Common-Femoral Lesions: LINC 2020 Experts Hash Out the Best PAD Treatment

LEIPZIG, GERMANY—What’s the best course of corrective action for obstructive lesions of the common femoral artery (CFA) caused by PAD? At LINC 2020, two experts took to the main stage to debate this critical question.

Dittmar Böckler, MD (University Hospital Heidelberg, Germany), backed the surgery-first option, while Thomas Zeller, MD, PhD (Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany), argued for the endovascular-first approach.

Surgery remains the current gold standard—an approach backed by the guidelines—but endovascular options have increasingly shown promise and are becoming more widely used.

From the offset, Böckler had his work cut out for him as moderator Jos van den Berg, MD, PhD (Ospedale Regionale di Lugano, Switzerland), began by asking for a show of hands in support of a surgery-first strategy. Clearly in the minority, about 20 members of the nearly full main arena their support for surgery. Endovascular therapy dominated the room.

Ten Reasons Why Surgery Is Best

Undaunted, Böckler presented fully 10 reasons to support the surgical position. He began by citing the 2017 European Society of Cardiology guidelines on PAD diagnosis and management, which recommend surgery first except in the case of isolated iliac lesions not extending down to the CFA; in the latter instance, endovascular therapy is an acceptable first option.

The CFA, he added, also tends to be hostile for stenting due to the dynamic and constantly changing arterial motion. “Biomechanical forces, at least for the stents we have so far, may cause fracture and occlusion,” Böckler asserted.

There is no such thing as “zero complications” with endovascular approaches, since there is always risk of restenosis and reintervention, as well as access complications due to closure devices in about 33% of cases, he said. Among patients requiring transbrachial rather than transfemoral access, the risk of stroke is greater than 10%.

Böckler also noted that endovascular therapies for PAD are not standardized and include a host of diverse options from plain old balloon angioplasty (POBA) to debulking, atherectomy, laser therapy, and stents. “It's a combination of everything. So, it's difficult to interpret results these days,” he observed.

Surgery these days, so far, is still the first choice for this kind of PAD. Dittmar Böckler

Moreover, published data are often misinterpreted, he said, citing the 2017 TECCO trial, which compared stenting and surgery in atherosclerotic CFA lesions. While TECCI concluded that perioperative morbidity and mortality was significantly lower with stenting than with surgery, Böckler said the small 117-patient study with a follow-up period of only 30 days has numerous limitations that make it a poor source of support for endovascular first.

Böckler also argued that there are limited long-term results available for endovascular therapy compared with surgery. While most endovascular studies in the literature have an average follow-up of 24 months, surgery has shown excellent primary and secondary patency results out to 7 years with no differences between critical limb ischemia and claudication patients. “This is the baseline we should compare with new registries and trials looking at endo,” he said.

Many common presentations of femoral artery lesions also do not lend themselves as well to endovascular repair as they do to surgery, Böckler noted. Unless they are limited to the CFA alone, he said, surgery is the only option.

Additionally, the femoral artery is an important access site for other future procedures, such as TAVR or PCI. “If you put stents in there, you may really close the door you will have to enter tomorrow,” he said.

Beyond the potential for complications with endovascular therapies, such as such as perforation and false aneurysm, Böckler said that if endovascular stenting fails and surgery is needed, evidence in the literature indicates that risks for complications, bypass failure, amputation, and mortality all increase.

“Surgery these days, so far, is still the first choice for this kind of PAD,” he concluded.

Endovascular Therapy: No Support for the ‘Gold Standard’

In response, Zeller drew on recent studies of endarterectomy showing that while technical success and patency at 1 to 3 years is generally high, as many as 3.4% of patients die within 30 days, multiple major complications can occur after 30 days, and minor complications are seen in up to 20% of patients.

Data from the multicenter, single-arm VMI-CFA trial of the Supera (Abbott) peripheral stent—which Zeller said he does not necessarily think “is the way to go”—nonetheless show patency rates of 95% at 1 year, in the range of what’s seen in published surgical trials. Another recent study of atherectomy versus POBA shows primary patency of 87.1% at 4 years compared with 66.7% for the plain balloon (P = 0.04). Zeller also showed retrospective data from his own institution of 260 patients treated with atherectomy or surgery. At an average of 30 months, the rate of clinically driven TLR was 8.1% in the endovascular group and 6.9% in the surgery group. However, in patients with low rates of calcification, TLR-free survival at more than 4 years was 94%, with corresponding rates of 87.9% and 80.6% for moderate and mild calcification, respectively.

“This is at least in the range of open surgery,” Zeller noted.

As for the TECCO trial, he maintained that it is an important supportive argument for endovascular therapy because “at least at 2 years, a stent is as good as open surgery and this has never been shown before.”

TECCO also showed that delayed wound healing complications occurred in 16.4% of those who underwent surgery compared with none of the stented patients. Surgical patients also were more likely to have hematomas, lymphorrhea, and paresthesia, Zeller noted. Looking at primary patency at 24 months in TECCO, the data suggest it is closer to 80% in the surgical group, significantly lower than the 95% commonly cited in favor of surgery in retrospective studies.

[The surgical] reality looks different if you perform prospective analyses. Thomas Zeller

“Reality looks different if you perform prospective analyses,” Zeller said. While surgery is still considered the gold standard, he maintained that it lacks the needed prospective studies to underline that claim.

Zeller also took issue with Böckler’s suggestion that endovascular therapies impede future access of the groin for additional procedures, saying that the available data suggest this is not the case and that results from the ongoing PESTO-CFA trial, which he is heading, will clarify this and other misconceptions about endovascular therapy versus surgery.

At the conclusion of the debate, van den Berg again asked for a show of hands in support of surgery. While he observed a few more hands up than before the debate, endovascular still held the lead. Zeller quipped: “I knew that I would win.”