Abstract 268: Revascularization with Open Bypass vs. Angioplasty and Stenting of the Lower extremity Trial (ROBUST)

Abstract

Background Peripheral Arterial Occlusive Disease (PAD) is the most common vascular condition affecting 3-10% of the general population, and as high as 15-20% of those over 70 years of age. PAD is also a major marker for cardiovascular disease and stroke. The Transatlantic Inter-Society Consensus (TASC II) classified superficial femoral artery lesions into 4 categories based on length and extent of disease. For TASC II A (short) lesions angioplasty with stenting (PTA/S) has shown to be effective. For TASC II D (long occlusion) open bypass (OB) is superior to PTA/S in patency and long term outcome. However for TASC II B and C (moderate) lesions there are conflicting reports on the best treatment modality. ROBUST is the first randomized clinical trial comparing OB and PTA/S in TASC II B and C lesions. Primary objective Patency (<50% restenosis on duplex), re-intervention rate. Secondary objectives Quality of life improvement, morbidity and mortality rate. Methods:/Study Population Patients with intermittent claudication who fail medical management or patients with critical limb ischemia are eligible. Patients are maximized medically. Patients with TASC II B or C lesions are prospectively randomized into either OB or PTA/S group; patients with TASC A and D lesion are non-randomized receiving PTA/Stent or Bypass respectively. Patients are followed at 1, 6 and 12 month and yearly up to five years with physical exam, ABI, duplex and QOL questionnaire. Study Status Study approved by Hopkins IRB. The study is actively enrolling participants, and making steady progress. Last DSMB Approval on 10/31/12. ClinicalTrials.gov Identifier NCT01602159 Results Total Consented = 29, Total Enrolled = 22, Screen fail = 7, Withdrawn = 0, Death = 1, TASC A = 4, TASC B = 7, TASC C = 1, TASC D = 10, Total randomized = 8 Patency One patient with TASC A (non-randomized PTA/S group) and one TASC B (randomized to OB) had restenosis. Both restenosis were treated successfully with angioplasty. Mortality No intra operative death reported. One unrelated death at 6-month (TASC B lesion randomized to PTA/S) Discussion/Significance of Impact Providing level-1 evidence, ROBUST will establish treatment guidelines in such lesions and eliminate un-necessary procedures and reduce health care costs