Original Title: Randomized Trial of stent versus Surgery for Asymptomatic Carotid Stenosis. Kenneth Rosenfield. N Engl J Med. 2016 Feb 17. [Epub ahead of print]
Courtesy of Dr. Carlos Fava.
Stokes are one of the main causes of death and disability in the world and up to 20% of strokes can be explained by carotid stenosis. Even though it is true that the modern medical treatment has remarkably reduced its incidence, in case of asymptomatic lesions, the best course of treatment is still under debate.
The aim of this study was to compare the evolution of carotid stenting with embolic protection vs. endarterectomy in asymptomatic patients (no neurological events 6 months prior procedure) with severe stenosis in the internal carotid artery (70%-99%) and at low surgical risk.
Patients were randomized 3:1. 1089 received PCI and 364 endarterectomy.
Primary end point was the combination of death, stroke and MI at 30 days or ipsilateral stroke at one year.
Baseline characteristics were similar in the two groups: mean age was 68, more than 50% were men and a third part were diabetic.
Primary end point composite outcomes were not inferior with stenting, compared to endarterectomy (3.8% vs. 3.4%; p= 0.01 for non-inferiority).
toke or death at 30 days rate was 2.9% vs. 1.7% respectively (p=0.33).
Freedom from ipsilateral stroke for stenting and endarterectomy from 30 days to 5 years was 97.8% vs 97.3% (p=0.51) respectively, and survival rate was 87.1% vs. 89.4% (p=0.21) respectively.
Conclusions
Carotid stenting resulted non inferior to endarterectomy as regards the primary end point composite at one year in asymptomatic patients with severe carotid stenosis and regular surgical risk. The five year outcomes showed no differences in stroke and survival rates.
Editorial Comment
Non-inferiority of stenting in asymptomatic patients is auspicious, because it benefits patients with fast healing and avoids the complications associated to surgery.
To obtain good results, we need well trained operators, and staff well trained in post PCI management to optimize outcomes.
Courtesy of Dr. Carlos Fava.
Interventional Cardiologist
Favaloro Foundation, Buenos Aires.