A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA study)

Aims Rotablation is a widely used technique for the treatment of complex co ronary artery lesions but is so far only poorly supported by controlled stu dies. The Comparison of Balloon-Angioplasty versus Rotational Atherectomy s tudy (COBRA) is a multicentre, prospective, randomized trial to compare sho rt- and long-term effects of percutaneous transluminal coronary angioplasty (PTCA) and rotablation in patients with angiographically pre-defined compl ex coronary artery lesions. Methods and Results At seven clinical sites 502 patients with pre-defined c omplex coronary artery lesions were assigned to either PTCA (n=250) or rota blation (n=252). Primary end-points were procedural success, 6-month resten osis rates in the treated segments, and major cardiac events during follow- up. Procedural success was achieved in 78% (PTCA), and 85% (rotablation) (P =0.038) of cases. Crossover from PTCA to rotablation was 4% and 10% vice ve rsa (P=0.019). There was no difference between PTCA and rotablation with re spect to procedure-related complications such as Q wave infarctions (2.4% e ach), emergency bypass surgery(1.2% versus 2.4%), and death (1.6% versus 0. 4%). However, more stents were required after PTCA (14.9% versus 6.4%, P<0. 002), predominantely for bailout or unsatisfactory results. Including bail out stents as an end-point, the procedural success rates were 73% for angio plasty and 84% for rotablation (P=0.006). At 6 months, symptomatic outcome, target vessel reinterventions and restenosis rates (PTCA 51% versus rotabl ation 49%, P=0.33) were not different. Conclusion Complex coronary artery lesions can be treated with a high level of success and low complication rates either by PTCA with adjunctive stent ing or rotablation. The long-term clinical and angiographic outcome is comp arable. (Eur Heart J 2000; 21: 1759-1766, doi 10,1053/euhj, 2000.2242) (C) 2000 The European Society of Cardiology.