Annals of Vascular Surgery
Volume 23, Issue 2 , Pages 179-185, March 2009

The Role of Thrombolysis in Acute Infrainguinal Bypass Occlusion: A Prospective Nonrandomized Controlled Study

Department of Vascular Surgery, University Hospital Gasthuisberg, Leuven, Belgium

published online 21 December 2007.

Article Outline

Current treatment of acute infrainguinal bypass occlusion consists of either surgical revascularization or catheter-guided intra-arterial thrombolysis with adjunctive correction of the underlying flow-limiting lesion. In maintaining long-term patency, improving the number of outflow vessels could be of utmost importance. To compare the efficiency of both thrombolysis and primary surgical revascularization and to study the effect of thrombolysis on the number of patent outflow vessels, a prospective nonrandomized study was performed. Between February 2002 and August 2003, 54 patients with 56 occluded bypasses were included. Thirty bypasses were treated with thrombolysis, 26 primarily with surgery. Thrombolysis was successful in 80% of cases, with restoration of patency of the bypass but also with doubling of the amount of patent outflow vessels; surgery was successful in 85.71% of cases. However, in only 60% of the successfully lysed bypasses no adjunctive major surgery was needed. Amputation-free survival was 87.5% 1 year after surgery and 82.6% 1 year after thrombolysis. One year after thrombolysis without adjunctive major surgery, the amputation-free survival was only 39.7%. Therefore, a strategy could be to start with thrombolysis to improve outflow followed by a new bypass, whatever the underlying causative lesions are.

 

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Introduction 

Acute infrainguinal bypass occlusion is still an unsolved problem with risk of limb loss in the short or long term. Surgical revascularization by thrombectomy or complete graft replacement is one treatment option; catheter-guided intra-arterial thrombolysis is the other one.

Thrombolysis has been advocated because of poor long-term patency rates after thrombectomy and the invasiveness of complete graft replacement.1, 2, 3 An advantage of thrombolysis could be that successful lysis often reveals an underlying causative lesion which in a second step can be treated appropriately by either percutaneous or surgical techniques, providing a major reduction of the originally planned surgical intervention.1, 4, 5 Another advantage could be that thrombolysis resolves the cloth not only in the bypass but also in the outflow vessels. Lysis of the cloth in the arteries distal to the occluded bypass graft is at least as important as graft reopening itself.3

The 1980s were characterized by a wide variety of retrospective studies comprising large groups of patients treated with thrombolytic therapy. In the 1990s, the retrospective series were replaced by prospective ones.2, 4, 5, 6, 7, 8, 9, 10, 11, 12 A review of the available data suggests that thrombolysis cannot be viewed as an absolute alternative treatment to operative management but that the two approaches must be used in conjunction with each other.8, 13, 14 Thrombolytic therapy may be the appropriate initial approach to reveal the causative lesion that in a second step can be treated by endovascular or open surgical means.3, 13, 15, 16

However, review of these data also illustrates the caveat of thrombolytic therapy. Thrombolysis is not free of complications, and the question remains whether intra-arterial thrombolytic therapy offers an advantage over surgical revascularization as an initial treatment of acute infrainguinal bypass occlusion.13, 17, 18, 19, 20, 21, 22, 23, 24 It remains unclear if thrombolysis improves amputation-free survival and reduces the major surgical revascularization rate.25, 26 Moreover, the idea that thrombolysis improves outflow has never been studied well.

Therefore, we started a prospective nonrandomized but controlled study. The aim was to compare the efficiency of intra-arterial thrombolysis over surgical revascularization as the initial treatment of acute infrainguinal bypass graft occlusion and especially to document the effects of thrombolysis on outflow vessels.

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Material and Methods 

From February 2002 to August 2003 all patients presenting at our university hospital with acute occlusion of an infrainguinal bypass were included in a prospective study. Time from onset of symptoms to treatment had to be less than 2 weeks. All patients had severe claudication or limb-threatening ischemia according to the Society for Vascular Surgery/International Society of Cardiovascular Surgery (SVS/ISCVS) standards for acute limb ischemia (Table I).27, 28, 29

Table I. Patient demographics
Thrombolysis (n = 30)Primary surgery (n = 26)
Age (mean, range)65.2 (35–81)68.3 (46–81)
Gender (M/F)9/2110/16
Smoking (%)14 (46.7)11 (42.3)
Chronic renal insufficiency (%)2 (6.7)1 (3.8)
Diabetes (%)5 (16.7)6 (23.1)
ASHD (%)8 (26.7)9 (34.6)
Hypertension (%)16 (53.3)15 (57.7)
Hypercholesterolemia (%)12 (40)11 (42.3)

ASHD, atherosclerotic heart disease.

Patients were treated primarily with either surgery or thrombolysis, with adjunctive correction of the underlying lesion if appropriate. The type of treatment was decided on logistic reasons or contraindications for thrombolysis, turning it into a nonrandomized but controlled study.

Patients were excluded from thrombolysis if they had a contraindication to thrombolytic therapy. Absolute contraindications for thrombolysis were reversible limb-threatening ischemia necessitating urgent revascularization; hemorrhagic diathesis/active bleeding; history of stroke, transient ischemic attack, or cardiovascular accident within the previous 2 months; and neurosurgery or intracranial trauma within the previous 3 months. Relative contraindications for thrombolysis were reanimation within the previous 10 days, major nonvascular surgery or trauma within the previous 10 days, uncontrolled hypertension (systolic >180 mm Hg or diastolic >110 mm Hg), puncture of an uncompressible vessel within the previous 14 days, intracranial neoplasm, diabetic hemorrhagic retinopathy, and age >80 years.13, 29

Successful thrombolysis was defined as complete or at least 95% reopening of the graft with restoration of antegrade blood flow.30 Successful surgery was defined as restoration of antegrade blood flow. Surgical intervention after thrombolysis was defined in order of increasing magnitude of the intervention: no intervention, endovascular balloon angioplasty, surgical correction of a bypass anastomosis, and replacement of the existing graft.4 Endovascular procedures and surgical correction of a bypass anastomosis were considered “minor” adjunctive procedures, whereas a new bypass was considered a “major” adjunctive procedure.

After both thrombolysis and primary surgery, all patients were treated with clopidogrel and/or low-dose aspirin.31, 32 All patients were seen at 3-month intervals at the outpatient clinic for clinical examination and blood flow measurement. The clinical records and arteriographies of all patients were studied. For patients treated with thrombolysis, pre- and posttreatment arteriographs were studied for outflow vessels including the foot arteries.

The primary end point was amputation-free survival. Secondary end points were amputation-free survival without major or minor surgical intervention and mortality. Primary patency was defined as patency after thrombolysis with or without adjuvant intervention, patency after primary thrombectomy, or patency after primary complete graft replacement. Assisted primary patency was defined as uninterrupted patency but included procedures to be performed on a patent bypass graft to prevent eventual thrombosis.

To measure patency and limb salvage rates, actuarial survival curves were used. The log-rank test was used to evaluate differences in survival functions between groups. A significance level of 0.05 was assumed for all tests.

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Results 

From February 2002 to August 2003, 54 consecutive patients with 56 separate occluded bypasses were admitted with a recently occluded infrainguinal bypass graft. Figure 1 summarizes the distribution of patients to the different treatment groups. Table I summarizes the demographic data of patients in the different treatment groups; Table II summarizes the preprocedural anticoagulation regimen and the use of statins. No significant differences between groups were found for all these data.

Table II. Prethrombosis antiplatelet therapy and use of statins
Thrombolysis (n = 30)Primary surgery (n = 26)
Low dose of aspirin only (%)16 (53.3)9 (30)
Clopidogrel only (%)7 (23.3)7 (26.9)
Combination of low dose of aspirin and clopidogrel (%)1 (3.3)2 (7.7)
Warfarin/coumarin (%)4 (13.3)4 (15.4)
Statin (%)6 (20)4 (15.4)

Twenty-eight patients (18 men, 10 women) were treated with thrombolysis for thrombosis of 30 separate bypasses. One patient (3.57%) had two thrombolyses of the same bypass, and one patient (3.57%) had two thrombolyses of a different bypass. The mean age of the patients was 65.57 years (range 35–81).

Patients presented for thrombolytic treatment at a median time of 6.77 days after onset of symptoms of graft occlusion (0.5 hr–14 days). At the time of graft thrombosis, 16 patients had limb-threatening ischemia, whereas in 14 cases patients had return of severe claudication. In these patients treated with thrombolytic therapy, five bypass grafts were to the above-knee popliteal artery, 10 to the below-knee popliteal artery, and 15 to infrapopliteal vessels.

For 22 of the bypasses, polytetrafluoroethylene (PTFE) was used. Reversed saphenous vein conduit was used in one bypass and in situ saphenous vein in three bypasses. In four patients, a composite graft was used. The mean age of the bypasses was 57.29 months (range 1–125) (Table III). In three grafts staphylokinase and in 25 urokinase was infused. In two cases, the thrombolytic agent was not recorded.

Of the 30 thrombosed infrainguinal grafts undergoing thrombolytic therapy, 24 (80%) were successfully lysed, whereas failure to restore graft patency occurred in six cases (20%). Of the 24 successfully lysed grafts, nine required an adjunctive procedure to correct an underlying causative lesion. To correct these defects, two grafts underwent balloon angioplasty and one underwent minor surgical revision. In six cases, major secondary surgery was necessary to solve ongoing ischemia. Thus, only 18 cases (60%) reached satisfactory revascularization without major surgery.

After successful thrombolysis, a control arteriography was performed to study the outflow vessels including the foot arteries. Pretreatment, two patients had three patent outflow vessels, five patients had two, five patients had one, and 12 patients had none. Posttreatment, nine patients had three patent outflow vessels, six patients had two, six patients had one, and three patients had none (Fig. 2). In six patients, the plantar arch that was not visible pretreatment appeared posttreatment (Fig. 3). In no patient was the number of outflow vessels lower posttreatment.

In 11 cases (36.67%), thrombolysis-related complications were seen. Mortality was 6.67%. One patient developed an acute myocardial infarction immediately after thrombolysis and one patient after 5 days, in both cases leading to death. In four cases, patients developed a hematoma, one of which necessitated surgical correction. One patient developed nausea, dizziness, flushes, and photophobia. One patient developed cerebral bleeding, and two patients developed a pseudoaneurysm.

The mean follow-up of patients primarily treated with thrombolysis was 1.5 years, with a maximum of 2.5 years. After thrombolysis, the overall amputation-free survival was 86.4% at 1 month and 82.6% at 1 year (Fig. 5). The amputation-free survival after thrombolysis without major surgery was only 75% at 1 month and 39.7% at 1 year (Fig. 5).

The overall primary patency rate of successful thrombolysis was 95.8% at 1 month and 77.9% at 1 year. The primary patency rate of successful thrombolysis without major surgery was 77.8% at 1 month and 39.5% at 1 year (Fig. 6).

Twenty-six patients (14 men, 12 women) presenting with 26 occluded infrainguinal bypasses were surgically treated. The mean age of the patients was 68.04 years (range 46–81). Patients presented for surgical treatment at a median time of 8.76 days after onset of symptoms of graft occlusion (0.5 hours–14 days). At the time of graft thrombosis, nine patients had limb-threatening ischemia, whereas in 16 cases patients had return of severe claudication. In one case, the clinical symptoms were not recorded. Six bypass grafts were to the above-knee popliteal artery, 15 to the below-knee popliteal artery, and eight to the infrapopliteal vessels. For 21 bypasses, PTFE was used. Reversed saphenous vein conduit was used in two bypasses and in situ saphenous vein in one bypass. In two patients, a composite graft was used. The mean age of the bypasses was 53.66 months (range 1–110) (Table III).

Table III. Symptoms at admission and bypass characteristics
Thrombolysis (n = 30)Primary surgery (n = 26)
Time of onset of symptoms (median, range)6.8 (0.5 hr–14 days)8.8 (0.5 hr–14 days)
Severe claudication (%)9 (30)8 (30.8)
SVS/ISCVS grade I (%)14 (46.7)12 (46.2)
SVS/ISCVS grade II (%)7 (23.3)6 (23.1)
SVS/ISCVS grade III (%)0 (0)0 (0)
Age of occluded bypass (mean, range)57.3 (0–125 months)53.7 (1–110 months)
Above-knee femoropopliteal bypass (%)5 (16.7)6 (23.1)
Below-knee femoropopliteal bypass (%)10 (33.3)15 (57.7)
Infrapopliteal bypass (%)15 (50)8 (30.8)
Venous (%)4 (13.3)3 (11.5)
PTFE (%)22 (73.3)21 (80.8)
Composite (%)4 (13.3)2 (7.7)

Of the 26 thrombosed grafts, 24 (85.71%) were successfully treated with a new bypass (n = 20) or initial thrombectomy with a secondary new bypass within the first week (n = 4), whereas in two patients failure to restore antegrade blood flow occurred.

In 12 cases (42.86%), surgery-related complications were seen. The mortality was 0%. Four patients developed postischemic neuritis with paresthesia, and in another three cases patients developed reperfusion edema. In one patient, a fasciotomy was indicated because of a loge syndrome. One patient developed a cutaneous infection at the side of the bypass, and another patient developed an aneurysm at the distal anastomosis of the bypass. One patient developed a wound dehiscence with fistulation under the knee. One patient developed saphenous neuralgia.

The overall amputation-free survival after surgery was 96% at 1 month and 87.5% at 1 year. After successful surgery, this was 100% and 95.3%, respectively; after unsuccessful surgical therapy, this was 50% and 0%, respectively (Fig. 4).

The primary patency rate of successful surgical treatment was 87.0% at 1 month and 72.9% at 1 year (Fig. 5). In 10 patients (38.36%), reocclusion of the bypass occurred after initial surgical treatment of the ischemia. In one patient (3.84%), redo surgery was required. In one patient (3.84%), additional thrombolysis was performed after the initial surgical intervention. Four patients (15.38%) finally ended with amputation 1 year after surgery. There was no postoperative mortality.

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Discussion 

Because of the far from excellent results of surgical revascularization of acute bypass occlusion, thrombolysis has been proposed as a less invasive and effective alternative.

However, acute infrainguinal bypass occlusion remains an unsolved problem with a high risk of limb loss.

Catheter-guided intra-arterial thrombolysis gives excellent immediate results, with revascularization in >70% of recently thrombosed bypass grafts.3, 6, 25, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42 In our series, the immediate success rate was 80%.

However, restoring patency is one side of the problem; maintaining patency is the other one. Correction of the underlying flow-limiting lesion is essential to maintain long-term patency.3, 7, 13, 25, 35, 36, 41, 42, 43, 44 The idea that thrombolysis could be less invasive by exposing the underlying causative lesion, amenable to endovascular angioplasty or only minor surgical revision, could not always be confirmed convincingly. In our series, only 60% of patients initially treated with thrombolysis ended up with a satisfactory revascularization without major adjunctive surgery. When looking at patency rates in our series, overall primary patency at 1 year after successful thrombolysis was 77.9%. However, the primary patency rate after successful thrombolysis without a major surgical intervention was only 39.5%. Taking into account the considerable complication rate (36% in our series), it could be argued whether thrombolysis is as minimally invasive as it is thought to be.

When comparing efficacy of thrombolysis and surgery, the important end points are patency and, even more important, amputation-free survival. When looking at primary patency rates, in our series this was 72.9% at 1 year for surgery and 77.9% at 1 year for thrombolysis with or without major adjunctive surgery. Amputation-free survival rates are quite comparable as well (86.4% for thrombolysis and 87.5% for surgery). As far as can be concluded based on this rather small and nonrandomized series, the efficacy of primary surgery and of thrombolysis followed when needed by surgery is quite comparable.

However, when speculating on the value of thrombolysis in the treatment of acute infrainguinal graft occlusion, the ability of thrombolysis to resolve the clot not only in the bypass but also in the outflow vessels should carry much weight (Fig. 2). Increasing the number of outflow vessels could improve the long-term patency of bypasses substantially.

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Conclusion 

In this rather small prospective nonrandomized but controlled study of patients with acute infrainguinal bypass, we were able to demonstrate a clear improvement in number of patent outflow vessels in the majority of patients. However, this was not reflected in a better amputation-free survival rate or a better primary patency rate. Amputation-free survival 1 year after successful thrombolysis without adjunctive major surgery was even significantly worse. Therefore, a possible strategy could be to start thrombolysis to improve outflow followed by a new bypass, whatever the underlying causative lesions are. In this study, 1 year after successful thrombolysis with major surgery, the primary patency rate was 61.35% and the amputation-free survival was 66.7%.

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PII: S0890-5096(06)00015-X

doi:10.1016/j.avsg.2006.06.001

Annals of Vascular Surgery
Volume 23, Issue 2 , Pages 179-185, March 2009

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