An endovascular-first approach to revascularization of long femoropopliteal lesions doesn’t seem best for outcomes, according to an interim analysis of a small randomized trial.
Technical success with nitinol stent placement was worse than with primary vein bypass (87% vs 100%, P=0.006) in the cohort of 103 patients with femoropopliteal lesions averaging 276 mm in length, reported a team led by Florian Enzmann, MD, of Paracelsus Medical University in Salzburg, Austria.
However, there were no differences between groups in primary patency (60% vs 56%, P=0.42) and secondary patency (72% vs 73%, P=0.25) at two years, as the group reported in JACC: Cardiovascular Interventions.
Nevertheless, several metrics of clinical improvement indicated a disadvantage with the endovascular approach:
- Rutherford category improved by at least one category: 73% versus 84% (P=0.030)
- Mean Rutherford category change: 2 versus 3 (P=0.002)
- Asymptomatic status (Rutherford category 0 reached): 20% versus 51% (P<0.001)
“Technical success and clinical improvement in the bypass group were significantly better, but the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable,” Enzmann and colleagues wrote.
Longer-term follow-up with more patients is needed, they acknowledged, as they had calculated that they would need 218 patients in the final cohort to determine a difference in patency outcomes.
The authors’ main conclusion is “unsupported by the data and speculative at best,” according to Matthew Menard, MD, of Brigham and Women’s Hospital in Boston.
His accompanying editorial called on colleagues to “move beyond the internecine rancor of the last several decades, and the rigidity of the endovascular vs open debate.”
“A good place to start would be a general acknowledgement that both endovascular and open surgery work; a one-size-fits-all approach rarely is best in medicine, and there is no reason to think it well serves our highly complex PAD [peripheral artery disease] patients,” Menard emphasized.
Enzmann’s group studied 103 participants with 110 affected limbs, roughly half with claudication and the rest with critical limb ischemia. Patients were eligible if they had TASC II type C (60%) or D lesions (40%).
There were no between-arm differences in baseline or lesion characteristics between randomized treatment groups, except there were more chronic total occlusions and redo procedures following endovascular failure in the surgical arm.
A quarter in each group received target lesion revascularization in the two years following the assigned intervention. By then, the odds of limb salvage (100% vs 88%, P=0.057) and survival (90% vs 95%, P=0.27) were similar between stent and surgery groups as well.
The sole difference in complications was more anemia in the surgical group (nine vs two events, P=0.026).
Notably, the reported patency rates from the surgical arm were lower-than-expected given historical data. Enzmann and colleagues suggested this may have been due to the especially long lesions involved.
“An endovascular-first strategy for long femoropopliteal lesions is widely recommended without sufficient data comparing it with bypass surgery,” Enzmann’s team noted.
The authors cited the current European Society of Cardiology guidelines on PAD as well as the TASC II recommendations, which both advise an endovascular-first strategy for all femoropopliteal lesions shorter than 25 cm and vein bypass for longer ones without strong evidence.
Appropriate Use Criteria issued jointly by several U.S. societies also favor endovascular treatment, pending more data.
“In the face of such an evidence gap, there remains a clear need to clarify the appropriate role for endovascular and open surgery in the current era of fast-paced technologic advances,” Menard agreed.
He pointed out that the trial was conducted before mainstream adoption of drug-eluting technology and the recent mortality signal concerning paclitaxel-associated balloons and stents, first raised last December in a meta-analysis.
The editorialist commented that the current study was limited by “a few minor design details.”
“Allowing randomization of both legs introduces confounding for systemic complications. Excluding patients who have had a prior bypass, but not those who have had a prior endovascular procedure seems inconsistent at best and to introduce bias at worst,” Menard said.
Enzmann had no disclosures.
Menard disclosed being a national PI of the BEST-CLI trial.
Primary Source
JACC: Cardiovascular Interventions
Secondary Source
JACC: Cardiovascular Interventions
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