Angioplasty and stenting should not be restricted to clinical trials.

Abstract

Excellence in clinical practice necessitates the application of evidence-based medical decision-making in determining patient management. The evidence comes from many sources, including prospective randomized trials and prospective cohort studies with rigorous outcomes assessment. Prospective multicenter, randomized studies may provide a sense of generalization of results to the community at large but lack specificity for individual patients. Alternatively, individual operator results are highly specific in determining efficacy of carotid stenting. Arguments against restricting the performance of carotid stenting to the setting of a clinical trial center on the issues of individual operator expertise and the narrow eligibility criteria used in randomized trials. Even if widespread application of carotid stenting were to await the completion of prospective randomized trials, “level 1 scientific evidence” would be available for only a small subset of patients with carotid stenoses. The hypocrisy of vascular surgeons who advocate the restriction of carotid stenting lies first in the decades of carotid endarterectomy (CEA) procedures before availability of “level 1 evidence” of its benefit, and second and more importantly, the widespread application of CEA to large subsets of patients (eg, elderly and females) never satisfactorily studied in prospective randomized trials. An argument is often forwarded that allowing patients and physicians to choose a preferred therapy unduly impedes recruitment into ongoing randomized trials. Examination of the contemporary development of cardiovascular and cerebrovascular therapies does not support such arguments. The NIH-sponsored Coronary Artery Surgery Study (CASS),1 Bypass versus Angioplasty Revascularization Investigation (BARI),2 North American …