THE FALCON(TM) ECCENTRIC CORONARY BALLOON ANGIOPLASTY CATHETER - A RANDOMIZED SAFETY AND EFFICACY STUDY

Percutaneous coronary angioplasty (PTCA) is usually performed using co ncentric shaped balloon catheters with the guidewire passing through t he center of the shaft. The Falcon(TM) balloon catheter features a gui de wire lumen on the outside of the balloon so that an eccentric ballo on catheter profile is obtained concentrating the dilating force on th e wire supported side, allowing lower inflation pressures and potentia lly causing less vessel injury. The aim of this study was to evaluate the safety and efficacy of this new balloon catheter in patients with stable and unstable angina. In 95 prospectively randomized patients, 5 7 lesions were dilated with a concentric balloon and 51 with the eccen tric balloon. Technical success in the two groups was similar (73.3% v s. 74.5% control vs. Falcon respectively). Procedural success was 96.5 % vs. 96.1% in the control and Falcon groups respectively. The mean in crease in minimum luminal diameter (MLD) was 1.01 +/- 0.41 mm in the c ontrol vs 0.85 +/- 0.45 mm in Falcon (p = 0.053). There was an increas e in type A dissections in the Falcon group 18 (36.75%) vs. 10 (19.23% ) in the control group (p = 0.07) with no difference in stent implanta tion, myocardial infarction, CABG or death between the two groups. All patients with a technically successful PTCA were followed-up. Sevente en (43.6%) in the control and 11 (32.4%) in the Falcon had repeat coro nary angiography (p = 0.38), 12 (30.8%) vs. 7 (20.6%) had repeat PTCA (p = 0.37) and time to PTCA was 116 +/- 70 days vs. 154 +/- 103 days r espectively (p = 0.36). The Falcon performed technically as well as th e concentric balloons. Despite a smaller MLD and increase in Type A di ssections there was no associated increase in complications or reinter vention for restenosis. Further investigation is required to evaluate the role of this mechanism of dilatation in restenosis.