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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

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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.

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Authors and Affiliations

  1. San Donato Hospital, Arezzo, Health Authorities South East Tuscany, Italy, Via Pietro Nenni, 20, 52100, Arezzo, Italy

    Alessia Scatena, Matteo Apicella, Michele Mantuano, Francesco Liistro, Giorgio Ventoruzzo & Pasquale Petruzzi

  2. Pordenone Hospital, Pordenone, Italy

    Cesare Miranda

  3. AMD - Italian Association of Clinical Diabetologists, Rome, Italy

    Luca Monge

  4. Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy

    Benedetta Ragghianti, Antonio Silverii, Edoardo Mannucci & Matteo Monami

  5. Skidmore College, New York, USA

    Isabella Ferraro

  6. Diabetes Section CTO Hospital and Dept of Biomedicine and Prevention Tor Vergata, University of Rome, Rome, Italy

    Luigi Uccioli

  7. University Hospital Perugia, Perugia, Italy

    Cristiana Vermigli

  8. Ospedale Sandro Pertini, Rome, Italy

    Germano Scevola

  9. Azienda Ospedaliera Regionale “San Carlo”, Potenza, Italy

    Eugenio Stabile

  10. Vascular Surgery, University of Bologna – DIMEC, Bologna, Italy

    Mauro Gargiulo

  11. Vascular Surgery Unit, IRCCS, University Hospital Policlinico S. Orsola, Bologna, Italy

    Mauro Gargiulo

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Consortia

for the Panel of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome

  • Andrea Bernetti
  • , Corrado Bordieri
  • , Cristina Cappella
  • , Alessandro De Cassai
  • , Marco Falcone
  • , Mauro Gargiulo
  • , Valentina Lorenzoni
  • , Gerardo Medea
  • , Cesare Miranda
  • , Matteo Monami
  • , Luca Monge
  • , Alessia Scatena
  • , Germano Scevola
  • , Eugenio Stabile
  • , Laura Stefanon
  • , Rodolfo Tramonta
  • , Cristiana Vermigli
  • , Antonio Volpe
  •  & Luigi Uccioli

SID and AMD

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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.

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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.

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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

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