Dutch researchers have found that adding revascularization procedures to optimized medical therapy (OMT) provides no additional benefit for patients with carotid stenosis during the first two years of treatment, according to findings published in the May issue of The Lancet Neurology.
The multicenter randomized trial, led by Dr. Simone J.A. Donners from UMC Utrecht in the Netherlands, investigated whether patients with carotid stenosis who are at low or intermediate risk for stroke would benefit from revascularization procedures in addition to medication-based treatment.
Study Design and Patient Population
The research team enrolled patients aged 18 years and older with either asymptomatic or symptomatic carotid stenosis of 50 percent or greater. All participants had a five-year predicted risk for ipsilateral stroke of less than 20 percent, placing them in low to intermediate risk categories.
A total of 429 patients were randomly assigned to one of two treatment groups: 215 patients received optimized medical therapy alone, while 214 received OMT plus revascularization. The study design allowed for direct comparison of outcomes between these two approaches to carotid stenosis management.
Key Findings
After two years of follow-up, researchers found no significant difference between the treatment groups. The primary hierarchical outcome composite included:
- Periprocedural death, fatal stroke, or fatal myocardial infarction
- Nonfatal stroke
- Nonfatal myocardial infarction
- New silent cerebral infarction on imaging
Analysis showed 11.4 percent wins for the OMT alone group versus 11.3 percent wins for the OMT plus revascularization group, with 77.3 percent ties between groups. These results indicate no clear advantage for either treatment approach during the two-year study period.
Clinical Implications
These findings have important implications for clinical practice, suggesting that many patients with carotid stenosis may be safely managed with optimized medical therapy alone, at least in the short term. This could potentially spare patients from unnecessary invasive procedures and their associated risks.
"We cannot rule out the possibility that revascularization will provide a small to moderate benefit in our patients beyond two years. We are, therefore, continuing follow-up to five years after randomization," the authors noted in their publication.
Current Treatment Landscape
Carotid stenosis, the narrowing of arteries that supply blood to the brain, is a significant risk factor for stroke. Traditional management has often included revascularization procedures such as carotid endarterectomy or stenting for patients with significant stenosis. However, improvements in medical therapy have raised questions about whether all patients require these invasive interventions.
The current study adds valuable evidence to this ongoing discussion, particularly for patients with lower predicted stroke risk. It suggests a more conservative approach may be appropriate for these individuals, at least initially.
Longer-Term Questions Remain
While the two-year results show no benefit from adding revascularization, the researchers emphasized that longer-term outcomes remain unknown. The five-year follow-up data, when available, will provide more definitive guidance on whether certain patients might benefit from revascularization over a more extended period.
Several of the study authors disclosed relationships with biotechnology companies, publishing entities, and medico-legal industries, though these connections were properly managed according to standard scientific protocols.
