Regarding "Statement regarding carotid angioplasty and stenting".

Abstract

The recently published “Point of View” (1997;24:900) from the Joint Council of The Society for Vascular Surgery (SVS) and the International Society for Cardiovascular Surgery, North American Chapter (ISCVS-NA), was stated succinctly and is consistent with the objectives of the executive committee of the Carotid Revascularization Endarterectomy versus Stent Trial (CREST). The membership of the Joint Council meritoriously emphasized that the safety and efficacy of carotid angioplasty and stenting must be demonstrated before proceeding with a randomized clinical trial. If the trial is premature and “clinical equipoise”1Freedman B Equipoise and the ethics of clinical research.N Engl J Med. 1987; 317: 141-145Crossref PubMed Scopus (1550) Google Scholar does not exist, many clinicians will consider participation unethical. Conversely, if a trial is delayed until such time as the safety and efficacy are unequivocally proven, the proponents of the new interventional methods will recommend its use without testing its efficacy against the gold standard, carotid endarterectomy. This issue of “clinical equipoise” and vascular surgeons' participation in prospective randomized clinical trials has been reviewed previously.2Barnes RW Understanding investigative clinical trials.J Vasc Surg. 1989; 9: 609-618Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar, 3Hobson II, RW Randomized clinical trials: what can we expect?.J Vasc Surg. 1991; 13 (24/41/80966): 539-543Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar The ethical uncertainty about participating in a randomized clinical trial has been addressed by Freedman1Freedman B Equipoise and the ethics of clinical research.N Engl J Med. 1987; 317: 141-145Crossref PubMed Scopus (1550) Google Scholar in his discussion about “clinical equipoise.” He has chosen to define the term as a lack of consensus between expert clinical groups on the merits of one treatment versus another. It may therefore become clinically ethical to consider participation in a protocol, even though an individual clinician's body of knowledge suggests a preference for one of the two treatments. Clinicians must recognize that qualified and competent colleagues in other specialties would favor an alternate approach. In addition, they must be convinced that the design of the trial will in fact answer a question and address the state of equipoise, so that the results of the clinical trial will benefit their patients. Although “clinical equipoise” may be weaker than “theoretic equipoise,” which extracts from the investigator the position of nonparticipation in one treatment method or another is favored, the ethics of “clinical equipoise” seem clear and should be considered by members of the SVS and the ISCVS-NA as they assess their participation in randomized clinical trials designed to evaluate newer interventions as compared with the more standard operative procedures. During recent months, many of you have been asked to consider participation in CREST. In the summary statement about this clinical trial, an important credentialing phase for interventionalists who do not currently practice carotid angioplasty and stenting is described. Each clinical team, which would include an interventionalist, a neurologist, and a vascular surgeon or neurosurgeon, will participate in the selection of 30 symptomatic patients who prefer management by angioplasty and stenting, while continuing to perform carotid endarterectomy for the significant majority of patients at their center. After these results are reviewed by an independent data safety and monitoring board, randomization of patients may proceed only if the targeted morbidity and mortality rates are at or below the defined upper limits of acceptability. Recognizing that as many as 50 to 60 centers will be involved in this effort, the credentialing phase simultaneously should reassure experienced interventionalists that the newer centers can accomplish the procedure with acceptably low complication rates and should reassure the surgeons that safety and efficacy do, in fact, exist when rigorous clinical methods are applied to the assessment of patients. The executive committee of CREST has devoted the last 18 months to a series of clinical meetings sponsored by a private vascular foundation (Vascular Foundation of San Diego), as well as other industrial support. We are committed to submission of the grant to the National Institutes of Health no later than February 1, 1997, and recognize that funding will not be achieved before 1998. However, it is our opinion that this approach seems both ethical and clinically responsible, while also being consistent with the recent Joint Council “Point of View.”