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European Heart Journal 2000 21(21):1759-1766; doi:10.1053/euhj.2000.2242
Copyright © 2000 by the European Society of Cardiology.
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A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA study)

T Dilla, U Dietzb, C.W Hamma,f1, R Küchlerc, H.-J Rupprechtb, M Hauded, J Cyrane, C Özbekf, K.-H Kuckc, J Bergerg and R Erbeld

a Department of Cardiology, University Hospital Eppendorf, Hamburg
b Department of Cardiology, University Hospital, Mainz
c Department of Cardiology, St Georg Hospital, Hamburg
d Department of Cardiology, University Hospital, Essen
e City Hospital, Heilbronn
f Department of Cardiology, University Hospital, Homburg
g Institute of Mathematics and Computer Science in Medicine, University Hospital Eppendorf, Hamburg

Received April 18, 2000; accepted April 19, 2000

Abstract

Aims Rotablation is a widely used technique for the treatment of complex coronary artery lesions but is so far only poorly supported by controlled studies. The Comparison of Balloon-Angioplasty versus Rotational Atherectomy study (COBRA) is a multicentre, prospective, randomized trial to compare short- and long-term effects of percutaneous transluminal coronary angioplasty (PTCA) and rotablation in patients with angiographically pre-defined complex coronary artery lesions.

Methods and Results At seven clinical sites 502 patients with pre-defined complex coronary artery lesions were assigned to either PTCA (n=250) or rotablation (n=252). Primary end-points were procedural success, 6-month restenosis 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 versa (P=0·019). There was no difference between PTCA and rotablation with respect to procedure-related complications such as Q wave infarctions (2·4% each), 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 angioplasty and 84% for rotablation (P=0·006). At 6 months, symptomatic outcome, target vessel reinterventions and restenosis rates (PTCA 51% versus rotablation 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 stenting or rotablation. The long-term clinical and angiographic outcome is comparable.

Key Words: Coronary disease, balloon angioplasty, rotational atherectomy, stents, COBRA study

f1 Correspondence: Professor Dr Christian W. Hamm, Kerckhoff Klinik, Benekestrasse 2–8, 61231 Bad Nauheim, Germany.

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