PURPOSE: To evaluate the effect of different balloon inflation times on angiographic results in peripheral angioplasty. MATERIALS AND METHODS: Seventy-four infrainguinal arteriosclerotic lesions were randomized prospectively to undergo balloon dilation for 30 seconds (group I) or 180 seconds (group II). Each group consisted of 37 patients. Postinterventional angiograms were evaluated by two blinded readers. Dissections were graded as follows: 1 = no dissection; 2 = minor flap; 3 = extensive dissection membrane, not flow limiting; or 4 = flow-limiting flap. The rate of major-grade dissections (grades 3 and 4), residual stenosis (>30%), and further interventions were compared with the two-tailed chi(2) test. RESULTS: In group I, major dissections were noted in 16 patients (43%) compared with five patients (14%) in group II (P =.009). Residual stenoses were found in 12 patients (32%) in group I compared with five patients (14%) in group II (P =.096). The rate of additional interventions was significantly higher in group I than in group II (20 of 37 vs nine of 37; P =.017). CONCLUSION: A prolonged inflation time of 180 seconds improves the immediate angioplasty result of infrainguinal lesions compared to a short dilation strategy. Significantly fewer major dissections and a modest reduction of residual stenoses are observed. The requirement of costly and time-consuming further interventions is significantly reduced.
RCT Entities:
PURPOSE: To evaluate the effect of different balloon inflation times on angiographic results in peripheral angioplasty. MATERIALS AND METHODS: Seventy-four infrainguinal arteriosclerotic lesions were randomized prospectively to undergo balloon dilation for 30 seconds (group I) or 180 seconds (group II). Each group consisted of 37 patients. Postinterventional angiograms were evaluated by two blinded readers. Dissections were graded as follows: 1 = no dissection; 2 = minor flap; 3 = extensive dissection membrane, not flow limiting; or 4 = flow-limiting flap. The rate of major-grade dissections (grades 3 and 4), residual stenosis (>30%), and further interventions were compared with the two-tailed chi(2) test. RESULTS: In group I, major dissections were noted in 16 patients (43%) compared with five patients (14%) in group II (P =.009). Residual stenoses were found in 12 patients (32%) in group I compared with five patients (14%) in group II (P =.096). The rate of additional interventions was significantly higher in group I than in group II (20 of 37 vs nine of 37; P =.017). CONCLUSION: A prolonged inflation time of 180 seconds improves the immediate angioplasty result of infrainguinal lesions compared to a short dilation strategy. Significantly fewer major dissections and a modest reduction of residual stenoses are observed. The requirement of costly and time-consuming further interventions is significantly reduced.