Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial
| Autor: | A.R. Naylor, Amman Bolia, R. Abbott, N. Lennard, Andrew Lloyd, J. L. Smith, I. F. Pye, N. J. M. London, P. R. F. Bell |
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| Rok vydání: | 1998 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Carotid endarterectomy law.invention Postoperative Complications Randomized controlled trial law Recurrence medicine.artery Angioplasty medicine Data monitoring committee Humans Carotid Stenosis Prospective Studies Stroke Endarterectomy Aged Endarterectomy Carotid business.industry Middle Aged medicine.disease Surgery Cerebral Angiography Clinical trial Survival Rate Cerebrovascular Disorders Treatment Outcome Female Stents Internal carotid artery Cardiology and Cardiovascular Medicine business Angioplasty Balloon Carotid Artery Internal |
| Zdroj: | Journal of vascular surgery. 28(2) |
| ISSN: | 0741-5214 |
| Popis: | Background: Carotid angioplasty (CA) has been suggested to be a safer and more costeffective alternative to carotid endarterectomy (CEA) in the management of symptomatic severe internal carotid artery (ICA) disease. Methods: The study was conducted as a prospective consecutive randomised 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 with focal carotid territory symptoms and severe ICA stenosis (> 70%) who were randomized to either CEA or CA. However, only 17 had received their 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. Results: All 10 CEA operations proceeded without complication, but 5 of the 7 patients who underwent CA had a stroke ( P =0.0034), 3 of which were disabling at 30 days. Conclusions: After referral, the Data Monitoring Committee subsequently concluded that the trial was suspended. The investigators and the Ethics Committee subsequently concluded that the trial could not be restarted - even in an amended format - primarily because of problems with informed consent. We review many of the ethical dilemmas encountered in the performance of this study. If future trials do suggest a selected role for CA, it is essential that both the inclusion and the exclusion criteria are fully documented. |
| Databáze: | OpenAIRE |
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