The Comparison of Balloon versus Rotational Angioplasty (COBRA) study protocol: A prospective randomized study

Abstract

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