Journal of Vascular Surgery
Volume 48, Issue 6, Supplement , Pages 11S-16S, December 2008

Which is the best revascularization for critical limb ischemia: Endovascular or open surgery?

Presented as the Inaugural Robert B. Rutherford Lecture at the Second Annual Meeting of World Federation of Vascular Societies, San Diego, Jun 4, 2008.

  • Jonathan D. Beard, ChM, MEd, FRCS

      Affiliations

    • Corresponding Author InformationReprint requests: Jonathan D. Beard, Sheffield Vascular Institute, Northern General Hospital, Sheffield S5 7AU, UK

Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom

Received 6 August 2008; accepted 12 August 2008.

Article Outline

This review considers the roles of endovascular and open surgery for critical lower limb ischemia. The TransAtlantic Inter-Society Consensus document offers sensible guidelines for the treatment of both suprainguinal and infrainguinal disease. For bilateral/diffuse suprainguinal disease, aortobifemoral bypass remains the best option, but great care should be taken in this new era of hospital-acquired infection. Unilateral iliac occlusions should be treated by primary stenting, but an iliofemoral or femorofemoral bypass may be the best option when the disease extends down into the common femoral artery. Stents may reduce the risk of embolization in iliac stenoses but probably confer no benefit in long-term patency. Iliac stenoses should be treated by angioplasty, with stents reserved for flow-limiting complications. Although infrainguinal bypass surgery is in decline, probably due to better medical treatment and more endovascular intervention, bypass using autologous saphenous vein remains the gold standard. In the absence of leg veins, arm vein should be considered. Prosthetic grafts should be used as a last resort, and only with a venous cuff. The long-term results of the Bypass Versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial favor surgery rather than angioplasty if there is a good vein and the patient is fit. Further randomized studies of infrainguinal stenting vs bypass are required. Some patients with critical lower limb ischemia are best treated by analgesia or primary amputation.

 

This review considers the roles of endovascular and open surgery for critical lower limb ischemia (CLI). The choice of treatment modality will obviously depend upon whether the patient is fit enough for open surgery and whether the pattern of disease is suitable. Given the choice, most patients will opt for an endovascular-first approach, but some important factors can influence this choice. These are often overlooked and include:

•Evidence-based outcome—is the planned intervention worth it for the patient?

•Cost-effectiveness—is the planned intervention worth it for the health care system?

•Availability of treatment—can the clinician/hospital provide all the available options?

•Patient information—is it unbiased and nonpromotional?

•Local outcomes—are the clinician/hospital's results up to standard?

We should also remember that two other modalities are available for the treatment of CLI: conservative management and major amputation. Adequate analgesia and other supportive measures may well be the best option for a moribund patient. Major amputation may be the best option for a bedbound patient or when there is extensive foot necrosis or sepsis. Successful revascularization is less expensive than major amputation,1 but there is little evidence that it improves quality of life, although it does seem better at maintaining mobility.2

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The evidence 

A review of the world literature reveals numerous articles promoting the advantages of endovascular vs open surgery for CLI, or vice versa. Unfortunately, almost all of these studies are flawed for one or more of the following reasons:

•nonrandomized study, or no controls

•small numbers, single center, single operator

•poorly defined patient demographics and interventions

•intermittent claudication and CLI combined

•suprainguinal and infrainguinal disease combined

•short or incomplete follow-up, or both

•retrospective analysis

The result of this lack of evidence means that the same patient may be offered a completely different treatment (or no treatment) depending on the clinician and the hospital.3 This lack of evidence also means a large grey area of equipoise exists that should increase the willingness of clinicians to randomize patients. This makes the lack of published and ongoing randomized controlled trials (RCTs) both surprising and somewhat embarrassing.

TransAtlantic Inter-Society Consensus recommendations 

The TransAtlantic Inter-Society Consensus (TASC) Working Group and the Society of Interventional Radiology (SIR) have made recommendations for the type of lesion that is suitable or unsuitable for endovascular or open surgical treatment.4, 5 These recommendations differ, but the differences are not particularly significant. The recommendations have recently been updated to account for advances in endovascular techniques and are summarized in the Table. Both classify peripheral arterial disease according to the level of the disease (eg, aortic, iliac, femoropopliteal, or crural) and by the severity of the disease (eg, TASC type A to D). As the disease becomes more severe or more diffuse, or both, the recommendations move from endovascular to open intervention:

•Type A lesions should usually be treated by endovascular means

•Type B lesions should be preferentially treated by endovascular means

•Type C lesions should be preferentially treated by open revascularization

•Type D lesions should usually be treated by open surgery

The recommendations for type B, C, and D depend upon a patient's fitness, fully informed preference, and the operator's success rates.

Table. Summary of recommendations of the TransAtlantic Inter-Society Consensus II Working Groupa
Level of diseaseSegment/recommendation
Usually PTA (type A)PTA preferred (type B)Surgery preferred (type C)Usually surgery (type D)
Infrarenal aorta Stenosis ≤3 cm Aortic occlusion
Iliac (CIA/EIA)Stenosis ≤3 cmStenosis 3-10 cmBilat CIA occlusionsBilat EIA occlusions
Unilat CIA or EIA occlusionUnilat CIA + EIA occlusionDisease extending into aorta and/or CFAs
Femoral poplitealSFA stenosis ≤10 cm or occlusion ≤5 cmSFA stenosis or occlusion ≤15 cm; popliteal stenosisSFA stenosis or occlusion >15 cm; recurrent diseaseComplete SFA or popliteal occlusions
CruralNonebNonebStenoses ≤4 cm or occlusions ≤2 cmDiffuse disease or occlusions >2 cm
OutcomesExcellentcExcellentcPTA/stent only has modest results and is indicated when surgery is contraindicated for technical or patient reasonsEndovascular approach is not advised unless symptoms are limb threatening and surgery is not possible.

CFA, Common femoral artery; CIA, common iliac artery; EIA, external iliac artery; PTA, percutaneous transluminal angioplasty; SFA, superficial femoral artery.

aThe presence of calcification or multiple lesions generally moves a recommendation towards open surgery; eg, type B to type C.

bCrural interventions have severe outcomes if they go wrong; therefore there is no type A or B recommendation.

cExcellent results can be expected from an endovascular approach in all segments.

Aortic disease 

Hemodynamically significant stenoses of the infrarenal aorta are rare and usually seen in short, obese female smokers with a hypoplastic aorta. Before the advent of endovascular therapies, these patients would have undergone a localized aortic endarterectomy. Over time, endovascular techniques have evolved from the “kissing balloon” angioplasty technique to primary aortic stenting. Both balloon angioplasty and primary stenting have acceptable durability, with 5-year patency rates of 50%.6 Complications are rare and usually relate to embolization, pseudoaneurysm formation due to the size of the sheath required, and recurrent disease.7

Complete aortic occlusions are best treated by an aortobifemoral bypass. Kissing stents can be used, but there is a risk of one stent compressing the other. The infrarenal abdominal aorta can be approached laparoscopically or by conventional laparotomy. Advocates of laparoscopic aortic surgery claim lower morbidity and mortality rates and shorter hospital stays.8, 9 There remains no convincing evidence to support these claims because no randomized trials have been conducted. Laparoscopic aortic surgery requires extensive training, and the procedure times are longer than for open surgery.

In an unfit patient, aortouniiliac stenting, combined with a femorofemoral crossover, may be a better alternative to an axillofemoral bypass, although the patency rates are inferior.10 Axillofemoral bypass is associated with a hospital mortality of 5%, and 5-year limb salvage and patient survival rates of 75% and 35%, respectively.11 There appears to be no difference in patencies between axillobifemoral or axillounifemoral bypass grafts. A randomized clinical trial has reported an improved 3-year graft patency rate of 86% in grafts with a flow splitter vs 38% in a contralateral limb taken off at 90°.12

Iliac disease 

The traditional management of unilateral iliac occlusion is a femorofemoral crossover graft, especially when the disease extends into the femoral artery. This is considered to be a low-risk procedure with an operative mortality of 0% to 5%. However, these figures are influenced by the presence of critical ischemia, previous surgery, and the need for combined iliac interventions.13 Pursell et al,14 in a recent review, reported a 22% complication rate, including a 6% graft infection rate. Some observational evidence shows that externally supported grafts perform better over time.15 A recent study from France has demonstrated a superior outcome at 4 years in patients who underwent a unilateral iliofemoral grafting rather than femorofemoral crossover grafting.16

Only one RCT has compared open surgery with angioplasty in symptomatic iliac occlusive disease.17 This study randomized 263 men with an iliac occlusion that was a major component to rest pain or lifestyle-limiting claudication to bypass surgery (n = 123) or angioplasty (n = 129). Three patients died in the surgery group and none in the angioplasty group. There was no difference in patency and limb salvage rates at a median follow-up of 4 years. The authors concluded that the lower morbidity and mortality rate in the angioplasty group supported the concept of an angioplasty-first strategy because the outcomes of the two treatments did not differ. The study was limited by the absence of women, who have smaller arteries, and the relatively small numbers, which precluded subgroup analysis of length and location of the occlusion.

In a second, nonrandomized comparative study, the complication rate, primary patency, and cost of stent deployment were compared with direct surgical reconstruction for the treatment of severe aortoiliac occlusive disease.18 Treatment consisted of stent deployment in 65 patients and surgical reconstruction in 54. No significant differences were observed between the groups for clinical presentation, demographics, and late complications. However, the cumulative primary patency rate for bypass grafts was significantly better than for iliac stents at 18 months (93% vs 73%), 30 months (93% vs 68%), and 42 months (93% vs 68%). Multivariate analysis suggested that women, anyone with ipsilateral superficial femoral artery occlusion, and patients who had procedurally related vascular complications and hypercholesterolemia were more likely to present with bypass graft or stent thrombosis. Costs did not differ significantly.

So we have two studies with very different conclusions. The first is a RCT, and the second, an observational study. It is difficult to determine which of the many variables in the observational study affected which group, and it is of course possible that patients who were less fit for open surgery were treated by endovascular means. The literature regarding surgery or iliac intervention remains controversial. For this reason, the TASC Working Group looked at all the available evidence and concluded that endovascular treatment is the treatment of choice for type A aortoiliac lesions and open surgical treatment for type D lesions.5 TASC considered that the evidence for the efficacy of one treatment instead of another was insufficient for types B and C lesions.

Few data are available on the role of stents in aortoiliac stenotic disease. Early aortoiliac angioplasty had a high rate of embolic complications, particularly when treating occlusive rather than stenotic disease.19 As a result, stenting became the first line treatment for iliac occlusive disease. RCTs that have been performed have suffered from flawed design and study methodology. One such a study demonstrated 4-year patency rates of 91.6% for stents and 74.3% for percutaneous transluminal angioplasty (PTA) alone, but the results have never been fully published.20

Only one peer reviewed published RCT has compared primary stent placement with PTA, followed by stent placement if needed, in the iliac arteries. The Dutch Iliac Stent Trial (DIST) randomized patients to either a primary Palmaz stent (Cordis, Miami Lakes, Fla) or PTA alone.21 In the latter group, stents were reserved for patients with suboptimal PTA results. The authors reported that 43% of patients randomized to PTA received iliac stents and that 2-year cumulative patency rates for the two groups were similar at 71% vs 70%.

They concluded that because angioplasty followed by selective stent placement is less expensive than primary stent placement, the former should be the treatment of choice for lifestyle-limiting intermittent claudication caused by iliac artery occlusive disease. However, only 29 iliac artery occlusions were treated among 279 patients, and patients with occlusions >5 cm in length were ineligible for enrolment. Even with that strict length threshold for eligibility, PTA failed in 10 of the 12 subjects (83%) with occlusions. Although stents seem to offer special benefits in the treatment of longer segment lesions, little guidance about such patients is therefore provided by this trial.

Furthermore, most patients in the DIST study had mild clinical symptoms, and only 22% of patients in each group were classified as having Society for Vascular Surgery/International Society for Cardiovascular Surgery (SVS/ISCVS) grades 3 to 5 ischemia. Only 10% of patients had diabetes mellitus, and only 10% had simultaneous iliac artery disease and occlusion of the ipsilateral superficial femoral artery. The mean pretreatment, resting ankle-brachial index in both groups was 0.77. As a consequence, the milder pattern of atherosclerotic disease observed in the DIST study differed from that encountered in many interventional practices.

In addition, the study was designed to have a 90% likelihood of detecting a 10% difference in arterial patency 12 months after treatment between the two groups (90% power). Unfortunately, because of inadequate recruitment and funding, the trial was terminated after <80% of the intended sample had been enrolled. Outcome information after as little as 1 year is available in the published report for about 60% of the subjects who ultimately enrolled, a fraction that actually represents <45% of the intended patient sample. Thus, even though the authors did not observe “substantial differences” in clinical outcomes between their experimental groups, the DIST study was more likely to miss than to detect the same potential 10% improvement in 12-month patency rates that was used to configure the trial because the actual power was <50%.

Because of under-recruitment, the authors attempted to amplify their sample by reporting the number of lesions treated rather than the number of subjects actually involved. For example, a patient with simultaneous common and external iliac stenoses or occlusions was classified as two treated lesions, rather than as a single person. As a result, little information about crucial patient subgroups (eg, occlusions vs stenoses, common iliac vs external iliac lesions) can be gleaned from this report. Despite these problems, the authors continued to publish from the original data set, reporting patency rates and patient survival at 5 years.22

A second multicenter prospective RCT comparing angioplasty vs stenting for the management of iliac occlusions (STAG) in aortoiliac disease has recently been completed. This is not yet published, but a preliminary analysis suggests that there are significantly fewer major complications, particularly embolization, after stenting compared with PTA, but that stents confer no benefit in terms of patency.

A meta-analysis of observational studies found a better technical success rate for stent (97%) rather than PTA (91%; P < .05).23 It also found a better overall 4-year primary patency for iliac stents in critical limb ischemia (67% vs 35%), although this not the case for claudicant patients (77% vs 65%). This emphasizes the need for significant subgroup analysis in any study. A cost-effectiveness analysis of aortoiliac stenotic disease suggested that PTA and selective stent insertion for suboptimal results is the most cost-effective option, but did not deal specifically with technically more difficult and potentially complicated occlusive disease.24

Infrainguinal disease 

During the last decade a significant reduction has occurred in the number of infrainguinal bypass grafts. The reasons for this are unclear but may well relate to improvements in general medical care and risk-factor modification, earlier referral, better access to interventional vascular radiology, and improved endovascular techniques.

The great saphenous vein (GSV) is the conduit of choice for infrainguinal bypass. Preoperative ultrasound mapping is essential. In general, a single nonvaricose GSV is usable as long as it is not too small. Small GSVs (<3 mm) are associated with a twofold risk of early failure and should be discarded or used as a venous patch or cuff.25 By contrast, large veins (>6 mm) are often associated with focal varicosities that may require excision and splicing or alternatively plication of a local blow out. The use of complex GSV systems (two or more) is associated with increased dissection, local hematoma formation, and skin necrosis. If the GSV has been removed or is of poor quality, one should consider using the contralateral GSV or small saphenous vein rather than arm vein, which has lower patency rates.26 There is no good evidence to suggest that the in situ technique is any better than the standard reversed configuration.

When no vein is available, most surgeons favor a vein cuff at the distal anastomosis. The Joint Vascular Research Group RCT of Miller vein cuff vs noncuff for femoropopliteal polytetrafluoroethylene (PTFE) grafts demonstrated significantly higher patency rates for prosthetic grafts with a vein cuff at the below knee level at 3 years.27

The use of prosthetic material for both intermittent claudication and critical ischemia has fallen dramatically because of poor patency rates and concerns about graft infection.28 The patency rates for femoropopliteal bypass for CLI from a meta-analysis by Hunink et al29 gave primary patencies of 66% for vein (any level), 47% for above knee PTFE, and 33% for below knee PTFE at 5 years. The pooled weighted data for primary patency rates for femorodistal (tibial or pedal) bypass are reported in TASC as 85%, 80%, and 70% for femorodistal bypass with vein and 70%, 35%, and 25% for femorodistal bypass with a prosthetic graft at 1, 3, and 5 years, respectively.5 A Cochrane review of nine trials that included 1334 patients reported no differences between PTFE and Dacron (DuPont, Wilmington, Del).30 However, a subsequent multicenter randomized study of PTFE or Dacron for above knee femoropopliteal bypass has reported significantly better 2-year secondary patency rates for Dacron vs PTFE.31

Claims of 1-year patency rates after angioplasty of femoropopliteal stenosis of 70% and 50% for occlusions have been made; however, the studies are generally poor and rarely define the type of lesion that is being treated. The TASC document5 is probably more realistic about the type of lesion that should be treated. To improve outcomes, many alternatives to angioplasty have been proposed, including stents, cutting balloons,32 cryo-balloon angioplasty,33 and drug-eluting stents. Analysis of the literature on cryo-balloon angioplasty suggests it is no better than angioplasty alone.34

The results of femoropopliteal stents are variable, and because most trials have been industry sponsored, the results will have a positive reporting bias towards stenting. Patency rates of nearly 90% at 1 year and 78% at 3 years have been reported in noncontrolled observational studies.35, 36, 37 Stent grafts have also been used with variable results. Dacron-covered stents induce an intense inflammatory response and occlude early.38 In contrast, PTFE-covered stents have better patency rates, although they require long-term follow-up, a high rate of reintervention, and long-term use of aspirin and clopidogrel.39 Primary patency rates of 80% at 1 year and assisted patency of 87% at 2 years for stenoses have been reported. Other results are not as optimistic: One author demonstrated a 72% early occlusion rate.40 These two observational studies demonstrate no improvement in patency compared with standard angioplasty.

Sirolimus-eluting stents have been tested, and results from animal models demonstrated marked effects on smooth muscle proliferation and cell migration, with a reduction in intimal hyperplasia after stent placement. In the Sirolimus-Coated Cordis Self-Expanding Stent for the Treatment of Obstructing Superficial Femoral Artery Disease (SIROCCO) trial of sirolimus eluting stents vs bare SMART nitinol stents for TASC C lesions, the restenosis rates at 24 months were 22.9% and 21.1%, respectively.41, 42 In a recent multicenter study from Germany, angioplasty balloons coated in paclitaxel produced significantly better results at 6 and 24 months in terms of late lumen loss and target lesion revascularization.43

Although often described as a novel technique, subintimal angioplasty has been around for >20 years. It is perhaps considered novel because it was only described in detail in the last 10 years. An antegrade catheter and a hydrophilic guidewire are used to access the subintimal space above a femoropopliteal occlusion, and the wire is pushed down like a surgical ring stripper. If the artery is not too calcified, the wire will invariably re-enter the true lumen below the obstruction, and dilatation with a 5- or 6-mm angioplasty balloon will produce a patent although dissected channel offering a clean surface to blood flow. As a limb salvage procedure this technique works extremely well, with salvage rates of >75% being reported.44, 45

Endovascular interventions in the crural arteries are confined to those patients who have rest pain or tissue loss and in whom surgical options are limited because of anatomic considerations or comorbidities.46 The success of the procedure depends on a good inflow, stenotic rather than occlusive disease, and focal rather than widespread atherosclerosis. Limb salvage rates of 81% have been reported at 12 months.47

Only one randomized trial has compared angioplasty vs infrainguinal bypass, and only one has compared stents with bypass. In the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial, 452 patients were randomized to angioplasty or infrainguinal bypass.48 The primary outcome measure was amputation-free survival. Secondary outcome measures included all-cause mortality, morbidity, and reintervention, and quality of life and hospital costs.

The 30-day mortality was low in both groups, at 5% for surgery and 3% for angioplasty. Surgery was associated with a significantly higher morbidity (57% vs 41%), mainly due to myocardial infarction and wound infection. The surgical patients also stayed in the hospital longer, and this contributed to the cost of surgery being one-third higher than angioplasty at 1 year. By 3 years, however, the difference in costs was no longer significant because patients who had angioplasty had a significantly higher failure rate (20% vs 3% within 12 months) resulting in a higher reintervention rate (28% vs 17%). There was no difference in quality of life, amputation-free survival, or all-cause mortality at any time interval out to 2 years; and by 5 years, 36% of patients had died.

Subgroup analysis suggests that surgery is the best option for fit patients with a usable vein. The trial has been criticized for the combined end point, the high mortality that accounted for 75% of the end points, the failure to address the secondary risk factors, and the absence of data on diabetic control. One small randomized trial of expanded PTFE/Nitinol stent grafts vs femoral–to–above–knee popliteal expanded PTFE or Dacron bypass grafts has shown no difference in primary and secondary patency rates at 12 months (73.5% and 83.9% vs 74.2% and 83.7%, respectively).49 The superiority of stent grafts over open stents has not been demonstrated, and there are no trials of stents vs bypass grafts to the below–knee popliteal level, which is more commonly required in patients with CLI.

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Conclusion 

The TASC consensus document offers sensible guidelines for the treatment of both suprainguinal and infrainguinal disease. Aortobifemoral bypass remains the best option for bilateral/diffuse disease, but great care should be taken in this new era of hospital-acquired infection. Unilateral iliac occlusions should be treated by primary stenting, but an iliofemoral or femorofemoral bypass may be the best option when the disease extends down into the common femoral artery. Stents reduce the risk of embolization but probably confer no benefit in terms of long-term patency. Iliac stenoses should be treated by angioplasty, with stents being reserved for flow-limiting complications.

Although infrainguinal bypass surgery is in decline, probably due to better medical treatment and more endovascular intervention, bypass using autologous saphenous vein remains the gold standard. In the absence of leg vein, arm vein should be considered. Prosthetic grafts should be used as the last resort, and only with a venous cuff. The long-term results of the BASIL trial favor surgery over angioplasty if there is a good vein and the patient is fit. Further randomized studies of infrainguinal stenting vs bypass are required. Some patients with CLI are best treated by analgesia or primary amputation.

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 STATEMENT OF CONFLICT OF INTEREST: J. D. Beard reports that he has no conflicts of interest with the sponsor of this supplement article or products discussed in this article.

PII: S0741-5214(08)01387-6

doi:10.1016/j.jvs.2008.08.036

Journal of Vascular Surgery
Volume 48, Issue 6, Supplement , Pages 11S-16S, December 2008

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