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Published online before print February 12, 2008, 10.1148/radiol.2471070749
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(Radiology 2008;247:267-272.)
© RSNA, 2008

Vascular and Interventional Radiology

De Novo Superficial Femoropopliteal Artery Lesions: Peripheral Cutting Balloon Angioplasty and Restenosis Rates—Randomized Controlled Trial1

Jasmin Amighi, MD, Martin Schillinger, MD, Petra Dick, MD, Oliver Schlager, MD, Schila Sabeti, MD, Wolfgang Mlekusch, MD, Markus Haumer, MD, Rainer Mathies, MD, Gerald Heinzle, MD, Antonius Schuster, MD, Christian Loewe, MD, Renate Koppensteiner, MD, Johannes Lammer, MD, Erich Minar, MD, and Manfred Cejna, MD

1 From the Departments of Angiology (J.A., M.S., P.D., O.S., S.S., W.M., M.H., R.K., E.M.) and Radiology (C.L., J.L.), Vienna General Hospital, Medical University, Vienna, Austria; and Departments of Internal Medicine (R.M.) and Radiology (G.H., A.S., M.C.), University Teaching Hospital LKH Feldkirch, Carinagasse 47, A-6800 Feldkirch, Austria. Received April 27, 2007; revision requested June 27; revision received July 30; accepted August 24; final version accepted September 28. Address correspondence to M.C. (e-mail: manfred.cejna{at}lkhf.at).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Purpose: To prospectively determine, in a randomized controlled trial, whether cutting balloon angioplasty (CBA) yields superior morphologic and clinical outcomes at 6 months compared with the 6-month outcomes after conventional percutaneous transluminal angioplasty (PTA) in patients with short de novo superficial femoropopliteal artery (SFA) lesions.

Materials and Methods: This study was approved by the ethics committees of the two participating centers, and informed consent was obtained from all patients. The authors randomly assigned 43 patients (26 men, 17 women; median age, 69 years) who had 5 cm or shorter de novo SFA lesions in association with intermittent claudication or chronic limb ischemia to undergo CBA or PTA. The patients were followed up clinically, and restenosis was assessed with duplex ultrasonography (US) at 6 months. {chi}2 and Mann-Whitney U tests were used to compare data between the two treatment groups.

Results: The US-determined 6-month restenosis rate was 32% (seven patients) in the PTA group versus 62% (13 patients) in the CBA group (P = .048). Sixteen (73%) PTA group patients versus eight (38%) CBA group patients were asymptomatic at follow-up (P = .059). There was no significant difference in ankle-brachial index (median, 0.83 vs 0.77 for PTA vs CBA group, respectively; P = .56) or pain-free walking distance (median, >1000 m vs 600 m for PTA vs CBA group, respectively; P = .17) between the two groups.

Conclusion: CBA did not prove to be superior to conventional PTA for treatment of short de novo SFA lesions and yielded increased restenosis rates at 6 months.

© RSNA, 2008

Clinical trial registration no. NCT00437905.


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Percutaneous transluminal angioplasty (PTA) is a minimally invasive technique for treatment of superficial femoropopliteal artery (SFA) obstructions in patients with intermittent claudication and/or critical limb ischemia. Initial technical success rates higher than 95% can be achieved, and acceptably low complication rates are consistently reported in the literature (1). However, the long-term results of PTA for treatment of obstructive disease of the SFA are disappointing, as recurrent stenosis of the dilated segment (ie, restenosis) frequently occurs—even after the treatment of short lesions (2,3). This major drawback limits the applicability of PTA, and the indications for PTA in the SFA—particularly in patients with intermittent claudication—are often controversial.

Compared with PTA, stent implantation for treatment of short SFA lesions does not substantially improve patency rates (4–6). However, primary stent placement with self-expanding nitinol stents has yielded better anatomic and clinical intermediate-term outcomes than angioplasty alone with optional secondary stent placement (7) in patients with long and complex disease. Therefore, conventional balloon angioplasty remains the recommended treatment strategy for short SFA lesions (1).

The extent of vessel trauma—which is quite substantial after angioplasty—is suggested as a major determinant of negative vascular remodeling and neointimal hyperplasia and is directly associated with the recurrence of stenosis in the treated segment (8). Study findings suggest that cutting balloon angioplasty (CBA) induces controlled vessel injury (9–15); thus, this procedure may yield a reduction in trauma, inflammation, and neointima formation, which in turn may lead to a reduction in restenoses (16). Initial reports on the use of CBA for the treatment of obstructive atherosclerotic disease of the SFA have revealed promising results (17–19). However, data from randomized studies involving comparisons between conventional balloon angioplasty and CBA in the coronary arteries have failed to prove the superiority of CBA (20–23). Data from randomized trials of the application of CBA in peripheral arteries are lacking (24). Thus, the purpose of our study was to prospectively determine, in a randomized controlled trial, whether CBA yields superior morphologic and clinical outcomes after 6 months compared with the 6-month outcomes after conventional PTA in patients with short de novo SFA lesions.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Study Design
From August 2004 to June 2006, we enrolled 45 patients with SFA lesions up to 5 cm in length who were referred for endovascular treatment of the SFA owing to intermittent claudication or chronic critical limb ischemia in a two-center randomized controlled trial. Two patients (one treated with CBA and one treated with PTA) had to be excluded because of their withdrawal from follow-up examinations, so 43 patients remained for the final analysis. The study protocol was approved by the institutional ethics committees of the two participating centers, and the study was registered with the National Institutes of Health (http://clinicaltrials.gov). All patients provided written informed consent before enrollment. Both participating centers are tertiary-care referral centers.

For all included patients, the age, sex, body mass index (in kilograms per square meter), medical comorbidities (ie, hypertension, diabetes mellitus, and hyperlipidemia), statin treatment (administered or not administered), smoking history, clinical stage of peripheral arterial disease, and antiplatelet medication (administered or not administered) noted in the medical records were documented to additionally confirm the comparability of the two treatment groups—PTA or CBA.

The clinical criterion for study entry was symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb), or chronic critical limb ischemia (Fontaine stage III or IV). The anatomic inclusion criterion was a single SFA target lesion—specifically, an SFA with greater than 50% stenosis or occlusion—up to 5 cm in length. Exclusion criteria were previous bypass surgery or stent placement at the ipsilateral lower limb; history of intolerance to antiplatelet therapy, heparin, or contrast media; bleeding diathesis; active systemic bacterial infection; and severely impaired renal function (serum creatinine level > 2.5 mg/dL).

Study Endpoints
The primary study endpoint was the occurrence of a duplex ultrasonography (US)-evaluated relevant (>50%) restenosis in the treated vessel segment(s) 6 months after treatment. Secondary endpoints were clinical stage of peripheral artery disease, patient-reported pain-free walking distance, and at-rest ankle-brachial index (ABI) at 6 months. One observer from each center (J.A., M.C., 5–15 years experience in peripheral vascular disease and imaging), who was blinded to the treatment groups, evaluated all follow-up data from the other center.

Interventional Procedures
Experienced staff interventionalists (M.S., M.H., R.M., M.C.) with 6–15 years experience in peripheral vascular intervention performed PTA by following a standardized protocol involving an antegrade or over-the-bifurcation approach with use of 5–7-F sheaths. Heparin (5000 IU) was routinely administered intraarterially. Unless magnetic resonance angiography or computed tomographic angiography of the entire lower-limb vasculature was available, biplanar digital subtraction angiography was performed to evaluate inflow disease and runoff. Lesion characteristics (eg, length and degree of stenosis) were evaluated at biplanar digital subtraction angiography. For standardized documentation of lesion morphology and comparability during follow-up, an adhesive ruler was fixed to the patient's thigh, with the distal end of the ruler overlapping the upper edge of the patella. After the guidewire was successfully passed through the stenosis or occlusion, the patients were randomly assigned to be treated with PTA or CBA. This randomization was performed with use of computer-generated random digits and sealed numbered envelopes containing the patients' assignment to one of the two treatment groups.

The diameter of the balloon for PTA or CBA corresponded to the proximal nondiseased vessel area in a 1:1 ratio. The regular balloons were inflated to 8–10 atm for up to 2 minutes, and the cutting balloons were inflated slowly to a pressure of up to 8 atm according to manufacturer (Boston Scientific, Natick, Mass) recommendations. Throughout the study, 0.018-inch peripheral cutting balloons (5–6 mm in diameter, 10 or 20 mm in length) were used over a standard 0.018-inch guidewire. For 4-mm lesions, 0.014-inch cutting balloons (15 mm in length) were used over a standard 0.014-inch guidewire.

As a bailout procedure, self-expandable nitinol stent implantation was performed in patients who had greater than 30% residual stenosis after repeated angioplasty or because of flow-limiting dissection or elastic recoil in the worst angiographic view. The duration of fluoroscopy and the dose of contrast medium used were recorded as additional factors of the intervention.

Medical Therapy
All patients received acetylic salicylic acid (100 mg daily) for an indefinite period and clopidogrel (Plavix; Sanofi Pharmaceuticals, Bristol-Meyers Squibb, Vienna, Austria) (75 mg daily) for at least 3 months after revascularization. The patients began taking the 75-mg dose of clopidogrel at least 2 days before the intervention; otherwise, a loading dose of 300 mg was given immediately before angioplasty.

Follow-up
At 6 months, clinical examinations were performed, with documentation of the self-reported pain-free walking distance, Fontaine claudication stage, and ABI measurement. Experienced radiologists and angiologists (M.H., R.M., A.S.) with 10–15 years experience in peripheral vascular US performed color duplex US by using an Acuson Sequoia 512 unit (Siemens, Erlangen, Germany) equipped with the 8L5 multifrequency linear-array transducer, an ATL HDI 5000 unit (Philips Medical Systems, Best, the Netherlands) equipped with the L7-4 4-MHz transducer, or an iU22 unit (Philips Medical Systems) equipped with the L9-3 9–3-MHz linear transducer to evaluate restenosis at 6 months. Restenosis was defined according to hemodynamic criteria as a greater than 50% reduction in vessel diameter at the level of the previously treated lesion. The maximal peak systolic velocity in the dilated region was determined and compared with the peak systolic velocity in the preceding normal segment. A focal increase in peak systolic velocity of at least 140% (corresponding to a peak velocity ratio of ≥2.4) was considered to be indicative of greater than 50% stenosis at that site (8,25).

Statistical Analysis
We estimated that a sample size of 40–50 patients would be necessary to demonstrate any superiority of CBA compared with PTA. On the basis of data in the literature (1), we expected restenosis rates of 40% in the PTA group (literature-reported restenosis rates of 35%–45% in patients with short lesions) and 10%–20% in the CBA group (estimated). Continuous data are presented as medians and interquartile ranges (from 25th to 75th percentile), and discrete data are given as counts and percentages. {chi}2 and Mann-Whitney U tests were used to compare data between the two treatment groups, as appropriate. P < .05 was considered to indicate a significant difference. Data were analyzed by using SPSS, version 12.0, software (SPSS, Chicago, Ill).


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
Patients and Target Lesions
Twenty-two of the 43 patients included in the final analysis were randomly assigned to the PTA group, and 21 were assigned to the CBA group. Demographic and clinical characteristics were similar between the two treatment groups, without substantial differences in frequency of atherothrombotic risk factors, coexisting cardiovascular conditions, baseline pain-free walking distance, or ABI (Table 1).


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  		Table 1. Demographic, Clinical, and Angiographic Characteristics of Patients Treated with PTA or CBA for Short SFA Lesions

 
Target lesion characteristics and interventional data were also similar between the two groups (Table 1). The mean length of the treated segments was 2.5 cm, and the mean degree of stenosis was 90%. Four (18%) patients in the PTA group versus one (5%) patient in the CBA group (P = .17) underwent secondary stent placement owing to flow-limiting dissection or residual stenosis. One patient randomly assigned to undergo CBA had the minor complication of peripheral embolism of the tibioperoneal trunk, which was successfully resolved with thrombus aspiration during the intervention without clinical sequelae. In two patients, PTA of the ipsilateral pelvic arteries was additionally performed for treatment of inflow disease. Three of eight patients who had crural atherosclerotic disease with critical limb ischemia had to undergo concomitant revascularization of one crural artery owing to outflow disease. Following the intervention, two patients (one from CBA group and one from PTA group) developed a pseudoaneurysm at the puncture site: The PTA group patient had to undergo surgical repair, whereas the CBA group patient was successfully treated with US-guided compression and percutaneous thrombin injection.

Follow-up
No patient died during the follow-up period. Three patients—all with critical limb ischemia—underwent minor amputations (toe to distal forefoot) within 14 days after angioplasty. In one of these patients, a popliteopedal bypass had to be created. The restenosis rate at 6 months according to duplex US findings was 32% in the PTA group versus 62% in the CBA group (P = .048) (Table 2). The degree of restenosis was similar between the two groups of patients with recurrent disease (median restenosis degree, 70% vs 65% in PTA vs CBA group, respectively; P = .51).


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  		Table 2. Six-month Outcomes of Patients Treated with PTA or CBA for Short SFA Lesions

 
At the time of follow-up, 73% of patients in the PTA group versus 38% of patients in the CBA group were clinically asymptomatic (P = .059) (Table 2). Chronic critical limb ischemia was resolved in seven of eight patients. Patients in both groups had improved ABIs and pain-free walking distances compared with baseline values (Tables 1, 2). However, there was no significant difference in median postinterventional ABI values between the PTA (0.83) and CBA (0.77) groups (P = .56). The median pain-free walking distances (>1000 m for PTA group vs 600 m for CBA group, P = .17) indicated a trend in favor of PTA.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 
The main finding in this randomized controlled trial performed to compare CBA with PTA for treatment of short SFA lesions was that there was neither a substantial morphologic benefit nor a substantial clinical benefit after treatment of short de novo SFA lesions with CBA. CBA was even inferior with respect to restenosis rates compared with PTA. These data are consistent with previous findings (20) indicating that there is no general advantage to performing CBA as opposed to standard angioplasty in the coronary circulation and suggest that CBA should not be routinely used for treatment of short de novo SFA lesions.

Mauri et al (20) found no significant difference in the rates of restenosis in the coronary arteries at 6 months between the patients randomly assigned to undergo CBA (31.4%) and those randomly assigned to undergo standard balloon angioplasty (30.4%, P = .75). Their clinical results after CBA were even worse: The cutting balloon procedure was associated with a higher prevalence of myocardial infarction (4.7% vs 2.4% with standard angioplasty, P = .03) and a higher mortality rate (1.3% vs 0.3% with standard angioplasty, P = .06) at 9 months. In addition, in the coronary arteries, the use of CBA is limited to predilation before stent placement and treatment of rigid restenosis.

The peripheral CBA device is designed to relieve vessel expansion stress during dilation by means of precise and controlled incisions and thus reduce dilating force and barotrauma. Furthermore, elastic recoil is potentially resolved owing to disruption of the elastic and fibrotic continuity of the vascular wall. It has been shown previously that CBA can minimize both neointimal proliferation and the inflammatory response to local vascular trauma (16). However, this form of percutaneous intervention still induces injury to the vessel, exposing virtually all vessel layers to circulating blood and thus inducing restenosis. Thus, our findings confirm previous study results for the coronary arteries (20), which indicate that the use of CBA does not reduce the risk of restenosis and that the suggested benefit of using smaller localized incisions may be smaller than initially postulated.

Our findings regarding US restenosis rates were supported by the differences in ABI, clinical stage, and pain-free walking distance between the two groups, which favored treatment with conventional balloon angioplasty, even if these differences were not significant. In addition, we noticed trends toward shorter durations of fluoroscopy and the use of lower contrast medium doses in the PTA group, which also may be relevant in terms of patient safety during the procedure. Finally, we believe that from a cost-effectiveness perspective, the use of less expensive conventional balloons that yield equal or superior outcomes may be of interest in health care systems. On the other hand, there seemed to be a trend—although a nonsignificant one—toward a reduced frequency of bailout stent implantations after CBA in our small study population.

The relatively small patient sample in our study has to be recognized as a limitation. However, even in this small population, CBA was associated with a significantly lower patency rate at duplex US. Admittedly, the patient-reported walking distance is not as objective as standardized treadmill test results; however, we believe that this parameter provides important information about the effect of peripheral artery disease and the limitations it poses on a patient's daily activities. Finally, the results reported herein are from a relatively short follow-up period. Consequently, these data need to be confirmed in additional randomized studies. However, we believe that knowledge regarding the potentially adverse effects of CBA for treatment of short SFA lesions may have some immediate implications for daily routine clinical practice.

In conclusion, CBA did not prove to be superior to conventional PTA for treatment of short de novo SFA disease, and it even yielded a higher rate of restenosis at 6 months. Therefore, we believe that CBA should not be routinely used for treatment of peripheral artery disease involving short SFA lesions.


   ADVANCE IN KNOWLEDGE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCE IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE
 References
 


   IMPLICATION FOR PATIENT CARE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
References
 


   FOOTNOTES
 

Abbreviations: ABI = ankle-brachial index • CBA = cutting balloon angioplasty • PTA = percutaneous transluminal angioplasty • SFA = superficial femoropopliteal artery

Author contributions: Guarantors of integrity of entire study, J.A., M.S., M.C.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, J.A., M.S., P.D., O.S., S.S., M.H., C.L., M.C.; clinical studies, J.A., P.D., O.S., S.S., W.M., R.M., G.H., A.S., R.K., J.L., E.M., M.C.; statistical analysis, J.A., M.S.; and manuscript editing, J.A., M.S., M.H., E.M., M.C.

Authors stated no financial relationship to disclose.


   References
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCE IN KNOWLEDGE
 IMPLICATION FOR PATIENT CARE
 References
 

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A. R. Cotroneo, R. Iezzi, M. Cejna, J. Amighi, and M. Schillinger
Short Femoropopliteal Arterial Stenoses: Is Cutting Balloon Angioplasty the Solution?
Radiology, April 1, 2009; 251(1): 304 - 305.
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