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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Prophylactic angioplasty reduces thrombosis in virgin ePTFE arteriovenous dialysis grafts with greater than 50% stenosis: subset analysis of a prospectively randomized study.
PURPOSE: To determine if prophylactic percutaneous transluminal balloon angioplasty (PTA) can extend patency in functioning virgin ePTFE arteriovenous hemodialysis grafts.
MATERIALS AND METHODS: The results of a prospectively randomized study of 64 patients with greater than 50% stenosis of functioning ePTFE arteriovenous hemodialysis grafts who were blindly assigned to be treated with PTA (treatment group) or observed without treatment (control group) were subjected to statistical subset analysis. Within this group were 21 patients (virgins) who had never undergone surgery, PTA, or thrombolysis. Eight patients had been assigned to the treatment group and 13 to the control group. The virgin groups were well matched as to age, sex, and risk factors. The virgin treatment group versus virgin control group had 1.63 versus 1.46 stenoses per patient and 61.3% versus 63.3% average percentage stenosis per lesion, respectively. Stenoses were treated with PTA 27 times (average, 3.4 per patient) in the virgin treatment group. Primary study patency began at the time of randomization and ended with graft thrombosis or nonfunction.
RESULTS: Among the 32 patients randomized to treatment with PTA, study patency was significantly increased (P > .0001) and the incidence of graft thrombosis significantly decreased (P = .0151) in the eight-patient virgin subset when compared with the 24-patient nonvirgin subset of the treatment group. During the 81.3 patient-dialysis-year study period, patency in the virgin-treatment versus virgin-control groups, respectively, was terminated by thrombosis in two versus nine, by death in two versus two, and cadaveric renal transplant in one versus zero. There was a statistically significant prolongation of study patency (P = .0349) and a reduction of graft thromboses, 0.10 versus 0.44 thromboses per patient-dialysis year, in the virgin-treatment group compared to the virgin-control group.
CONCLUSION: Patency after PTA of ePTFE hemodialysis grafts is significantly affected by previous interventions. Prophylactic PTA of stenoses greater than 50% in functioning virgin ePTFE arteriovenous hemodialysis grafts can significantly extend their patency. PTA should be included as an important treatment option in this patient population.
MATERIALS AND METHODS: The results of a prospectively randomized study of 64 patients with greater than 50% stenosis of functioning ePTFE arteriovenous hemodialysis grafts who were blindly assigned to be treated with PTA (treatment group) or observed without treatment (control group) were subjected to statistical subset analysis. Within this group were 21 patients (virgins) who had never undergone surgery, PTA, or thrombolysis. Eight patients had been assigned to the treatment group and 13 to the control group. The virgin groups were well matched as to age, sex, and risk factors. The virgin treatment group versus virgin control group had 1.63 versus 1.46 stenoses per patient and 61.3% versus 63.3% average percentage stenosis per lesion, respectively. Stenoses were treated with PTA 27 times (average, 3.4 per patient) in the virgin treatment group. Primary study patency began at the time of randomization and ended with graft thrombosis or nonfunction.
RESULTS: Among the 32 patients randomized to treatment with PTA, study patency was significantly increased (P > .0001) and the incidence of graft thrombosis significantly decreased (P = .0151) in the eight-patient virgin subset when compared with the 24-patient nonvirgin subset of the treatment group. During the 81.3 patient-dialysis-year study period, patency in the virgin-treatment versus virgin-control groups, respectively, was terminated by thrombosis in two versus nine, by death in two versus two, and cadaveric renal transplant in one versus zero. There was a statistically significant prolongation of study patency (P = .0349) and a reduction of graft thromboses, 0.10 versus 0.44 thromboses per patient-dialysis year, in the virgin-treatment group compared to the virgin-control group.
CONCLUSION: Patency after PTA of ePTFE hemodialysis grafts is significantly affected by previous interventions. Prophylactic PTA of stenoses greater than 50% in functioning virgin ePTFE arteriovenous hemodialysis grafts can significantly extend their patency. PTA should be included as an important treatment option in this patient population.
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