A randomized study of the safety and efficacy of reused angioplasty balloon catheters.

ABSTRACT

BACKGROUND: To lower costs, many centers around the world utilize previously used, resterilized balloon catheters to perform coronary angioplasty There are no controlled trials regarding their safety and efficacy. METHODS AND RESULTS: We performed the first randomized, double-blind, controlled, single-center clinical trial comparing the safety (clinical success) and efficacy (angiographic success) of reused versus new coronary angioplasty balloon catheters. A total of 377 procedures were included, 178 in the reused catheter arm and 199 in the new catheter arm. There were no significant differences in clinical or lesion characteristics among the two arms. The incidence of first balloon failure in the reused catheter arm was similar to that of the new catheter arm (12 cases [7%] v. 10 cases [5%], respectively). The angiographic success rate was also similar-176 cases (98.9%) in the reused catheter arm and 196 cases (98.5%) in the new catheter arm. The number of balloon catheters used per lesion, amount of contrast, and procedural and fluoroscopy time were similar in the two arms. At 30 days, the incidence of major adverse cardiac events was similar in both arms, 8 cases (4.5%) in the reused catheter arm and 10 cases (5%) in the new catheter arm. The incidence of fever was also similar. CONCLUSIONS: When performing coronary angioplasty, reused catheters are as effective (similar angiographic success) and safe (similar clinical success) as new catheters.