Multicenter Evaluation of Fixed‐Wire PTCA Catheters with Modified Distal Tips: Initial and 2‐Month Follow‐Up Results

Abstract

Lesions in the distal portion of coronary arteries are technological challenges with currently available percutaneous transluminal coronary angioplasty (PTCA) equipment. A study was performed at multiple centers to determine if new “fixed‐wire” devices with a modified distal tip (a 2‐cm flexible tip and 1‐cm standard tip) would be useful in these situations. Three hundred twenty‐three patients were included in the study, 75% male, mean age 63 ± 11 years. Four hundred ninety‐three lesions were attempted; the overall success rate was 85%. Forty‐six (14.2%) clinical complications occurred including: 5 deaths (1.1%); 2 nonfatal myocardial infarctions (0.6%); and 6 emergency coronary artery bypass grafting procedures (2.6%). A device malfunction was noted in 32 patients (9.9%), and included: 8 balloon ruptures or perforations (2.0%); 6 bent or damaged tips (1.9%); and 4 shaft/manifold leaks (1.2%). Two‐month follow‐up assessment for restenosis was done in 352 of 371 (95%) patients and at that time 89% were asymptomatic, had a negative functional test, or patent PTCA site by angiography. The new fixed‐wire PTCA catheters with 1‐ and 2‐cm flexible tips hold promise for dilating lesions in distal locations with an acceptable rate of complications. Additional investigation is needed to determine their role in the treatment of coronary artery disease with PTCA.