ABSTRACT
BACKGROUND: To reduce procedural cost, cardiac centers increasingly use resterilized balloon catheters for percutaneous coronary interventions. Data addressing the procedural and mid-term outcome in a prospective randomized trial comparing new and resterilized balloons are not available. METHODS AND RESULTS: Percutaneous coronary interventions were performed at random in 238 consecutive patients with either new or 1-3 times reused balloon catheters. Crossing of the stenosis decreased from 96% with new balloon catheters to 93.2% (p=0.46), with 1 time reused balloon catheters to 81.8% (p=0.0056) with 2 times reused balloon catheters and to 80.8% (p=0.01) with 3 times reused balloon catheters. In all primary failures using resterilized balloon catheters, new ones of the same nominal diameter were successful. The 4.1 +/- 1.9 month angiographic follow-up rates were 96/124 (77.4%) for new balloon catheter, 35/44 (79.5%) for 1 time reused balloon catheters, 33/44 (75.0%) for 2 times reused balloon catheters, and 21/26 (80.8%) for 3 times reused balloon catheters (p for all >0.05). The late losses for new versus reused balloon catheters were 0.48 +/- 0.75 mm versus 0.73 +/- 0.79 mm (p=0.03). The percent stenosis was higher in reused versus new balloon catheters (51.9 +/- 23.2% v. 42.3 +/- 22.3%; p=0.0042) as was the restenosis rate [39/89 (43.8%] v. 31/96 (32.3%), p=0.13]. There was one death in reused balloon catheter category but no event of myocardial infarction. Rates of target lesion revascularizations were similar in stent recipients and more frequent after stand-alone balloon angioplasty with reused versus new balloon catheters [15/55 (27.3%) versus [5/59 (8.5%), p=0.01]. CONCLUSIONS: The use of two or three times resterilized balloon catheters of the type tested does not seem to be justified in stand-alone balloon angioplasty of de novo coronary stenoses and should be limited to stent procedures until data is available for other indications.