The Success of Endovascular Therapy for All TransAtlantic Society Consensus Graded Femoropopliteal Lesions

The Success of Endovascular Therapy for All TransAtlantic Society Consensus Graded Femoropopliteal Lesions Daniel K. Han, Tejas R. Shah, Sharif H. Ellozy, Ageliki G. Vouyouka, Michael L. Marin, and Peter L. Faries, New York, New York

Background: Advances in technology and practice have led to increased endovascular management of all TransAtlantic Society Consensus (TASC)-graded lesions. This study aims to evaluate the success of endovascular therapy in the management of TASC-graded femoropopliteal lesions. Methods: Patients undergoing endovascular treatment for femoropopliteal lesions between July 1999 and August 2008 were divided by TASC scores and evaluated for primary, assisted-primary, and secondary patency rates at 12 and 24 months. Secondary endpoints included limb loss and postoperative complications. Results: A total of 499 femoropopliteal lesions in 427 patients were treated with endovascular interventions. Score distribution for TASC type A, type B, type C, and type D lesions was 26 (5.2%), 140 (28.1%), 168 (33.7%), and 165 (33.1%), respectively. Primary, assisted-primary, and secondary patency rates at 24 months were 77.7 ± 3.2%, 78.9 ± 3.2%, and 86.7 ± 2.6%, respectively, for TASC type A + B lesions, 76.0 ± 3.3%, 77.2 ± 3.2%, and 85.0 ± 2.8%, respectively, for TASC type C lesions, and 61.2 ± 3.8%, 61.2 ± 3.8%, and 78.2 ± 3.2%, respectively, for TASC type D lesions. Compared with TASC type A + B and TASC type C lesions, TASC type D lesions were associated with worse primary and assisted-primary patency rates. However, there was no statistically significant difference in secondary patency between TASC type A + B and TASC type D lesions. The TASC score was not a significant predictor of postoperative complication rates. The 24-month limb salvage rate in patients with TASC type D lesions presenting with critical limb ischemia was 71.9 ± 8.0%. Conclusion: It was observed that all femoropopliteal lesions can be safely and effectively managed with endovascular therapy. Although TASC type D lesions do have lower primary and assisted-primary patency rates, high secondary patency rates comparable with other TASC scores can be achieved with effective prevention of limb loss. These data provide evidence to support endovascular therapy as primary management for all femoropopliteal lesions regardless of the TASC score.

Presented at the 20th Annual Winter Meeting of the Peripheral Vascular Surgery Society, Vail, CO, January 29-31, 2010. Division of Vascular Surgery, Department of Surgery, Mount Sinai School of Medicine, New York, NY. Correspondence to: Peter L. Faries, MD, FACS, Mount Sinai Medical Center, 5 E 98th Street Rm. 415, New York, NY 10029, USA, E-mail: [email protected] Ann Vasc Surg 2011; 25: 15-24 DOI: 10.1016/j.avsg.2010.06.003 Ó Annals of Vascular Surgery Inc. Published online: October 7, 2010

INTRODUCTION Peripheral artery disease (PAD) accounts for >400,000 hospitalizations and results in >250,000 amputations annually.1,2 Patients with PAD have an increased risk of other concurrent comorbid conditions including cerebral and cardiovascular disease.3 For patients presenting with critical limb ischemia (CLI), nonhealing leg ulcers, or rest pain, infrainguinal bypass has served as the gold standard 15

16 Han et al.

for the treatment of these complex lesions, reporting 5-year limb salvage rates of >80%.4 With the advances and increasing popularity of endovascular technology, the TransAtlantic InterSocietal Consensus (TASC) Working Group set out to establish guidelines and classifications for the treatment of femoropopliteal lesions in 2000. The aim of the TASC group was to establish recommendations for the treatment of lesions defined by the classification system. As technology advanced and operator skills improved, the TASC classification proved to be outdated and the TASC Working Group reconvened in 2007 to reclassify lesions best suited for primary therapy by endovascular intervention and those reserved for open surgical bypass. In general, the lesions are graded on the basis of the length of the lesion, number of lesions, degree of calcification, and number of endovascular interventions. It was recommended that an endovascular approach be used for lesions defined by TASC type A and type B, whereas TASC type C and type D lesions should be treated surgically. These recommendations have since been challenged in several studies. Rabellino et al. retrospectively reviewed 234 TASC type C and type D lesions presenting with symptoms of either disabling claudication (49.5%) or CLI (50.5%). After a mean follow-up of 13 months, patients treated for disabling claudication were found to fare better with improvement in symptoms, clinical improvement in circulation (measured by ankle-brachial index [ABI]), and reduction of major amputation rates.5 With these considerations and technological advances overcoming the most challenging lesions, greater focus should be placed on endovascular treatment as the first-line therapy for all TASCgraded lesions. This study aims to retrospectively evaluate the largest known series of isolated femoropopliteal lesions treated by endovascular therapy and define outcomes by immediate and long-term clinical results.

PATIENTS AND METHODS Study Design Between July 1999 and August 2008, all patients undergoing endovascular procedures for femoropopliteal lesions were included in a prospectively maintained, computerized database. Various patient parameters including demographics, comorbidities, clinical presentation, vascular studies, and postoperative complications were evaluated. In addition, various lesion characteristics including length of lesion, degree of stenosis, and patency rates through

Annals of Vascular Surgery

follow-up vascular studies were also evaluated. Patients were stratified according to the TASC I classification system. Only patients with disease limited to the femoropopliteal segment were included in the analysis. Patients who had concurrent disease in the iliac or tibial arteries were excluded. Methodology All endovascular procedures were performed by experienced vascular surgeons in the operating room using either fixed fluoroscopic equipment (Siemens, Munich, Germany) or a portable imaging fluoroscopic C-arm (OEC 9800; GE Medical Systems, Milwaukee, WI). Endovascular interventions included angioplasty-alone, angioplasty with stent placement, cryoplasty, and excisional atherectomy through either antegrade or retrograde femoral artery access. All procedures were performed under local anesthesia with intravenous sedation. The type of procedure performed was left to the discretion of the operating surgeon. Iodinated contrast was used only in patients with normal creatinine levels (<1.3 mg/dL). For patients with creatinine levels >1.3 mg/dL, gadolinium or gadolinium with iodinated contrast was used (majority of the cases using gadolinium were performed before the release of ‘‘black-box’’ warnings relating gadolinium to nephrogenic fibrosing dermopathy). Selective angiography was performed to localize target lesions and to plan necessary interventions. Antegrade punctures were performed with short 5-8F sheaths, whereas retrograde punctures and contralateral interventions were performed with 6-8F Balkin sheaths (Cook, Bloomington, IN). Patients were given 100 U/kg of intravenous heparin after sheath placement or before crossing critical lesions. The activating clotting time was maintained above 250 seconds throughout the procedure. Lesions were crossed through the lumen or the subintima using 0.035, 0.018, or 0.014 inch hydrophilic guide wires. The wires were supported using a 4F or 5F angled catheter (Angiodynamics, Queensbury, NY) or Quick cross catheter (Spectranetics, Colorado Springs, CO). Angiography was used to confirm re-entry into the luminal space beyond the lesion before further intervention. Balloon angioplasty was performed by inflation of appropriately sized, noncompliant balloons for 60180 seconds at 6-15 atm. Lesions with >30% residual stenosis, flow-limiting dissections, or vessel recoil were subsequently treated with stent placement. All excisional atherectomies were performed using the Silverhawk atherectomy device (Fox Hollow Industries, Redwood City, CA). Pre- or post-atherectomy adjunctive procedures included angioplasty-alone and

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angioplasty with stent placement to assist in the initial passage of the atherectomy device or to treat residual disease. Completion angiography with evaluation of distal runoff was performed after all interventions. Postoperatively, all patients without contraindications for antiplatelet therapy received aspirin. Additionally, patients undergoing angioplasty with stent placement or atherectomy were loaded with 450 mg of Plavix preoperatively and were maintained with a dose of 75 mg/day for 30 days. Determination of Patency Postoperative follow-up for patients undergoing endovascular procedures was routinely performed at 2 weeks, 3, 6, 9, and 12 months, and annually thereafter. Hospital, office, and laboratory records were reviewed to obtain clinical, anatomic, and hemodynamic follow-up data to determine primary, assisted-primary, and secondary patency rates. Patency was first determined by arterial duplex of the treated vessel and then by ABIs and clinical evaluation. Loss of patency on arterial duplex was defined as an occlusion or a reduction of the arterial lumen diameter by >50%, with a velocity ratio greater than 2.5:1. A decrease of >0.15 in the ABI or a CT angiography demonstrating vessel reocclusion was also considered as a loss of patency. At follow-up, a patient was considered to have a loss of patency if restenosis or occlusion was detected in any of the lesions treated. Thus, the analysis was performed on the basis of the limb affected or the intervention used rather than the lesion treated. Statistical Analysis KaplaneMeier analysis was used to analyze primary, assisted-primary, and secondary patency rates. Comparison between KaplaneMeier curves was performed by log-rank test for significance. Continuous variables were compared using oneway analysis of variance or Student’s t test. Discrete parameters were compared using the chi-square test for independence. Cox proportional hazard analyses were performed to identify independent predictors of primary and secondary patency. Significance was assumed for p values < .05. Statistical analysis of the prospectively collected data was performed with the SPSS 17.0 software (SPSS Inc, Chicago, IL).

RESULTS Patient Demographics and Comorbidities Between July 1999 and August 2006, a total of 625 index endovascular interventions for femoropopliteal

Endovascular therapy for femoropopliteal lesions 17

lesions were performed at three institutions. Of these, information necessary to determine TASC scores was available for 499 index interventions performed in 427 patients. Lesions isolated to the femoral and popliteal arteries were found in 248 cases (39.7%) and 37 cases (5.9%), respectively. Concurrent disease in femoral and popliteal arteries was present in 340 cases (54.4%). The demographics of the 427 patients included in the analysis are shown in Table I. Compared with patients with TASC type A or TASC type B lesions, patients with TASC type C lesions had lower rates of hypertension, whereas patients with TASC type D lesions were more likely to be female and have hypercholesterolemia, coronary artery disease, and congestive heart failure. Lesion Distribution, Indications, and Treatment Modality Score distribution for TASC type A, type B, type C, and type D lesions was 26 (5.2%), 140 (28.1%), 168 (33.7%), and 165 lesions (33.1%), respectively. The mean lesion length in the femoral and popliteal artery was 97.6 ± 77.7 mm and 79.0 ± 47.3 mm, respectively. Of the femoral artery lesions, 459 (92.0%) were found in the superficial femoral artery, 14 (2.8%) in the profunda femoral artery, and 21 (4.2%) in the common femoral artery. Patient presentation and treatment modalities utilized are shown in Table II. Patients with TASC type C lesions were more likely to present with CLI than patients with TASC type A + B lesions. There was no significant difference in presentation between patients with TASC type A + B lesions versus patients with TASC type D lesions. Compared with patients with TASC type A + B lesions, patients with TASC type C lesions were more likely to receive angioplasty with stenting, whereas patients with TASC type D lesions were more likely to receive atherectomy and less likely to receive angioplasty alone. Morbidity and Mortality Patients were reviewed for perioperative development of hematomas, pseudoanuerysms, wound infections, access site thrombosis, acute renal failure, myocardial infarction (MI), and death (Table III). The overall perioperative complication rate for all patients was 13.6%. Death in the perioperative period occurred in one (0.6%), two (1.2%), and two (1.2%) patients in the TASC type A + B, type C, and type D groups, respectively. Two patients with TASC C lesions had a postoperative MI. Mean length of hospital stay was found to be equivalent between all TASC groups. However,

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Annals of Vascular Surgery

Table I. Demographics and comorbidities of patients with TASC type A + B, TASC type C, and TASC type D lesions undergoing endovascular intervention

Total N Mean age (yrs) Male Smoking history Diabetes mellitus Hypercholesterolemia Hypertension Coronary artery disease Previous CABG History of MI Congestive heart failure End-stage renal disease

TASC type A + B

TASC type C

TASC type D

p value

N (%)

N (%)

N (%)

Type A + B vs. type C

Type A + B vs. type D

166 71.2 ± 10.2 102 (61.4) 93 (56.0) 89 (53.6) 82 (49.4) 144 (86.7) 78 (47.0) 32 (19.3) 41 (24.7) 27 (16.3) 8 (4.8)

168 72.8 ± 11.2 91 (54.2) 100 (59.5) 98 (58.3) 94 (56.0) 130 (77.4) 92 (54.8) 32 (19.0) 48 (28.6) 30 (17.9) 8 (4.8)

165 72.4 ± 10.4 81 (49.1) 94 (57.0) 90 (54.5) 105 (63.6) 141 (85.5) 101 (61.2) 47 (28.5) 56 (33.9) 50 (30.3) 11 (6.7)

0.190 0.222 0.547 0.477 0.298 0.035 0.208 0.979 0.578 0.903 1.000

0.280 0.032 0.950 0.952 0.012 0.856 0.013 0.066 0.091 0.004 0.627

CABG, coronary artery bypass graft; MI, myocardial infarction.

Table II. Presentation and treatment modality utilization

Presentation Claudication Critical limb ischemia Treatment modality Angioplasty alone Primary stenting Atherectomy

TASC type A + B

TASC type C

TASC type D

p value

N (%)

N (%)

N (%)

Type A + B vs. type C

Type A + B vs. type D

95 (57.2) 69 (41.6)

76 (45.2) 89 (53.0)

80 (48.5) 85 (51.5)

0.047

0.108

85 (51.2) 89 (53.6) 20 (12.0)

71 (42.3) 110 (65.5) 16 (9.5)

36 (21.8) 102 (61.8) 47 (28.5)

0.139 0.030 0.583

<0.001 0.131 <0.001

no significant differences were found in morbidity and mortality between TASC groups. Primary, Assisted-Primary, and Secondary Patency Mean follow-up time for all patients was 7.7 ± 9.6 months. The 12- and 24-month primary patency rates for TASC type A + B lesions were 82.5 ± 2.9% and 77.7 ±3.2%, compared with 78.4 ± 3.2% and 76.0 ± 3.3% for TASC type C lesions and 66.1 ± 3.7% and 61.2 ± 3.8% for TASC type D lesions (Fig. 1). Although there was no significant difference between TASC type A + B lesions versus TASC type C lesions ( p ¼ 0.890), primary patency for TASC type D lesions compared with primary patencies for both TASC type A + B and TASC type C lesions was found to be statistically significant ( p ¼ 0.001 and 0.002, respectively). The 12- and 24-month assisted-primary patency rates for TASC type A + B lesions were 83.7 ± 2.9% and 78.9 ± 3.2%, compared with 78.4 ± 3.2% and

77.2 ± 3.2% for TASC type C lesions and 66.1 ± 3.7% and 61.2 ± 3.8% for TASC type D lesions (Fig. 2). Similarly, there was no significant difference in assisted-primary patency between TASC type A + B lesions versus TASC type C lesions ( p ¼ 0.822). However, assisted-primary patency for TASC type D lesions compared with assisted-primary patencies for both TASC type A + B and TASC type C was found to be statistically significant ( p ¼ 0.001 and 0.003, respectively). The 12- and 24-month secondary patency rates for TASC type A + B lesions were 91.0 ± 2.2% and 86.7 ± 2.6%, compared with 87.4 ± 2.6% and 85.0 ± 2.8% for TASC type C lesions and 81.8 ± 3.0% and 78.2 ± 3.2% for TASC type D lesions (Fig. 3). There was no statistically significant difference in secondary patency rates between TASC type A + B versus TASC type C lesions, TASC type A + B versus TASC type D lesions, and TASC type C versus TASC type D lesions ( p ¼ 0.862, 0.085, and 0.130, respectively).

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Endovascular therapy for femoropopliteal lesions 19

Table III. Postoperative complications and length of hospital stay

Complications Hematoma Pseudoaneurysms Wound infection Thrombosis Acute renal failure New/acute heart disease Death Mean length of hospital stay Median length of hospital stay

TASC type A + B

TASC type C

TASC type D

p value

N (%)

N (%)

N (%)

Type A + B vs. type C

Type A + B vs. type D

10 1 2 3 3 e

6 1 3 4 3 2

6 (3.6) 2 (1.2) 4 (2.4) 8 (4.8) 5 (3.0) e

0.413 1.000 1.000 1.000 1.000 0.043

0.420 1.000 0.697 0.232 0.740 1.000

1.000 0.194

1.000 0.251

(6.0) (0.6) (1.2) (1.8) (1.8)

(3.6) (0.6) (1.8) (2.4) (1.8) (1.2)

1 (0.6) 4.5 ± 8.3 days

2 (1.2) 5.8 ± 9.2 days

2 (1.2) 5.7 ± 9.4 days

1 day

1 day

2 days

Fig. 1. Primary patency rates for TASC type A + B, TASC type C, and TASC type D lesions.

Fig. 2. Assisted-primary patency rates for TASC type A + B, TASC type C, and TASC type D lesions.

Rate of Reintervention and Limb Salvage

71.9 ± 8.0% for TASC type D lesions (Fig. 4). No statistically significant difference was found between limb salvage rates between TASC type A + B versus TASC type C lesions ( p ¼ 0.352), as well as between TASC type A + B versus TASC type D lesions ( p ¼ 0.078).

The rate and type of reintervention performed per TASC classification are shown in Table IV. TASC type D lesions required a higher rate of first and second reintervention when compared with TASC type A + B lesions. The rates for a third reintervention were equivalent. There were no statistically significant differences in the rates of reintervention between TASC type A + B and TASC type C lesions. For patients presenting with CLI, KaplaneMeier analysis was performed to determine limb salvage rates. The 24-month limb salvage rate for TASC type A + B lesions was 81.0 ± 12.9% compared with 81.1 ± 6.8% for TASC type C lesions and

Independent Predictors of Primary and Secondary Patency Cox proportional hazard analyses were performed for all TASC-graded lesions to identify independent predictors of primary and secondary patency (Table V). Hypertension and hypercholesterolemia were significant predictors of primary and secondary patency failure for all femoropopliteal

20 Han et al.

Fig. 3. Secondary patency rates for TASC type A + B, TASC type C, and TASC type D lesions.

lesions. Analyzing TASC type D lesions alone, it was found that hypertension and age at surgery were independent predictors of primary patency failure, whereas hypertension and hypercholesterolemia were significant predictors of secondary patency failure. All other characteristics, including gender, diabetes, end-stage renal disease, history of MI, congestive heart failure, and history of smoking did not significantly affect primary and secondary patency. CLI as the presenting symptom was strongly associated with both reduced primary and secondary patency rates for all TASC lesions. There were no significant differences in primary or secondary patency rates between different treatment modalities (angioplasty alone, angioplasty with stenting, or atherectomy) for all TASC-graded lesions.

DISCUSSION Endovascular therapy has increasingly become the procedure of choice for lesions in the femoropopliteal region. Atherectomies and angioplasties, with or without stenting, offer the distinct advantages of low morbidity, decreased length of hospital stay, increased patient satisfaction, and faster return to function. However, there is great concern over long-term efficacy, cost-effectiveness, and the number of reinterventions required for achieving acceptable clinical outcomes. The original TASC I classification system was geared toward vascular specialists to assist in the pathophysiologic stratification and subsequent treatment of lower extremity diseases. Through

Annals of Vascular Surgery

this classification system, type A lesions would follow a primary recommendation of endovascular therapy, whereas type D lesions would carry a recommendation of open bypass. Type B and type C lesions, lacked a recommendation for either endovascular intervention or open bypass under the TASC I system because strong evidence for either modality was found to be inconclusive. The TASC I document had quickly fallen out of favor because it was too cumbersome, lacked practical utility, and did not focus on its intended goal of providing a practical tool for primary care physicians to direct referral to various vascular specialists. In addition, advances in technology, user skill, and more prudent patient selection, TASC I recommendations became outdated and gave way to the creation of a TASC II report. The 2007, TASC II report was largely aimed at primary care physicians to better recognize, characterize, diagnose, and better manage intermittent claudication and CLI. The primary goal of the TASC II report was to emphasize the correlations of comorbidities, such as diabetes mellitus and PAD. Strict glycemic control and routine screening with ABI are recommended in the updated report. In addition, TASC II accounts for improvements in endovascular technology and stratifies each category to a more severe disease. Thus, a lesion once considered as a type B lesion in the TASC I report is now stratified as a type A lesion in the TASC II report. However, the recommendations for each individual class remained the same, with endovascular therapy still being recommended for type A lesions and open surgical bypass still being favored for type D lesions. Although TASC II recommendations suggest open surgical bypass for good candidates with type C and type D lesions, technological advances in catheter-based therapy are challenging these guidelines. In many institutions, including our own, an endovascular first approach is being used to attempt even the most difficult lesions by percutaneous therapy. Open surgical bypass has been well studied, with published data describing patency rates for both vein and synthetic graft material. For above-knee femoropopliteal bypasses using saphenous vein, primary patency rates have been reported to be upward of 70-75.6% at 5 years.6,7 These patency rates, however, come at a high cost of increased morbidity, mortality, and greater time to return to function.8 For patients without an adequate vein conduit, synthetic bypass material with either Dacron or polytetrafluoroethylene has even lower primary patency rates at 2 years of 70% or 57%, respectively9 and drops to as low as 37% at 5 years.8,10,11

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Endovascular therapy for femoropopliteal lesions 21

Table IV. Rate and type of reintervention for TASC type A + B, type C, and type D lesions TASC

Reintervention 1 PTA Bypass BKA AKA Reintervention 2 PTA Bypass BKA AKA Reintervention 3 PTA Bypass BKA AKA

p-value

Type A + B

Type C

Type D

25 16 5 3 1 4 2 1 1 e 1 e e 1 e

35 20 6 6 3 9 1 1 1 1 2 1 1 e e

57 43 7 6 2 16 9 1 4 2 5 4 e 1 e

(15.1%) (64.0%) (20.0%) (12.0%) (4.0%) (2.9%) (50.0%) (25.0%) (25.0%) (0.7%)

(100.0%)

(21.0%) (57.1%) (17.1%) (17.1%) (8.6%) (5.4%) (11.1%) (11.1%) (11.1%) (11.1%) (1.2%) (50.0%) (50.0%)

(34.5%) (74.1%) (12.1%) (10.3%) (3.4%) (9.7%) (56.3%) (6.3%) (25.0%) (12.5%) (3.0%) (80.0%)

Type A + B vs. type C

Type A + B vs. type D

0.209

<0.001

0.262

0.011

1.000

0.098

(20.0%)

PTA, percutaneous transluminal angioplasty; BKA, below-knee amputation; AKA, above-knee amputation.

Fig. 4. Limb salvage rates for TASC type A + B, TASC type C, and TASC type D lesions.

This study was specifically aimed at evaluating endovascular therapy in patients with TASC type C and type D lesions. Several similar studies have reported both technical success and equivalent primary and secondary patencies with endovascular therapy in the femoropopliteal region as compared with open bypass surgery. In a recent study, Sultan et al. performed 5-year observational study on 309 patients, of which 119 received subintimal angioplasty and the remaining 190 received a bypass for TASC type C and type D lesions. At 5 years, clinical

improvement (noted by improvement in ABI) was sustained in 82.8% of the patients in the subintimal group verses 68.2% of patients in the bypass group ( p ¼ 0.106). The authors noted that although the 5-year freedom from target lesion revascularization rates (endovascular 85.9% versus bypass 72.1%, p ¼ 0.262) was not statistically significant, the risk of major adverse events ( p < 0.002) and length of hospital stay ( p < 0.0001) were significantly reduced in the endovascular group. The study went on to conclude that, overall, improved quality of life and reduced overall costs were found to be associated with endovascular management of TASC C and D lesions as compared with open bypass surgery.12 Similarly, DeRubertis et al. recently compared a single-center experience of 1,000 consecutive percutaneous interventions in the infrainguinal region. With a mean follow-up time of 9.9 months, the authors were able to achieve 2year primary and secondary patiency rates of 62.4% and 79.3%, respectively, for patients presenting with indications of claudication. For patients presenting with limb-threatening ischemia, primary and secondary patencies of 37.4% and 55.4% were achieved. The authors of this study went on to support a percutaneous revascularization as a firstline modality of all patients with infrainguinal disease.13 In our study, a total of 499 lesions were evaluated, 33.7% of which were TASC type C lesions and 33.1% were TASC type D lesions. Primary patencies for TASC type C and type D lesions at 2 years were 76% and 61%, respectively,

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Table V. Cox proportional hazard analysis evaluating independent predictors of primary and secondary patency loss HR

95% CI

Predictors of primary patency failure in all TASC lesions Hypertension 1.864 Hypercholesterolemia 0.679 CLI 1.724 Predictors of secondary patency failure in all TASC lesions Hypertension 2.122 Hypercholesterolemia 0.521 CLI 2.143 Predictors of primary patency failure in TASC D lesions Hypertension 2.693 Age at surgery 1.032 CLI 2.749 Predictors of secondary patency failure in TASC D lesions Hypertension 2.605 Hypercholesterolemia 0.330 CLI 5.223

p

1.196-2.905 0.472-0.978 1.179-2.520

0.006 0.037 0.005

1.213-3.710 0.319-0.850 1.302-3.526

0.008 0.009 0.003

1.326-5.468 1.004-1.060 1.471-5.138

0.006 0.023 0.002

0.987-6.877 0.135-0.809 2.108-12.945

0.053 0.015 <0.001

HR, Hazard ratio; CI, Confidence interval; CLI, Critical limb ischemia.

with no significant difference between patency rates of TASC type C lesions and TASC type A + B lesions ( p ¼ 0.890). Patients with TASC type D lesions were noted to have significantly lower primary and assisted-primary patency rates at 2 years as compared with TASC type A + B graded lesions ( p ¼ 0.001). However, with a second endovascular intervention, TASC type D patients were found to have no statistically significant difference in patency as compared with TASC type A + B lesions (78.2% vs. 86.7%; p ¼ 0.085). To further evaluate causes for loss of primary patency, a subanalysis of comorbidities was performed, revealing that patients with hypertension and hypercholesterolemia at the time of intervention had significant effects on primary and secondary patency. In addition, age was also an independent predictor of primary patency failure in patients with TASC type D. Similar factors were reported in other studies where hypertension, hypercholesterolemia, and chronic renal failure were associated with failure of primary patency, whereas immediate hemodynamic improvement was associated with improved primary patency.14,15 However, it remains unclear as to why these comorbidities negatively influence patency rates. An endovascular first approach was used for the population analyzed in this study. Standard bypass was used for those patients in whom dense calcifications and extensive occlusions precluded endovascular treatment, and these patients were not included in the analysis. A majority of the patients of this study in all TASC groups received angioplasty alone or angioplasty

with stent implantation, with few lesions being treated with atherectomy devices. Primary stenting was performed to treat ulcerated plaques, marked dissection, or elastic recoil, taking into account that primary versus provisional stenting was found to be equivalent.16 However, direct stenting has been found to reduce the likelihood of distal embolization, particularly in total occlusions.17 Overall, >85% of our lesions were treated by angioplasty, and of those, 61% required stenting. When comparing angioplasty alone to stenting, published data report a wide range of restenosis rates (5-50%) with conflicting recommendations depending on the characteristics of the lesion.18 Kudo et al. found poorer long-term patency rates with stenting alone in TASC type C and type D lesions,19 whereas Tetteroo et al. found no difference between primary or secondary stenting when compared with angioplasty alone.16 In our study, we found restenosis rates of 29.2%, 28.9%, and 28.9% for angioplasty alone, angioplasty with stenting, and atherectomy, respectively. The type of stent used (balloon expandable vs. self-expanding) was not specifically evaluated but had been found to have no effect on patency either in the published data.14,20,21 On evaluating limb salvage rates in patients presenting with CLI, it was seen that the results in this study (overall 78%) are comparable with or better than published studies evaluating 2-year limb salvage rates for endovascular treatment as well as open surgical bypass with prosthetic conduits (70-87%).22-25 Conrad et al. evaluated 238 limbs

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and found limb salvage rates of 94.3% when combining both TASC type C and type D lesions with a 96.4% limb salvage rate for TASC type A and type B lesions.26 In our study, although TASC type D was found to have a lower limb salvage rate when compared with TASC type A + B (71.9% vs. 81.0%), this difference was not statistically significant ( p ¼ 0.078) and the limb salvage rates was comparable with open bypass surgery. As recently as 10 years ago, reported rates of major and minor complications after percutaneous endovascular interventions for lower extremity ischemia exceeded 15%.27,28 More recently, Haider et al. described lower rates (8.3%) in low risk patients, with most complications occurring in patients with occlusions rather than stenoses.25 Although the overall complication rate was relatively high (13.6%) in the present study, the proportion of patients with major comorbidities (coronary artery disease, coronary artery bypass graft, congestive heart failure, end-stage renal disease, or diabetes mellitus) was >50%, with 66% of the patients suffering from a TASC type C or type D lesions. The rate of major complications (acute renal failure, MI, or death) was 3.6%, which is comparable with other published data (4.4%).24 In comparison, open bypass reported a 30-day mortality to be as high as 10% and minor complication rates exceeding 25%.29 The limitations of this study include the retrospective analysis of technical and clinical data and partially incomplete follow-up information which handicapped the evaluation of the data. Additionally, there was no retrospectively maintained database of the cohort of open bypass patients of this study from which the endovascular results obtained could be compared. However, given the expansive literature on infrainguinal open bypass surgery, the endovascular results can be easily compared with the published data. Finally, because a significant portion of the patients in this study were classified before the TASC II reclassification system in 2007, all the patients were uniformly classified on the basis of the TASC I system. Notably, the major focus of the TASC Working Group was not to provide alterations in treatment guidelines from the original recommendations but rather focus on disease prevention and provide a clear and concise document directed at the primary physicians for earlier and more appropriate patient referral. Additionally, although the lack of angiographies limit the reclassification of the treated lesions, recorded lesion characteristics are strongly suggestive of little alteration in TASC grade from changes in the classification system. Despite these limitations, this study currently represents the largest

Endovascular therapy for femoropopliteal lesions 23

retrospective review to our knowledge of isolated femoropopliteal lesions for all TASC grades.

CONCLUSIONS The study supports the finding that all femoropopliteal lesions can be safely and effectively managed with endovascular therapy. TASC type A, type B, and type C lesions can be treated with comparable primary, assisted-primary, and secondary patency rates. Although TASC type D lesions do have lower primary and assisted-primary patency rates, high secondary patency rates comparable with other TASC scores can be achieved with effective prevention of limb loss. These data provide evidence to support endovascular therapy as primary management for all femoropopliteal lesions regardless of the TASC score. REFERENCES 1. Gregg EW, Sorlir P, Pauloseram R, et al. Prevalence of lowerextremity disease in the US adult population >¼ 40 years of age with and without diabetes: 1999-2000 national health and nutrition examination survey. Diabetes Care 2004;27: 1591-1597. 2. Hunik MG, Wong JB, Donaldson MC, et al. Revascularization for femoropopliteal disease: a decision and costeffectiveness analysis. JAMA 1995;274:165-171. 3. Kro¨ger K, Dragano N, Stang A, et al on behalf of the Heinz Nixdorf Recall Study Investigator Group. An unequal social distribution of peripheral arterial disease and the possible explanations: results from a population-based study. Vasc Med 2009;14:289-296. 4. Faries PL, LoGerfo FW, Arora S, et al. A comparative study of alternative conduits for lower extremity revascularization: all-autogenous conduit versus prosthetic grafts. J Vasc Surg 2000;32:1080-1090. 5. Rabellino M, Zander T, Baldi S, et al. Clinical follow-up in endovascular treatment for TASC C-D lesions in femoro-popliteal segment. Cathet Cardiovasc Interv 2009;73:701-705. 6. Klinkert P, Schepers A, Burger D, et al. Vein versus polytetrafluoroethylene in above-knee femoropopliteal bypass grafting: five years results of a randomized control trials. J Vasc Surg 2003;37:149-158. 7. Tilanus HW, Obetrop H, Van Urk H. Saphenous vein or PTFE for femoropopliteal bypass: a prospective randomized trial. Ann Surg 1985;202:780-782. 8. Goshima KR, Mills JL Sr, Hughes JD. A new look at outcomes after infrainguinal bypass surgery: traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg 2004;39:330-335. 9. Jenson LP, Lepantalo M, Fossdal JE, et al. Dacron or PTFE for above-knee femoropopliteal bypass. A multicenter randomized study. Eur J Vasc Endovasc Surg 2007;34:749, author reply 749. 10. Pereira CE, Albers M, Romiti M, Brochado-Neto FC, Pereira CA. Meta-analysis of femoropopliteal bypass grafts for lower extremitiy arterial insufficiency. J Vasc Surg 2006;44:510-517.

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