Abstract
The purpose of this study was to evaluate the safety and efficacy of the new 8 Fr guide catheter‐compatible Flexicut directional atherectomy device and to compare it with the conventional Atherocath GTO catheter. The 6 Fr Flexicut catheter has a larger cutting window and a titanium nitride‐coated cutter to effect more tissue removal as well as treat mildly calcified lesions. A group of 143 lesions in 117 consecutive patients treated with the Flexicut catheter in four centers were compared with a control group of 277 lesions in 212 consecutive patients treated with the GTO device. Postatherectomy luminal diameters were larger (2.92 ± 0.79 vs. 2.52 ± 0.64 mm; P < 0.0001), with more luminal gain (relative gain: 0.58 ± 0.24 vs. 0.48 ± 0.25; P = 0.0007) using fewer directional coronary atherectomy (DCA) cuts (12 ± 7 vs. 16 ± 9; P = 0.0001) in the Flexicut group. A residual diameter stenosis < 20% immediately after DCA was obtained in 77% of the lesions in the Flexicut group vs. 45% in the GTO group (P < 0.0001). Histology in the former group revealed large calcium speckles in the retrieved specimens. In the Flexicut group, there was a lower incidence of access site complications and damage to the coronary ostium (2.5% vs. 7.5%; P = 0.08). The new Flexicut catheter is more effective than the conventional GTO catheter with a trend for reduced guiding catheter‐related complications. Cathet Cardiovasc Intervent 2002;56:452–459. © 2002 Wiley‐Liss, Inc.