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Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial
A R Naylor1, A Bolia, R J Abbott
1Department of Vascular Surgery, Leicester Royal Infirmary, United Kingdom.
Insights
Carotid angioplasty (CA) showed a significantly higher stroke risk compared to carotid endarterectomy (CEA) in patients with severe internal carotid artery disease. The trial was halted due to safety concerns and ethical issues.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Clinical Trials
Background:
- Carotid angioplasty (CA) is proposed as a safer, cost-effective alternative to carotid endarterectomy (CEA) for symptomatic severe internal carotid artery (ICA) disease.
- This study aimed to compare the safety and efficacy of CA versus CEA.
Purpose of the Study:
- To evaluate the outcomes of carotid angioplasty (CA) compared to carotid endarterectomy (CEA) in patients with symptomatic severe internal carotid artery stenosis.
- To assess the incidence of death or stroke within 30 days post-procedure.
Main Methods:
- A prospective, randomized trial comparing CEA with CA in patients with severe ICA stenosis (>70%) and symptoms.
- 17 patients received allocated treatment before trial suspension: 10 underwent CEA, 7 underwent CA.
- Outcomes included death or disabling/nondisabling stroke within 30 days.
Main Results:
- All 10 carotid endarterectomy (CEA) procedures were completed without complications.
- Five of seven patients (71%) undergoing carotid angioplasty (CA) experienced a stroke, with three being disabling (P=.0034).
Conclusions:
- The trial was suspended due to a high stroke rate in the CA group and informed consent issues.
- Ethical dilemmas encountered highlight the need for rigorous protocol adherence in future trials.
- Careful documentation of inclusion/exclusion criteria is crucial for any future studies on carotid angioplasty.
Background:
Carotid angioplasty (CA) has been suggested to be a safer and more cost-effective 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 randomized 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=.0034), 3 of which were disabling at 30 days.
Conclusions:
After referral, the Data Monitoring Committee invoked the stopping rule and 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.
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