The Falcon(TM) eccentric coronary balloon angioplasty catheter : A randomized safety and efficacy study

Percutaneous coronary angioplasty (PTCA) is usually performed using concentric shaped balloon catheters with the guidewire passing through the center of the shaft. The Falcon(TM) balloon catheter features a guide wire lumen on the outside of the balloon so that an eccentric balloon catheter profile is obtained concentrating the dilating force on the wire supported side, allowing lower inflation pressures and potentially 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, 57 lesions were dilated with a concentric balloon and 51 with the eccentric balloon. Technical success in the two groups was similar (73.3% vs. 74.5% control vs. Falcon respectively). Procedural success was 96.5% vs. 96.1% in the control and Falcon groups respectively. The mean increase in minimum luminal diameter (MLD) was 1.01 +/- 0.41 mm in the control vs 0.85 +/- 0.45 mm in Falcon (p = 0.053). There was an increase 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 implantation, myocardial infarction, CABG or death between the two groups. All patients with a technically successful PTCA were followed-up. Seventeen (43.6%) in the control and 11 (32.4%) in the Falcon had repeat coronary 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 respectively (p = 0.36). The Falcon performed technically as well as the concentric balloons. Despite a smaller MLD and increase in Type A dissections there was no associated increase in complications or reintervention for restenosis. Further investigation is required to evaluate the role of this mechanism of dilatation in restenosis.