Angiographic impact of the GuardWire system on inflated coronary segments after six months: does the distal protection balloon of the GuardWire Plus lead to restenosis?

Aims: To investigate the consequences of inflating low-pressure balloon occlusion devices in native coronary arteries. Methods and results: One hundred eighteen segments of 118 patients who were enrolled in the ASPARAGUS study were analysed post-procedure and at six months by means of quantitative coronary angiography. ASPARAGUS was a randomised study to assess the efficacy of the PercuSurge GuardWire system in acute myocardial infarction. Patients were divided into two groups; protection group (group P, n=53) and control group (group C, n=65). Matched 15 mm segments were selected for quantitative coronary angiographies using anatomical landmarks post-procedure and at six months. There were 118 matched QCA analysis (Group P 53, Group C 65). Baseline characteristics were similar between groups. The mean minimal lumen diameter (MLD) post procedure was 1.94±0.57 mm in group P and 1.92±0.57 mm in group C. The MLD at six months was 1.98±0.54 mm in group P and 1.92±0.54 mm in group C. There was virtually no late loss in both group (P: -0.04±0.38 mm, C: 0.00±0.38 mm, p=0.561). Conclusions: The inflation of the low-pressure PercuSurge balloon in native coronary arteries was not associated with angiographic vascular response during the 6-month follow-up. This finding may suggest the safety of using similar technology such as the low-pressure balloon system in human native coronary arteries.