versus classical surgical stripping study. clinicaltrials.gov/show/NCT02304146 2014 (first received 1 December 2014).
    1. Shadid N, Nelemans P, Lawson J, Sommer A. Predictors of recurrence of great saphenous vein reflux following treatment with ultrasound-guided foam sclerotherapy. Phlebology 2015;30(3):194-9. - PubMed
Sincos 2018 {published data only}
    1. Sincos IR, Puggina J, Campos W, Baptista-Sincos AP, Porta RM, De Luccia N, et al. Effects of saphenous and perforating vein radiofrequency ablation in ulcer healing: midterm results of a randomized controlled trial (VUERT). Journal of Vascular Surgery 2018;67(6):e81.
Stotter 2005 {published data only}
    1. Stotter L, Schaaf I, Bockelbrink A, Baurecht HJ. Radiofrequency obliteration, invagination or cryostripping: which is the best tolerated treatment by the patients? Phlébologie 2005;34(1):19-24.
Tawfik 2020 {published data only}
    1. Tawfik AM, Sorour WA, El-Laboudy ME. Laser ablation versus mechanochemical ablation in the treatment of primary varicose veins: a randomized clinical trial. Journal of Vascular Surgery 2020;8(2):211-5. - PubMed
Wright 2006 {published data only}
    1. Wright D, Gobin JP, Bradbury AW, Coleridge-Smith P, Spoelstra H, Berridge D, et al. Varisolve polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 2006;21(4):180-90.
    1. Wright D. European randomized controlled trial of Varisolve® PD microfoam compared with alternative therapy in management of moderate-to-severe varicose veins: preliminary results. In: Abstracts from the UIP World Congress Chapter Meeting, 2003 Aug 27-31; San Diego, California. 2003.

References to studies awaiting assessment

Belramman 2020 {published data only}
    1. Belramman A, Bootun R, Tang TY, Lane TR, Davies AH. Early results of a randomised clinical trial of mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins (MOCCA). European Journal of Vascular and Endovascular Surgery 2019;58(6 Suppl 3):E703.
    1. Belramman A, Bootun R, Tang TY, Lane TR, Davies AH. Randomized clinical trial of mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2020;8(2):315-6.
Morrison 2020 {published data only}
    1. Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2020;8(6):978-89. - PubMed
Rai 2019 {published data only}
    1. Rai A, Porsalman M, Khatony A, Sobhiyeh M. Comparison of foam sclerotherapy versus radiofrequency ablation in the treatment of primary varicose veins due to incompetent great saphenous vein: randomized clinical trial. Journal of Vascular Nursing 2019;37(4):226-31. - PubMed
Vähäaho 2021 {published data only}
    1. Vähäaho S, Halmesmäki K, Mahmoud O, Albäck A, Noronen K, Venermo M. Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2021;9(3):652-9. [DOI: 10.1016/j.jvsv.2020.08.007] - DOI - PubMed

References to ongoing studies

Belramman 2018 {published data only}
    1. Belramman A, Bootun R, Tang TY, Lane TR, Davies AH. Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial. Trials 2018;19:428. [DOI: 10.1186/s13063-018-2807-0] - DOI - PMC - PubMed
Cho 2020 {published data only}
    1. Cho S, Park HS, Lee T, Byun SJ, Yun WS, Yang SS, et al. CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins. Trials 2020;21:460. [DOI: 10.1186/s13063-020-04393-0] - DOI - PMC - PubMed
NCT04526626 {published data only}
    1. NCT04526626. Endovenous radiofrequency ablation versus high ligation and stripping for treatment of varicose veins: a prospective controlled trial. ClinicalTrials.gov/show/NCT04526626 (first received 26 August 2020).
NCT04534244 {published data only}
    1. NCT04534244. Management of tributary veins in superficial venous insufficiency of the lower limbs: impact of endovenous steam treatment versus phlebectomy on quality of life (INVOLVE). ClinicalTrials.gov/show/NCT04534244 (first received 1 September 2020).

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References to other published versions of this review

Eifell 2006
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Nesbitt 2014
    1. Nesbitt C, Bedenis R, Bhattacharya C, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No: CD005624. [DOI: 10.1002/14651858.CD005624.pub3] - DOI - PubMed

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