Surgical and endovascular revision of infrainguinal vein bypass grafts: analysis of midterm outcomes from the PREVENT III trial.

OBJECTIVE: Data supporting the utility of percutaneous treatment to maintain vein graft patency have been limited to a collection of single-institution, retrospective analyses. Using the prospective, multi-institutional PREVENT III database, we sought to define the outcomes for endovascular vs surgical vein bypass graft revision and to define predictors for the success or failure of these interventions.
METHODS: A nested cohort study of 1404 patients in the PREVENT III trial who underwent infrainguinal vein bypass grafting for critical limb ischemia was performed to identify those patients who underwent either open surgical or endovascular graft revision. All patients in PREVENT III were followed up for 1 year from the initial bypass operation. The following were modeled as end points from the time of the initial open surgical or endovascular revision: freedom from graft reintervention, occlusion, amputation, and death.
RESULTS: A total of 156 open surgical and 134 endovascular reinterventions were performed, with a mean follow-up after revision of 193 and 151 days, respectively. Although the demographics for each group were similar, the choice of repair was influenced by the interval between the index graft placement and the initial revision, with a high percentage of the early graft revisions treated with an open surgical procedure (0-1 months: 84% open surgical vs 16% endovascular; P < .001). The primary end point (ie, failure resulting in repeat graft revision, graft occlusion, or major amputation) was reached in 30.2% of the endovascular and 26.2% of the open surgical individuals, with significant improvements in the durability of graft revisions noted in the open surgical group (12-month amputation-/revision-free survival of 75% for the open surgical and 56% for the endovascular group; hazard ratio, 2.2; 95% confidence interval, 0.92-5.26; P = .043). Furthermore, subgroup analysis revealed this benefit to be most profound within the subset of thrombosed grafts undergoing salvage (P = .006). For revisions performed to treat graft stenosis, early outcomes were similar, with a trend favoring the open surgical group developing beyond 6 months. Although 80% of open surgical and 64% of endovascular-revised grafts required no further intervention, endovascular revisions necessitated significantly more reinterventions to maintain patency. The mean hospital lengths of stay (open surgical, 2.1 days; endovascular, 1.7 days) and quality of life at completion of the study (VascuQoL: open surgical, 4.72; endovascular, 4.76) were similar between the groups.
CONCLUSIONS: Open surgical revision of infrainguinal vein grafts provides an increased freedom from further reinterventions or major amputation, but early success rates for endovascular procedures were similar, particularly for nonoccluded grafts. With time, endovascular revisions necessitate an increasing number of reinterventions and manifest higher rates of failure.

RCT Entities:   Population Interventions Outcomes