Abstract
To report a review and meta-analysis of all randomized controlled trials (RCTs) comparing bypass surgery (BS) and endovascular treatment (ET) in infrainguinal peripheral arterial disease (PAD) for several endpoints, such as major and minor amputation, major adverse limb events (MALEs), ulcer healing, time to healing, and all-cause mortality to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS). A MEDLINE and EMBASE search was performed to identify RCTs, published since 1991 up to June 21, 2023, enrolling patients with lower limb ischemia due to atherosclerotic disease (Rutherford I–VI). Any surgical BS or ET was allowed, irrespective of the approach, route, or graft employed, from iliac to below-the-knee district. Primary endpoint was major amputation rate. Secondary endpoints were amputation-free survival major adverse limb events (MALEs), minor amputation rate, all-cause mortality, ulcer healing rate, time to healing, pain, transcutaneous oxygen pressure (TcPO2) or ankle-brachial index (ABI), quality of life, need for a new procedure, periprocedural serious adverse events (SAE; within 30 days from the procedure), hospital lenght of stay, and operative time. Twelve RCTs were included, one enrolled two separate cohorts of patients, and therefore, the studies included in the analyses were 13. Participants treated with ET had a similar rate of major amputations to participants treated with BS (MH-OR 0.85 [0.60, 1.20], p = 0.36); only one trial reported separately data on patients with diabetes (N = 1), showing no significant difference between ET and BS (MH-OR: 0.67 [0.09, 5.13], p = 0.70). For minor amputation, no between-group significant differences were reported: MH-OR for ET vs BS: 0.83 [0.21, 3.30], p = 0.80). No significant difference in amputation-free survival between the two treatment modalities was identified (MH-OR 0.94 [0.59, 1.49], p = 0.80); only one study reported subgroup analyses on diabetes, with a non-statistical trend toward reduction in favor of ET (MH-OR 0.62 [0.37, 1.04], p = 0.07). No significant difference between treatments was found for all-cause mortality (MH-OR for ET vs BS: 0.98 [0.80, 1.21], p = 0.88). A significantly higher rate of MALE was reported in participants treated with ET (MH-OR: 1.44 [1.05, 1.98], p = 0.03); in diabetes subgroup analysis showed no differences between-group for this outcome (MH-OR: 1.34 [0.76, 2.37], p = 0.30). Operative duration and length of hospital stay were significantly shorter for ET (WMD: − 101.53 [− 127.71, − 75.35] min, p < 0.001, and, − 4.15 [− 5.73, − 2.57] days, p < 0.001 =, respectively). ET was associated with a significantly lower risk of any SAE within 30 days in comparison with BS (MH-OR: 0.60 [0.42, 0.86], p = 0.006). ET was associated with a significantly higher risk of reintervention (MH-OR: 1.57 [1.10, 2.24], p = 0.01). No significant between-group differences were reported for ulcer healing (MH-OR: 1.19 [0.53, 2.69], p = 0.67), although time to healing was shorter (− 1.00 [0.18, 1.82] months, p = 0.02) with BS. No differences were found in terms of quality of life and pain. ABI at the end of the study was reported by 7 studies showing a significant superiority of BS in comparison with ET (WMD: 0.09[0.02; 0.15] points, p = 0.01). The results of this meta-analysis showed no clear superiority of either ET or BS for the treatment of infrainguinal PAD also in diabetic patients. Further high-quality studies are needed, focusing on clinical outcomes, including pre-planned subgroup analyses on specific categories of patients, such as those with diabetes and detailing multidisciplinary team approach and structured follow-up.
Similar content being viewed by others
References
Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, GVG Writing Group (2019) Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. https://doi.org/10.1016/j.jvs.2019.02.016
Kim TI, Mena C, Sumpio BE (2020) The role of lower extremity amputation in chronic limb-threatening ischemia. Int J Angiol 29(3):149–155. https://doi.org/10.1055/s-0040-1710075. (In eng)
Martelli E, Zamboni M, Sotgiu G et al (2023) Sex-related differences and factors associated with peri-procedural and 1 year mortality in chronic limb-threatening ischemia patients from the CLIMATE Italian registry. J Pers Med 13(2):316. https://doi.org/10.3390/jpm13020316]
Farber A, Menard MT, Conte MS et al (2022) Surgery or endovascular therapy for chronic limb-threatening ischemia. N Engl J Med 387(25):2305–2316. https://doi.org/10.1056/NEJMoa2207899. (In eng)
Setacci C, Sirignano P, Galzerano G et al (2013) Endovascular first as “preliminary approach” for critical limb ischemia and diabetic foot. J Cardiovasc Surg (Torino) 54(6):679–684
Abu Dabrh AM, Steffen MW, Undavalli C, Asi N, Wang Z, Elamin MB et al (2015) The natural history of untreated severe or critical limb ischemia. J Vasc Surg 62:1642e1651e3
El Khoury R, Wu B, Kupiec-Weglinski SA, Liu IH, Edwards CT, Lancaster EM, Hiramoto JS, Vartanian SM, Schneider PA, Conte MS (2022) Limb-based patency as a measure of effective revascularization for chronic limb-threatening ischemia. J Vasc Surg 76(4):997-1005.e2. https://doi.org/10.1016/j.jvs.2022.04.042. (Epub 2022 Jun 10)
Almasri J, Adusumalli J, Asi N, Lakis S, Alsawas M, Prokop LJ, Bradbury A, Kolh P, Conte MS, Murad MH (2018) A systematic review and meta-analysis of revascularization outcomes of infrainguinal chronic limb-threatening ischemia. J Vasc Surg 68(2):624–633. https://doi.org/10.1016/j.jvs.2018.01.066. (Epub 2018 May 24)
Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N (2008) Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 47(5):975–981. https://doi.org/10.1016/j.jvs.2008.01.005. (In eng)
Tsai TT, Rehring TF, Rogers RK, Shetterly SM, Wagner NM, Gupta R et al (2015) The contemporary safety and effectiveness of lower extremity bypass surgery and peripheral endovascular interventions in the treatment of symptomatic peripheral arterial disease. Circulation 132:1999–2011
Jones WS, Dolor RJ, Hasselblad V, Vemulapalli S, Subherwal S, Schmit K et al (2014) Comparative effectiveness of endovascular and surgical revascularization for patients with peripheral artery disease and critical limb ischemia: systematic review of revascularization in critical limb ischemia. Am Heart J 167:489–98.e7
Siracuse JJ, Van Orden K, Kalish JA, Eslami MH, Schermerhorn ML, Patel VI et al (2017) Endovascular treatment of the common femoral artery in the Vascular Quality Initiative. J Vasc Surg 65:1039–1046
Antoniou GA, Georgiadis GS, Antoniou SA, Makar RR, Smout JD, Torella F (2017) Bypass surgery for chronic lower limb ischaemia. Cochrane Database Syst Rev 4(4):Cd002000. https://doi.org/10.1002/14651858.CD002000.pub3. (In eng)
Antonopoulos CN, Mylonas SN, Moulakakis KG et al (2017) A network meta-analysis of randomized controlled trials comparing treatment modalities for de novo superficial femoral artery occlusive lesions. J Vasc Surg 65(1):234. https://doi.org/10.1016/j.jvs.2016.08.095. (In eng)
Fowkes F, Leng GC (2008) Bypass surgery for chronic lower limb ischaemia. Cochrane Database Syst Rev 2:Cd002000. https://doi.org/10.1002/14651858.CD002000.pub2. (In eng)
Zhang R, Ni L, Zeng R et al (2021) An indirect comparison by Bayesian network meta-analysis of drug-coated devices versus saphenous vein graft bypass in femoropopliteal arterial occlusive disease. J Vasc Surg 74(2):478-486.e11. https://doi.org/10.1016/j.jvs.2020.11.054. (In eng)
McQuade K, Gable D, Hohman S, Pearl G, Theune B (2009) Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg 49(1):109–15. https://doi.org/10.1016/j.jvs.2008.08.041. (In eng)
Björkman P, Auvinen T, Hakovirta H et al (2018) Drug-eluting stent shows similar patency results as prosthetic bypass in patients with femoropopliteal occlusion in a randomized trial. Ann Vasc Surg 53:165–170. https://doi.org/10.1016/j.avsg.2018.04.014. (In eng)
Bradbury AW, Moakes CA, Popplewell M et al (2023) A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet 401(10390):1798–1809. https://doi.org/10.1016/s0140-6736(23)00462-2. (In eng)
Monami M, Scatena A, Miranda C., et al. (2023) Development of the Italian clinical practice guidelines for the treatment of diabetic foot syndrome: design and methodological aspects. Acta Diabetol
Guyatt GH, Oxman AD, Santesso N et al (2013) GRADE guidelines: 12. Preparing summary of findings tables-binary outcomes. J Clin Epidemiol 66(2):158–72. https://doi.org/10.1016/j.jclinepi.2012.01.012. (In eng)
Liberati A, Altman DG, Tetzlaff J et al (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. Bmj 339:b2700. https://doi.org/10.1136/bmj.b2700
Moher D, Liberati A, Tetziaff J, and D.G.J.A.o.i.m. Altman 2009 Vol.151 Issue 4 Pages 264–269.
Higgins JP, Altman DG, Gøtzsche PC et al (2011) The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj 343:d5928. https://doi.org/10.1136/bmj.d5928. (In eng)
Katsamouris A, Brewster DC, Megerman J, Cina C, Darling RC, Abbott WM (1984) Transcutaneous oxygen tension in selection of amputation level. Am J Surg 147(4):510–517. https://doi.org/10.1016/0002-9610(84)90014-x. (In eng)
Greenland P, Smith SC Jr, Grundy SM (2001) Improving coronary heart disease risk assessment in asymptomatic people: role of traditional risk factors and noninvasive cardiovascular tests. Circulation 104(15):1863–1867. https://doi.org/10.1161/hc4201.097189. (In eng)
Holm J, Arfvidsson B, Jivegård L et al (1991) Chronic lower limb ischaemia. A prospective randomised controlled study comparing the 1-year results of vascular surgery and percutaneous transluminal angioplasty (PTA). Eur J Vasc Surg 5(5):517–522. https://doi.org/10.1016/s0950-821x(05)80338-x. (In eng)
Bergan JJ, Wilson SE, Wolf G, Deupree RH (1992) Unexpected, late cardiovascular effects of surgery for peripheral artery disease. Veterans Affairs Cooperative Study 199. Arch Surg 127(9):1119–1123. https://doi.org/10.1001/archsurg.1992.01420090127019. (In eng)
Lepäntalo M, Laurila K, Roth WD et al (2009) PTFE bypass or thrupass for superficial femoral artery occlusion? A randomised controlled trial. Eur J Vasc Endovasc Surg 37(5):578–584. https://doi.org/10.1016/j.ejvs.2009.01.003. (In eng)
van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ (2004) Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc Surg 28(2):132–137. https://doi.org/10.1016/j.ejvs.2004.04.003. (In eng)
Eleissawy MI, Elbarbary AH, Elwagih MM, Elheniedy MA, Santoso C, Fourneau I (2019) Ipsilateral antegrade angioplasty for flush superficial femoral artery occlusion versus open bypass surgery. Ann Vasc Surg 61:55–64. https://doi.org/10.1016/j.avsg.2019.05.062. (In eng)
Adam DJ, Beard JD, Cleveland T et al (2005) Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 366(9501):1925–34. https://doi.org/10.1016/s0140-6736(05)67704-5. (In eng)
Enzmann FK, Nierlich P, Aspalter M et al (2019) Nitinol stent versus bypass in long femoropopliteal lesions: 2-year results of a randomized controlled trial. JACC Cardiovasc Interv 12(24):2541–2549. https://doi.org/10.1016/j.jcin.2019.09.006. (In eng)
Gouëffic Y, Della Schiava N, Thaveau F et al (2017) Stenting or surgery for de novo common femoral artery stenosis. JACC Cardiovasc Interv 10(13):1344–1354. https://doi.org/10.1016/j.jcin.2017.03.046. (In eng)
Pecoraro RE, Reiber GE, Burgess EM (1990) Pathways to diabetic limb amputation. Basis for prevention Diabetes Care 13(5):513–521. https://doi.org/10.2337/diacare.13.5.513
Tsetis D, Belli AM (2004) The role of infrapopliteal angioplasty. Br J Radiol 77(924):1007–1015. https://doi.org/10.1259/bjr/97382129
Gottrup F (1994) Physiology and measurement of tissue perfusion. Ann Chir Gynaecol 83(3):183–189
Niinikoski J (1980) Cellular and nutritional interactions in healing wounds. Med Biol 58(6):3039
Gatti C, Cecchini S, Fabbietti P, Romagnoli F, Ricci S (2018) Endovascular treatment of diabetic peripheral arterial disease in older and oldest old patients: a retrospective study. Aging Clin Exp Res 30(2):205–207. https://doi.org/10.1007/s40520-017-0760-5. (Epub 2017 Jun 3)
https://iwgdfguidelines.org/pad-guideline-2023/ August 11th 2023
Author information
Authors and Affiliations
Consortia
Contributions
AS, MA, BR, AS, MM, CM, LU, LM, CV and MM were involved in each of the following points: (1) Design, (2) Data collection, (3) Analysis, (4) Writing manuscript. FL, IL, EM, es, MG: (1) Manuscript revision. AS, MA, CV, BR, AS, MM, CM, LU, LM, and MM were involved in each of the following points: (1) Manuscript revision, (2) Data collection.
Corresponding author
Ethics declarations
Conflict of interest
MM received speaking fees by Zuccato srl, Molteni Therapeutics, and Biomedica. All the other authors did not report any potential COI. All the authors approved the final version of this manuscript. Dr. Alessia Scatena is the person who takes full responsibility for the work as a whole, including the study design, access to data, and the decision to submit and publish the manuscript.
Human and animal rights
This article does not contain any studies with human participants or animals performed by any of the authors.
Additional information
Managed By Massimo Federici.
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Scatena, A., Apicella, M., Mantuano, M. et al. Bypass surgery versus endovascular revascularization for occlusive infrainguinal peripheral artery disease: a meta-analysis of randomized controlled trials for the development of the Italian Guidelines for the treatment of diabetic foot syndrome. Acta Diabetol 61, 19–28 (2024). https://doi.org/10.1007/s00592-023-02185-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00592-023-02185-x