RANDOMIZED STUDY OF CAROTID ANGIOPLASTY AND STENTING VERSUS CAROTID ENDARTERECTOMY - A STOPPED TRIAL

Background Carotid angioplasty (CA) has been suggested to be a safer a nd more cost-effective alternative to carotid endarterectomy (CEA) in the management of symptomatic severe internal carotid artery (ICA) dis ease. Methods: The study was conducted as a prospective consecutive ra ndomized trial of CEA versus CA for symptomatic severe ICA disease in a university teaching hospital. All patients were assessed before and after surgery by a neurologist. The study consisted of 23 patients wit h focal carotid territory symptoms and severe ICA stenosis (> 70%) who were randomized to either CEA or CA. However, only 17 had received th eir allocated treatment before trial suspension. CEA with patching or CA with stenting were used as interventions. The main outcome measures were death or disabling or nondisabling stroke within 30 days. Result s: All 10 CEA operations proceeded without complication, but 5 of the 7 patients who underwent CA had a stroke (P =.0034), 3 of which were d isabling at 30 days. Conclusions: After referral, the Data Monitoring Committee invoked the stopping rule and the trial was suspended. The i nvestigators and the Ethics Committee subsequently concluded that the trial could not be restarted-even in an amended format-primarily becau se of problems with informed consent. We review many of the ethical di lemmas encountered in the performance of this study. Lf future trials do suggest a selected role for CA, it is essential that both the inclu sion and the exclusion criteria are fully documented.