In common femoral artery lesions, surgery confers better patency vs. endovascular therapy
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Compared with endovascular therapy, thromboendarterectomy surgery was associated with better 1-year patency, but longer hospital stays, in patients undergoing revascularization for common femoral artery lesions, researchers reported.
Risk for restenosis after thromboendarterectomy was lower compared with endovascular therapy only in patients who were ambulatory, whereas risk was not significantly different among those who were nonambulatory.
The results of the CAULIFLOWER study were published in JACC: Cardiovascular Interventions.
“Over the past 20 years, endovascular therapy (EVT) for peripheral arterial disease has shown marked advancement,” Tatsuya Nakama, MD, deputy director of the department of cardiology at Tokyo Bay Medical Center in Urayasu, Japan, and colleagues wrote. “Surgical thromboendarterectomy is recommended as the gold-standard revascularization method in the latest guidelines because of its promising long-term efficacy. However, common femoral artery EVT is often performed as an alternative therapy in current clinical practice.”
This nationwide multicenter CAULIFLOWER study used data from 66 institutions in Japan and included 1,193 consecutive patients with symptomatic common femoral artery disease who underwent revascularization via EVT or thromboendarterectomy. The primary outcome was primary patency at 1 year.
The cohort included patients with Rutherford categories 2 to 5 common femoral artery lesions.
Researchers also conducted an interaction analysis to identify the appropriate target population for common femoral artery EVT.
At 1 year, the primary patency rate was higher among patients who underwent thromboendarterectomy compared with EVT (96.6% vs. 82.3%; P < .001); however, perioperative complications were more frequently observed during thromboendarterectomy (P = .047).
Patients in the EVT group were more often nonambulatory (9.7%) or on hemodialysis (33%), whereas those in the thromboendarterectomy cohort had more complex lesions, such as type III lesions (48.6%), nodular calcification (87.3%), 99% stenotic lesions (28%) and occlusive lesions (22%), according to the study.
After revascularization, 98.6% of patients in the thromboendarterectomy group had residual stenosis less than 25% compared with 60.6% in the EVT group (P < .001).
Moreover, patients in the EVT group stayed in the hospital for an average of 2 days compared with an average of 8 days in the thromboendarterectomy group.
Restenosis risk across subgroups
Risk for restenosis in ambulatory patients was greater in the EVT cohort compared with thromboendarterectomy (HR = 9.38; 95% CI, 4.4-20; P < .001). The risk difference was not significantly different in patients who were nonambulatory (HR = 1.23; 95% CI, 0.25-6.14; P = .8).
Nodular calcification was also tied to restenosis risk in the EVT group compared with the thromboendarterectomy cohort (HR = 10.6; 95% CI, 4.72-23.6) and was lower without the presence of nodular calcification (HR = 2.31; 95% CI, 0.68-7.83; P for interaction = .04).
Among patients who underwent EVT, stent use was associated with the lowest risk for restenosis compared with regular balloon angioplasty and drug-coated balloon angioplasty (P < .001), according to the study.
“In daily clinical practice, EVT is often selected as an alternative therapy because of patients’ clinical complexity and/or social problems. ... Patients are often reluctant to be treated with thromboendarterectomy, as it is more invasive and requires a long hospital stay,” the researchers wrote. “Thromboendarterectomy had significantly higher rates of primary patency and freedom from reintervention in the propensity-matched cohort in our CAULIFLOWER data. ... Although the reduced rate of reintervention in EVT may be acceptable, thromboendarterectomy is the gold-standard revascularization strategy for common femoral artery diseases in real-world Japanese target populations.”
Interpreting results of CAULIFLOWER
In a related editorial, Christopher J. White, MD, professor of medicine at Ochsner Clinical School of the University of Queensland in Brisbane, Australia, and system chairman for cardiovascular disease and director of John Ochsner Heart and Vascular Institute at the Ochsner Medical Center in New Orleans, discussed how clinicians could interpret these findings.
“The randomized control trial demonstrates that with experienced operators in candidates eligible for either surgery or EVT, it is reasonable to prefer EVT to minimize the costs of complications and hospital stay,” White wrote. “The randomized control trial emphasizes the benefit of common femoral artery stent use to enhance patency. Concerns over stent fracture and stent jail of the common femoral artery have been shown to not be of significant concern. The patency advantage of surgery over EVT in the observational trial is undermined by the dominant use of plain balloon angioplasty.
“In candidates for common femoral artery revascularization with lesions unsuitable for EVT, or for less experienced EVT operators, surgery is a reasonable choice,” White wrote. “However, in a patient who is a candidate for common femoral artery revascularization with either EVT with stent or surgery, the evidence suggests that in experienced hands, surgery is no longer the gold standard for common femoral artery revascularization.”
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