THE COMPARISON OF BALLOON VERSUS ROTATIONAL ANGIOPLASTY (COBRA) STUDYPROTOCOL - A PROSPECTIVE RANDOMIZED STUDY

The Comparison of Balloon versus Rotational Angioplasty (COBRA) study is a prospective, randomized study to compare short-and long-term effe cts of PTCA and high speed PTCRA (or rotablation) in patients with com plex coronary stenoses. Patients with angiographically defined complex coronary stenoses (> 70% diameter reduction) are included in the stud y. The trial has recruited 501 patients who will have detailed follow- up for 6 months. The primary end points are: (1) procedural success, d efined as angiographically proven residual stenoses < 50% and stenosis reduction of greater than or equal to 20% in absence of new myocardia l infarction, emergency CABG, or death; (2) 6-month restenosis in the treated segment; and (3) major cardiac events during the follow-up per iod. Additionally, improved exercise tolerance will be scored. The fin al results of the study are expected by late 1997.