Angiographic analysis of immediate and long-term results of PTCR vs. PTCA in complex lesions (COBRA study)

We conducted a prospective, randomized trial to compare immediate and long- term effects of percutaneous transluminal coronary angioplasty (PTCA) and h igh-frequency rotational atherectomy (PTCR) in patients with angiographical ly predefined complex coronary artery lesions (AHA type B2 and C). The rela tion of lesion characteristics to procedural results is reported in this an giographic analysis. Patients were randomly assigned to balloon angioplasty (n = 250 patients) or rotational atherectomy (n = 252 patients). Quantitat ive coronary angiography could be performed in 447 patients to evaluate imm ediate results and in 293 patients with a 6-month angiographic follow-up. P rocedural success was comparable in the PTCR and in the PTCA group (80% vs. 76%, P = 0.260). The need for stent implantation due to a residual stenosi s > 50% or a bail-out situation was significantly higher in the PTCA group (9.7% vs. 2.0%, P = 0.0011. In both treatment groups, diameter stenosis was effectively reduced and MLD increased. The acute gain did not differ betwe en the two groups. At 8-month control, the restenosis rate was comparable i n the PTCR and in the PTCA group (37% vs. 35%, P = 0.658), whereas diameter stenosis was significantly more severe in the PTCR group than in the PTCA group (52% vs. 46%, P = 0.039) and, correspondingly, the MLD was significan tly smaller in the PTCR group 11.29 mm vs. 1.44 mm, P = 0.031). Late loss w as about the same in both groups, however, net gain and net gain index were significantly higher in the PTCA group (0.82 mm vs. 0.64 mm, P = 0.008; ac id 31% vs. 24%, P = 0.009). Analysis of procedural results for various lesi on characteristics revealed no significant difference between treatment gro ups. In this randomized trial, complex coronary artery lesions were treated with comparable results for angiographic and procedural success and the re stenosis rate by both, PTCA and PTCR. Late loss, however, was significantly higher and net gain significantly smaller after PTCR. Stents, although inf requently used, had a relevant impact on immediate PTCA results but not on late results. (C) 2001 Wiley-Liss, Inc.