Annals of Vascular Surgery
Volume 20, Issue 2 , Pages 200-208, March 2006

Transluminal Stenting for Femoropopliteal Occlusive Disease: Analysis of Restenosis by Serial Arteriography

  • Trung D. Bui, MD

      Affiliations

    • Department of Vascular Surgery, Veterans Administration Long Beach Healthcare System, Long Beach, CA, USA
    • Department of Vascular Surgery, University of California Irvine, Medical Center, Orange, CA, USA
    • ,
  • Ian L. Gordon, MD, PhD

      Affiliations

    • Department of Vascular Surgery, Veterans Administration Long Beach Healthcare System, Long Beach, CA, USA
    • Department of Vascular Surgery, University of California Irvine, Medical Center, Orange, CA, USA
    • Corresponding Author InformationCorrespondence to: Ian L. Gordon, MD, PhD, Department of Vascular Surgery, University of California Irvine, Medical Center, 101 The City Drive, Building 53, Route 81, Orange, CA, 92868, USA
    • ,
  • Thang Nguyen, MD

      Affiliations

    • Department of Vascular Surgery, Veterans Administration Long Beach Healthcare System, Long Beach, CA, USA
    • Department of Vascular Surgery, University of California Irvine, Medical Center, Orange, CA, USA
    • ,
  • Roy M. Fujitani, MD

      Affiliations

    • Department of Vascular Surgery, University of California Irvine, Medical Center, Orange, CA, USA
    • ,
  • Samuel E. Wilson, MD

      Affiliations

    • Department of Vascular Surgery, Veterans Administration Long Beach Healthcare System, Long Beach, CA, USA
    • Department of Vascular Surgery, University of California Irvine, Medical Center, Orange, CA, USA
    • ,
  • Robert C. Conroy, MD

      Affiliations

    • Department of Radiology, Veterans Administration Long Beach Healthcare System, Long Beach, CA, USA

Article Outline

Our objective was to evaluate restenosis after stenting of femoropopliteal occlusions and the impact of percutaneous transluminal angioplasty (PTA) on recurrent stenosis. We used a retrospective analysis of contrast angiograms obtained during follow-up of stented limbs. Subjects included 27 claudicants (34 limbs) who had complete superficial femoral artery occlusion treated with PTA and Wallstents at the Veterans Adminstration Medical Center. During follow-up, 31 PTAs, three thrombolytic treatments, and one additional stenting were performed. Outcome was measured by contrast angiography. Primary patency at 1 and 3 years was 38% and 8% after stenting, and secondary patency (PTA required at least once in 21/34 limbs) was 89% and 55%, respectively. PTA performed during follow-up reduced within-stent restenosis on average from 48.3 ± 13.6% to 22.8 ± 18.0%. Recurrent stenosis after PTA measured 14.9 ± 10.9 months later was 46.8 ± 16.7%, showing little permanent impact of PTA on stenosis. Severe within-stent stenosis develops commonly after initial stenting of complete femoropopliteal occlusions. Supplemental PTA performed during follow-up provides immediate improvement in lumen diameter, but severe restenosis is still likely to recur.

 

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INTRODUCTION 

Endovascular interventions are increasingly employed to treat lower extremity atherosclerotic occlusion, but the use of stents as an adjunct to mechanical recanalization of femoropopliteal lesions is controversial. Several randomized trials have shown that the addition of stents to percutaneous transluminal angioplasty (PTA) offers no advantage over PTA alone as a primary intervention in this arterial segment.1, 2, 3 We have observed4 that primary stenting of long (mean length 14.5 cm) femoropopliteal occlusions with self-expanding Wallstents® (Boston Scientific, Boston, MA) yielded better results than were achieved in a comparable group treated earlier with PTA alone.5 Our previous report on the results of PTA with stenting in the femoropopliteal segment combined clinical, ultrasound, and angiographic evaluations to determine patency in a series of 71 limbs (57 subjects); duplex ultrasound was the primary method employed to determine patency.4 Recognizing that compared to contrast arteriography ultrasound tends to overestimate luminal dimensions,6, 7 we have reanalyzed patency after PTA with stenting using solely angiographic criteria in accord with recommended standards,8 where development of within-stent restenosis of 50% or more diameter reduction is considered treatment failure. This analysis has been applied to the subset of the original cohort of 71 limbs where follow-up contrast angiograms were available. This has provided more precise data on the development of restenosis within the stented arterial segments and the impact of supplemental PTA performed during follow-up on within-stent hyperplasia. A better understanding of these phenomena should assist evaluating the role of stenting in the management of femoropopliteal occlusive disease.

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PATIENTS AND METHODS 

An institutional review board-approved clinical trial of PTA and stenting was conducted between 1994 and 1998 on patients at the Veterans Administration Medical Center Long Beach. Eligible subjects had complete occlusion in the superficial femoral or popliteal artery with reconstitution of the popliteal artery at least 2.5 cm above the knee joint and at least one intact tibial run-off vessel. All patients (n = 27) were male claudicants [Society for Vascular Sugery (SVS) 1–3]. The mean age was 64 ± 7 years; 70% (n = 19) were Caucasian, 19% (n = 5) were black, and 11% (n = 3) were Hispanic. The majority of patients, 78% (n = 21), were current or former smokers; and 63% (n = 17) had diabetes. The average length of occlusion was 15.0 ± 10.2 cm, 3.2 ± 1.2 stents (Wallstents) were deployed per limb, and the mean preprocedural ankle-brachial index (ABI) was 0.63 ± 0.16. In every case, stenting was the first intervention applied to the treated arterial segment and a similar endovascular method was used:9 initial stiff guidewire penetration of the obstruction, then PTA with 6 or 7 mm noncompliant balloon-tipped catheters, followed by deployment of overlapping Wallstents throughout the area of initial occlusion and neighboring stenotic segments. Further balloon dilation was performed within the stents after their deployment to ensure optimal expansion. Subintimal passage of the guidewire through the area of obstruction with return into the lumen distally was routinely but not invariably observed; in most cases, the wire returned into the lumen within a few centimeters distally. After recanalization and preliminary balloon angioplasty, stents were deployed in a continuous, overlapping fashion through the occlusion and 10–20 mm into the neighboring segments. If significant stenosis was present in neighboring segments, these were stented in continuity in the same fashion; as a consequence, the length stented in some limbs was two or three times greater than the length of complete occlusion. In eight limbs, periprocedural thrombosis led to the use of intra-arterial catheter-delivered urokinase to achieve initial patency. Heparin was maintained for the first 24–48 hr, followed by coumadin therapy for 1 month and then indefinite antiplatelet therapy with aspirin.

Duplex ultrasound assessment was performed every 6 months after stenting, continuing for up to 6 years; the mean follow-up interval was 48 ± 23 months. Study subjects were asked to return between 6 and 12 months for follow-up angiography as part of study participation. Additional diagnostic angiography was performed for new clinical symptoms of ischemia or when ultrasound evaluation (duplex scan or fall in ABI) indicated the presence of recurrent disease or, in a few instances, as part of radiological investigation of the contralateral limb. Follow-up angiograms were obtained in 38 limbs at 5 months or more after the initial stent deployment. Of these 38 cases, four were excluded from the present analysis because of incomplete imaging or clinical records. The average interval between initial stenting and the last angiogram obtained for a limb was 24 ± 18 months. In 12 cases, only one follow-up angiogram was obtained; two or more were available for analysis in the remaining 24 limbs. Supplemental PTA for restenosis occurring within the originally deployed stents was performed a total of 31 times in 21 limbs during follow-up – seven limbs twice and three limbs thrice. PTA was routinely performed when ≥50% stenosis within the stented segment was observed within the stented segment. In one patient, a Palmaz stent was deployed within the original Wallstent due to severe residual stenosis immediately after secondary PTA.

On a routine basis, only a single angiographic view was obtained to assess within-stent restenosis. Measurements were performed on the portion of the stent showing the most severe stenosis. Tracings with a fine-tip marker were made on transparencies laid over the illuminated X-ray image. The least diameter (LD) within the stented arterial segment was measured to within 0.2 mm, as were two reference diameters. One reference was the transverse diameter of the most proximal segment of the artery distal to the segment stented that appeared free of disease (distal artery diameter, DAD). The second reference was the average transverse distance, metal to metal, within the stent determined from five points spaced equally along the area stented (mean stent diameter, MSD). The degree of within-stent restenosis was calculated using the following formula: % stenosis = 100 × [1 − (reference diameter − LD)/reference diameter)], using either DAD or MSD. The lengths of the reference diameters on completion angiograms obtained immediately after stent deployment and on follow-up angiograms were compared after adjusting for magnification differences based on measurements of femoral shaft diameters.

Primary patency (based on angiographic findings) is defined as the interval during which no stenosis of ≥50% developed within the stented arterial segment and no adjunctive procedures were performed. Loss of primary patency was considered to have occurred in cases where duplex ultrasound showed complete occlusion, when additional endovascular intervention was performed, or when stenosis of >50% was observed within the stent lumen on angiogram. If secondary procedures restored the within-stent lumen to <50% stenosis, the interval after the secondary intervention until patency was lost again (occlusion on duplex, repeat angiographic finding of >50% stenosis) is defined as secondary patency. All the data employed to determine these angiographically defined patency results derive either from duplex ultrasound studies showing unequivocal complete occlusion or from quantitative angiogram measurements. Survival curves based on life table analysis, t-tests, linear correlation analysis, and other statistical analyses were performed using the microcomputer software program Prism (v. 2.01; GraphPad Software, San Diego, CA).

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RESULTS 

Angiograms were performed on 34 limbs at intervals of 5 months or more. A total of 64 angiograms were performed during follow-up, which ranged 10–77 months (average 48 ± 23 months). During this interval, three interventions with catheter-directed thrombolyis were used to treat complete occlusions, 31 additional balloon angioplasties were performed for within-stent restenosis, and one additional stent was deployed within a previously placed stent. The additional therapeutic procedures were successful in restoring or maintaining patency; none led to immediate rethrombosis or surgical complications such as bleeding or increased ischemia.

The reference diameter measurements (MSD, DAD) derived from completion angiograms obtained after stent deployment and those derived on the first angiograms during follow-up are shown (Fig. 1). The average interval between stent deployment and first follow-up angiography was 307 ± 211 days. The value for MSD was 6.3 ± 1.0 mm immediately after stent deployment and 5.9 ± 2.0 mm at first follow-up. Corresponding values for DAD were 5.4 ± 1.3 mm and 5.1 ± 1.6 mm. The difference between initial and follow-up MSD was not significant (paired t-test p = 0.166). Similarly, the difference between initial and follow-up DAD was not significant (p = 0.127). Immediately after stenting, we found MSD on average to measure 0.7 mm more than DAD (p < 0.0001) and MSD was 0.8 mm greater than DAD at the time of first follow-up (p = 0.0003).

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  • Fig. 1. 

    Difference in reference diameters between stent deployment and first follow-up angiography. The mean interval between deployment and follow-up angiography was 10 ± 7 months. Shown are the mean values and standard deviations for both MSD and DAD. The difference between MSD at stent deployment and follow-up was not significant, nor was the minor change in DAD. The difference between MSD and DAD at both time intervals was significant (p < 0.0003).

We compared the two sets of stenosis calculations, one using MSD and the other DAD. The measurements were taken only from angiograms obtained during follow-up prior to repeat intervention such as PTA within the originally stented segment. When MSD was employed as the reference, 49.6 ± 18.6% is the average value for lumen diameter reduction compared to 41.8 ± 20.0% with the DAD reference. The difference between the two sets of stenosis calculations is highly significant (p < 0.0001). For further analysis of the angiographic data, we chose DAD as the appropriate reference as use of the larger MSD exaggerates the severity of the restenosis phenomenon.

Figure 2 shows the progression of stenosis using angiographic findings with DAD as the reference to determine the patency after stenting the 34 limbs with available follow-up angiography. One-year and 3-year primary angiographic patencies were 38% and 8% compared to 89% and 55% for secondary angiographic patencies, respectively.

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  • Fig. 2. 

    Patency analysis based on arteriographic assessment. Primary patency is defined as the interval between stenting and subsequent development of within-stent diameter reduction. Secondary patency is defined as the interval between original stenting and subsequent development of diameter reduction of ≥50% after one or more PTA interventions were performed. At 1 and 3 years, respectively, primary patency was 38% and 8% and secondary patency after supplemental PTA was 89% and 55%.

Figure 3A depicts the relationship between the severity of within-stent restenosis and the interval between first follow-up angiography, which displays a moderately strong positive correlation (p = 0.0001 and r2 = 0.35). Figure 3B is the scatter plot constructed by adding to the data of Figure 3A more measurements obtained on limbs from the same cohort whose repeat angiography was performed without subsequent intervention (e.g., PTA) in the interval between original stenting and angiographic assessment. Some limbs were represented in the plot more than once. The slope of the correlation line is less steep but still borders on being significantly different from 0 (p = 0.054). Figure 3C incorporates the data from 19 additional angiograms performed on limbs treated as part of the original cohort where PTA was performed during follow-up and subsequent angiography was available to measure recurrent within-stent restenosis after PTA. The slope of the correlation line is now flatter, and the difference from 0 is less significant (p = 0.12). Although this type of analysis is limited by including repeat measurements on the same limbs, the overall pattern suggests that in the first few years after stenting within-stent stenosis tends to worsen but that PTA partially limits the progression.

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  • Fig. 3. 

    Relation between time after stenting and severity of stenosis at first follow-up angiography. In (A), only the data from the first follow-up angiogram are plotted. The linear regression line with 95% confidence limits is superimposed. (B) The same data points are shown with additional stenosis measurements from limbs studied again without intervening therapy. (C) Data from all angiograms obtained during follow-up on the 34 limbs studied, including repeat angiograms obtained after performance of PTA for restenosis during the follow-up interval. Measurements obtained from completion angiograms immediately after PTA are not depicted.

The immediate effect of PTA on lumen morphology when used to treat restenosis in stents is shown in Figure 4. There were 21 limbs which underwent at least one PTA during the follow-up period. On average, the first balloon angioplasty decreased stenosis (DAD used as reference diameter) from 52.3 ± 18.6% to 22.1 ± 18.9%, corresponding to an average reduction in stenosis of 30.9 ± 18.8%. Also shown are the measurements assessing the second angioplasty; stenosis immediately before second PTA was 44.8 ± 6.0%, falling to 26.9 ± 12.4% afterward, corresponding to a 17.9 ± 9.6% reduction in luminal narrowing. The impact of PTA at the second episode, although lower, was not significantly different from that observed with the first PTA (unpaired t-test, p = 0.094). At both treatment epochs, the calculated stenosis significantly fell after PTA (p < 0.001). In three cases, a third PTA applied to the originally stented segment led to an average reduction in luminal narrowing of 45%. The mean interval between initial stenting and first PTA was 15.6 ± 12.7 months, between stenting and second PTA 30.4 ± 20.1 months, and between stenting and third PTA 38 ± 18.9 months.

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  • Fig. 4. 

    Immediate effect of PTA. Stenosis measurements before and immediately after PTA are analyzed. There were three limbs that underwent a total of three PTAs during follow-up, seven that had two PTAs, and 21 that had only one PTA. The mean interval between first stenting and PTA was 15.6 ± 12.7 months, that between stenting and second PTA was 30.4 ± 20.1 months, and that between stenting and third PTA was 38 ± 18.9 months. The reduction in stenosis achieved by first PTA was, on average, 30.9 ± 18.8% compared to 17.9 ± 9.6% for second PTA. The difference bordered on being statistically significant (p = 0.094).

Figure 5 depicts the impact of initial stenting and subsequent PTA for restenosis on ABI measurements. The mean ABI before initial stenting in all 34 limbs was 0.63 ± 0.16, increasing to 0.91 ± 0.1 afterward. In 16 limbs, ABI measurements were available both before and after PTA for within-stent restenosis, averaging 0.72 ± 0.19 before PTA and 0.92 ± 0.11 after (paired t-test p = 0.003), indicating that restenosis induced a significant restriction of blood flow in the limb. The increase in ABI induced by PTA indicates that within-stent restenosis probably had an effect on limb blood flow.

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  • Fig. 5. 

    Impact of stenting and adjunctive PTA on ABI. ABI measurements performed before and after the initial stent deployment are depicted as well those obtained before and after adjunctive PTA during follow-up to manage within-stent restenosis.

The durability of the improvement in luminal morphology induced by PTA during the follow-up period was also assessed. Figure 6 shows the mean values for diameter reduction found immediately before and after PTA in 19 cases where follow-up angiograms were performed 14.9 ± 10.9 months later. Although PTA immediately reduced stenosis in this subset of limbs by an average of 25%, at subsequent follow-up the mean degree of within-stent restenosis was 48.3%, almost identical to the level seen prior to antecedent PTA. Thus, the tendency of restenosis to recur after most supplemental PTA procedures performed during the follow-up after stenting is clearly delineated.

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  • Fig. 6. 

    Restenosis after supplemental PTA. There were 19 cases in which follow-up angiograms were obtained after PTA for stenosis within the stented segment. The average interval between PTA and follow-up was 14.9 months. Although the immediate impact of PTA in this subgroup was to reduce luminal narrowing from 48.3 ± 13.6% to 22.8 ± 18.0%, the average stenosis on the next angiogram obtained was 46.8 ± 16.7%.

Figure 7 is an example of the impact of PTA on within-stent restenosis where the outcome of PTA was good. At follow-up 6 months after initial stent deployment, severe restenosis within the stent was observed, with a maximum diameter reduction of 59%. A 7 mm balloon angioplasty was performed, resulting in a near complete restoration of the lumen. Follow-up angiography performed 36 months after initial stenting showed fairly good preservation of lumen diameter, with no significant restenosis.

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  • Fig. 7. 

    PTA after initial stenting can lead to durable improvement in luminal morphology. (A) A complete occlusion of the right superficial femoral-popliteal junction is present. (B) Wallstent deployment and 6 mm balloon angioplasty resulted in excellent restoration of flow through the obstruction; arrows mark the stent position. (C) Six months later, within-stent restenosis with a diameter reduction is present. (D) Balloon angioplasty (7 mm) markedly improves within-stent restenosis. (E) Angiography 36 months after intitial stent deployment shows fair preservation of luminal dimensions without restenosis >50%.

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DISCUSSION 

We retrospectively assessed restenosis developing in a group of limbs with long femoropopliteal occlusions treated by PTA and stenting as primary therapy. Angiographic analysis showed primary patency to be 38% and 8% and secondary patency to be 89% and 55% at 1 and 3 years, respectively. Our analysis is limited to patients who either agreed to undergo repeat angiography in 6–12 months after stent deployment in the absence of recurrent ischemic symptoms or for clinical reasons underwent angiographic investigation that provided stent images. As we tended not to study asymptomatic patients after 1 year if they developed less restenosis, our data may have been skewed in a negative fashion, making the observed restenosis somewhat worse than it might have been if we had incorporated measurements on all subjects. Despite this limitation, the angiographic data do provide some useful insights into the severity of restenosis after the procedure. The strong positive correlation between the interval between stenting and severity of within-stent restenosis suggests that the intimal hyperplasia stimulated by stenting does not necessarily subside within the first 6 months and, in many cases, progresses continuously until thrombosis supervenes. Furthermore, although PTA during follow-up has an immediate beneficial impact on the lumen, subsequent angiography shows that in most cases restenosis of similar magnitude ensues. Although this latter observation is discouraging, we believe that the secondary patency rate we achieved probably was due, in part, to the liberal use of PTA, such that the progressive restenosis was partially inhibited or ameliorated. That PTA performed after primary stenting improves patency (based on angiographic criteria) is supported, but in no way proven, by our data.

The patients and limbs treated in this study differ in some aspects from those described in previous studies that have followed the fate of stented femoropopliteal segments, several of which are referred to in Table I. Only complete occlusions were treated (not stenoses), the average occlusion length of 15 cm is significantly longer than that reported in most previous studies, and PTA and stenting was always primary therapy, not a salvage intervention. Self-expanding, flexible steel stents were employed as opposed to nitinol, tantalum, or rigid steel stents. In the context of these parameters, we view our patency results as consistent with the findings of previous studies.

Table I. Reported cases of femoropopliteal stents
AuthorsnMean lesion length (cm)Stent typePercentage of lesions totally occludedIndications for stentingRestenosis measurement1-year restenosis <50%
Do et al. (1992)1268.6Wa100Primary therapyDuplex US, angiography59%e
Henry et al. (1995)21413.8Pb100Suboptimal PTA or restenosisAngiography84%
Bray et al. (1995)6576.8Sc61Suboptimal PTADuplex US56%
Gray et al. (1997)225716.5W or P89Suboptimal PTADuplex US, hemodynamics22%
Strecker et al. (1997)23478.2S100Primary therapy or suboptimal PTAClinical, Duplex US, angiography48%
Vroegindeweij et al. (1997)2424<5P17Primary therapyDuplex US62%
Grimm et al. (2001)2302.8P43Primary therapyDuplex US, hemodynamics, angiography73%
Cheng et al. (2001)256012.4W52Primary therapyDuplex US63%
Cejna et al. (2001)3382.6P45Primary therapyAngiographyd63%

US, ultrasound.

a Wallstent.

b Palmaz.

c Strecker.

d Defined restenosis as >70% diameter reduction.

e 6 Months follow-up.

Of note, we had only single angiographic projections in virtually all the cases, which probably led to some underestimation of the maximum severity of stenosis. Historically, using the criterion of 50% diameter reduction to define failure is based on experience with PTA for incomplete occlusions and was eminently reasonable given the likely hemodynamic impact of recurrent stenosis in a vessel not originally occluded.9, 10 We believe, however, that in some cases some hemodynamic benefit is maintained with restenosis near 50% when the original lesion is an occlusion. We observed in our previous analysis a durable increase in resting ABI compared to the immediate poststenting level as long as stents maintained blood flow based on duplex or clinical criteria, without reference to diameter measurements. If these same relaxed standards for patency were applied to the limbs analyzed here, 1- and 3-year primary patency would be 54.6 ± 6.3% and 29.9 ± 6.6% and secondary patency would be 81.6 ± 4.8% and 68.3 ± 6.5%, respectively.4 Our ABI data show that when restenosis develops requiring PTA during follow-up, there probably is significant restriction of limb blood flow. The question remains whether restenosis of ≥50% completely ablates the benefit of stents and whether this level of diameter reduction should be applied routinely to patency assessments after interventions for occlusion. As reporting standards for infrageniculate bypass do not mandate diameter measurement, comparisons between open and endovascular interventions are not based on identical considerations, making this a troublesome issue that deserves more study.

Our opinion is strongly colored by our retrospective realization that in virtually all cases, within-stent restenosis of ≥50% triggered repeat intervention. Thus, from an operational viewpoint. ≥50% stenosis does serve to define a clinically important end point: the perceived need for reintervention. The current standard for defining stent patency may not adequately take into account the possible hemodynamic benefit of stents that remain patent but stenosed >50%, but it still has validity as a marker of suboptimal treatment outcome. It may be, however, that a more stringent choice of diameter reduction, perhaps ≥70%, would be a more appropriate criterion.

Despite the lack of randomized clinical trial data to support routine stenting of femoropopliteal lesions, we believe that, for long or complex lesions, stents probably do improve long-term patency modestly compared to PTA alone. This belief is based on our experience with two different historical groups4 – one treated with PTA alone and one with PTA and stents only – where combined clinical, ultrasound, and angiographic assessments were used to determine patency. The crux of the problem is that the intimal hyperplasia reaction induced by stenting, even when employed as primary therapy, is often worse and more persistent than that stimulated by PTA alone, and no randomized prospective study has shown, in a compelling manner, superiority for PTA and stents over PTA alone in the femoropopliteal segment.11, 12 In contrast, there is a substantial body of evidence supporting the superiority of stents over PTA alone in the coronary position.13, 14, 15

Current results with endovascular methods do not justify routine application of PTA and stenting to the management of atherosclerotic occlusions in claudicants, particularly in light of the well-known benefits of graded exercise programs; nor is there sufficient evidence to favor stents over PTA alone in the femoropopliteal position. Application of this technique to critical ischemia should be regarded with caution. The apparent advantage of less immediate invasiveness than conventional surgical reconstruction is matched by the combined disadvantages of having both mediocre patency results and significant cumulative risks and costs imposed by the need for frequent reinterventions. Stenting of the femoropopliteal segment with current methods probably should be reserved for limited circumstances, such as a patient with critical ischemia who is at excessive risk for surgery or a claudicant with short lesions. The impact of medicated stents releasing drugs that inhibit myointimal hyperplasia on therapy of coronary lesions has been substantial.16, 17 Based on the clear evidence that local drug delivery significantly reduces within-stent restenosis, in most settings, when feasible, medicated stents are being employed for endovascular coronary interventions when the vessel diameter is 1.8 mm or larger.

The SIROCCO trials18, 19, 20 compared plain nitinol stents and rapamycin-coated nitinol stents in the femoropopliteal position. One-third of the limbs treated had stenosis rather than occlusion, therapy was limited to deployment of two stents, and the average lesion length (8.2 ± 4.2 cm) was approximately half of the average length seen in our cohort. At 6 months, there was a trend showing less lumen loss with rapamycin-coated stents, but there were no significant differences in mean lumen diameters or patency. Of note, restenosis of >50% was only 7.7% in the bare stent group and 0% in the medicated stents. The low rates of restenosis observed in these trials are surprising and hard to reconcile with our own results, but they may reflect the shorter lesion lengths and treatments of stenoses or possibly a biological difference in the response to nitinol compared to steel.

Future directions in endovascular therapy in the femoropopliteal position may require longer periods of drug release from stents or more effective drugs delivered by either local or system administration. Alternatively, successful adaptation of endovascular therapy in this position may ultimately require other adjunctive modalities such as fabric coating of stents or intraluminal brachytherapy to provide long-term durable suppression of myointimal hyperplasia to realize the promise of endovascular techniques.26, 27

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PII: S0890-5096(06)60032-0

doi:10.1007/s10016-006-9011-5

Annals of Vascular Surgery
Volume 20, Issue 2 , Pages 200-208, March 2006

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