Advertisement

Editor's Choice – A Comparison of Clinical Outcomes Between Primary Bypass and Secondary Bypass After Failed Plain Balloon Angioplasty in the Bypass versus Angioplasty for Severe Ischaemia of the Limb (BASIL) Trial

Open ArchivePublished:March 27, 2018DOI:https://doi.org/10.1016/j.ejvs.2018.02.015

      Objective

      Chronic limb threatening ischaemia (CLTI) is a growing global health problem. The UK NIHR HTA funded BASIL trial is still the only randomised controlled trial to have compared a “bypass surgery first” with a “plain balloon angioplasty (PBA) first” strategy for the management of CLTI. In patients who were likely to survive for 2 years and had a suitable vein, primary bypass (PB) was associated with better clinical outcomes. Furthermore, PBA was associated with a high technical and clinical failure rate and many went on to have secondary bypass (SB). This study aimed at comparing clinical outcomes following PB and SB in the BASIL trial.

      Methods

      Demographic, procedural, and outcome data were obtained from the BASIL case report forms. Outcomes were amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from revascularisation (FFR). The SB cohort comprises patients whose first trial intervention was PBA and who subsequently underwent bypass during follow up. The PB cohort comprises those patients whose first trial intervention was bypass.

      Results

      The 190 PB and 49 SB patients were well matched except that the SB patients were more likely to be current smokers. At a median of 7 years, PB was associated with better AFS (PB 60% vs. SB 40%; HR 1.58, p = .04), LS (PB 85% vs. SB 73%, p = .06), and OS (PB 68% vs. 51%, p = .06). FFR was equivalent (PB 53% vs. 53%, p = .3).

      Conclusion

      In the BASIL trial, clinical outcomes following PB were significantly better than in patients undergoing SB after failed PBA. Prior to treating patients with CLTI with primary PBA, clinicians should consider that if this should fail, the outcome of attempted subsequent bypass is likely to be significantly worse than if PB were attempted.

      Keywords

      Angioplasty has been seen as a “free shot” at revascularisation of chronic limb threatening ischaemia. This work suggests that patients requiring secondary bypass after failed initial angioplasty do significantly worse than those who undergo primary bypass surgery.

      Introduction

      Although chronic limb threatening ischaemia (CLTI) is a growing global health problem,
      • Ricco J.B.
      • Parvin S.
      • Veller M.
      • Brunkwall J.
      • Wolfe J.
      • Sillesen H.
      • et al.
      Statement from the European Society of Vascular Surgery and the World Federation of Vascular Surgery Societies: Transatlantic Inter-Society Consensus Document (TASC) III and International Standards for Vascular Care (ISVaC).
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • Björck M.
      • Brodmann M.
      • Cohnert T.
      • et al.
      2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS).
      the evidence underpinning the choice of revascularisation strategy remains poor. The UK NIHR HTA funded Bypass versus Angioplasty for Severe Ischaemia of the Limb (BASIL) trial remains the only randomised controlled trial (RCT) to have compared a “bypass surgery first” with a “plain balloon angioplasty (PBA) first” strategy for CLTI resulting from infra-inguinal disease. An intention to treat analysis (ITT) of BASIL outcome data showed that, in patients who were likely to survive for at least 2 years and who had a suitable vein, primary bypass (PB) led to better clinical outcomes than primary PBA. Furthermore, primary PBA was associated with a high technical and clinical failure rate such that many of the patients went on to have secondary bypass (SB). Despite this ‘level 1’ evidence in support of surgical bypass as the preferred revascularisation strategy for patients with a suitable vein, enthusiasm for an endovascular first approach to most, perhaps even all, patients with CLTI continues to grow.
      • Bisdas T.
      • Borowski M.
      • Stavroulakis K.
      • Torsello G.
      CRITISCH Collaborators
      Endovascular therapy versus bypass surgery as first-line treatment strategies for critical limb ischemia: results of the interim analysis of the CRITISCH registry.
      As a result, vein bypass is increasingly being viewed as a secondary, salvage procedure to be performed when all endovascular revascularisation options have been exhausted.
      • Joels C.S.
      • York J.W.
      • Kalbaugh C.A.
      • Cull D.L.
      • Langan E.M.
      • Taylor S.M.
      Surgical implications of early failed endovascular intervention of the superficial femoral artery.
      • Goodney P.P.
      • Beck A.W.
      • Nagle J.
      • Welch H.G.
      • Zwolak R.M.
      National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.
      There are surprisingly few published reports of outcomes following SB for failed endovascular revascularisation. Furthermore, in the few studies that are available, patient numbers are often small, patients were not randomised, and patients with intermittent claudication and CLTI are often conflated.
      • Nolan B.W.
      • De Martino R.R.
      • Stone D.H.
      • Schanzer A.
      • Goodney P.P.
      • Walsh D.W.
      • et al.
      Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass.
      • Gifford S.M.
      • Fleming M.D.
      • Mendes B.C.
      • Stauffer K.C.
      • De Martino R.R.
      • Oderich G.S.
      • et al.
      Impact of femoropopliteal endovascular interventions on subsequent open bypass.
      • Cury M.V.M.
      • Brochado-Neto F.C.
      • Matielo M.F.
      • de Athayde Soares R.
      • Sarpe A.K.
      • Sacilotto R.
      Results of bypass graft surgery after prior angioplasty in critical limb ischaemia treatment.
      This topic was briefly reported in the analysis by treatment received, only SB within 8 weeks of primary PTA were included and only AFS was reported but no further in depth analyses were performed.
      • Bradbury A.W.
      • Adam D.J.
      • Bell J.
      • Forbes J.F.
      • Fowkes F.G.
      • Gillespie I.
      • et al.
      Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received.
      The aim of this study, therefore, was to compare clinical outcomes following PB, and all SB after failed primary PBA in the BASIL trial.

      Method

      The BASIL trial methodology has been published previously. Ethical approval was obtained from the Multi-Centre Research Ethics Committee for Scotland. Briefly, patients with CLTI resulting from infra-inguinal disease were randomised to either a PB or primary PBA revascularisation strategy between 1999 and 2004. Patients were followed up until death or the censor date of July 1, 2007. This provided all surviving patients with a minimum of 3 years follow up (median 51, range 0–92 months).
      BASIL trial case report forms (CRF) were interrogated to obtain demographic, procedural, and outcome data including amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from re-intervention (FFR) defined as any further revascularisation of the index limb. The SB cohort comprised patients whose first trial intervention was PBA and who subsequently underwent SB (with any conduit) at any point during trial follow up. The PB cohort comprised those patients whose first trial intervention was PB with any conduit. Time to event analyses are presented over a 7 year period using Kaplan-Meier plots. Hazard ratios were used to detect statistically important differences in outcomes using 95% CI. Differences between the cohorts were compared using t test, chi-squared and Wilcoxon Rank Sum tests according to distribution of data. Statistical analysis was performed using SAS v 9.4.

      Results

      There were 238 attempted primary PBA in the BASIL trial; of these, 69 patients went on to have a secondary intervention, 17 had a tertiary intervention, and seven had a fourth intervention. Twenty-five (36.2%) of the secondary interventions were PBA; of these, three (12%) subsequently underwent SB. The remaining 46 SBs were performed after failed primary PBA. In BASIL, 190 patients underwent PB.
      The 190 PB and the 49 SB patients were well matched at the time of randomisation in terms of baseline demographics except that the SB patients were more likely to be current smokers (Table 1). Medical management was also similar (Table 2). Of those who went on to have SB, 49% (24/49) had a technically successful primary PBA. Tissue loss was present in most patients in both groups (ulcer 62% vs. 69%, p = .3, gangrene 34% vs. 29% p = .5). The median time interval between primary PBA and SB was 0 months (range 0–20 months). Of those who underwent PB, 9.5% (18/190) underwent secondary PTA, 94.4% (17/18) of these were for vein graft stenosis and 100% survived with their limb at the end of trial follow up.
      Table 1Comparison of primary and secondary bypass patients in the BASIL trial.
      Primary bypassSecondary bypassp value
      Number of patients19049
      Age, yearsMean (SD)72 (9.3)73 (7.3)0.4
      Range39–9858–87
      GenderMale127 (66%)28 (57%)0.2
      LimbLeft105 (55%)27 (55%)1.0
      Right85 (45%)22 (45%)
      ABPIMean (SD)0.5 (0.18)0.48 (0.11)0.5
      SmokerNever30 (16%)12 (24%)0.05
      Ex86 (45%)13 (27%)
      Current74 (39%)24 (49%)
      DiabetesNo113 (60%)23 (47%)0.2
      IDDM31 (16%)12 (24%)
      NIDDM46 (24%)14 (29%)
      HypercholesterolemiaNo45 (24%)11 (22%)0.6
      Yes, untreated22 (11%)3 (6%)
      Yes, treated66 (35%)17 (35%)
      No record of assessment57 (30%)18 (37%)
      HypertensionNo77 (41%)19 (39%)0.8
      Yes, untreated12 (6%)2 (4%)
      Yes, treated101 (53%)28 (57%)
      MobilityIndependent91 (48%)22 (45%)0.8
      Cane79 (41%)22 (45%)
      Prosthesis2 (1%)1 (2%)
      Wheelchair13 (7%)4 (8%)
      Bedbound5 (3%)0 (−)
      Myocardial infarctionYes26 (14%)8 (16%)0.6
      AnginaNo153 (81%)44 (90%)0.2
      Yes, on exercise31 (16%)3 (6%)
      Yes, at rest6 (3%)2 (4%)
      TIAYes19 (10%)1 (2%)0.07
      StrokeYes25 (13%)6 (12%)0.9
      Rest painYes170 (89%)45 (92%)0.6
      UlcerYes117 (62%)34 (69%)0.3
      GangreneYes64 (34%)14 (29%)0.5
      CreatinineN18645
      Mean (SD)116 (79.4)111 (62.0)0.7
      Range50–70240–452
      IDDM = insulin dependent diabetes mellitus; NIDDM = non-insulin dependent diabetes mellitus; TIA = transient ischaemic attack; ABPI = ankle brachial pressure index.
      Table 2Medical management in patients undergoing primary and secondary bypass in BASIL.
      Primary bypassSecondary bypassp value
      Number of patients19049
      AntiplateletNone52 (27%)17 (35%)0.2
      Single111 (59%)24 (49%)
      Double2 (1%)1 (2%)
      Antiplatelet + other15 (8%)1 (2%)
      Other10 (5%)6 (12%)
      AntihypertensiveNone81 (43%)18 (37%)0.3
      One53 (28%)19 (39%)
      Two40 (21%)6 (12%)
      Two or more16 (8%)6 (12%)
      StatinNone123 (65%)31 (63%)0.8
      Yes67 (35%)18 (37%)
      Diabetes treatmentNone131 (69%)25 (51%)0.1
      At a median of 7 years, PB was associated with significantly better AFS (PB 60% vs. SB 40%; HR 1.58, 95% CI 1.03–2.44, p = .04). Although LS and OS did not reach statistical significance there was a trend to better outcomes in the PB group (LS; PB 85% vs. SB 73%; HR 1.86, 95% CI 0.97–3.58, p = .06, and OS; PB 68% vs. 51%; HR 1.57, 95% CI 0.97–2.54, p = .06). FFR was the same in both groups (PB 53% vs. 53%; HR 1.43, 95% CI 0.74–2.74, p = .3) except that, of course, by definition, those patients undergoing SB were all undergoing a re-intervention (Figure 1, Figure 2, Figure 3, Figure 4).
      Figure thumbnail gr1
      Figure 1Comparison of amputation free survival in patients undergoing primary and secondary bypass in the BASIL trial.
      Figure thumbnail gr2
      Figure 2Comparison of limb salvage in patients undergoing primary and secondary bypass in the BASIL trial.
      Figure thumbnail gr3
      Figure 3Comparison of overall survival in patients undergoing primary and secondary bypass in the BASIL trial.
      Figure thumbnail gr4
      Figure 4Comparison of freedom from re-intervention in patients undergoing primary and secondary bypass in the BASIL trial.
      Procedural data were available for all patients who underwent SB (Table 3). All SB were deemed technically successful at the end of the procedure. Four (8%) SB were prosthetic compared with 22% (41/190) PB (p = .03). The absolute amputation rate to the end of follow up was 15.3% vs. 26.5% (p = .06). The distal anastomosis was not statistically different between PB and SB with 68% (130/190) versus 64% (31/49) being to the popliteal artery (p = .4). There was no significant difference between PB and SB in terms of 30 day morbidity and mortality (Table 4).
      Table 3Frequencies of proximal and distal anastomosis location for primary and secondary bypass.
      Primary bypassSecondary bypassp value
      Number of patients19049
      Distal anastomosisNot known2 (1%)0 (−)0.4
      AKPA63 (33%)10 (20%)
      BKPA67 (35%)21 (44%)
      PTA17 (9%)2 (4%)
      ATA20 (11%)9 (18%)
      PA17 (9%)6 (12%)
      DP2 (1%)0 (−)
      TPS1 (0.5%)1 (2%)
      DPP1 (0.5%)0 (−)
      ConduitVein149 (78%)45 (92%)0.03
      Synthetic41 (22%)4 (8%)
      AKPA = above knee popliteal artery; BKPA = below knee popliteal artery; PTA = posterior tibial artery; ATA = anterior tibial artery; PA = peroneal artery; DP = dorsalis pedis; TPS = tibial peroneal stem; DPP = dual popliteal and pedal.
      Table 4Mortality and morbidity (30 days) in patients undergoing primary and secondary bypass in BASIL.
      Primary bypassSecondary bypassp value
      Number of patients19049
      Angina2 (1%)0 (−)0.5
      MI8 (4)2 (4)1.0
      TIA0 (−)0 (−)
      CVA1 (0.5%)1 (2%)0.3
      Haematoma (no surgery)8 (4%)1 (2%)0.5
      Haematoma (surgery)3 (2%)0 (−)0.4
      LRTI6 (3%)1 (2%)0.7
      UTI9 (5%)1 (2%)0.4
      False aneurysm (no surgery)1 (0.5%)0 (−)0.6
      False aneurysm (surgery)0 (−)0 (−)
      30 day mortality11 (6%)4 (8%)0.5
      30 day morbidity and mortality83 (44%)19 (39%)0.5
      MACE17 (9%)6 (12%)0.5
      MI = myocardial infarction; TIA = transient ischaemic attack; CVA = cerebrovascular accident; LRTI = lower respiratory tract infection; UTI = urinary tract infection; MACE = major adverse cardiac event.

      Discussion

      In the BASIL trial, 190 patients underwent PB and, of the 238 patients who underwent an attempt at primary PBA, 49 (21%) went on to require a SB at some point during the trial follow up. The key finding of the present study is that PB was associated with statistically significantly better AFS and a strong trend (p = .06) towards better LS and OS. It is accepted that the SB group are a group of failures, which suggests they are different to the PB group, the challenge for this analysis is to identify why. It is also accepted that the BASIL trial was not powered to investigate this relationship, nevertheless it is an important relationship that is poorly understood. The two cohorts were well matched in terms of baseline demographics and medical therapy at randomization, PB patients were more likely to be current smokers and have a history of TIA; however, it is noted that this group was observed to have better clinical outcomes. This suggests that the observed differences are not related to the patient's medical characteristics. The anatomical burden of disease is certainly influential in type of revascularisation required and outcome of said intervention. Bollinger analysis of these groups suggests that there is no difference in burden or distribution of disease between these groups (Table 5).
      Table 5Comparison of Bollinger scores between primary and secondary bypass.
      SegmentStatsPBSBp value
      ProfundaMean (SD)2.4 (3.4)2.5 (3.6)0.828
      Proximal SFAMean (SD)6.7 (5.6)5.8 (5.3)0.3
      Distal SFAMean (SD)9.2 (5.4)10.4 (5.0)0.2
      Proximal POPMean (SD)6.6 (5.7)7.3 (6.3)0.5
      Distal POPMean (SD)3.7 (5.1)3.7 (5.1)1.0
      TPTMean (SD)4.1 (5.8)2.8 (5.0)0.2
      Proximal PTMean (SD)8.5 (7.0)8.7 (7.0)0.9
      Distal PTMean (SD)9.7 (6.5)9.2 (6.9)0.7
      Proximal ATMean (SD)6.9 (6.5)8.5 (7.0)0.2
      Distal ATMean (SD)7.3 (6.9)8.7 (7.0)0.3
      Proximal PEROMean (SD)4.8 (5.8)4.2 (5.9)0.6
      Distal PEROMean (SD)5.5 (6.5)2.2 (5.0)0.005
      Total FP scoreMean (SD)25.7 (9.9)26.3 (9.0)0.7
      Total IP scoreMean (SD)45.3 (24.8)46.3 (26.6)0.8
      Total scoreMean (SD)71.1 (26.4)72.7 (26.6)0.8
      SFA = superficial femoral artery; POP = popliteal artery; TPT = tibio-peroneal trunk; PT = posterior tibial artery; AT = anterior tibial artery; PERO = peroneal artery.
      The appropriateness of the observed trend in recent years towards an endovascular first strategy for most, perhaps even all, CLTI is now being challenged.
      • Reifsnyder T.
      • Arhuidese I.J.
      • Hicks C.W.
      • Obeid T.
      • Massada K.E.
      • Khaled A.
      • et al.
      Contemporary outcomes for open infrainguinal bypass in the endovascular era.
      • Mehaffey J.H.
      • Hawkins R.B.
      • Fashandi A.
      • Cherry K.J.
      • Kern J.A.
      • Kron I.L.
      • et al.
      Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention.
      • Chen S.L.
      • Whealon M.D.
      • Kabutey N.K.
      • Kuo I.J.
      • Sgroi M.D.
      • Fujitani R.M.
      Outcomes of open and endovascular lower extremity revascularization in active smokers with advanced peripheral arterial disease.
      However, although several groups have reported outcomes following PB and primary endovascular revascularisation, few have analysed the effect of failed endovascular intervention on the success of SB. But, these reports, taken with the data from the BASIL trial presented here, indicate that primary endovascular intervention is not the “free shot” that it has so often been claimed to be.
      Although BASIL trial data are often said to be outdated and so no longer relevant to current practice, in reality, there is no evidence that is the case.
      • Gifford S.M.
      • Fleming M.D.
      • Mendes B.C.
      • Stauffer K.C.
      • De Martino R.R.
      • Oderich G.S.
      • et al.
      Impact of femoropopliteal endovascular interventions on subsequent open bypass.
      For example, Darling and colleagues recently studied 2869 patients undergoing lower limb revascularisation for CLTI and concluded that PB resulted in better outcomes in wound healing, FFR, and OS; and that patients undergoing SB had higher rates of further intervention.
      • Mustapha J.A.
      • Finton S.M.
      • Diaz-Sandoval L.J.
      • Saab F.A.
      • Miller L.E.
      Percutaneous transluminal angioplasty in patients with infrapopliteal arterial disease.
      In another study, Jones and co-workers analysed 1154 CLTI patients undergoing SB and concluded that these patients had worse MALE, FFR, OS, and AFS.
      • Darling J.D.
      • McCallum J.C.
      • Soden P.A.
      • Korepta L.
      • Guzman R.J.
      • Wyers M.C.
      • et al.
      Results for primary bypass versus primary angioplasty/stent for lower extremity chronic limb-threatening ischemia.
      Interestingly, although more BASIL patients in the PB group underwent synthetic bypass (PB 22%, SB 8%), overall, the clinical results of PB were far superior to those observed after SB. In the UK, synthetic grafts are almost always reserved for those patients with no usable leg or arm vein.
      • Moreira C.C.
      • Leung A.D.
      • Farber A.
      • Rybin D.
      • Doros G.
      • Siracuse J.J.
      • et al.
      Alternative conduit for infrageniculate bypass in patients with critical limb ischemia.
      • Jackson M.R.
      • Belott T.P.
      • Dickason T.
      • Kaiser W.J.
      • Modrall J.G.
      • Valentine R.J.
      • et al.
      The consequences of a failed femoropopliteal bypass grafting: comparison of saphenous vein and PTFE grafts.
      • Jones D.W.
      • Schanzer A.
      • Zhao Y.
      • MacKenzie T.A.
      • Nolan B.W.
      • Conte M.S.
      • et al.
      Growing impact of restenosis on the surgical treatment of peripheral arterial disease.
      As such, it could be argued that patients undergoing prosthetic bypass should have been removed from this analysis. However, the decision was made to include them as a proportion of CLTI patients requiring bypass will not have useable veins. Approximately a third of the patients in each group underwent infra-popliteal bypass and so this can be discounted as a cause of the differences observed between PB and SB.
      Going forward, it will be important to determine whether drug coated balloons and drug eluting stents will increase the clinical success of primary endovascular intervention for CLTI. The ongoing UK NIHR HTA funded BASIL 2 and 3 trials,
      • Popplewell M.A.
      • Davies H.
      • Jarrett H.
      • Bate G.
      • Grant M.
      • Patel S.
      • et al.
      Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial.
      • Hunt B.D.
      • Popplewell M.A.
      • Davies H.
      • Meecham L.
      • Jarrett H.
      • Bate G.
      • et al.
      BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial.
      and US NIH funded BEST CLI trial,
      • Menard M.T.
      • Farber A.
      • Assmann S.F.
      • Choudhry N.K.
      • Conte M.S.
      • Creager M.A.
      • et al.
      Design and rationale of the Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) Trial.
      will together recruit more than 3500 CLTI patients undergoing PB and primary endovascular intervention and will address this and many other important question so informing evidence based revascularisation (EBR).

      Conclusion

      In the BASIL trial, clinical outcomes following PB were significantly better than in patients undergoing SB after failed PBA. Prior to treating patients with CLTI by primary PBA, clinicians should consider that if this should fail, the outcome of attempted subsequent bypass is likely to be significantly worse than if PB were attempted.

      Conflict of interest

      None.

      Funding

      National Institute of Health Research, Health Technology Assessment Programme.

      References

        • Ricco J.B.
        • Parvin S.
        • Veller M.
        • Brunkwall J.
        • Wolfe J.
        • Sillesen H.
        • et al.
        Statement from the European Society of Vascular Surgery and the World Federation of Vascular Surgery Societies: Transatlantic Inter-Society Consensus Document (TASC) III and International Standards for Vascular Care (ISVaC).
        Eur J Vasc Endovasc Surg. 2014; 47: 118
        • Aboyans V.
        • Ricco J.B.
        • Bartelink M.E.L.
        • Björck M.
        • Brodmann M.
        • Cohnert T.
        • et al.
        2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS).
        Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      1. https://www.journalslibrary.nihr.ac.uk/programmes/hta/960501#/.

        • Bisdas T.
        • Borowski M.
        • Stavroulakis K.
        • Torsello G.
        • CRITISCH Collaborators
        Endovascular therapy versus bypass surgery as first-line treatment strategies for critical limb ischemia: results of the interim analysis of the CRITISCH registry.
        JACC Cardiovasc Interv. 2016; 9: 2557-2565
        • Joels C.S.
        • York J.W.
        • Kalbaugh C.A.
        • Cull D.L.
        • Langan E.M.
        • Taylor S.M.
        Surgical implications of early failed endovascular intervention of the superficial femoral artery.
        J Vasc Surg. 2008; 47: 562-565
        • Goodney P.P.
        • Beck A.W.
        • Nagle J.
        • Welch H.G.
        • Zwolak R.M.
        National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.
        J Vasc Surg. 2009; 50: 54-60
        • Nolan B.W.
        • De Martino R.R.
        • Stone D.H.
        • Schanzer A.
        • Goodney P.P.
        • Walsh D.W.
        • et al.
        Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass.
        J Vasc Surg. 2011; 54: 730-736
        • Gifford S.M.
        • Fleming M.D.
        • Mendes B.C.
        • Stauffer K.C.
        • De Martino R.R.
        • Oderich G.S.
        • et al.
        Impact of femoropopliteal endovascular interventions on subsequent open bypass.
        J Vasc Surg. 2016; 64: 623-628
        • Cury M.V.M.
        • Brochado-Neto F.C.
        • Matielo M.F.
        • de Athayde Soares R.
        • Sarpe A.K.
        • Sacilotto R.
        Results of bypass graft surgery after prior angioplasty in critical limb ischaemia treatment.
        VASA. 2016; 45: 305-310
        • Bradbury A.W.
        • Adam D.J.
        • Bell J.
        • Forbes J.F.
        • Fowkes F.G.
        • Gillespie I.
        • et al.
        Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received.
        J Vasc Surg. 2010; 51: 18S-31S
        • Reifsnyder T.
        • Arhuidese I.J.
        • Hicks C.W.
        • Obeid T.
        • Massada K.E.
        • Khaled A.
        • et al.
        Contemporary outcomes for open infrainguinal bypass in the endovascular era.
        Ann Vasc Surg. 2016; 30: 52-58
        • Mehaffey J.H.
        • Hawkins R.B.
        • Fashandi A.
        • Cherry K.J.
        • Kern J.A.
        • Kron I.L.
        • et al.
        Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention.
        J Vasc Surg. 2017; 66 (e1): 1109-1116
        • Chen S.L.
        • Whealon M.D.
        • Kabutey N.K.
        • Kuo I.J.
        • Sgroi M.D.
        • Fujitani R.M.
        Outcomes of open and endovascular lower extremity revascularization in active smokers with advanced peripheral arterial disease.
        J Vasc Surg. 2017; 65: 1680-1689
        • Mustapha J.A.
        • Finton S.M.
        • Diaz-Sandoval L.J.
        • Saab F.A.
        • Miller L.E.
        Percutaneous transluminal angioplasty in patients with infrapopliteal arterial disease.
        Circ Cardiovasc Interv. 2016; 9e003468
        • Darling J.D.
        • McCallum J.C.
        • Soden P.A.
        • Korepta L.
        • Guzman R.J.
        • Wyers M.C.
        • et al.
        Results for primary bypass versus primary angioplasty/stent for lower extremity chronic limb-threatening ischemia.
        J Vasc Surg. 2017; 66: 466-475
        • Moreira C.C.
        • Leung A.D.
        • Farber A.
        • Rybin D.
        • Doros G.
        • Siracuse J.J.
        • et al.
        Alternative conduit for infrageniculate bypass in patients with critical limb ischemia.
        J Vasc Surg. 2016; 64 (e1): 131-139
        • Jackson M.R.
        • Belott T.P.
        • Dickason T.
        • Kaiser W.J.
        • Modrall J.G.
        • Valentine R.J.
        • et al.
        The consequences of a failed femoropopliteal bypass grafting: comparison of saphenous vein and PTFE grafts.
        J Vasc Surg. 2000; 32: 498-505
        • Jones D.W.
        • Schanzer A.
        • Zhao Y.
        • MacKenzie T.A.
        • Nolan B.W.
        • Conte M.S.
        • et al.
        Growing impact of restenosis on the surgical treatment of peripheral arterial disease.
        J Am Heart Assoc. 2013; 2e000345
        • Popplewell M.A.
        • Davies H.
        • Jarrett H.
        • Bate G.
        • Grant M.
        • Patel S.
        • et al.
        Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial.
        Trials. 2016; 17: 11
        • Hunt B.D.
        • Popplewell M.A.
        • Davies H.
        • Meecham L.
        • Jarrett H.
        • Bate G.
        • et al.
        BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial.
        Trials. 2017; 18: 224
        • Menard M.T.
        • Farber A.
        • Assmann S.F.
        • Choudhry N.K.
        • Conte M.S.
        • Creager M.A.
        • et al.
        Design and rationale of the Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) Trial.
        J Am Heart Assoc. 2016; 5e003219

      Comments

      Commenting Guidelines

      To submit a comment for a journal article, please use the space above and note the following:

      • We will review submitted comments as soon as possible, striving for within two business days.
      • This forum is intended for constructive dialogue. Comments that are commercial or promotional in nature, pertain to specific medical cases, are not relevant to the article for which they have been submitted, or are otherwise inappropriate will not be posted.
      • We require that commenters identify themselves with names and affiliations.
      • Comments must be in compliance with our Terms & Conditions.
      • Comments are not peer-reviewed.