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▪ ▪ ▪ ▪ ▪ ▪N Engl J Med 2022; 387:2305-2316 DOI: 10.1056/NEJMoa2207899 Dr Ndidi Edi-Osagie Enrolment began in August 2014. Cohort 1 were followed until October 2021, cohort 2 until December 2019. ▪ Patients were enrolled into cohort 1 or cohort 2 based on duplex US of the right ▪ and left great saphenous veins. ▪ ▪ Surgeons were allowed to choose any bypass technique that was currently ▪ being used in clinical practice. Interventionalists were allowed to choose any available endovascular technique. ▪ ▪ Follow ups at 30 days, 3 months, then 6 ▪ monthly until 84 months after randomisation. CLI, defined as arterial Atherosclerotic, infrainguinal PAD Candidate for either open or Male or female, age 35 years or (occlusive disease of the arteries insufficiency with gangrene, non- endovascular infrainguinal older. below the inguinal ligament healing ischemic ulcer, or rest revascularization as judged by caused by atherosclerosis). pain consistent with Rutherford the treating investigators. Categories 4-6. Adequate popliteal, tibial or pedal revascularization target Willingness to comply with defined as an infrainguinal protocol, attend follow-up Adequate aortoiliac inflow arterial segment distal to the area appointments, complete all study of stenosis/occlusion which can assessments, and provide written support a distal anastomosis of a informed consent. surgical bypass. Disease limited to the Presence of a femoral, Life expectancy of less than 2 Femoropopliteal segment popliteal or tibial aneurysm in years. only. the index limb. Planned above ankle amputation on ipsilateral limb Deemed excessive risk for within 4 weeks of index Renal dysfunction, current surgical bypass procedure, regardless of dialysis or history or renal whether revascularization is transplant performed. Prior percutaneous or surgical Presence of a documented intervention involving arteries Pregnancy or lactation hypercoagulable state below the knee joint.The null hypothesis was that there would be no difference in the time from randomization to a primary- outcome event between the surgical group and the endovascular group. Large sample size Kaplan-Meier plots SAS statistics The authors used appropriate statistical methods to analyse their data and considered multiple sources of variability in their analyses.▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ The surgical group had 307 femoral- popliteal, 276 femoral-tibial or 1434 patients with a single segment The patient characteristics were pedal, and 115 popliteal-tibial or of great saphenous vein were The median follow-up time was 2.7 generally well balanced between the pedal bypass operations, with 85% randomised in cohort 1. years. groups. of the procedures performed with a single segment of great saphenous vein. The endovascular group had 487 procedures performed on the Endovascular interventions were superficial femoral artery, 382 on the performed by vascular surgeons in The technical success of the index 66 cases of early technical failure in popliteal artery, and 381 on the tibial 73% of cases, interventional procedure was 98% in the surgical the endovascular group treated with or pedal arteries, with the type of cardiologists in 15% of cases, and group and 85% in the endovascular a bypass operation within 30 days. endovascular procedure varying interventional radiologists in 13% of group. depending on the arterial segment cases. that was treated. Surgery Endovascular (%) therapy (%) major adverse 42.6 57.4 limb events or death Major 9.2 23.5 reinterventions Above-ankle 10.4 14.9 amputation death from any = = cause major adverse = = cardiovascular events Serious adverse 1.7 1.3 events (perioperative death) In cohort 2 of the study, 396 patients without a single segment The patients were followed for a Three patients (0.8%) were The index procedure was of great saphenous vein were excluded from the primary performed after a median time of randomized, with 197 receiving median of 1.6 years in both analysis due to missing baseline 4 days in the surgical group and 1 surgical treatment and 199 groups. data. day in the endovascular group. receiving endovascular therapy. The technical success was 100% The primary outcome of major The time until major in the surgical group and 80.6% adverse limb events or death reintervention favoured the Adverse events were similar in the endovascular group, with occurred in 42.8% of patients in surgical group, while there were between the two groups, with the 26 patients undergoing surgical the surgical group and 47.7% in no material between-group median length of hospital stay bypass within 30 days after 37 the endovascular group, with no differences in the time until being longer in the surgical early cases of technical failure in significant difference between above-ankle amputation or death group. the endovascular group. the two groups. from any cause.Selection and operator bias Local eligibility Judgement of individual Technique operators in heterogeneity determining successful revascularisationIn patients with a good-quality great saphenous vein for conduit, initial surgery was associated with a 32% lower risk of major adverse limb events or death than was the endovascular strategy. In patients without a great saphenous vein for conduit, overall efficacy and safety outcomes appeared to be similar in the two treatment groups. Highlighted importance of patient centred, informed decision making. The findings suggest that preprocedural planning of treatment in patients with CLTI should include a surgical risk assessment and a determination of saphenous-vein availability.Thank you