Journal of Vascular Surgery
Volume 48, Issue 5 , Pages 1166-1174, November 2008

Stenting vs above knee polytetrafluoroethylene bypass for TransAtlantic Inter-Society Consensus-II C and D superficial femoral artery disease

Presented at the Thirty-sixth Annual Symposium, Society for Clinical Vascular Surgery, Las Vegas, Nev, Mar 5-8, 2008.

  • Hasan H. Dosluoglu, MD

      Affiliations

    • Division of Vascular Surgery, Department of Surgery, VA Western New York Healthcare System, Buffalo, NY
    • State University of New York at Buffalo, Buffalo, NY
    • Corresponding Author InformationCorrespondence: Hasan H. Dosluoglu, MD, Chief, Division of Vascular Surgery, VA Western NY Healthcare System, 3495 Bailey Ave, Buffalo, NY, 14215
    • ,
  • Gregory S. Cherr, MD

      Affiliations

    • State University of New York at Buffalo, Buffalo, NY
    • ,
  • Purandath Lall, MBBS

      Affiliations

    • Division of Vascular Surgery, Department of Surgery, VA Western New York Healthcare System, Buffalo, NY
    • State University of New York at Buffalo, Buffalo, NY
    • ,
  • Linda M. Harris, MD

      Affiliations

    • State University of New York at Buffalo, Buffalo, NY
    • ,
  • Maciej L. Dryjski, MD

      Affiliations

    • State University of New York at Buffalo, Buffalo, NY

Received 4 April 2008; accepted 2 June 2008. published online 11 August 2008.

Article Outline

Objectives

TransAtlantic Society Consensus (TASC)-II recommends bypass for TASC D and low-risk patients with TASC C lesions but does not specify graft types. Percutaneous balloon angioplasty/stenting (PTA/S) and above knee femoropopliteal bypass (AK-FPB) using polytetrafluoroethylene (PTFE) for these lesions were compared to determine if graft type should be part of the TASC-II recommendations for the treatment of TASC C lesions.

Methods

Consecutive patients who underwent AK-FPB with PTFE, or PTA/S for TASC-II C (PTA/S-C) or D (PTA/S-D) SFA lesions between June 2001 and April 2007 were retrospectively analyzed. The primary end points were primary, assisted-primary, and secondary patency rates.

Results

In 127 patients (mean age, 68.7 ± 10.0 years; median, 68; range, 49-97), 139 limbs were treated (46 AK-FPB, 49 PTA/S-C, 44 PTA/S-D). The mean occlusion and stented lengths were 9.9 ± 3.8 and 24.3 ± 6.6 cm (median, 10 and 20 cm) in PTA/S-C, and 26.6 ± 5.5 and 30.0 ± 5.2 cm (median, 26 and 29 cm) in PTA/S-D. Technical success was 84% in PTA/S-D and 100% in other groups. Mean follow-up was 26.4 ± 18.0 months (median, 24). The 12- and 24-month primary patency was 83% ± 6% and 80% ± 7% for PTA/S-C; 54% ± 8% and 28% ± 12% for PTA/S-D; and 81% ± 6% and 75% ± 7% for AK-FPB (P < .001 PTA/S-D vs PTA/S-C and AK-FPB); assisted-primary patency was 95% ± 3% and 95% ± 3% for PTA/S-C, 62% ± 8% and 49% ± 10% for PTA/S-D, and 81% ± 6% and 75% ± 7% for AK-FPB (P < .001, PTA/S-C vs PTA/S-D; P = .003, PTA/S-C vs AK-FPB; and P = .03, PTA/S-D vs AK-FPB). Secondary patency was 98% ± 3% and 98% ± 3% for PTA/S-C; 72 % ± 7% and 54% ± 11% for PTA/S-D, and 81% ± 6% and 78% ± 7% for AK-FPB. Secondary patency was significantly better in PTA/S-C than AK-FPB (P = .003) and PTA/S-D groups (P < .001). The difference was marginally better in AK-FPB than in PTA/S-D (P = .064).

Conclusions

PTA/S for TASC-II C lesions has a superior midterm patency than AK-FPB using PTFE, and AK-FPB with PTFE has better primary and assisted-primary patency than PTA/S-D. The TASC-II recommendations should be modified to recommend treatment of SFA TASC-II C lesions by PTA/S rather than PTFE bypass for all patients. PTA/S of TASC-II D lesions should only be considered in high-risk patients who cannot tolerate a bypass procedure using PTFE.

 

The rapid development of endovascular interventions and their adoption by vascular surgeons have revolutionized the treatment of patients with peripheral arterial disease. The superficial femoral artery (SFA) is one of the most commonly intervened-on arteries; however, the optimal approach for treating this artery is still debated.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19

The optimal approach for each patient is determined by lesion complexity, indication for intervention, and the overall condition of the patient. The original TransAtlantic Inter-Society Consensus (TASC) classification20 defined TASC C as a single stenosis or occlusion >5 cm, or multiple stenoses or occlusions each between 3 and 5 cm; however, TASC-II, the newer version, defines TASC-II C lesions as multiple stenoses or occlusions totaling >15 cm.21 Although the recommended treatment for TASC-II C lesions is surgical bypass, patient comorbidities, fully informed patient preference, and the operator's long-term success are suggested to be important factors in making treatment recommendations for each patient.21 The recommendations, however, do not specify the graft type (synthetic vs autologous vein) to be used for bypass procedures in these patients.

Increasingly, endovascular therapy is successfully used for complex SFA lesions with long occlusions. Although primary balloon angioplasty with selective stenting is used in less severe lesions,1 primary stenting is still the most common treatment for long occlusions in the SFA, and 12-month primary patency rates have been 50% to 90% in recent years.1, 3, 4, 5, 6, 7, 8, 9 Subintimal angioplasty with selective stenting10, 11, 12, 13, 14, 15 and revascularization using covered stents16, 17, 18, 22 have also been increasingly used, with promising results.

Several randomized studies have documented superior patency rates for above knee (AK) femoropopliteal bypass (FPB) using great saphenous vein (GSV) compared with prosthetic grafts,23, 24, 25 Polytetrafluoroethylene (PTFE) grafts are still widely used for the AK position. Justification for using PTFE grafts for AK femoropopliteal bypass include preservation of the GSV and equivalence of results from early studies.26, 27 However, a review of 25 studies showed that AK-FPB using GSV has better patency rates at each time point,28 and a more recent meta-analysis of 75 studies found that the difference was more pronounced in patients with critical limb ischemia (CLI).29

Considering the significant difference between FPB using prosthetic or GSV grafts as conduits, our aim was to compare our results of PTA/S for TASC-II C and D SFA lesions with results in patients who underwent FPB using PTFE, and to determine if graft type should be incorporated into the TASC-II recommendations for the treatment of TASC C lesions.

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Material and methods 

Design 

All consecutive patients who presented to the Veterans Administration Western New York Healthcare System between June 1, 2001, and April 1, 2007, who underwent an AK-FPB with PTFE (AK-FPB group), or PTA/S for TASC-II C (PTA/S-C group) or D (PTA/S-D group) SFA lesions for disabling claudication or CLI (Rutherford 3-6)30 were identified, and retrospectively analyzed from our prospectively maintained database. Institutional Review Board approval was obtained. Patients with isolated common femoral artery occlusion, popliteal artery lesions extending to the P2 segment (popliteal artery segment in the popliteal fossa extending to the knee joint), isolated popliteal occlusions, and those who had previous bypass procedures were not included. Also excluded were patients whose lesions were initially staged as TASC C, but were down-staged to TASC-II B after the TASC II recommendations were published.

Methodology 

Demographics, comorbidities, clinical presentation, noninvasive arterial studies, angiograms, TASC-II classification14 of the treated lesions, length of occlusions and stenoses, number of runoff vessels, number of stents, total stented vessel length, postoperative course, hospital length of stay (LOS), follow-up arterial studies, patency, and status of limbs on last follow-up were prospectively entered into our database. The preoperative angiograms were analyzed, and TASC-II category of the SFA lesions in patients who underwent AK-FPB was determined in 44 patients. The angiograms were not available in the remaining two patients, and the TASC-II category could be determined by the dictated report.

All endovascular procedures were performed by vascular surgeons in the operating room using the OEC 9800 system (General Electric Medical Systems, Salt Lake City, Utah). All interventions were performed by a contralateral femoral artery approach using 6F sheaths. Most lesions were crossed using a combination of Glidewire (Terumo, Somerset, NJ) and 4F or 5F Glidecath (Terumo). Intraluminal crossing was intended for all cases. The actual crossing method was recorded as intraluminal, subintimal, or a combination of the two. An intravascular ultrasound-guided reentry device (Pioneer catheter, Medtronic, Santa Rosa, Calif) was used in five patients (4 successfully). Predilation with a 4-mm × 10-cm balloon was used, followed by stent placement in all cases (Smart, Cordis, Johnson and Johnson, Miami Lakes, Fla). The size of the stent and postdilation balloon diameter were estimated by comparing the target size with the 4-mm predilation balloon. Most commonly used stent diameters were 6 and 7 mm. Postdilatation angioplasty was always performed with a 5- or 6-mm balloon. When multiple stents were used, the overlap was 0.5 to 1 cm. True flush SFA occlusions were not attempted by endovascular means.

Clopidogrel bisulfate (75 mg) was started before the planned procedure, or was started in the recovery room (300 mg). All patients continued to take clopidogrel (75 mg) and enteric-coated acetylsalicylic acid (ASA; 81 mg) for a minimum of 30 days, followed by lifelong ASA therapy.

AK bypasses were preferentially performed using 7-mm PTFE grafts, and the selection was based on the diameter of the popliteal artery (72% had 7 mm, 24% had 6 mm, and 4% had 8 mm grafts). Postoperatively, all patients who had AK-FPB continued to receive ASA, or clopidogrel when ASA could not be used, unless the patient was taking warfarin.

An increasingly aggressive endovascular-first approach was adopted for all patients starting from 2002. The decision to proceed with endovascular intervention or open bypass was made by the vascular surgeon, with increasing attempts for endovascular revascularization during the study period. Most (83%) of the AK-FPB with PTFE were performed before January 2004 and comprise 83% of all the interventions performed during this period. After that time, only eight (17%) additional AK-FPB with PTFE were performed, and this represented only 9% of the cases performed during that period in this cohort. During the same time period, only two patients underwent FPB to an AK segment using vein grafts and were excluded.

All patients were followed up by clinical assessment and by our vascular laboratory during the first postoperative visit (1 to 4 weeks), and at 3, 6 months, and every 6 months thereafter for ankle-brachial index (ABI) measurements, graft or stent velocities and patency, by duplex ultrasound (DUS) imaging. All patients with wounds were monitored in our vascular surgery wound clinic until wounds were all healed. Angiography was performed when noninvasive studies suggested restenosis or occlusion or when adequacy of the patency or adequacy of foot perfusion was in question due to suboptimal DUS imaging or lack of clinical improvement. Restenosis was defined as >50% decrease in luminal diameter seen on angiography or DUS imaging, as defined by an elevated ratio of greater than four times the velocity of the more proximal segment. Reinterventions were performed to assist patency, or when clinically indicated (recurrent claudication, nonhealing wound, recurrent ulcer or pain), and Society for Vascular Surgery (SVS) reporting standards for lower extremity arterial procedures were followed.29

Definitions 

TASC-II C lesions included those with multiple stenoses or occlusions totaling >15 cm with or without heavy calcification, and TASC-II D lesions included chronic total occlusions of SFA (>20 cm). A patent runoff vessel was defined as an infrapopliteal vessel without a hemodynamically significant (<50%) angiographic stenosis distal to the treated site,30 and the number of adequately patent runoff vessels (0 to 3) was calculated after all interventions were completed for that limb. Technical success was defined as a patent vessel with <30% residual angiographic stenosis after the intervention. Diabetes mellitus (DM) was defined as fasting plasma glucose >110 mg/dL or a hemoglobin A1c >7%. Noninsulin dependent DM (NIDDM) was defined as a patient who did not receive insulin therapy for management of DM, and insulin-dependent DM (IDDM) was defined as a patient who routinely received insulin therapy.

Statistical analysis 

Data analysis was performed using SPSS 15.0 software (SPSS Inc, Chicago, IL). Kaplan-Meier analysis and log-rank test were used to compare groups for primary patency, assisted-primary patency, secondary patency, limb salvage, and overall survival on an intent-to-treat basis. Recanalization failures were recorded as treatment failures at time 0. Demographic comparisons were made using two-tailed χ2 or Fisher exact test for categoric variables, and by the Student t test or Mann-Whitney U test for continuous variables with or without normal distribution, respectively. Univariate analyses were performed for identifying factors predicting limb loss, and multivariate analysis was performed using Cox proportional regression to identify the independent predictors of primary patency. Values of P < .05 were considered significant.

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Results 

A total of 127 consecutive patients (139 limbs, 125 male) were treated (46 in AK-FPB, 49 in PTA/S-C and 44 in PTA/S-D). The median age was 68.7 ± 10.0 years (range, 49-97 years), Demographics, comorbidities, and indications are reported in Table I. The patients in PTA/S-C and PTA/S-D were older than AK-FPB patients (P = .001, AK-FPB vs PTA/S-C; P = .068, AK-FPB vs PTA/S-D). The AK-FPB group had fewer patients than the other groups with renal insufficiency and CLI, but more active smokers. More patients in PTA/S-D group had hypercholesterolemia. In patients who had AK-FPB, eight (17%) had TASC B, seven had TASC C (15%), and the remaining 31 (67%) had TASC D lesions.

Table I. Demographic characteristics, comorbidities, and indications for intervention between groups
VariableAK-FPBPTA/S-CPTA/S-DP
Age, mean ± SD years64.7±8.071.6±10.4a69.4±10.2bSee note
CAD, %636570.460
Hypertension, %747880.526
Diabetes mellitus, %526755.804
CVA, %111820.221
Dyslipidemia, %636984.027
COPD, %302227.727
Renal, %73120.091
Dialysis, %267.283
Smoker (active), %673739.006
DC, %572027.001
Tissue loss, %307361.001

AK-FPB, Above-knee femoropopliteal bypass group; CAD, coronary artery disease; CVA, cerebrovascular accident; COPD, chronic obstructive occlusive disease; DC, disabling claudication; PTA/S-C, percutaneous balloon angioplasty/stenting in TransAtlantic Inter-Society Consensus-II C group; PTA/S-D, percutaneous balloon angioplasty/stenting in TransAtlantic Inter-Society Consensus-II D group.

Note:

aP = .001 and

bP = .068 vs AK-FPB.

The mean occlusion and stented lengths were 9.9 ± 3.8 cm (median, 10; range, 2-16 cm), 24.3 ± 6.6 cm in PTA/S-C (median, 20; range, 10-40 cm; 2.9 ± 0.9 stents), and 26.6 ± 5.5 cm (median, 26; range, 15-38 cm), 30.0 ± 5.2 cm in PTA/S-D (median, 29; range, 19-40 cm, 3.5 ± 0.8 stents). Primary technical success was 100% in PTA/S-C group, whereas in PTA/S-D recanalization failed in seven patients (success rate, 84%). Of the failures, two had immediate FPB, one patient had below knee (BK) FPB using saphenous vein graft 4 weeks later, and one had a successful stenting of his SFA 3 months later. One patient with venous ulcers had PTA/S of his severe external iliac artery stenosis had complete wound healing. One patient underwent an AK amputation (AKA) within 2 months, and one patient died 2 months later without further intervention. The causes of failure were extreme calcification in two and inability to reenter the distal true lumen in five patients. Successful crossing of SFA occlusions were recorded as intraluminal in 73%, subintimal in 8%, and mixed in 19% of patients in PTA/S-C, and 24%, 16% and 70% respectively in PTA/S-D (P < .001).

The number of patent runoff vessels was 2.1 ± 0.7 (median, 2; range, 1-3) in AK-FPB, 1.7 ± 08 (median, 2; range, 0-3) in PTA/S-C (P = .045 vs AK-FPB) and 1.8 ± 0.7 (median, 2; range, 0-3) in PTA/S-D (P = .069 vs AK-FPB). There were more patients in whom in-line flow to the foot was not achieved in PTA/S-D (16%) than in the other groups (PTA/S-C, 2%; AK-FPB, 0%; P = .001). Five of these eight patients eventually had a major amputation. The ABI was reliable only in 72% of patients, and increased from 0.46 ± 0.19 to 0.90 ± 0.09 in AK-FPB, 0.54 ± 0.21 to 0.93 ± 0.10 in PTA/S-C, and 0.53 ± 0.12 to 0.95 ± 0.11 in PTA/S-D.

The mean LOS was 5.9 ± 4.3 days (median, 4; range, 2-19 days) for AK-FPB, 3.3 ± 4.7 days (median, 2; range, 0-26 days) for PTA/S-C, and 2.8 ± 3.8 days (median, 1; range, 0-16 days) for PTA/S-D (P < .001 for PTA/S-C and PTA/S-D vs AK-FPB). Complications included one death in the PTA/S-C group due to myocardial infarction in a patient with tissue loss, and one puncture site pseudoaneurysm treated with thrombin injection. Postoperative (30-day) SFA occlusion was seen only in one patient with CLI in the PTA/S-D group. Rheolytic thrombectomy (Angiojet, Possis Medical Inc, Minneapolis, Minn), thrombolysis, and placement of an additional stenting was initially successful but reoccluded, necessitating a BK FPB with a vein graft. One patient each in the PTA/S-C and PTA/S-D groups had distal embolization, which was successfully treated with rheolytic thrombectomy, followed by thrombolysis.

In the AK-FPB group, one patient had a nonfatal myocardial infarction, one developed pneumonia and a perigraft seroma necessitating operative débridement, one developed an early graft infection necessitating graft removal, and two patients had superficial wound infections treated with débridement and local wound care. Although other complication rates were similar among the groups, occurrence of any infectious complication was significantly more in the AK-FPB group than in the PTA/S groups (8.7% vs 0%, P = .013).

Mean follow-up was 26.4 ± 18.0 months (median, 24; range, 0-70 months). The 12-, 24-, and 36-month primary patency rates in the PTA/S-C group were 83% ± 6%, and 80% ± 7%, and 74% ± 8%, and in AK-FPB group were 81% ± 6%, 75% ± 7%, and 65% ± 8% (P < .001 PTA/S-D vs PTA/S-C and AK-FPB groups). The 12- and 24-month primary patency rates in PTA/S-D group were 54% ± 8% and 28% ± 12% (Fig 1). Primary patency for PTA/S-D was significantly worse than both PTA/S-C (P < .001) and AK-FPB (P = .001).

  • View full-size image.
  • Fig 1. 

    Primary patency in percutaneous balloon angioplasty/stenting in the TransAtlantic Inter-Society Consensus (TASC)-II C group (PTA/S-C), in the TASC-II D group (PTA/S-D), and in the above-knee (AK) femoropopliteal bypass (FPB) group (P < .001). Hashed line indicates standard error >10%.

The 12-, 24-, and 36-month assisted-primary patency rates in PTA/S-C group were 95% ± 3%, 95% ± 3%, and 95% ± 3% and in AK-FPB group were 81% ± 6%, 75% ± 7%, and 65% ± 8%. The 12- and 24-month assisted-primary patency rates in PTA/S-D group were 62% ± 8%, and 49% ± 10% (Fig 2). Assisted-primary patency was significantly different among the three groups (P < .001, PTA/S-C vs PTA/S-D; P = .003, PTA/S-C vs AK-FPB; and P = .03, PTA/S-D vs AK-FPB).

  • View full-size image.
  • Fig 2. 

    Assisted-primary patency in percutaneous balloon angioplasty/stenting in the TransAtlantic Inter-Society Consensus (TASC)-II C group (PTA/S-C), in the TASC-II D group (PTA/S-D) and in the above-knee (AK) femoropopliteal bypass (FPB) group (P < .001). Hashed line indicates standard error >10%.

The 12-, 24-, and 36-month secondary patency rates in PTA/S-C group were 98% ± 3%, 98% ± 3%, and 98% ± 3% and in the AK-FPB group were 81% ± 6%, 78% ± 7%, and 71% ± 8%. The 12- and 24-month secondary patency rates in PTA/S-D group were 72% ± 7% and 54% ± 11% (Fig 3). Secondary patency rates were significantly better in PTA/S-C than AK-FPB (P = .003) and PTA/S-D groups (P < .001); however, the difference was marginally better in the AK-FPB than PTA/S-D group (P = .064). In the AK-FPB group, the patency rates were not affected by the TASC class of the bypassed SFA (P > .31).

  • View full-size image.
  • Fig 3. 

    Secondary patency in percutaneous balloon angioplasty/stenting in the TransAtlantic Inter-Society Consensus (TASC)-II C group (PTA/S-C), in the TASC-II D group (PTA/S-D) group, and in the above-knee (AK) femoropopliteal bypass (FPB) group (P < .001). Hashed line indicates standard error >10%.

The 24-month limb salvage rates were 95% ± 3%, 96% ± 3%, and 88% ± 6% in AK-FPB, PTA/S-C, and PTA/S-D groups (P = .190), and overall survival rates were 74% ± 7%, 73% ± 7%, and 72% ± 8%, respectively (P = .622).

When the patients were analyzed by the actual treatment received, the 24-month primary patency for AK-FPB (n = 47), PTA/S-C (n = 49), and PTA/S-D (n = 37) was 76% ± 7%, 80% ± 7%, and 33% ± 14% (P = .01); 24-month assisted-primary patency was 76% ± 7%, 95% ± 3%, and 58% ± 12% (P = .002); and 24-month secondary patency was 78% ± 7%, 98% ± 3%, and 64% ± 12% (P = .005), respectively.

There was no statistically significant difference in coronary artery disease (P = .958), renal insufficiency (P = .227), hypertension (P = .408), hyperlipidemia (P = .847), or smoking status (P = .157), indication for surgery (claudication vs CLI; P = .345), and three or fewer runoff vessels (P = .678) on patency rates in any group. Interestingly, we found at 24 months that patients with DM had a better assisted-primary patency than non-DM patients (82% ± 5% vs 65% ± 7%, P = .05) and there was a trend for patients with DM to have better primary patency (74% ± 6% vs 55% ± 8%, P = .056) and secondary patency (87% ± 4% vs 68% ± 7%, P = .062).

Despite the better patency rates, all limb loss occurred in patients with DM, and the limb salvage rate at 36 months was significantly worse in patients with DM (86% ± 5% vs 100%, P = .009). We also found a trend for worse primary patency at 24 months in the 52 IDDM patients compared with the 29 NIDDM patients (67% ± 8% vs 83% ± 7%, P = .162), whereas assisted-primary and secondary patency rates were almost identical. We also noted that all limb loss occurred in IDDM patients (24-month limb salvage, 83% ± 6% vs 100%, P = .015).

One patient had an early graft removal due to infection, and 12 patients had graft occlusions 2 to 32 months after FPB (median, 7; mean, 13 months). Three were asymptomatic. Six had Angiojet thrombectomy, thrombolysis, and inflow or runoff endovascular procedures. Four had new bypass grafts, two of whom had a repeat occlusion of their grafts after thrombolysis. One patient had recanalization of his SFA without any attempt at salvaging the old graft. Only one patient in this group had an amputation. Only one patient had a PTA of his popliteal artery 68 months later, maintaining assisted-primary patency.

Seven patients in the PTA/S-C group underwent a repeat intervention to maintain patency between 1 and 27 months after intervention. One was asymptomatic, and the remaining had either nonhealing wounds (n = 3) or recurrent claudication symptoms (n = 3). Five of these had cryoplasty of the in-stent restenosis, with or without additional debulking procedures. The remaining two had PTA of runoff vessels. One patient required a repeat angioplasty after recurrence of the in-stent restenosis. Five patients in the PTA/S-D group had a repeat intervention for maintaining assisted-primary patency 6 to 23 months after the initial intervention. One was asymptomatic, and the remaining four had nonhealing wounds. One patient developed recurrent restenosis and underwent a second stenting of his restenosed segment, and another who initially had a nonhealing ulcer reoccluded 6 months later and remains a claudicant.

Two symptomatic occlusions in PTA/S-C at 7 and 10 months were successfully treated by rheolytic thrombectomy, thrombolysis, and additional stenting. There were 10 occlusions in the PTA/S-D patients between 0 and 23 months after the initial procedure (median, 6; mean, 6.3 months). Two were asymptomatic, with healed wounds; six patients underwent rheolytic thrombectomy plus thrombolysis, with additional endovascular intervention. Three of these later reoccluded and underwent bypass procedures, and one remained with mild claudication. One patient underwent a bypass procedure after occlusion, and one had a BKA.

In the PTA/S groups, six patients underwent bypass procedures. One had an immediate bypass to AK popliteal artery after crossing failed, and five had bypasses to the BK popliteal segment at 0, 1, 2, 9, and 18 months after the initial PTA/S procedure. After reviewing the angiograms, we determined that four of these five patients would have had a FPB to the BK popliteal artery and that the attempted PTA/S did not affect the level of bypass. In the FPB group, four patients had new bypass procedures 6, 7, 9, and 12 months after FPB, two of which were to the BK popliteal artery using PTFE, and two were to infrapopliteal vessels (1 GSV, 1 PTFE).

No amputations were performed for any patient treated for disabling claudication in this series. The 24-month limb salvage rates for patients who presented with CLI were 95% ± 3%, 96% ± 3% and 88% ± 6% in FPB, PTA/S-C, and PTA/S-D, respectively (P = .190). Ten amputations were performed (3 in FPB, 2 in PTA/S-C, and 5 in PTA/S-D). All amputations occurred in patients with DM, and 70% of the amputations occurred, despite a patent graft or stented segment, due to extensive tissue loss after débridement for infection control, or recurrent foot infection.

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Discussion 

Although the number of endovascular interventions on the SFA has dramatically increased to include more complex lesions with long occlusions, surgical bypass remains the recommended treatment for good-risk patients with TASC C lesions, and TASC D lesions, in the TASC-II document.21 However, these recommendations are mostly based on historical data from results of bypass procedures with different conduits, and very few reports on endovascular treatment of long SFA occlusions (TASC C and D lesions) are available on which to base these recommendations. Femoropopliteal bypass to the AK popliteal segment using PTFE is a widely performed bypass procedure for patients with SFA occlusions, and the treatment recommendations in the TASC document do not specify the graft type. However, after the initial sentinel report by Veith et al26 suggesting comparable patency rates for AK-FPB with vein and PTFE grafts, multiple studies have suggested that there is a significant difference in patency rates between PTFE and vein grafts in this location.28, 29 A recent meta-analysis of 75 studies suggested that a GSV graft to above the knee had better patency29 and that this difference was more pronounced in patients with CLI (24-month primary patency, 65% vs 81%, 77% vs 84% in claudicant patients). Our 24-month primary patency rate of 75% with PTFE grafts is closer to the 77% primary patency in claudicant patients in the meta-analysis, although nearly half of our patients who had AK-FPB presented with CLI.

The endovascular treatment of long SFA occlusions has recently been reported to have increased patency rates, especially with increased use of routine nitinol-based stenting.6, 7, 8, 9 Schillinger et al8 randomized 104 patients with symptomatic SFA disease to primary stenting vs PTA plus selective stenting, and the stented lengths of each group were 127 ± 55 and 132 ± 71 mm. The 1-year restenosis rates were 37% in primary stenting vs 63% in selective stenting groups, respectively (P = .01). The 1-year patency rates of PTA/S of long segment SFA stenting with nitinol stents has been 35% to 87% (Table II),1, 3, 4, 5, 6, 7, 8, 9, 19 with decreasing patency in longer lesions and subgroups, such as DM patients.5 Most of these studies included lesions in the TASC-II C category, with the minority of lesions being in the TASC D category. Our results with primary PTA/S of long SFA occlusions in the TASC-II C category is favorable compared with the reported literature, with a 2-year primary patency of 80% and secondary patency of 98%, whereas the primary patency in TASC D was very poor (28%). Our close surveillance protocol enabled us to improve the patency rates in PTA/S groups, and most of the occlusions were addressed by endovascular means, both of which improved assisted-primary and secondary patency rates in PTA/S groups.

Table II. Reported patency rates of balloon angioplasty and nitinol stenting of long SFA occlusions
AuthorPts/limbsCLI, %LengthTech success, %PP, %SP, 1 year, %
1 year2 years
Cheng3 (2003)70/7367>5 cm(median, 16 cm)NS563569
Meuwissen7 (2004)122/137(87%B/C)NS12.2 cm(57% >10 cm)987660
Sabeti5 (2005)6520>10 cm(median, 16 cm)NS54 (DM, 22)
Suriewic1 (2005)111(C:69,D:42)34TASC C/D93 (incl all)C: 70; D: 50 (6 mo)
Schlager9 (2005)17012 NS
45 SMa 139±88mm 8766
125 DLb 125±84mm 7864
Ferreira6 (2007)59(C:16%,D:61%)1519.2±10.8cm 907896
Ko19 (2007)106/121NS22.7±9.9cm(SI) 95 (SI)72 (SI)
22.0±8.5cm(IL)87 (IL)51 (IL)

CLI, Critical limb ischemia; DM, diabetes mellitus; IL, intraluminal plus stented group; NS, not specified; PP, primary patency; SI, subintimal plus stented group; SP, secondary patency.

aSmart, Cordis, Johnson and Johnson, Miami Lakes, Fla.

bDynalink, Abbott Laboratories. Abbott Park, Ill.

Only a few studies have compared endovascular treatment of long-segment SFA occlusions with bypasses. Kedora et al22 randomized 100 limbs to AK-FPB using PTFE graft vs covered stent (mean covered SFA length, 25.6 ± 15 cm), and reported an identical 12-month primary patency rate of 74% and secondary patency of 84% in both groups. Surowiec et al1 reported their experience in 329 patients who underwent PTA/S of SFA lesions. They used self-expanding nitinol stents routinely in 69 patients with TASC C and 42 with TASC D lesions. They found that FPB with synthetic graft performed similar to the TASC B lesions; however, the 6-month patency of PTA/S of TASC C and D lesions in their series was 70% and 50%, respectively. The 12-month primary, assisted-primary and secondary patency rates of 80% ± 7%, 95% ± 3%, and 98% ± 3% in our TASC-II C patients were significantly better than patients who underwent AK-FPB using PTFE, although our patency rates with TASC D lesions was significantly worse than both groups.

Only TASC D lesions were found to be an independent predictor of having poor primary, assisted-primary, and secondary patency rates, when controlled for DM, number of runoff vessels, coronary artery disease, hypertension, renal insufficiency and hyperlipidemia. Previous reports have also identified TASC D as being an independent predictor of poorer patency31, 32, 33; however, most reports on long SFA occlusions bundle TASC C and D lesions together, making it hard to detect any difference between the two groups in terms of patency.2, 3, 4, 5, 6, 34

When our results along with the literature are considered, we think that the results in TASC C and D patients should be reported separately, because patients with TASC D lesions clearly represent a different group with increased atherosclerotic burden, and durability of endovascular interventions are significantly worse in these patients. We also think that the revised description of TASC-II C lesions, with its inclusion of longer lesions in this category, is appropriate; however, further studies are needed to evaluate the difference between TASC-II B and C lesions, because the midterm patency rates in our patients with TASC-II C lesions were very good. Incidentally, the patency did not seem to be affected by TASC category in patients who underwent AK-FPB in our series.

The effect of DM on patency rates, and limb salvage after endovascular interventions of the SFA has been inconsistent33, 34, 35, 36, 37 and is mostly influenced by the patient selection criteria used in these retrospective analyses. DeRubertis et al35 reported similar patency rates in claudicant patients, whereas the patency was worse in those presenting with CLI, although similar limb salvage could be achieved. In contrast, Bakken et al33 reported similar patency rates in those with CLI after endoluminal SFA interventions, yet significantly worse limb salvage in patients with DM, with 12-month limb salvage of 89% in non-DM vs 67% in NIDDM, and 73% in IDDM. They also found that patients with IDDM who had claudication had worse patency, whereas those with NIDDM had similar patency rates. Interestingly, the DM patients in our study had better assisted-primary patency rates at 24 months (82% ± 5% vs 65% ± 7%, P = .05), and although patients with IDDM had somewhat worse primary patency at 24 months, this did not reach statistical significance (67% ± 8% vs 83% ± 7%, P = .162).

Despite the better patency rates, all limb loss occurred in patients with DM (36-month limb salvage, 86%), and all occurred in those with IDDM. It is important to note that 70% of our DM patients had tissue loss, and 74% of patients with tissue loss had DM. Limb salvage rates in our study were still acceptable in DM patients. Our patients fared better than those in the Bakken et al series33 and were similar to DeRubertis et al,35 who reported a 12-month limb salvage of 88%.

The proponents of preferential treatment of all lesions with endovascular means claim that this approach does not have any negative effect on future interventions when recanalized vessels occlude.13, 38 Gallaria et al38 reported that early failure of SFA intervention was seen in 8% of their patients who underwent SFA PTA/S (31% in TASC C, 41% in TASC D); however, this did not have any negative effect on the site of distal anastomosis or the level of amputation. Joels et al39 found similar early failure rates (9%) after SFA interventions and found that the distal target was changed in about 30% of their patients. Endovascular reintervention was feasible in most of these patients, and limb loss was extremely rare. Our experience parallels these observations, and the distal anastomosis site was changed from an AK to a BK site only in one of six patients in whom a bypass was eventually needed. In an additional patient, a second attempt of PTA/S was successful 5 months later.

The main limitation of our study is that it is retrospective and nonrandomized in a predominantly male population, and the number of patients in each group was relatively small. In addition, most of the patients who had FPB were treated before 2004, and patients in PTA/S group were older, had more CLI, renal insufficiency, and fewer runoff vessels, whereas there were more smokers in the FPB group. These factors, however, did not have any effect on patency rates and therefore did not seem to have any significant effect on our overall findings.

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Conclusions 

PTA/S of TASC-II C lesions in SFA is found to be safe, has excellent midterm patency rates, and performs better in midterm than AK-FPB with PTFE graft, and PTA/S of TASC D lesions. Thus, PTA/S should be the preferred method of treatment in all TASC-II C lesions, if the alternative is AK-FPB with a PTFE graft. We also found that PTA/S of TASC D lesions is safe, feasible in 84% of cases when attempted, and it can achieve acceptable secondary patency rates with excellent limb salvage. PTA/S in TASC D may be considered as the first choice in high-risk patients, especially in those with CLI. TASC-II C lesions should not be grouped with TASC D, which represent patients with more advanced disease and less durable results with endovascular interventions. The type of bypass graft should be included in the decision whether to choose endovascular or open intervention for TASC-II C SFA lesions. We think that a randomized study comparing PTA/S of TASC-II C and D lesions to FPB using vein grafts should be considered, because the question of durability remains unanswered.

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Author contributions 


Conception and design: HD

Analysis and interpretation: HD, GC, PL, LH, MD

Data collection: HD

Writing the article: HD

Critical revision of the article: HD, GC, PL, LH, MD

Final approval of the article: HD, GC, PL, LH, MD

Statistical analysis: HD

Obtained funding: NA

Overall responsibility: HD

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References 

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 Competition of interest: none.

PII: S0741-5214(08)00937-3

doi:10.1016/j.jvs.2008.06.006

Journal of Vascular Surgery
Volume 48, Issue 5 , Pages 1166-1174, November 2008

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