Trial seeks best outcomes in midgrade SFA PAD

Angela Marshall | | Cardiovascular Business | Vascular & Endovascular

When a patient’s peripheral artery disease (PAD) is in the middle of two extremes, which is the best method of treatment: open bypass or angioplasty and stenting? A randomized trial is under way to compare treatment outcomes for patients with the middle two tiers of PAD in the superficial femoral artery (SFA).

The Revascularization with Open Bypass vs. Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) team wrote about ongoing enrollment for their trial in an article published online Oct. 29 in JAMA: Surgery. Patients admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center in Baltimore with symptoms of intermittent claudication or critical limb ischemia may be enrolled.

Patients with TransAtlantic Inter-Society Consensus (TASC II) B or C superficial femoral artery lesions would be randomized between open bypass surgery or angioplasty and stenting. Patients with TASC II A or D lesions would receive percutaneous transluminal angioplasty with stenting (PTA/S) or femoropopliteal bypass surgery (FBS), respectively, as per current recommendations.

Currently, 29 patients are enrolled.

The goal, wrote Mahmoud B. Malas, MD, MHS, of the surgical department at the Johns Hopkins Bayview Medical Center, and colleagues, is to determine patency, quality of life, clinical improvement and ischemic limb healing and salvage. The ROBUST team also will look at how long patients remain amputation-free, reintervention rates and they will evaluate 30-day mortality, morbidity and complications.

The hope is that a best practice for these patients will be identified. Cost-effectiveness also will be a component of determining best outcomes.

Malas et al wrote, “ROBUST will establish level one evidence of the effectiveness of each treatment modality based not only on patency but also on improving quality of life. The trial will provide longitudinal data on the morbidity and mortality associated with FPB and PTA/S that will help to develop guidelines for treating symptomatic SFA lesions that have not responded to exercise therapy.”

 

Angela Marshall

Related Content

IVUS-guided PCI reduces risks in patients with diabetes
LAAC with Watchman FLX reduces bleeding risks after AFib ablation
Bioresorbable BTK stent superior to ballon angioplasty at 2 years
Shockwave Medical’s IVL technology delivers more positive outcomes for PAD patients
Standing desks fail to lower blood pressure or minimize heart risks—they may even do damage
IVL vs. RA for chronic total occlusion PCI: Key data cardiologists should know

Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."