Angioplasty May Be Alternative to Surgery for Common Femoral Artery Disease

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In patients with common femoral artery disease, balloon angioplasty plus stenting if needed achieves acceptable restenosis and target lesion revascularization (TLR) rates at 1 year. The results render endovascular therapy a viable alternative to surgical treatment for significant atherosclerosis in this region, according to a retrospective analysis appearing in the August 16, 2011, issue of the Journal of the American College of Cardiology.

Researchers led by Robert F. Bonvini, MD, of the University Hospital of Geneva (Geneva, Switzerland), analyzed outcomes of 360 consecutive percutaneous interventions (n = 321 patients) for atherosclerotic disease of the common femoral artery that were performed at the Heart Center (Bad Krozingen, Germany) from September 1996 to December 2007.

Balloon angioplasty was used as the primary intervention in almost all cases (98.6%), with stenting used only as bailout in the event of flow-limiting dissections or suboptimal results (ie, > 50% residual stenosis). This occurred in about one-third of cases (36.9%). A small number (6.9%) of excisional atherectomy procedures were also performed in the later years of this series. Over half of the patients (64.8%) presented with class IIb claudication, and 26.9% of cases were isolated common femoral interventions, whereas 43.6% and 42.2% also involved inflow and outflow vessels, respectively. Bifurcation lesions were present in over one-third of cases (38.9%).

Positive Midterm Results

Procedural success was high (92.8%), and periprocedural complications were low (6.4%), including thrombotic vascular events (1.7%). On duplex ultrasound at 10.3 ± 5.4 months, restenosis was 27.6% and TLR was 19.9%. After 18 months, these rates were 20.7% and 19.5%, respectively.

One-year mortality was 9%, with a major amputation rate of 0.3% and a minor amputation rate of 0.6% over the same time period.

On multivariable analysis, common femoral interventions during the second half of the study period (2002-2007) were independently associated with a decreased risk of procedural failure (OR 0.35; 95% CI 0.15-0.83; P = 0.013), probably due to operator experience and improved equipment, the researchers note.

Interestingly, stented patients showed lower rates of procedural failure, restenosis, and TLR than nonstented patients (table 1).

Table 1. Multivariable Analysis of Outcomes in Stented vs. Nonstented Patients

 

Stented
(n = 133)

Nonstented
(n = 227)

OR
95% CI

P Value

Failure

2.2%

10.1%

0.20
(0.06-0.69)

0.005

Complications

7.5%

5.7%

1.34
(0.57-3.14)

0.510

Restenosis

20.0%

31.8%

0.53
(0.29-0.97)

0.046

1-Year TLR

13.1%

23.6%

0.49
(0.26-0.91)

0.021


When stenting is necessary, the authors recommend using a self-expanding device as short as possible (20-30 mm) to allow placement of the femoral bypass anastomosis or the common femoral puncture just above or below the implanted stent.

In comparing the results with those of surgery, currently the gold standard, the authors note that cumulative patency rates with endarterectomy are up to 90% at 5 years. However, complications including major hematoma, wound infection, nerve damage, and need for surgical revision may occur in up to 5% of cases, while the rate of minor complications including seroma and hematoma can approach 20%.

Endovascular Approach First?

According to the authors, modern endovascular equipment and techniques, combined with the current retrospective series, “sugges[t] that [common femoral artery] stenosis may reasonably be treated with an endovascular approach first.”

However, in an accompanying editorial, John R. Laird Jr, MD, of the University of California Davis Medical Center (Sacramento, CA), was not so sure. “Although the 1-year results are quite acceptable, the longer-term outcomes are not as promising,” he writes, pointing out that restenosis greater than 50% observed beyond 18 months was excluded from the analysis because it was considered disease progression not related to the procedure.

“This is an artificial distinction that would have little meaning to the patient who returns after 2 years with recurrent symptoms due to renarrowing or reocclusion of the [common femoral artery],” Dr. Laird writes. Furthermore, the 5-year primary patency rate appeared to only be about 50%, he notes. “These longer-term results are inferior to those achieved with endarterectomy and patch angioplasty.”

Better Long-term Patency Needed

Dr. Laird proposes that this situation may be different with more contemporary techniques or in Europe, where drug-eluting balloons are commercially available. Nevertheless, the current results “highlight . . . that balloon angioplasty alone with or without stent implantation is not ready to replace surgery as the ‘gold standard’ treatment for [common femoral artery] occlusive disease,” he concludes. “A demonstration of better long-term patency with newer endovascular modalities will be necessary for that to occur.”

According to Debabrata Mukherjee, MD, of Texas Tech University Health Sciences Center (Lubbock, TX), it makes sense that surgery has been the preferred treatment in this area. “The reason we’ve avoided percutaneous intervention in the common femoral artery is that we often end up using stents, so imagine how much movement happens in the groin (sitting, walking) that would crush the stent,” he told TCTMD in a telephone interview. “And from the surgical point of view, it’s a superficial vessel that’s easy to get to.”

He noted that the current results are good, “but nothing that should change practice. What this study may do is open the door to a randomized trial of angioplasty and surgery where before people did not see equipoise.” Dr. Mukherjee added that it would also be important to make sure the outcomes of the current study are independently adjudicated to verify the results.

Surgery Hard to Beat

Dr. Mukherjee agreed with Dr. Laird that the long-term outcomes after stenting are still a problem in this vascular region. “I would say it’s not ready for prime time,” he said. “It will be hard to beat surgery—almost impossible—because the results are so good. The argument one may make [relates to] the morbidity, not necessarily the mortality, because the morbidity, hematomas, etc, may be less with percutaneous intervention compared with surgery, but again that needs to be tested.”

Factors that may help with the interventional approach are more recent techniques and technologies, the authors note, such as atherectomy. “I don’t think atherectomy is a game changer,” Dr. Mukherjee commented. “But I’m much more enthusiastic about drug-eluting balloons, because a lot of these people may not get restenosis and may not need stents. But that still needs to be validated because you can’t just extrapolate based on data from the coronaries or elsewhere.”

Regardless, this is an area where interventionalists should walk before they run, Dr. Mukherjee stressed. “There are a lot of areas where intervention is clearly the better approach, with less morbidity and equivalent outcomes or even less mortality,” he said. “But this is an area for the surgeon that’s easily accessible with very good long-term outcomes, so I would be cautious in terms of proceeding.”

 


Sources:
1. Bonvini RF, Rastan A, Sixt S, et al. Endovascular treatment of common femoral artery disease: Medium-term outcomes of 360 consecutive procedures. J Am Coll Cardiol. 2011;58:792-798.

2. Laird JR. Endovascular treatment of common femoral artery disease: Viable alternative to surgery or just another short-term fix? J Am Coll Cardiol. 2011;58:799-800.

 

Jason R. Kahn, the former News Editor of TCTMD, worked at CRF for 11 years until his death in 2014…

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Disclosures
  • Drs. Bonvini and Mukherjee report no relevant conflicts of interest.
  • Dr. Laird reports receiving consulting fees from and serving on the scientific advisory boards of Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cordis, eV3, and Medtronic.

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