Immunologic response to collagen-impregnated vascular grafts: a randomized prospective study. The Canadian Multicenter Hemashield Study Group.

The potential for bovine collagen-impregnated vascular prostheses to stimulate an immune response was tested in 128 patients randomized prospectively to receive either a Dacron graft or a Dacron graft with collagen coating. Clinical variables and laboratory tests for antibovine collagen antibody were used to identify patients who developed humoral immunity up to 6 months after graft implantation. In a subgroup of 20 subjects, a lymphocyte proliferation assay by freshly isolated leukocytes was used to test for cell-mediated immune response. Of the patients randomized to receive a collagen-coated graft, five showed seroconversion to bovine, type I collagen. Seroconversion also occurred in one of the patients randomized to the noncollagen coated graft. No patient had a positive lymphocyte proliferation response, indicating an absence of cell-mediated immune response. No evidence for the development of cross-reactivity with human collagen was seen. The potential for bovine collagen to stimulate an immune response after implantation of a collagen-coated graft is low. The response is weak, and when it does occur it appears to be without clinical consequences.

RCT Entities:   Population Interventions Outcomes