Superficial femoral-popliteal veins and reversed saphenous veins as primary femoropopliteal bypass grafts: a randomized comparative study.

From April 1981 to April 1985, 128 limbs in 120 patients who had primary femoropopliteal bypasses were entered in a randomized comparative study. Grafts used were 56 randomized and five obligatory reversed saphenous veins (RSVs), 41 randomized and 24 obligatory superficial femoral-popliteal veins (SF-PVs), and two obligatory prosthetic grafts. The primary patency rates of randomized SF-PVs (64% at 3 years) and RSVs (60% at 3 years) were not significantly different. Similarly, there was no statistically significant difference in the secondary patency rates of 68% for SF-PVs and 63% for RSVs at 3 years. Combinations of obesity, hypertension, and poor medical condition mandated obligatory RSV use. Obligatory SF-PV use was necessitated by absence (eight cases) or inadequacy (16 cases) of the saphenous vein. Indications for bypass were critical ischemia (RSVs, 93% and SF-PVs, 92%) and claudication (RSVs, 7% and SF-PVs, 8%). Diabetes was present in 69% of patients with SF-PV bypass and 49% of those with RSV bypass. Limb retention, operative mortality, and patient survival rates were not significantly different with each graft. Continuation of the study as originally structured, with nonselective SF-PV use, became ethically untenable when it was appreciated that results in black patients and patients with excessively large grafts were markedly inferior and that construction of 3 cm moderately tapered anastomoses significantly reduced the incidence of distal anastomotic hyperplasia. These results, obtained during a period when important lessons about SF-PV use were being learned, indicate that during the first three years of observation after primary femoropopliteal bypass, the differences in cumulative primary and secondary patency rates of SF-PVs and RSVs were not statistically significant. Results in the most recent 76 SF-PV grafts, with primary and secondary patency rates of 82% and 89% at 3 years, provide a more realistic picture of the effectiveness of SF-PVs as primary femoropopliteal bypass grafts.

RCT Entities:   Population Interventions Outcomes