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?
To investigate the consequences of inflating low-pressure balloon occlusion devices in native coronary arteries.



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).



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.
Kyono
Hiroyuki
H
Division of Cardiology, Teikyo University Hospital, Tokyo, Japan.
Kozuma
Ken
K
Muramatsu
Toshiya
T
Suwa
Satoshi
S
Fujita
Naoya
N
Koyama
Shiho
S
Saito
Masahiko
M
Isshiki
Takaaki
T
D021721:Balloon Occlusion / Q000009:adverse effects* / Q000295:instrumentation*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000209:etiology*; D023921:Coronary Stenosis / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors